Elon University Institutional Review Board

Elon University Institutional Review Board RESEARCH PACKET INFORMATION

Revised:

07/10/1998 12/8/2006 07/24/1998 5/21/2007 02/24/1999 12/10/2007 07/26/1999 07/13/2000 08/06/2001 10/03/2003 08/18/2004 08/29/2005 11/03/2005

1 02/17/2006 09/28/2006,

PURPOSE

The purpose of this packet is to summarize and clarify the full Academic Memorandum on Ethical Principles and Review Procedures for Human Participants in Research (Memorandum). A copy of the Memorandum is on file in the library and in the Faculty Development Center. Faculty and research investigators are encouraged to read the full Memorandum. Forms that will be used by the IRB throughout the research process are presently found in this packet only.

RESPONSIBILITIES OF IRB

It is the responsibility of the Institutional Review Board (IRB) to provide independent initial and continuing review of research involving human participants. The IRB has been delegated by Elon University (the University) to protect the rights and welfare of human participants recruited for research activities conducted under the auspices of the University. The IRB has the right to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policies. The fundamental responsibilities of the IRB are to assess the risks and potential benefits of the investigation, ascertain the appropriateness of the methods used to gain participant consent, and to protect the rights and welfare of the individuals involved.

MEMBERSHIP AS OF SPRING 2008

Mathew Gendle, Chair Psychology, 2337 CB [email protected] x6431

Gregory Haenel Biology, 2625 CB

Tonya Riney Business Administration, 2075 CB

Michael Skube Communications, 2850 CB

Jack Smith Performing Arts, 2800 CB

Deborah Stetts Physical Therapy, 2085 CB

2 Susan Walton (voting, community representative)

Bonnie S. Bruno (non-voting, Ex-officio) Sponsored Programs, 2610 CB

RESEARCH / TEACHING TOOL

The IRB will review only those assignments, activities, or investigations that are defined as research. “Research” as defined by federal administrative bodies is “a systematic investigation designed to develop or contribute to generalizable knowledge” (45 CFR 46.102).  Research: those studies that are systematically designed to add to the general body of knowledge will be subject to IRB review (See Types of Review). Those studies designed as research in nature may be 1) a component of a content based course, 2) the primary focus of a research based course or 3) unassociated with a course of study.  Teaching Tool: course projects whose primary intent and design is pedagogical. The original design and intent are not to contribute to the body of knowledge. Although such activities are generally not subject to review, it is the position of the IRB that the individual faculty member retains ethical responsibility for the proper conduct of such instructional studies and that the ethical principles set forth in the Memorandum addressing the dignity and welfare of others and the respect for their right to confidentiality and freedom from undue harm are always to be followed.

 Teaching Tool:  Primarily pedagogical focused on non-research content: classroom or class projects that encourage students to connect course material with specific applications from their own lives or the lives of others. For example, in a course examining patterns of courtship and dating, students may be asked to interview someone from a different generation or cultural background to learn more about variations in dating norms.  Primarily pedagogical focused on research skill acquisition: in which the primary focus is not the acquisition of new knowledge, but rather the development of procedural, research skills  Ethical responsibility of individual faculty member: in each of the above instances, it is the position of the IRB that the individual faculty member retains ethical responsibility for the proper conduct of such assignments. The faculty member has a definite obligation to use such opportunities to instruct students in issues of ethical scholarship. The faculty is strongly encouraged to consult with departmental colleagues and/or members of the IRB in deciding whether a study is primarily pedagogical for the teaching of research skills or primarily research oriented and in assuring that the ethical principles stated in the Memorandum have been properly addressed.

3 TYPES OF REVIEWS

There are three types of research reviews:  Exempted  Expedited  Full The primary investigator will recommend whether the proposal qualifies as exempt or qualifies for expedited or full IRB review. The IRB certifies the final status of the proposal.

Exempted Review  Exempted: those research activities seen to involve minimal risk falling under the following categories: 1. Use of routine educational tests, surveys, or interviews. 2. Research conducted in established or commonly accepted educational settings examining pedagogical methods or questions. 3. Research involving collection or study of existing data, documents, records, pathological specimens, diagnostic specimens, if these sources are publicly available. 4. Research involving observation of public behavior (or participant observation).

