EFSC IRB Manual

Institutional Review Board (IRB) Manual

Updated: April 8, 2015

Table of Contents

Eastern Florida State College IRB Mission Statement ...... 2 Acceptable Research Requests ...... 2 EFSC - IRB Checklist for Outside Investigators ...... 3 Submission Instructions IRB Review ...... 4 Using the Online Research Proposal Submission System ...... 6 Human Subjects Research Application Form for Full IRB and Expedited IRB Review ...... 7 Sample Assent Form for Minors ...... 19 EFSC Consent form Template ...... 20 Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure1 ...... 23 Guidance on the Use of Expedited Review Procedures ...... 26 Federal Regulations & Institutional Responsibilities...... 28 Investigator Responsibilities & Informed Consent ...... 36 Human Protections Administration ...... 43 IRB Responsibilities ...... 46 Criteria for IRB approval of research: ...... 48

Eastern Florida State College IRB Mission Statement The mission of the Eastern Florida State College Institutional Review Board (IRB) is to protect the safety, welfare, and confidentiality of human subject participants, researchers, and the Institution. The merit of the research is not within the scope of the duties of this board. The Eastern Florida State College IRB will act in accordance with guidelines provided by federal regulations.

Acceptable Research Requests

In terms of human subjects, the types of research requests and/or methods that Eastern Florida State College Institutional Review Board (EFSC IRB) is willing to accept would be approved assessments, questionnaires, interviews, and surveys. When conducting research as a requirement for a degree or for another institution, researchers must receive clearance from their home institution and from the EFSC IRB (see checklist). Currently the EFSC IRB will not review research involving animals or that would require FDA oversight. For information on conducting research with animals, click here.

The EFSC IRB will permit faculty, staff, and students as human research subjects. All subjects must give informed consent. At Eastern Florida State College, the use of human subjects in research activities is governed by the Office for Human Research Protection (CFR 45 Part 46).

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EFSC - IRB Checklist for Outside Investigators

☐ Obtain IRB approval from primary research institution ☐ Download and prepare EFSC IRB application ☐ Prepare project description which includes:

1. Brief description the proposed project and explain the purpose(s) of the research. 2. Describe how human subject information will be collected (experiment, observation, telephone survey, questionnaire, etc…). 3. Include a copy of any instrument(s) that will be used and describe the procedures that will be followed. If the information will be collected verbally, provide a list of all questions that will be used. 4. Are there any foreseeable risks or discomforts to the subjects? ("Risk" means exposure to the possibility of physical or psychological harm). If so, describe the nature and magnitude of these risks. 5. What potential benefits justify the risks or discomfort, and what steps have been taken to minimize the risks or discomfort? 6. What is the anticipated number of subjects who will be involved in the research?

7. What is the expected duration of an individual subject's participation? 8. Describe the extent to which confidentiality or anonymity of subjects will be maintained and how, both during the data collection and after the research is completed. What, if any, records may link the subject's identity to the research? 9. State specifically what information will be provided to the subject about the research. (Provide copies of any and all written materials that will be provided to subjects.) 10. Will the research involve any deception of subjects? If so, describe and justify the deception.

☐ Submit all documents via the online research proposal submission system

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Submission Instructions IRB Review

Before the Institutional Review Board (IRB) will approve an application the investigator, all co- investigators, and all research personnel must have completed training in the use of human participants. Certificate of completion of appropriate training must be submitted along with the research application.

Acceptable training certifications for research with human subjects include: • Protecting Human Research Participants through the National Institutes of Health (NIH) • Human Subjects Protection for Biomedical and/or Social/Behavioral Research Investigators through the Collaborative Institutional Training Initiative (CITI) • Other certifications will be considered

List of documents needed to submit a research application to the EFSC IRB • IRB Research Application • Description of including at minimum: o Rational and purpose of the study o Description of the participants o Summary of the materials/instruments required, design and procedure(s) • Copies of all assessments, questionnaires, survey, and interview protocols expected to be used in the research • Informed consent forms used in the research • Any documents that will be used for recruitment purposes • External IRB approval if research has been reviewed already

Instructions:

Please read and follow these directions carefully. Omission of required components of the application will delay review of your application pending receipt of all materials.

1. All information must be typed. Handwritten proposals are not accepted by the IRB.

2. If you are currently receiving or applying for funding for this study from an external sponsor (e.g., NIH, NSF, USDA, etc.), include copies of your proposal to the funding agency. The IRB cannot review your application without concurrently reviewing the funding proposal. If your research is part of your dissertation from another institution, you MUST have IRB approval from your primary institution first.

3. All documents and research instruments used in this study must be included: such as consent forms, surveys, questionnaires, deception debriefing scripts, recruitment ads/flyers/emails, etc. Omission of these items prevents review of your application.

4. You also must include any required components of Informed Consent Documents when constructing a consent form. Providing the IRB with an inadequately constructed consent

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form delays the review process, and is the most common reason for delayed approvals. (Please see a sample consent form.)

5. Submit the IRB application and the following documents in a compressed format or zipped file via the online research proposal submission system:

a) One (1) copy of the complete funding proposal (minus appendices; you may block out salary figures) and funding review comments that pertain to the use of human participants in your study (if applicable). b) One (1) copy of IRB approval from your primary institution. c) One (1) copy of the Initial Request, consent form(s), recruitment materials, and debriefing scripts. The Initial Approval Request must contain original signatures. d) One (1) copy of all other instruments: surveys, questionnaires, focus group guides, etc. e) Copy of all applicable human research ethical training certificates (NIH, CITI, etc.)

If full committee review is required: Applications must be received at least three weeks prior to the next scheduled IRB meeting. There are no exceptions to the deadline. Turn-around can therefore be between three weeks and six weeks.

If your study qualifies for expedited review: Please allow two to three weeks for review and notification. (If EFSC is closed for holidays, please allow additional time equivalent to the time the college is closed.)

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Using the Online Research Proposal Submission System

When you are ready to submit a research proposal download the required forms and follow instructions below complete your submission.

Research requests must be submitted to the Eastern Florida State College Institutional Review Board through the online research application submission system. Prior to submitting a research application, investigators must complete the downloadable research application and provide a description of research. The research application and additional information can be found on the EFSC IRB web page: http://www.easternflorida.edu/administration- departments/irb/

Once you are ready to submit your application proceed to the online application submission system.

Directions for submitting proposals online:

Research requests must be submitted to the Eastern Florida State College Institutional Review Board through the online research application submission system. Please review the IRB Meeting and Submission Dates page to be sure you submit your protocol on time for a full board review. Prior to submitting a research application, investigators must: • Complete the downloadable Human Subjects Research Application • Provide a description of research which includes: o The rationale and purpose of the study o Description of the participants o Summary of the materials/instruments required, design and procedure(s) o Copies of any assessments, questionnaires, survey, and/or interview protocols expected to be implemented • Obtain IRB approval from primary research institution (if applicable) • Submit the proposal through the EFSC IRB online research proposal submission system

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Human Subjects Research Application Form for Full IRB and Expedited IRB Review

1. Project Title and Identification As Principal Investigator of this study, I assure the IRB that the following statements are true: . The information provided in this form is correct. . I will seek and obtain prior written approval from the IRB for any substantive modifications in the proposal, including changes in procedures, co-investigators, funding agencies, etc. . I will promptly report any unexpected or otherwise significant adverse events or unanticipated problems or incidents that may occur in the course of this study. . I will report in writing any significant new findings which develop during the course of this study which may affect the risks and benefits to participation. . I will not begin my research until I have received written notification of final IRB approval. . I will comply with all IRB requests to report on the status of the study. . I will maintain records of this research according to IRB guidelines. . The grant that I have submitted to my funding agency which is submitted with this IRB submission accurately and completely reflects what is contained in this application. . If these conditions are not met, I understand that approval of this research could be suspended or terminated.

I Agree Click here to enter text. (Initial)

Project Title (If project title does not match grant title, please provide grant title) Click here to enter text.

Principal Investigator (PI) (Full Name and Contact Information)

Occupational Position: ☐EFSC Faculty ☐ EFSC Staff ☐EFSC Student ☐Other Click here to enter text.

Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: ☐ Investigator ☐ 101 ☐ NIH ☐ HIPAA ☐ Other ☐ None

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Co-Investigators/Research Staff (Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up.)

Add Co-Investigators (or Research Staff).

First: Click here to enter text. Middle: Click here to enter text. Last: Click here to enter text. Mailing Address or Campus Mail Address: Click here to enter text. Phone: Click here to enter text. Email: Click here to enter text. College/University Department: Click here to enter text. Highest Education Level: Click here to enter text. Occupational Position: ☐EFSC Faculty ☐ EFSC Staff ☐EFSC Student ☐Other Click here to enter text. Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: ☐ Investigator ☐ 101 ☐ NIH ☐ HIPAA ☐ Other ☐ None

Faculty Advisor/Chair/Dean Information (If the PI is a student, the advisor's information is required. If PI is faculty or staff, the Department Head's information is required. If PI is also the Department Head, the Dean or Division Head's information is required.)

☐ Faculty Advisor ☐ Department Chair ☐ Director ☐ Dean ☐ Other Click here to enter text. First: Click here to enter text. Middle: Click here to enter text. Last: Click here to enter text. Mailing Address or Campus Mail Address: Click here to enter text. Phone: Click here to enter text. Email: Click here to enter text. College/University Department/Unit: Click here to enter text.

Funding Is this research funded by an internal (EFSC) or external agency? ☐ Yes ☐ No

Sponsored or Funded Projects If you are applying for funding, please answer all of the following questions. If you are receiving funding from multiple sources, please fill out the form for each of your sources.

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Funding Source #1: This project has been/will be submitted to the following funding agency: Name of Sponsor: Click here to enter text. OMNI Number: Click here to enter text. SRS/Researcher Foundation Contact Person: Click here to enter text. The funding decision: ☐ is pending ☐ has been awarded Type of funding source: Click here to enter text.

Funding Source #2: This project has been/will be submitted to the following funding agency: Name of Sponsor: Click here to enter text. OMNI Number: Click here to enter text. SRS/Researcher Foundation Contact Person: Click here to enter text. The funding decision: ☐ is pending ☐ has been awarded Type of funding source: Click here to enter text.

Non-funded Projects If no, please explain how costs of research will be covered: Click here to enter text.

Institutional Oversight Is this research proposal being reviewed by any other institution or peer review committee? ☐ Yes ☐ No Please select which other committee approvals are required for this research and provide documentation of their approval if it has been granted, or the application submitted if approval has not been granted (please attach the documentation at the end of the application): ☐ CRC ☐ Other IRB, please specify: Click here to enter text. ☐ Other, please specify: Click here to enter text.

Conflict of Interest Federal guidelines encourage Institutions to assure there are no conflicts of interest in research projects that could adversely affect the rights and welfare of human subjects. If this proposed research study involves a potential conflict of interest, additional information will need to be provided to the IRB. Examples of potential conflicts of interest may include: any sort of compensation, in cash or other form, for services to an individual and his or her immediate family, the value of which exceeds $10,000 in a one-year period or an equity interest which exceeds $10,000 or which exceeds a five percent ownership interest.

Do any of the Investigators or personnel listed on this research have a potential conflict of interest associated with this study? ☐ Yes ☐ No

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Identify the individual(s): Click here to enter text. Has this potential conflict of interest been disclosed and managed? ☐ Yes ☐ No

If you are an Eastern Florida State College researcher, please disclose your potential conflict of interest in writing for review by IRB. Final IRB approval cannot be granted until all potential conflict matters are settled. The full IRB committee determines what disclosure language should be in the consent form.

Payment or Other Compensation for Research Subjects Will you give subjects gifts, payments, compensation, reimbursement, services without charge or extra credit/class credit? ☐ Yes ☐ No Please explain: Click here to enter text.

Protocol Description and Other Detail (Use lay language, do not refer to grant or abstract. All questions are required!)

Describe the objective(s) of the proposed research including purpose, research question, hypothesis, method, data analysis, research design and relevant background information etc.

Click here to enter text.

For Evaluation of your project, please check the following which apply: ☐ Mentally or Physically Challenged Subjects ☐ Children or Minor Subjects (under 18 years old) ☐ Prisoners, Parolees, or Incarcerated Subjects ☐ Filming, Video or Audio recording of Subjects ☐ Questionnaires or Surveys to be administered ☐ Review of Existing Data, Archives, or Medical Records ☐ Subjects’ major language is not English ☐ Involves Deception ☐ Exclusion of Women or Children Subjects (must explain why they are being excluded) ☐ Subjects studied at EFSC ☐ Subjects studied at non-EFSC location(s) ☐ Students as Subjects ☐ Employees as Subjects ☐ Pregnant Subjects ☐ Fetal, placental, or surgical pathology tissues(s) ☐ Involves blood Samples (finger pricks, venipuncture, etc.)

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Survey Techniques: (check applicable category if the only involvement of human subjects will be in one or more of the following categories)

☐ Research on normal educational practices in commonly accepted educational settings ☐ Research involving educational tests (cognitive, diagnostic, aptitude, achievement) ☐ Research involving survey or interview procedures ☐ Research involving the collection or study of existing data, documents, records, archives, specimens

Which methods will this study include? (check all that apply or specify other)

☐ Descriptive Formative Phenomenological ☐ Ethnographic Longitudinal Qualitative ☐ Experimental/Control ☐ Design Oral history Quantitative ☐ Field work ☐ Other, specify: Click here to enter text.

Describe the tasks subjects will be asked to perform. Click here to enter text.

Describe the frequency and duration of procedures, psychological tests, educational tests, and experiments; including screening, intervention, follow-up etc. (If you intend to pilot a process before recruiting for the main study please explain.) Click here to enter text.

Attach surveys, instruments, interview questions, focus group questions etc.

How many months do you anticipate this research study will last from the time final approval is granted? Click here to enter text.

Participant (Subject) Population

Expected number of participants # of males: Click here to enter text. # of females: Click here to enter text. Total: Click here to enter text.

Expected Age Range (Check all that apply) ☐ 0-7 (Attach parental permission form) ☐ 8-17 (Attach child's assent form and parental permission form) ☐ 18-65 ☐ 65 and older

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Inclusion/Exclusion of Children in this Research: ☐ Inclusion ☐ Exclusion

Other Protected Populations to be Included in this Research (Check all that apply)

☐ Protected by Federal Regulations ☐ Pregnant Woman/Fetuses/Neonates ☐ Prisoners ☐ Protected by Federal Guidelines (Refer to 45 CFR 46 subpart B and 45 CFR 46 subpart C on the populations protected by Federal Regulations) ☐ Mentally/Emotionally/Developmentally/Decisionally Impaired Persons ☐ Minority Group(s) and Non-English Speakers ☐ Elderly Subjects -- 65+ ☐ Gender Imbalance - all or more of one gender

Inclusion and Exclusion of Subjects in this Research Study (Describe criteria for inclusion and exclusion of subjects in this study) Inclusion Criteria: Click here to enter text. Exclusion Criteria: Click here to enter text.

Location of subjects during research activity or location of records to be accessed for research (check all that apply and specify): ☐ Eastern Florida State College ☐ Other, specify: Hospitals, specify: ☐ Community Clinic, specify: ☐ Elementary/Secondary Schools, specify: ☐ Community Center, specify: ☐ University Campus (non-clinical), specify: ☐ Prisons/Halfway ☐ Houses, detention centers, specify: Nursing Home(s), specify: ☐ Subject's Home, specify: ☐ International Location, specify: ☐ Other Special Institutions, specify:

Describe the rationale for using each location checked above Click here to enter text.