Exceptions  The above proposals are not exempt if: 1. Data are recorded in such a manner that the identity of the particular participants can be determined, directly or through other information linked to the specific participants. 2. The data could reasonably place the participant at risk of criminal or civil liability or be damaging to participant’s financial standing or employability. 3. The research deals with sensitive aspects of the participant’s own behavior or experiences, such as illegal conduct, drug use, or past psychological experience. 4. The class of participants are considered vulnerable (children, prisoners).

Expedited Review  Expedited: those research activities involving no more than minimal risk falling under the following categories: 1. The research proposals that do not meet the criteria for exemption as defined above. 2. Collection of excreta and external secretions including sweat and saliva if the information is recorded by the investigator in such a manner that participants can be identified, directly or through identifiers linked to participants. 3. Recording data using non-invasive procedures such as surface application of sensors and anthropometric measurements (such as weighing) 4. Voice recordings made for research purposes. 5. Moderate exercise by healthy volunteers. 6. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate participants’ behavior and the research will not involve stress to the participants.

4 7. The study of existing data, documents, or records if the information recorded in such a manner as to identify the participants (directly or through identifiers).

Full Review  Full: those research activities 1. Involving more than minimal risk 2. Involves interventions or interactions not specified in any of the statements under Exempted or Expedited Review

REVIEW PROCEDURES

♦Exempted  Reviewed by IRB Chair and one other member  Possible outcomes  Exemption certified  Certified contingent upon specific modification/clarification  Referred for expedited or full IRB review ♦Expedited  Reviewed by IRB Chair and at least two other members  Possible outcomes  Approved  Approved contingent upon specific modification/clarification  Referred for full IRB review ♦Full  Reviewed by full IRB  Possible outcomes  Unconditional approval (2/3 majority)  Conditional approval (2/3 majority)  Rejection (less than 2/3 majority approval based on noncompliance with policies of guidelines)  Tabled (requires significant amount of additional information)

CRITERIA FOR APPROVAL

 Complies with ethical principles stated in the guidelines, specifically: 1. Risks to participants are minimized. 2. Risks are reasonable in relation to anticipated benefit. 3. Participants are recruited honestly, equitably, and without coercion. 4. Elements of informed consent via the consent form are present. 5. The investigator(s) have submitted the required paperwork.

5 INSTRUCTIONS TO AUTHORS

All proposals must be submitted to the Chairperson of the IRB. See ‘Type of Review’ on cover sheet for number of copies to be submitted.  Cover Sheet 1. Fill out cover sheet (see attached form in Appendix C). Cover sheet includes: a) Title of the study b) Name, address, social security number, and phone number of principal investigator c) Status of principal investigator d) Student information, if student is primary investigator e) Name(s) and phone number(s) of other researcher(s) f) Estimated beginning and ending date of study g) Academic purpose of research h) Sponsor/grant information i) Type of review (exempted, expedited, full)

NOTE: In order to facilitate timely reviews and reduce paper waste, electronic submissions are now used. While one signed and complete paper copy of each application is still required, electronic submission takes the place of the multiple hard copies that used to be required for exempted and expedited reviews. IRB applications should be submitted to the chair of the IRB. Electronic copies should be submitted to the chair via e-mail as .pdf or .doc files. Refer to the list below to determine how many paper and electronic copies are required for each proposal type.

Type of review expected: Exempted (Provide the original and 1 electronic copy) Expedited (Provide the original and 1 electronic copy) Full (Provide the original, 7 paper copies, and 1 electronic copy)  Body of proposal 2. A written proposal should be submitted to the IRB and shall contain the following: a) Statement of the research problem b) Description of the study population, sampling methodology, and specific criteria for selection of the participants c) Detailed description of the research design d) Your assessment of the risk and risk management (how risk is to be minimized) e) Potential benefits to human participants (even if there is/are none) f) Informed consent procedure (i) how investigator intends to obtain informed consent (ii) copy of consent form if written g) Describe procedures for insuring the confidentiality of data and anonymity of participants h) Length of time that records will be kept, where kept, by whom the records will be kept, and time and methods of destroying the data (can be included in confidentiality section) i) Feedback sheet or explanation of procedures for participant feedback (how will you provide individual and/or study results back to the subjects) j) Other documentation that the researcher feels would help the IRB better evaluate the proposal.