Attach copies of IRB approvals or letters of cooperation from other agencies or sites, if it has been granted or the application submitted if approval has not been granted.

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Recruitment of Participants (Subjects)

Describe the recruitment process to be used for each group of subjects Click here to enter text.

Attach a copy of any and all recruitment materials to be used e.g. advertisements, bulletin board notices, e-mails, letters, phone scripts, or URLs.

Explain who will approach potential subjects to take part in the research study and what will be done to protect individuals' privacy if required in this process Click here to enter text.

Are subjects chosen from records? ☐ Yes ☐ No Are records "private" medical or student records? ☐ Yes ☐ No Who or what entity is the custodian of the records? Click here to enter text. Who gave approval for use of the records? Click here to enter text.

EFSC policy prohibits researchers from accepting gifts for research activities. Is the study sponsor offering any incentive connected with subject enrollment or completion of the research study (i.e. finder’s fees, recruitment bonus, etc.) that would be paid directly to the research staff? ☐ Yes ☐ No

Risks and Benefits

Does the research involve any of these possible risks or harms to subjects? (check all that apply) ☐ Use of a deceptive technique ☐ Use of private records (educational or medical records) ☐ Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stresses ☐ Any probing for personal or sensitive information in surveys, interviews or questionnaires ☐ Presentation of materials which subjects might consider sensitive, offensive, threatening, degrading or dangerous ☐ Possible invasion of privacy of subject or family ☐ Financial standing, employability, or reputation ☐ Criminal, civil, or legal liability ☐ Other risks, specify:

Does Research Involve Greater Than Minimal Risk to Human Subjects? ☐ Yes ☐ No "Minimal Risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

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Describe the nature and degree of the risk or harm checked above (The described risks/harms must be disclosed in the consent form.) Click here to enter text.

Explain what steps will be taken to minimize risks or harms and to protect subjects' welfare. If the research will include protected populations (see question 7.4) please identify each group and answer this question for each group Click here to enter text.

Describe the anticipated benefits of this research for individual subjects in each subject group. If none, state "None" Click here to enter text.

Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks. Click here to enter text.

Confidentiality of Data

Will you record any direct identifiers, names, social security numbers, addresses, telephone numbers, email addresses, cookies etc.? ☐ Yes ☐ No

Explain why it is necessary to record findings using these identifiers and describe the coding system you will use to protect against disclosure of these identifiers: Click here to enter text.

Will you retain a link between study code numbers and direct identifiers after the data collection is complete? ☐ Yes ☐ No

Explain why this is necessary and state how long you will keep this link: Click here to enter text.

Will you provide the link or identifier to anyone outside the co-investigators/research staff? ☐ Yes ☐ No

Explain why and to whom: Click here to enter text.

Where, how long, and in what format (such as paper, digital or electronic media, video, audio, or photographic) will data be kept? In addition, describe what security provisions will be taken to protect this data (password protection, encryption, etc.) Click here to enter text.

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Will you place a copy of the consent form or other research study information in the subjects' record such as medical, personal or educational record? ☐ Yes ☐ No

Explain why this is necessary: Click here to enter text.

If the data collected contains information about illegal behavior, please refer to the NIH Certificates of Confidentiality Kiosk for information about obtaining a Federal Certificate of Confidentiality.

Use of Protected Health Information (PHI): HIPAA Requirements In the course of conducting research, researchers may desire to obtain, create, use, and/or disclose individually identifiable health information. Under the HIPAA Privacy Rule, covered entities (healthcare providers, health plans, employer or healthcare clearinghouses) are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule.

As part of this study, will you be accessing PHI from a covered entity for research purposes? ☐ Yes ☐ No

Please explain which of the following you will be utilizing to comply with the HIPAA regulations for use of PHI: ☐ Research Use/Disclosure Without Authorization ☐ Documented Institutional Review Board or Privacy Board Approval (alteration or waiver of research participants' authorization) ☐ Preparatory to Research ☐ Research on Protected health Information of Decedents ☐ Limited Data Sets with a Data Use Agreement ☐ Research Use/Disclosure With Individual Authorization

Rationale: Click here to enter text.

Informed Consent Process

Recognizing that consent itself is a process of communication, please expand on your responses to questions 8.1 and 8.2 and describe what will be said to the subjects to introduce the research. Do not say “see consent form”. Write the explanation in lay language. If you are using telephone surveys, telephone scripts are required. Click here to enter text.

In relation to the actual data gathering, when will consent be discussed and documentation obtained? (e.g., mailing out materials, delivery of consent form, meetings) Be specific. Click here to enter text.

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Please name the specific individuals who will obtain informed consent and include their job title/credentials and a brief description of your plans to train these individuals to obtain informed consent and answer subject's questions: Click here to enter text.

What questions will you ask to assess the subjects' understanding of the risks and benefits of participation? (Questions should be open-ended and go beyond requiring only a yes/no response.) Click here to enter text.

Attach all supporting documents to the online application submission system such as consent forms, assent forms, cover letters, parental permission forms, guardianship permission form, reminder postcards, recruiting flyers, questionnaires, support letters for research sites, and other IRB approval letters. . The following file extensions are acceptable formats: .doc, .pdf, .xls, .ppt, and .vsd. Name each file with the PI's last name and type of document it is. ( e.g. Smithconsentform.doc ) . Save all files in a zipped folder prior to attaching to submission

Total Number of Files Attached: Click here to enter text.

Appendix A: Inclusion of Vulnerable Populations The targeting or inclusion of potentially vulnerable populations (other than children, pregnant women/fetuses and prisoners) in research requires special considerations. Provide information on the following populations, if applicable, in this research. Note: 1-4 not all required but at least one must be filled out.

☐ 1. Mentally/Emotionally/Developmentally Disabled Provide justification: Click here to enter text. Explain how competency to provide consent will be determined and plan for obtaining surrogate consent: Click here to enter text. ☐ 2. Minority Group(s)/Non-English Speakers Provide justification: Click here to enter text. Provide plan for obtaining consent: Click here to enter text. ☐ 3. Elderly (65+) Provide justification: If competency to provide consent may be an issue, describe how competency will be determined and plan for obtaining consent: Click here to enter text. ☐ 4. Gender Imbalance If all or more of one gender are targeted, provide justification for this: Click here to enter text.

Appendix B: Pregnant Women, Human Fetuses and Neonates involved in Research Federal regulations define pregnancy as encompassing the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. Fetus means the product of conception from implantation until delivery.

1. Does your research involve a pregnant woman or her fetus? ☐ Yes ☐ No

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If yes, please explain: Click here to enter text.

2. Is there any risk involved in this research? ☐ Yes ☐ No If yes, the risk must be the least possible for achieving the objectives of the research. Please explain how any risk has been minimized for subjects: Click here to enter text.

3. Is there any direct benefit to the pregnant woman and/or the fetus? ☐ Yes ☐ No If yes, please explain: Click here to enter text.

4. Is the pregnant woman a minor (under age 18)? ☐ Yes ☐ No If yes, how will you obtain assent and permission of the parent? Click here to enter text.

5. Does this research involve a neonate? Neonate is defined in the federal regulations to mean a newborn. ☐ Yes ☐ No If yes, please explain: Click here to enter text.

6. Is the neonate of uncertain viability? ☐ Yes ☐ No

7. Does the research involve nonviable neonates? A nonviable neonate means a neonate after delivery that, although living, is not viable. ☐ Yes ☐ No If yes, please explain: Click here to enter text.