6 k) Statement of compliance. The following statement of compliance must appear on all proposals submitted for review:

To the best of my knowledge, the plan of conduct for this research conforms with the policies and procedures for the use of human participants at Elon University.

______Signature of the Primary Researcher Date

l) Faculty/Staff sponsor statement of approval. Proposals submitted by undergraduate and graduate students must be sponsored by a member of the faculty or staff. Sponsors of student research must submit an approval statement that describes briefly the nature of the project (e.g., senior seminar project; independent research project), the faculty or staff member’s relationship to the project (e.g. instructor, supervisor), and the procedures for monitoring student work on the project. The sponsor must also include the following statement of compliance in his or her approval statement:

To the best of my knowledge, the plan of conduct for this research conforms with the policies and procedures for the use of human participants at Elon University.

______Signature of the Faculty/Staff Sponsor Date

 Informed Consent 3. Copy of Informed Consent.

Informed consent shall be obtained from all persons participating as subjects in a research study. Most of the time, this will be obtained through the use of a written consent form. The form should be titled “Consent Form” NOT “Informed Consent”. The form is a means of achieving informed consent. (One is the action of obtaining the other.) The full procedures for obtaining informed consent are:

 Procedures: informed consent shall consist of any of the following: 1. Written consent document embodying the elements of informed consent. 2. ‘Short form’ written document which states that the elements of informed consent have been presented orally to the participant. (Note: Participants have to sign the forms used in # 1and 2 above.) 3. An alternative informed consent procedure provided that the proposal adequately documents a compelling reason for such alteration. For example, certain investigations of large numbers of people engaging in naturally occurring, public behavior might preclude obtaining prior informed consent from all persons present. Alternative informed consent procedures including waivers of informed consent as specified in the guidelines.

 Elements of Informed Consent 1. Any language used in a consent form must be understandable by participants.

7 2. Must include a statement that indicates the study involves research and states the purpose(s) of the research. You may want to add some general things the subject should know about research. 3. Must include how long the subjects’ participation will last (and sometimes where appropriate, the approximate number of subjects that will participate). 4. Must include a description of the procedures of the study. This should include what will be required of, or done to, the research subject. Identify any procedures that are experimental (that deviate from standard care or practice). 5. Must include a statement of risk(s) (reasonable and foreseeable) to participant followed by an explanation of the steps to be taken to protect the subjects from these risks. 6. Must include a statement of possible benefit(s) to participant even if there are none. 7. Must include a statement describing alternative procedures if the research involves clinical trials or there is more than one means of achieving an effect or treatment. 8. Must include a statement addressing the confidentiality of records including storage, length records are kept, access to records, where the data is stored, and how that data may be destroyed if not stored. Can be included as part of risk statements. 9. Statement regarding any possible compensation for participation. 10. If research involves more than minimal risk, an explanation of what should happen if the subject is injured during the research – if there is any compensation or treatment and where further information can be obtained. 11. Statement specifying contact personnel for answers to questions about the research (usually primary or secondary investigators) and participants’ rights (usually the Chair of the IRB). 12. Must include a statement that participation is voluntary and that the participant is free to withdraw from the study at any time without penalty of any kind which includes grades in class.

In certain circumstances, additional elements may be included in the consent form: 1. Include an explanation of the circumstances in which the investigator(s) may terminate the subject’s participation without regard to the subject’s consent. 2. Any additional costs to the subjects that may result from participation in the research. 3. An explanation of the consequences of a subject’s decision to withdraw and the procedures for terminating the subject’s participation. 4. A statement that new findings or new information gained during the course of the study may affect the subject’s willingness to participate in the study.

See Appendix B for an example of the elements to be included in of one type of consent form. Note that this example is explicit in detail that may not apply to all studies. However, the questions that are underlined address the elements of informed consent that must be included in all consent forms.

DEADLINES FOR THE ACADEMIC YEAR

At present, the IRB only officially meets in session during the regular academic year (fall and spring semesters). However, the IRB attempts to be flexible in meeting the needs of the research

8 investigators and tries to review proposals during non-academic times (Winter term and summer).

The IRB meets every month. Contact the Chair or other members for specific dates.

Deadlines for investigators to submit their proposals for consideration by the IRB are:  Full Review – not less than 8 working days prior to the published meeting dates

 Expedited or Certification for Exemption – may be submitted to the Chairperson at other times and all attempts will be made to process these proposals in a timely manner

DEADLINES FOR CLASS PROJECTS CLASSIFIED AS RESEARCH

The IRB attempts to notify investigators of the status of their proposals in a timely manner. However, when multiple proposals are received for immediate review, it is difficult for the reviewers to meet time restrictions. This is especially true when proposals are received when IRB members themselves have projects or activities that may take them out-of-town.

Therefore, the IRB respectfully requests that faculty members who will be employing original research as a classroom function to submit to the IRB a rough timetable of the research deadlines. If the IRB is aware that it will be receiving 8 reviews in a given time frame and that decisions are needed by another given time frame, it will help expedite the entire process.

FILES / RECORDS

By law (45 CFR 46.115), the IRB is required to maintain records of IRB activity including copies of all research proposals reviewed, minutes of meetings, and copies of correspondence between IRB and investigators.

ONGOING RESEARCH

In the upcoming year, all research projects that have been proposed since the inception of the IRB will be subject to review for continuation or termination. This is in accordance with the federal guidelines.

MISCELLANEOUS

There are topics that have not yet been addressed or clarified in the Academic Memorandum (ongoing reviews, more details on children as participants) that the IRB acknowledges may be instrumental in a given research proposal and for grant applications. The IRB intends to address these issues in its meetings and to propose amendments to the Academic Memorandum.

The IRB works with the Director of Sponsored Programs who is a non-voting, ex-officio member. The IRB utilizes the services of Sponsored Programs as a clearinghouse for proposals and as a central agency for all ongoing research.

9 APPENDIX A

i Definitions

 Research A systematic investigation designed to develop or contribute to generalizable knowledge.

 Human Participant A living individual about whom an investigator conducting research obtains: a) data through intervention or interaction with the individual b) identifiable private information

 Minimal Risk Any harm anticipated in the proposed research is neither more probable nor of greater magnitude than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

** The IRB acknowledges that information used in the preparation for this packet was obtained from: 1. Federal documents governing the policies and procedures of any IRB (45 CRF 46, Belmont Report, etc) 2. Elon University Academic Memorandum on Ethical Principles and Review Procedures for Human Participants in Research 3. University of North Carolina Academic Affairs Institutional Review Board Manual 4. Texas Woman’s University, Denton campus, Human Subjects Review Committee

ii iii APPENDIX B

SAMPLE COPY OF CONSENT FORM

iv Elon University Consent to Participate in a Research Study Adult Subjects ______

(DELETE THIS AND ALL OTHER INSTRUCTIONS IN ITALICS) IRB Study #______(Leave blank if new submission) Consent Form Version Date: ______(Enter or update for all submissions)

Title of Study:

Principal Investigator: (name and degree) Elon University Department: Phone number:

Co-Investigators: (names and degrees)

Sponsor: (National Cancer Institute, Name of Pharmaceutical Company, etc) ______

You are being asked to take part in a research study. The investigators listed above are in charge of the study; other professional persons may help them or act for them.

What are some general things you should know about research studies?

Research studies are designed to gain scientific knowledge that may help other people in the future. You may or may not receive any direct benefit from participating. There may also be risks associated with participating in research studies.

Your participation is voluntary. You may refuse to participate, or may withdraw your consent to participate in any study at any time, and for any reason, without jeopardizing your future care at this institution or your relationship with your doctor. If you are a patient with an illness, you do not have to participate in research in order to receive treatment.