Appendix C: Prisoners as Subjects in Research Federal Regulations require that investigators comply with the additional protections as summarized below. Please respond to each factor below for consideration:

1. Will this study examine the possible causes, effects, or processes of incarceration and/or criminal behavior? ☐ Yes ☐ No 2. Will this study examine prisons as institutional structures or prisoners as incarcerated persons? ☐ Yes ☐ No 3. Will this study examine a condition(s) particularly affecting prisoners as a class of people? ☐ Yes ☐ No 4. Will this study examine a procedure, innovative or accepted, that will have the intent or reasonable probability of improving the health or well-being of the subjects? ☐ Yes ☐ No

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5. Will prisoners receive any incentives or advantages by agreeing to participate? ☐ Yes ☐ No

Appendix D: Children Involved as Subjects in Research Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (in Florida, the age of 18). Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Permission means the agreement or parent(s) or guardian to the participation of their child or ward in research. Parent means a child's biological or adoptive parent. Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

1. What is the age range of the children involved in the research? Click here to enter text. 2. What is the psychological and maturity state of the children involved in the research? Click here to enter text. Are any of the children involved in the research wards of the State? ☐ Yes ☐ No 3. Is the research not involving greater than minimal risk? ☐ Yes ☐ No 4. Explain how assent of the children will be obtained in this research: Click here to enter text. 5. Explain how permission will be obtained from the parent(s) or guardian for the participation of their child or ward in this research: Click here to enter text.

Appendix D: Use of Deception Subjects must be told the purpose of the study, the reason for the deception and given an opportunity to withdraw their data from the project. (For guidance, see APA Ethical Standard 8.07)

1. Explain the scientific rationale for deceiving the study subjects. Which aspects of study procedures will be withheld from subjects? Why? Click here to enter text.

2. Describe when the subjects will be told the true purpose of the study, the reason for the deception and explain how they will be informed and by whom. (Attach a copy of the material or script to be used) Click here to enter text.

3. Describe how and when subjects will be given an opportunity to withhold use of the data gathered under deceptive conditions. Click here to enter text.

4. Attach the full debriefing "protocol" or explanation that will be provided to subjects. Click here to enter text.

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Sample Assent Form for Minors My name is ______. I am a student from ______. I am asking if you would like to take part in a research study called “______”, which is about ______. If you agree to be in this study, you will be participating by taking part in ______

______.

The study may make you feel a little frustrated. This study will help me learn better the ______.

Please talk this over with your parent(s) or guardian(s) before you decide whether or not to participate. Your parent(s) or guardian(s) must give their permission for you to take part in this study. Even if permission is granted you can still decide not to take part in the study.

This study is voluntary; which means you decide whether or not to participate. No one will be upset in any way if you do not want to participate or if you change your mind later and want to drop out of the study.

You can ask any questions that you have about this study. If you think of a question later you can call me at , or ask me the next time we meet.

Signing your name at the bottom means that you agree to be in this study. You and your parents will be given a copy of this form after you have signed it.

Name of child (please print) Signature of parent of guardian Date Signature of child Date

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EFSC Consent form Template

[Insert title of study and “Consent Form”]

You are invited to participate in a research study of [Insert general statement about the study]. You were selected as a possible participant because [Explain how the subject was identified]. We ask that you read this form and ask any questions you may have before agreeing to be in the study.

This study is being conducted by [indicate the investigator’s name and University/College Department with earned degrees(s)]. It is funded by [Indicate study sponsor, if any and state if the sponsor is also the manufacturer of the drug/device being studied if applicable].

Study Purpose The purpose of the study is [explain the research question and purpose in lay language. Indicate if the drug/device being tested is experimental].

Study Procedures If you agree to participate in this study, we would ask you to do the following: [describe in lay language the tasks and procedures to be followed and indicate if any procedures are experimental. Describe assignment to study groups, length of time for participation and frequency of procedures- include a table of study visits if applicable. Indicate if study participation involves withholding of standard treatment. Quantities such as blood volume to be drawn should be listed in lay language equivalents, i.e. teaspoons.]

Risks of Study Participation The study has the following risks: [describe foreseeable risks or discomforts to the subject in lay language in order of severity and likelihood. Include any risks to subject confidentiality. Indicate the risks associated with being in the placebo group, if such a group exists. If standard treatment is to be withheld, indicate the risks associated with this.]

Benefits of Study Participation The benefits to study participation are: [describe any direct benefit to the subject or benefit to others, which may reasonably be expected from the research. If there is no direct benefit to the subject, declare that fact. Note that payment to subjects is not considered a benefit of participation.] Alternatives to Study Participation [If the study involves treatment, disclose available alternative procedures or courses of treatment, if any, which might be advantageous to the subject.]

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Study Costs/Compensation [Indicate whether subjects may incur any costs as a result of participation in the study and whether subjects will receive any payment. Note that subjects are not paid for participation, but are compensated for their time and inconvenience. If payments to subjects may be pro-rated, indicate how payment will be prorated.]

Research Related Injury [If the research involves the potential for injury, include whether treatment will be available, including first aid, emergency treatment, and follow-up care as needed. Include whether study sponsor will pay for care. State whether care for injuries will be billed in the ordinary manner to research subject or his/her insurance company].

Confidentiality The records of this study will be kept private and confidential, to the extent allowed by law. In any publications or presentations, we will not include any information that will make it possible to identify you as a subject. Your record for the study may, however, by reviewed by [indicate if the drug/device manufacturer, study sponsor or representatives of the FDA may have access] and by departments at the University with appropriate regulatory oversight. [Indicate whether study information will be recorded in the subject’s medical record. If any study data will be transmitted via the Internet, indicate what provisions for protection of privacy are in place].

Protected Health Information (PHI): Your PHI created or received for the purposes of this study is protected under the federal regulation known as HIPAA. Refer to the HIPAA authorization for details concerning the use of this information.

Voluntary Nature of the Study Participation in this study is voluntary. Your decision whether or not to participate in this study will not affect your current or future relations with the University. [Indicate any other cooperating institutions]. If you decide to participate, you are free to withdraw at any time without affecting those relationships.

Contacts and Questions The researchers conducting this study are [list investigator’s names]. You may ask any questions you have now, or if you have questions later, you are encouraged to contact them at [provide telephone numbers. If the researcher is a student, include the faculty advisor’s name and telephone number as well]. [Include the following contact language].

If you have any questions or concerns regarding the study and would like to talk to someone other than the researcher(s), you are encouraged to contact the EFSC IRB Chair at 321-433-5364.

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You may also contact this office by email at [email protected], or by writing or in person to EFSC-IRB Chairperson, Dr. Mark Quathamer, 1519 Clearlake Rd, Cocoa FL, 32922.

You will be given a copy of this form for your records.

Statement of Consent

I have read the above information, I have asked questions, and have received answers. I consent to participate in this study.

Signature of Subject Date

Signature of Investigator Date

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Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure1

Applicability

(A) Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

(D) The expedited review procedure may not be used for classified research involving human subjects.

(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories

(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

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(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

(3) Prospective collection of biological specimens for research purposes by noninvasive means.

Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

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(NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

(6) Collection of data from voice, video, digital, or image recordings made for research purposes.

(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

(8) Continuing review of research previously approved by the convened IRB as follows:

(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long- term follow-up of subjects; or

(b) where no subjects have been enrolled and no additional risks have been identified; or

(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

2 Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).

Source: 63 FR 60364-60367, November 9, 1998.

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Guidance on the Use of Expedited Review Procedures Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS)

Date: August 11, 2003

Scope: The purpose of this document is to provide guidance on the use of the expedited review procedure by Institutional Review Boards (IRBs)

Target Audience: IRBs, sponsors, and investigators.

Regulatory Requirements: Expedited review procedures are described in HHS regulations at 45 CFR 46.110 . Under an expedited review procedure, the IRB Chairperson, or one or more experienced reviewers designated by the Chairperson from among the members of the IRB, reviews the research protocol. The IRB shall adopt a method for keeping all IRB members advised of research proposals that have been approved under the expedited review procedure. In conducting expedited review, the IRB reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research. A research activity may be disapproved only after review by the convened IRB in accordance with the nonexpedited procedure set forth in 45 CFR 46.108(b). Under 45 CFR 46.110(d), HHS may restrict an institution's or IRB's authority to use the expedited review procedure.

Guidance: The list of categories of research that may be reviewed by the IRB through an expedited review procedure was updated in 1998 and can be found at http://www.hhs.gov/ohrp/policy/expedited98.html. Additions to, and extrapolation from, this list by the institution or the IRB are not appropriate. For example, it is inappropriate to use an expedited review procedure for the initial review of either research that involves minimal risk but does not appear in the categories of research published in the Federal Register or research that involves greater than minimal risk.

Institutions and IRBs are reminded that expedited review usually is not appropriate at the time of continuing review if the research required review by the convened IRB at the time of initial review (for information about expedited continuing review see OHRP Guidance at http://www.hhs.gov/ohrp/policy/continuingreview2010.html#section-e).

Like review by the convened IRB, expedited review must fulfill all the requirements of review found at 45 CFR 46.111 and subparts B, C, and D, if applicable. IRBs are reminded that the requirements for informed consent (or for altering or waiving the requirement for informed consent) apply regardless of whether research is reviewed by the convened IRB or under an expedited procedure.

OHRP policy provides that any institution with an OHRP-approved Assurance may use expedited review for initial or continuing review of HHS-supported or conducted research and

EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 26 for review of minor changes in previously approved research as described in 45 CFR 46.110(b)(2) .

Consultants may assist the IRB in the review of issues which require expertise beyond, or in addition to, that available on the IRB. Only the IRB Chairperson, or one or more experienced reviewers designated by the Chairperson from among members of the IRB, may carry out the expedited review. The person(s) conducting the expedited review may either approve, require modifications (to secure approval) or refer the research to the convened IRB for review in accordance with the non-expedited review procedures set forth in HHS regulations at 45 CFR 46.108(b).

Finally, OHRP recommends that:

(1) documentation for initial and continuing reviews conducted under an expedited review procedure include: (a) the specific permissible categories justifying the expedited review; and (b) documentation of the review and action taken by the IRB Chairperson or designated reviewer and any findings required under the HHS regulations;

(2) written IRB procedures include a description of policies describing the types of minor changes in previously approved research which can be approved under an expedited review procedure in accordance with HHS regulations at 45 CFR 46.110(b)(2); and

(3) expedited review procedures NOT be used for research involving prisoners. However, if an IRB chooses to use expedited review for research involving prisoners, OHRP recommends that the prisoner representative of the IRB be one of the designated reviewers.

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Federal Regulations & Institutional Responsibilities

This tutorial provides an introduction to the Federal Policy (Common Rule) and DHHS Regulations for the Protection of Research Subjects.

The Federal regulations are intended to implement the basic ethical principles governing the conduct of human subjects research. These ethical principles are set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"). No one should be involved in human subjects research at any level without being familiar with these ethical principles.

The Belmont Report

The Belmont Report sets forth three basic ethical principles:

1. Respect for Persons • Respect individual autonomy • Protect individuals with reduced autonomy 2. Beneficence • Maximize benefits and minimize harms 3. Justice • Equitable distribution of research burdens and benefits

Application of the general ethical principles to the conduct of human subjects research leads to the following requirements:

1. Respect for Persons • Informed Consent • Protecting privacy and maintaining confidentiality • Additional safeguards for protection of subjects likely to be vulnerable to coercion or undue influence 2. Beneficence • IRB assessment of risk/benefit analysis including study design • Ensure that risks to subjects are minimized • Risk justified by benefits of the research 3. Justice • Ensure that selection of subjects is equitable.

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Introduction

Under Federal regulations, any institution engaged in Federally-supported human subjects research must commit itself in writing to the protection of those subjects.

This written commitment is called an Assurance of Compliance.

For human subjects research supported by the Department of Health and Human Services (DHHS), the Office for Human Research Protections (OHRP) must approve the institution's Assurance before the funds can be awarded.

Before OHRP can approve an Assurance, it must be satisfied that the Institutional Official, the Chair of the Institutional Review Board (IRB), and the Human Protections Administrator (Primary Contact) at the institution understand the responsibilities involved in an institutional program of human subject protection.

The purpose of this tutorial is to explain these responsibilities, as well as the informed consent process. OHRP will not approve an institution's Assurance unless these key individuals have completed this tutorial or equivalent training.

The tutorial can be done online and consists of three modules: 1. HHS Regulations & Institutional Responsibilities 2. Investigator Responsibilities & Informed Consent 3. Human Research Protections Program

Online tutorial link: http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp

In order to qualify for an Assurance, the Institutional Official must complete Module 1. The Human Protections Administrator (Primary Contact) and the IRB Chair must complete all three modules. IRB members and investigators may take this tutorial, but this would not fulfill the education requirement in the institution's Assurance.

Federal Regulations & Institutional Responsibilities

This tutorial provides an introduction to the Federal Policy (Common Rule) and DHHS Regulations for the Protection of Research Subjects.

The Federal Policy for the Protection of Human Subjects (Common Rule) was adopted on June 18, 1991

EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 29 and covers research supported by the Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS, as well as NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.

The provisions of the Common Rule are identical to the DHHS Regulations (45 CFR 46, Subpart A). DHHS regulations include additional protections for vulnerable populations as Subparts of 45 CFR 46: • Subpart B - Additional DHHS Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization; • Subpart C - Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects; • Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research.

Food and Drug Administration

The Food and Drug Administration (FDA) has a separate set of regulations governing human subjects research (21 CFR 56 – IRBs and 21 CFR 50 – Informed Consent). The basic requirements for IRBs and for Informed Consent are congruent between the two sets of regulations.

Differences center on differences in applicability:

• HHS regulations at 45 CFR Part 46 apply to research conducted or supported by HHS. • FDA regulations apply to clinical investigations of FDA regulated products: drugs, devices, or biologics.

Definitions

Research - A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of the HHS regulations, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human Subject - A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Exempt Research

Certain low-risk research is exempt from the requirements of the Federal regulations. These exemptions do not imply that investigators have no ethical responsibilities to subjects in such research; they mean only that IRB review and approval of the research is not required by Federal regulations.

In no case should investigators make the final determination of exemption from applicable Federal

EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 30 regulations or provisions of their institution's Assurance.

Institutions should adopt clear procedures under which the IRB (or some authority other than the investigator) determines whether proposed research is exempt from the human subjects regulations.

Basic Protections The regulations contain three basic protections for human subjects: 1. Institutional assurances of compliance 2. IRB review 3. Informed Consent

Institutional Assurances

What is an Institutional Assurance?

• The documentation of an institutional commitment to comply with Federal regulations and maintain adequate programs and procedures for the protection of human subjects. • The principal mechanism for compliance oversight by OHRP.

Assurances

Federal departments and agencies will conduct or support research covered by the regulations (non- exempt) only if • the institution has an OHRP-approved Assurance, • the institution has certified to the department or agency head that the research has been reviewed and approved by the IRB, and • the research will be subject to continuing review by the IRB.

IRB Review

The Institutional Review Board (IRB) is a committee established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

IRB Membership

IRBs must have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of their racial and cultural heritage and their sensitivity to issues such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

In addition to possessing the professional competence necessary to review specific research activities,

EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 31 the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

Every nondiscriminatory effort must be made to ensure that the IRB does not consist entirely of men or entirely of women.

No IRB may consist entirely of members of one profession.

Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

No IRB member may have a member participate in the review of any project in which the member has a conflicting interest.

An IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

Except when an expedited review procedure is used, the IRB must review research at convened IRB meetings at which a majority of the IRB members are present, including one member whose primary concerns are in non-scientific areas.

IRB Review

The IRB reviews, and has the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human subject research.

The IRB conducts continuing review of approved research at intervals appropriate to the degree of risk, but not less than once per year.

The IRB has the authority to suspend or terminate previously approved research that is not being conducted in accordance with the IRB's requirements, or that has been associated with unexpected serious harm to subjects.

Institutional Officials may not authorize or approve the conduct of human subjects research that has not been approved by the IRB. Research approved by an IRB may be subject to further review and approval or disapproval by officials of the institution.

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Consent

Unless specifically authorized by the IRB, no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.

Informed consent is the voluntary choice of an individual to participate in research based on an accurate understanding of its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate.

Informed consent must be legally effective under applicable state law and must include the eight specific elements described in the Federal regulations.

Unless specifically waived by the IRB, informed consent must be documented in writing.

Institutional Responsibility

The responsibility for the protection of human subjects does not rest solely with the IRB. It is a shared responsibility between the Institutional Official, the IRB, and the investigator. Each has a crucial, yet distinct, role to play

Institutional Official

The Institutional Official is the individual authorized to act for the institution and assumes on behalf of the institution the obligations in the institution's Assurance.

The Institutional Official is responsible for • setting the "tone" for an institutional culture of respect for human subjects, • ensuring effective institution-wide communication and guidance on human subjects research, • ensuring that investigators fulfill their responsibilities, • encouraging that all staff engaged in the conduct or oversight of human subject research participate in education activities; • Serving as a knowledgeable point of contact for OHRP, or delegating this responsibility to another appropriate individual.

Administratively, the Institutional Official is typically responsible for • Designating one or more IRBs that will review research covered by the institution's FWA. • Providing sufficient resources, space, and staff to support the IRB's review and record keeping duties. • Providing training and educational opportunities for the IRB and investigators. • Depending on the organizational structure at a given institution, other administrative arrangements may be appropriate.

Depending on the organizational structure at a given institution, other administrative arrangements may be appropriate.

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Institutional Responsibilities

The Institution bears full responsibility for all research involving human subjects covered under its Assurance. For all HHS-conducted or supported research, all of the requirements of the HHS Regulations at 45 CFR Part 46, Subpart A, as well as Subparts B through D, must be met.

OHRP strongly encourages institutions to embrace the Federal regulations, regardless of sponsorship, and to commit to this standard in their Assurance.

Institutions are responsible for • Developing policies and procedures for effective and efficient administration of the Human Research Protections Program (HRPP). • Ensuring that Assurances are in place and certifications of IRB review are submitted to the appropriate authorities for all HHS-sponsored research, not only for themselves, but also for collaborating performance sites for which the institution has agreed to accept oversight responsibility. • Implementing appropriate oversight mechanisms to ensure compliance with HHS regulations and effective administration of the HRPP.

All persons involved in human subjects research should be familiar with the following references:

The Common Rule and DHHS Regulations: http://www.hhs.gov/ohrp/humansubjects/commonrule/

The Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

For institutions conducting FDA regulated research:

21 CFR 50 and 21 CFR 56: http://www.gpo.gov/fdsys/pkg/CFR-2000-title21-vol1/content-detail.html

Where international research is involved: Declaration of Helsinki http://www.wma.net/en/30publications/10policies/b3/

Operational Guidelines for Ethics Committees - World Health Organization http://www.who.int/ethics/publications/research_standards_9789241502948/en/

International Ethical Guidelines for Human Subject Research - Council for International Organizations of Medical Sciences http://www.cioms.ch/index.php/publications/available- publications?task=showCategory&catid=53

International Conference on Harmonization of Technical Requirements for Registration of

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Pharmaceuticals for Human Use, Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance http://www.nus.edu.sg/irb/Articles/ICH%20GCP%20E6.pdf

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Investigator Responsibilities & Informed Consent

Investigator Responsibilities

Investigators have the primary responsibility for protecting the rights and welfare of human research subjects and are responsible for complying with all applicable provisions of their institution's Assurance. Investigators are expected to

• be knowledgeable about the requirements of the Federal regulations, applicable state law, their institution's Assurance, and institutional policies and procedures for the protection of human subjects; • conduct their research according to the IRB approved protocol and complying with all IRB determinations; • obtain and document the informed consent of each subject or each subject's legally authorized representative, unless the IRB has waived these requirements. • ensure that each potential subject understands the nature of the research and of the subject's participation and taking whatever steps are necessary to gain that comprehension; • provide a copy of the IRB-approved informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement (all signed consent documents are to be retained for at least 3 years after the completion of the research and according to institutional policy); • promptly report proposed changes in previously approved human subject research activities to the IRB (the proposed changes may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects); • report progress of approved research to the IRB, as often as and in the manner, prescribed by the IRB; • promptly report to the IRB any unanticipated problems involving risks to subjects or others or any serious or continuing non-compliance with the HHS regulations or determination of the IRB.

Informed Consent

Unless specifically authorized by the IRB, no investigator may involve a human being as a subject in research covered by the HHS regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.

Informed consent refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person's decision to participate.

The Consent Process

Informed consent is not a single event or just a form to be signed. Rather, it is an educational process that takes place between the investigator and the prospective subject.

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The basic concepts of the consent process include: • Full disclosure of the nature of the research and the subject's participation, • Adequate comprehension on the part of the potential subjects, and • The subject's voluntary choice to participate.

General Requirements

• Informed consent must be prospectively obtained from the subject or legally authorized representative of the subject (if allowed by state law). • Information must be conveyed in understandable language. • Subjects must be given sufficient opportunity to consider whether they want to participate. • Consent must be sought only under circumstances that minimize the possibility of coercion or undue influence • Subjects must not be made to give up legal rights or be given the impression that they are being asked to do so.

Comprehension

• Even if the IRB has approved a consent procedure, it is the investigator's responsibility to ensure that each potential subject understands the information and to take the appropriate steps necessary to gain that comprehension. • Individuals may not be involved as research subjects unless they understand the information that has been provided or the IRB has approved a waiver for informed consent of the subject.

Competency to Consent

• Informed consent must be legally effective under applicable State law. Only legally competent adults can give consent. • In most cases, minors cannot give consent – only parents or legal guardians can give permission for minors to participate in research. • Incompetent adults cannot give consent – this may include the developmentally disabled, the cognitively-impaired elderly, and unconscious or inebriated individuals. Only legally authorized representatives in accordance with state law can give permission for incompetent adults to participate in research. • The evaluation of competence must be made on a case-by-case basis. • In addition to obtaining permission from parents or legal guardians, provisions must be made for soliciting the assent of the children or incompetent adults.

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Elements of Informed Consent

The Federal regulations detail specific elements of information which must be provided to each subject:

• statement that the study involves research, an explanation of the purposes of the research, the expected length of the subject's participation, a description of the procedures to be followed , and identification of procedures which are experimental in nature; • description of any reasonably foreseeable risks or discomforts to the subject; • description of any benefits, to the subject or others which may reasonably be expected from the research; • disclosure of appropriate alternative procedures or courses of treatment, if any, that are available that might be advantageous to the subject; • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. • for research involving more than minimal risk, an explanation as to whether any compensation or medical treatments, are available to the subject if injury occurs and if so, what that may consist of or when further information can be obtained; • an explanation of whom to contact for pertinent questions about the research and research subjects rights; • an explanation of whom to contact in the event the subject experiences a research-related injury; and • a statement that participation is voluntary and refusal to participate will not result in penalty or loss of benefits to which the subject is otherwise entitle and the subject may withdraw at any time without penalty or loss of benefits to which the subject is entitled.