Details about this particular study are discussed below. It is important that you understand this information so that you can decide in a free and informed manner whether you want to participate. You will be given a copy of this consent form. You are urged to ask the investigators named above, or staff members who may assist them, any questions you have about this study at any time.

of __ (repeat on each page)

v What is the purpose of this study? The purpose of this research study is ... (If applicable, include a statement that the study involves testing an investigational device, or an approved device whose use in this study is investigational. Bear in mind, in this section and all others, that you are describing complex concepts to laypeople.)

How many subjects will participate in this study? (For single-center studies) If you decide to participate, you will be one of approximately (number) subjects in this research study.

(For multi-center studies) A total of approximately (number) subjects at (number) institutions will take part in this study. A total of approximately (number) subjects from this institution are expected to participate.

How long will your participation last? Your participation in this study will last for approximately ... (How long entire study is projected to run is less important than this individual subject’s participation, in hours, days, months or years. Include required follow-up)

What will happen if you take part in the study? During the course of this study, the following will occur: (Describe in lay language, step-by-step, what will be required of, or done to, the research subject. This should include, but need not be limited to: Overall design. Methods and probability of assignment, randomization and placebos. If applicable, blinding procedure, and a statement that a research subject's treatment can be determined rapidly in case of emergencies.

Procedures to be performed, including frequency and follow-up.

Differentiate between procedures/test articles that are investigational or included solely for research purposes and those that are standard clinical care.

Research medications or supplements to be administered and method, dose and frequency of administration.

Number, frequency and duration of visits, if known.

Specific requirements of the research subject, such as post-treatment follow-up, diary cards, questionnaires, etc.

In research involving patients as subjects, provide the name of the physician responsible for the patient's welfare during the study.

vi Specimens to be collected including frequency and size/amount.

Are there any reasons you should not participate? You should not participate in this study if… (List only those exclusion criteria about which subjects will know, and that may be unknown to the investigator. Do not necessarily list all the exclusions shown in the Master Protocol, for which investigators will screen every subject.)

What are the possible risks or discomforts? This study might involve the following risks and/or discomforts to you: (For each research procedure/intervention, describe immediate and long-term physical, psychological, social and reproductive risks/discomforts. If frequency of such risks or discomforts is known from previous studies, provide estimates of frequency. It may be more meaningful for subjects to see side effects grouped as Common, Uncommon, Rare, etc, as opposed to a long unbroken list of every side effect ever noted.)

(If women of childbearing age are included as subjects and the research procedure/drug/device may cause harm to an unborn fetus or breast feeding child, state whether pregnancy or breast-feeding excludes participation, whether birth control is required (and if so, which method), and that the P.I. should be notified immediately if the subject becomes pregnant.)

In addition, there may be uncommon or previously unrecognized risks that might occur.

What are the possible benefits? The benefits to you of participating in this study may be… (Describe potential benefits that might reasonably be expected to result from this research. Identify those that might accrue to the individual subject as well as those that might benefit society in general. If the individual subject will receive no direct benefit, make a statement to that effect.)

If you choose not to participate, what other options do you have? You do not have to participate in this research study in order to receive treatment. Other procedures/treatments that are available are… (For research that does not involve treatment, eliminate this section. For protocols involving treatment, describe any alternative procedures or courses of treatment that might be available to the subject. For some terminally ill patients considering a treatment trial, supportive care only may be an alternative.)

What if we learn about new risks during the study? You will be given any new information gained during the course of the study that might affect your willingness to continue your participation.

vii How will your privacy be protected? No subjects will be identified in any report or publication about this study. Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, Elon University will take all steps allowable by law to protect the privacy of personal information.

(Indicate how privacy and confidentiality will be protected. How will records be secured? To whom will access be limited? Will names be used, or will there be ID numbers only, and a linkage file? Is any sensitive information being collected, and will it be treated differently?)

(If reviewed or sponsored by a manufacturer or government agency, include a statement that the manufacturer or government agency may review all records. If the study involves products regulated by the Food and Drug Administration (FDA), add a statement that the FDA may inspect the records.)

(Include the following if research is clinically relevant for these subjects. Delete for healthy volunteers.) Because this study involves the treatment of a medical condition, a copy of this consent form will be placed in your medical record. This will allow the doctors caring for you to obtain information about what drugs or procedures you are receiving in the study and treat you appropriately, if you have other health problems or needs during the study.

Will you be paid for participating? You will receive (amount) for your participation in this study.

(Or, “You will not be paid for your participation in this study.” if that is the case.)

(If payment will be made, address how payments will be prorated in the event the subject withdraws, or is withdrawn by the investigator, from the study prior to completion.)

Will it cost you anything to participate? The costs of this research will be... (e.g. “… billed to you and/or your insurance.” Or “… paid by the sponsor. There will be no costs to you for participating.” Elaborate as necessary, to describe specific items or procedures that may/may not be covered.)

What will happen if you are injured by this research? In the event of personal injury resulting directly from the research procedures, financial compensation cannot be provided by Elon University. All forms of medical diagnosis and treatment, (or moderate exercise programs, participation in this activity, etc.) whether routine or experimental, involve some risk of injury. In spite of all precautions, you might develop medical complications from participating in this study. If such complications arise, the researchers will assist you in obtaining appropriate medical treatment but Elon University does not provide

viii financial assistance for medical or other costs. You do not waive any liability rights for personal injury by signing this form.

(The above statement may be omitted if the study involves only minimal risk. "Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering both probability and magnitude, than those encountered in daily life or during the performance of routine physical or psychological examinations.)

(For research not involving diagnosis or treatment, omit the sentence: "All forms of diagnosis and treatment, whether routine or experimental, involve some risk of injury".

(If applicable, add a separate paragraph about any compensation for injury that will be provided by the study sponsor.)

What if you want to stop before your part in the study is complete? You can withdraw from this study at any time, without penalty. The investigators also have the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped.

(Modify the above paragraph, if necessary, to fit the study. For students participating in a study for which they were recruited during a class, make it clear that there will be no grade penalty should they choose to withdraw from the study)

What if you have questions about this study? You have the right to ask, and have answered, any questions you may have about this research. If you have further questions, or if a research-related injury occurs, you should call (name and degree of investigator) at (phone number).

What if you have questions about your rights as a subject? This research has been reviewed and approved by the IRB at Elon University, North Carolina. If you have any questions or concerns regarding your rights as a research subject, you may contact the Chairman of the IRB (Dr. Mathew Gendle) at 336-278-6431 or [email protected].

------Subject’s Agreement:

I have read the information provided above. I voluntarily agree to participate in this study.

______Signature of Research Subject Date

______Printed Name of Research Subject ______Signature of Person Obtaining Consent Date

ix ______Printed Name of Person Obtaining Consent

x APPENDIX C

IRB APPLICATION COVER PAGE

xi Elon University Application to Institutional Review Board (IRB) Cover Page

Title of the Study/Project: ______

Name of Principal Investigator: ______Email:______Phone: ______

Check Status of Principal Investigator: ____ Faculty ____ Student ____ Staff ____ Other

Address of Principal Investigator: ______

If the Principal Investigator is a student, provide the following information: Dept: ______Name, Campus box, & Phone # of Research Advisor: ______Email: ______Name(s) and phone number(s) of other investigator(s) ______

Estimated beginning date of the study: ______

Estimated completion date of the study: ______

Research being conducted for: ____ thesis ____ professional paper ____ research project ____ independent study ____ class project ____ other

If this research is or may be supported by a grant or outside sponsor, list name(s) of sponsor(s): ______Type of review expected: ______Exempted (Provide the original and 1 electronic copy) ______Expedited (Provide the original and 1 electronic copy) ______Full (Provide the original, 7 copies, and 1 electronic copy)

xii Date Application Received by IRB: ______PLEASE NOTE: IRB APPLICATIONS SHOULD BE SUBMITTED TO THE CHAIR OF THE IRB. Electronic copies should be submitted to the Chair via e-mail as .pdf or .doc files.