Research and Procedures

The information provided to subjects should: • make clear that the activity involves research and describe the overall experience that will be encountered; • explain the research activity, including any parts that are experimental (e.g., a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment or other design issues); and • include the expected length of time it will take for study visits or scheduled procedures, as well as, the total expected length of participation.

Risks

• All reasonably foreseeable risks, discomforts, inconvenience, and harms that are associated with the research activity, should be described. • Investigators should be forthcoming about risks and not underestimate or gloss over reasonably foreseeable risks. • If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are re-contacted or newly contacted.

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Benefits

• Any benefits that subjects may reasonably expect to encounter should be described. • Investigators should be frank about benefits and not overestimate or magnify the possibility of benefit to the subject. There may be no benefit other than a sense of helping the public at large. • Payment to subject should not be listed or described as a benefit of participating in the research.

Alternatives to Participation

• Appropriate alternatives to participating in the research project, particularly alternatives that might be advantageous to the subject, should be described. For example, in drug studies, the medication(s) may be available through their family doctor or clinic without the need to volunteer for the research activity. • Investigators should be reasonably specific about describing the nature and type of available alternatives. It is not sufficient simply to state that "the researcher will discuss alternative treatments" with the subject.

Confidentiality Protections

HHS regulations require that subjects be told the extent, if any, to which confidentiality of research records identifying the subject will be maintained. For example, sponsors, funding agencies, regulatory agencies, and the IRB may review research records. Some studies may need sophisticated encryption techniques to prevent confidentiality breaches or may need a Certificate of Confidentiality to protect the investigator from being compelled to release (e.g., under subpoena) subjects' names or identifiable private information.

Compensation for Injury

If research-related injury (i.e., physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk, an explanation must be given of whatever voluntary compensation and treatment will be provided. Note that the regulations do not limit injury to "physical injury." This is a common misinterpretation.

The regulations prohibit i. requiring subjects to waive any of their legal rights, and ii. leading subjects to believe they are waiving their rights. iii. Consent language regarding compensation for injury must be selected carefully so that subjects are not given the impression that they have no recourse to seek satisfaction beyond the institution's voluntarily chosen limits.

Contact Persons

The regulations require that the subject be provided with information on who to contact to answer

EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 39 questions about the research and the rights of research subjects. Subjects must also be informed of whom to contact in the event of any research-related injuries.

This information must be explicitly stated and addressed in the consent process and documentation.

A single contact person is not likely to be appropriate to answer questions in all areas. This is because of real or apparent conflicts of interest. Questions about the research are frequently best answered by the investigator(s). However, questions about the rights of research subjects may best be referred to persons not on the research team. These questions could be addressed to the IRB, an ombudsperson, an ethics committee, or other informed individual or committee. Each consent document can be expected to have at least two names with local telephone numbers for contacts to answer questions in these specified areas.

Voluntary Participation

The regulations require statements regarding voluntary participation and the right to withdraw at any time. Subjects must be informed that: • participation is voluntary; • subjects may discontinue participation at any time; • there is no penalty or loss of benefits for not participating or discontinuing participation.

Additional Elements

Where appropriate, the following additional elements of informed consent shall be included: • treatments or procedures that may involve risks to the subject, or to an embryo or fetus if the subject is or may become pregnant, that are currently unforeseeable; • anticipated circumstances under which a subject's participation may be terminated by the investigator without regard to the subject's consent; • any additional costs to subjects that may result from participation; • the consequences of the subject's decision to withdraw from the research and procedures of orderly termination of participation by the subject; • a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and • the approved number of subjects involved in the study.

Additional Protections for Vulnerable Populations

Incompetent adults cannot give consent. This may include the developmentally disabled, the cognitively- impaired elderly, and unconscious or inebriated individuals. Only legally authorized representatives in accordance with state law can give consent for incompetent adults to participate in research.

Additionally, when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons, additional safeguards shall be included in the study to protect the rights and

EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 40 welfare of these subjects.

Waiver of Consent

Under certain circumstances, HHS regulations specify that the IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

• the research or demonstration project is to be conducted by or subject to the approval of the state or local government officials and is designed to study, evaluate, or otherwise examine:

o public benefit or service programs; o procedures for obtaining benefits or services under those programs; o possible changes in or alternatives to those programs or procedures; or o possible changes in methods or levels of payment for benefit or service under those programs; AND o the research could not practicably be carried out without the waiver or alteration. IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that the following four conditions have been met: • the research involves no more than minimal risk to the subjects; • the waiver or alteration will not adversely affect the rights and welfare of subjects; • the research could not practicably be carried out without the waiver or alteration; and • whenever appropriate, the subjects will be debriefed — provided with additional pertinent information — after they have participated in the study.

Documentation of Consent

Except as noted below, informed consent must be documented by use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy will be given to the person signing the form.

The purpose of the written presentation of information in the consent form is to document the basis for consent and provide the subject future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process. All revisions must be reviewed and approved by the IRB before a revised consent form may be used to enroll a subject.

The information that is given to the prospective subject, or his/her legally authorized representative, must be in language understandable to the subject or representative.

Consent forms should be written at a level appropriate to the understanding of the subjects to be enrolled; technical language should be avoided.

OHRP strongly discourages use of the "first person" statement in consent documents (using, "I have been

EASTERN FLORIDA STATE COLLEGE INSTITUTIONAL REVIEW BOARD 41 fully informed about..."). Such statements unacceptably ask subjects to make statements that the subject is not in a position to verify (e.g., the subject has no way to verify that the investigator has provided full and complete information).

The consent form is merely the documentation of informed consent and does not, in and of itself, constitute informed consent.

The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent.

Waiver of Documentation of Consent

The IRB may waive the requirement for written documentation of consent in cases where: • the principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research; and the consent document is the only record linking the subject with the research; OR

• the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.

The Consent Process

Please also review the following additional guidance.

• Informed Consent Checklist http://www.hhs.gov/ohrp/policy/consentckls.html • Informed Consent, Legally Effective and Prospectively Obtained http://www.hhs.gov/ohrp/policy/hsdc93-03.html • Informed Consent, Non-English Speakers http://www.hhs.gov/ohrp/policy/ic-non-e.html • Certificates of Confidentiality http://www.hhs.gov/ohrp/policy/certconf.html

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Human Protections Administration

All assured institutions should have a Human Protections Administration (HPA) program in place to ensure that human subjects involved in research are adequately protected and that the institution remains in compliance with the regulations. This applies equally to institutions with their own IRB, as well as to institutions who rely on another IRB

Administrative procedures may be handled differently from one institution to another. The following describes procedures that many institutions follow to ensure effective administration and compliance with regulations.

Human Protections Program Administrator

Effective administration of a Human Protections Program requires the designation of a Human Protections Administrator who serves as OHRP's primary institutional contact person and has administrative responsibility for the program.

Institutions with a very small human research program may be able to assign other duties to the Human Protections Administrator, but that person's primary responsibility should be the Human Protections Program.

Depending on the volume of work, the administration of the program may fall to the Human Protections Administrator alone, or to an office staffed by many persons with differing areas of responsibility.

The administrative responsibilities for the HPA fall into three general areas: • IRB Communication & Education • Recordkeeping & Reporting • Monitoring & Oversight

Communication & Education

Promoting communication among the research administrators, department heads, investigators, clinical care staff, human subjects, and institutional officials to maintain a high level of awareness regarding the ethical conduct of research and safeguarding the rights and welfare of subjects.

Maintaining access to the institution's Assurance; copies of pertinent Federal regulations, policies, and guidelines related to the involvement of human subjects in research; and institutional policies and procedures.

Educating the members of its research community in order to establish and maintain a culture of compliance with Federal regulations and institutional policies relevant to the protection of human subjects.

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Recordkeeping & Reporting

• Ensuring that IRB records are being maintained per HHS regulations and that the records are accessible, upon request, to authorized HHS officials. For institutions relying on another IRB, records may be retained at the IRB site. • The HRPP is responsible for ensuring certification of IRB approval of proposed research to the appropriate HHS agency for HHS-conducted or supported research. • Ensuring that changes in approved research, during the period for which IRB approval has already been given, are not initiated without IRB review and approval, except when necessary to eliminate apparent, immediate hazards to the subject. • Ensuring prompt reporting to the IRB all proposed changes in a research activity. • Ensuring the prompt reporting to the IRB, appropriate institutional officials, OHRP, and any sponsoring Federal department or agency head of: o any unanticipated injuries or problems involving risks to subjects or others; o any serious or continuing noncompliance with the regulations or requirements of the IRB, and o any suspension or termination of IRB approval for research.

Monitoring & Oversight

• Ensuring that appropriate oversight mechanisms have been implemented to ensure compliance with the determinations of the IRB. • Ensuring that all cooperating performance sites in HHS-conducted or supported research conducted primarily under the direction of the institution have appropriate OHRP-approved assurances and provide certifications of IRB approval to the appropriate federal authorities. • Ensuring that cooperative IRB review arrangements are documented in writing, in accordance with OHRP guidance. • Ensuring that all independent investigators that rely on the institution's IRB have documented, in accordance with OHRP guidance, their commitment to the institution's human subjects protections requirements and to the IRB's determinations.

Institutional Review Boards

Review by an IRB is the cornerstone of an institution's program for the protection of human subjects. IRBs are responsible for ensuring that the rights and welfare of the subjects are adequately protected. Although most institutions will have their own IRB, institutions have the option of relying on the IRB of another institution to review their research.

Relying on Another IRB

An institution relying on another IRB has the following responsibilities: • To ensure that the reviewing IRB is in compliance with the IRB requirements in the Federal regulations;

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• To ensure that the particular characteristics of the institution's local research context are considered, either through knowledge of its local context by the reviewing IRB; or through subsequent review by appropriate designated institutional officials.

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IRB Responsibilities

IRB Authority

• To approve, require modifications in to secure approval, or disapprove all research activities covered by the HHS regulations, including proposed changes in ongoing, previously approved, human subjects research. • To suspend or terminate the approval of ongoing, previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected, serious harm to subjects.

Continuing Review

An IRB must conduct continuing review of ongoing approved research at intervals appropriate to the degree of risk, but not less than once per year. For approved research, the IRB determines which activities require continuing review more frequently than every 12 months. Continuing IRB reviews are preceded by receipt of appropriate progress reports from the investigator, including available study- wide findings. Continuing review must be substantive and meaningful.

IRB Expertise

• IRBs should be familiar with the requirements of the Federal regulations, applicable state law, their institution's Assurance, and institutional policies and procedures for the protection of human subjects.

• IRBs should have effective knowledge of subject populations and other factors that can foreseeably contribute to a determination of risks and benefits to subjects and subjects' informed consent.

• IRBs should be able to judge the adequacy and accuracy of information in the informed consent document, advertising, and any other materials to be presented to subjects.

• An IRB that regularly reviews research that involves a vulnerable category of subjects such as children, prisoners, pregnant women, or handicapped or disabled persons, membership should include in its membership one or more individuals who are knowledgeable about and experienced in working with these subjects.

• IRBs must have the professional competence necessary to review the specific research activities presented for approval.

• IRBs may, in their discretion, invite individuals with competence in special areas to assist in the review of issues, which require expertise beyond, or in addition to, that available on the IRB.

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Review of Performance Sites

IRB roster submitted to OHRP should include members knowledgeable about any other institution for which the IRB regularly conducts reviews. For performance sites for that the IRB does not regularly conduct reviews, the IRB must obtain effective input on the local research context from knowledgeable persons other than those conducting the research.

IRB Communication

IRBs must provide the investigators and the institution with written notification of decisions to approve or disapprove research and of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, the written notification must include reasons for the decision and give the investigator an opportunity to respond in person or in writing.

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Criteria for IRB approval of research:

• Risks to subjects are minimized by using procedures which are consistent with sound research design and do not unnecessarily expose subjects to risks, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

• Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research;

• Selection of subjects is equitable; in making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations;

• Informed consent will be sought from each subject or the subject's legally authorized representative; informed consent will be appropriately documented, in accordance with, and to the extent required by the HHS regulations.

Additional criteria for IRB approval as appropriate: • the research plan makes adequate provision for monitoring the data collected to ensure subject safety; • there are adequate provisions to protect the privacy of the subjects and confidentiality of data; • when some of all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards are included to protect the rights and welfare of these subjects.

Expedited Review

HHS regulations allow some categories of minimal risk research to be reviewed by the IRB through an expedited review procedure. Expedited review may be carried out by the IRB chairperson or by one or more experienced IRB members designated by the chairperson. All of the requirements for IRB approval of research apply to expedited review. Expedited review should not be viewed as a less rigorous review. Under expedited review, the reviewers may exercise all of the authorities of the IRB, except that the reviewers may not disapprove the research.

Expedited review procedures may be used for:

• research appearing in the published list of eligible research and found by the reviewer to involve no more than minimal risk; • minor changes in previously approved research during the authorized approval period.

All other non-exempt research must be approved at a convened meeting of the IRB.

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Convened Meetings The IRB observes the following requirements for convened meetings: • A majority of the members of the IRB must be present including at least one member whose primary concerns are in non-scientific areas. • If the required number and type of members is lost during a meeting, no action may be taken until a quorum is restored. • In order for research to be approved, it must receive the approval of a majority of those members present at the meeting. • Scheduled meetings of the IRB should occur at intervals appropriate to the level of reviewed research and with sufficient frequency so that the IRB can adequately oversee the progress of the research it has approved. • Convened meetings may be conducted by telephone conference call, provided that each participating IRB member has received all pertinent material prior to the meeting and can actively and equally participate in the discussion of all protocols. • Minutes of such meetings must clearly document which members were present via conference call and that the criteria for a member's participation via conference call have been satisfied.

IRB Minutes

Minutes of IRB meetings must include: • a list of attendees at the meeting; • actions taken by the IRB; • the vote on these actions, including the number of members voting for, against, and abstaining; • the basis for requiring changes in or disapproving research; • a written summary of the discussion of controverted issues and their resolution.

IRB Recordkeeping

IRBs shall prepare and maintain adequate documentation of IRB activities, including the following:

• copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects; • minutes of IRB meetings; • records of continuing review activities; • copies of all correspondence between the IRB and the investigators; • a list of IRB members; • written procedures for the IRB; • statements of significant new findings provided to subjects.

Human Protections Administration

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All Human Protections Administrators and IRB Chairs should review the following references:

• Investigator Responsibilities – FAQs: http://answers.hhs.gov/ohrp/categories/1567 • Guidance on the Use of Expedited Review Procedures: http://www.hhs.gov/ohrp/policy/exprev.html • Exempt Research Determination – FAQs: http://answers.hhs.gov/ohrp/categories/1564 • Human Subject Regulations Decision Charts: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html • IRB knowledge of local context: http://www.hhs.gov/ohrp/policy/local.html • Guidance on Engagement of Institutions in Human Subjects Research: http://www.hhs.gov/ohrp/policy/engage08.html • Guidance on Written IRB Procedures: http://www.hhs.gov/ohrp/policy/irbgd107.html • Continuing review – Institutional and Institutional Review Board responsibilities: http://www.hhs.gov/ohrp/policy/continuingreview2010.html • OHRP Compliance Activities – common findings and guidance: http://archive.hhs.gov/ohrp/references/findings.pdf

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