Molloy College HUMAN SUBJECT RESEARCH PROPOSAL FORM

Molloy College

HUMAN SUBJECT RESEARCH PROPOSAL FORM BASIC APPLICATION FOR RESEARCH INVOLVING HUMAN SUBJECTS

I. IDENTIFYING DATA

Principal Investigator Name (Degree) Department/Division Email Phone: Completion Dates RC and HSP CITI training

I accept responsibility for conducting the proposed research in accordance with the policy regarding protection of human subjects as specified by the Molloy College Institutional Review Board, including the supervision of faculty and student co-investigators. By typing your name below, you are electronically signing this document.

Signature:

Other Investigator(s) Department/ Email Completion Role in Name Division Date RCR Study (Use and HSP Codes below, CITI training include ALL that apply)

Role Code Recruitment A Conduct Informed Consent B Provide Intervention (tests, procedures, questionnaires) C Access Stored Pre-existing Documents D Obtain History (Medical, Social, Cognitive Psychological) E Conduct Exam (Physical, Psychological, Cognitive) F Collect Data ( biological samples, Vital Signs- e.g. pulse, recordings, surveys, G observations) Manage Data and Research Records H Analyze Data I Other (please specify) J 1

I accept responsibility for conducting the proposed research in accordance with the policy regarding protection of human subjects as specified by the Molloy College Institutional Review Board.

Signature (each co-investigator or others):

NOTE- If this study is a clinical trial, Good Clinical Practice (GCP) needs to be completed and on file for each investigator.

Title of the Research:

Date submitted:

Reason for Study: ___ Degree Requirement. School affiliation: Committee Chairperson: ___ Independent Study ___ Other (Specify):

STUDY DESCRIPTION: 1. Lay Summary Provide an abstract of the proposed research study in language that can be understood by a non-scientist, including all procedures that will involve human subjects and their data. (250- word limit)

2. Describe the Purpose and Objectives of this Study:

Have you submitted this to any other IRBs? __ Yes __ No

If yes, to which IRB? What was the outcome of that review?

II. DECISIONS REGARDING IS ACTIVITY RESEARCH; DOES IT INVOLVE HUMAN SUBJECTS? CATEGORY OF REVEW? CLINICAL TRIAL 3 DEFINITION MET?

A. RESEARCH 1. Indicate whether the activity meets the following criteria: ☐ The activity a systematic investigation: an activity that involves a prospective research plan which incorporates data collection, quantitative OR qualitative, and data analysis to answer a research question.

☐ The activity is designed to develop or contribute generalizable knowledge: designed to draw general conclusions (i.e. knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

2. Are both criteria met? ☐ Yes. The activity meets the definition of research. If YES, you MUST PROCEED TO #2B BELOW. This activity is Research and will need IRB approval.

☐ No. The activity is not research and does not need IRB approval, however, it will undergo Molloy IRB review as to a classification as an Action Research (AR) Project, Quality Improvement (QI), Evidence-based Practice (EBP) Project or Market Research Project. The Molloy IRB will then provide applicant the directive to proceed. STOP HERE and GO TO ACTION RESEARCH, MARKET RESEARCH PROJECT or QI or EBP forms AND complete for submission to IRB for determination.

The finding of the project may be published if NO individual level or identifiable data are used. An example of text for publication in a journal could read: “This action research (or Quality Improvement or Evidence-based practice, or Market Research Project) was reviewed by the Molloy College IRB and deemed to not be research as defined the Common Rule 45 CFR part 46, subpart A.

IF THE ACTIVITY MET BOTH ABOVE CRITERIA, IT IS RESEARCH. NOW, IS THIS HUMAN SUBJECT RESEARCH?

B. HUMAN SUBJECTS 1. Indicate whether the research meets the following criteria:  The research involves living individuals.  The investigator will obtain data or information about these individuals.  The investigator will obtain EITHER of the following: Data through intervention or interaction with the individuals. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) And manipulations of the subject or subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

4 Identifiable private information. Private information includes information about behavior that occurs in a context in which an individual can reasonable expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. (For example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may be readily ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving humans.

2.Are all of the criteria met? Yes. The research involves human subjects. Go to next section (C.) to decide category of determination. No . The research does not involve human subjects. Contact IRB for determination of this activity.

C. CATEGORIES OF EXEMPT and EXPEDITED HUMAN SUBJECTS RESEARCH PROTOCOLS DETERMINATION:

EXEMPTION 1. Does the research involve prisoners? Yes. The research is not eligible for exemption. FULL BOARD REVIEW REQUIRED. No. Review the Exemption/Expedited Categories.

2. Exemption Categories. To be exempt, the only involvement of the human subjects must be in one or more of the following categories. Indicate all applicable.

45 CFR 46.101(b) Categories of Exempt Human Subjects Research* 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods. 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: a. information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and b. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation. 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph # 2 (above) if: a. the human subjects are elected or appointed public officials or candidates for public office, or b. federal statute(s) require(s) without exception that the

5 confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. 4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects. 5. Research and demonstration projects which are conducted by or subject to the approval of (federal) department or agency heads and which are designed to study, evaluate or otherwise examine: (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures or (d) possible changes in methods or levels of payment for benefits or services under those programs. 6. Taste and food quality evaluation and consumer acceptance studies, if: a. wholesome foods without additives are consumed or b. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U. S. Department of Agriculture. *Important Notes: • Molloy IRB registration is required for all exempt research. • "Existing" means at the time the research is proposed. • These exemptions do not apply to research involving prisoners (45 CFR Part 46 Subpart C). • Exempt, Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed. EXPEDITED Categories of Expedited Review Human Subjects Research (45 CFR 46.110 and 21 CFR 56.110)* In 1998, the Department of Health and Human Services (DHHS 45 CFR 46.110) and Food and Drug Administration (FDA 21 CFR 56.110) regulations were revised with regard to categories of research that may be reviewed by an expedited review procedure. The list of research categories eligible for an expedited review was expanded and clarified. The following two criteria must be met before a protocol may be considered for an expedited review process: 1. The activity must present no more than minimal risk to subjects. The regulatory definition of "minimal risk" is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life

6 or during the performance of routine physical or psychological examinations or tests. AND 2. The protocol procedures must be listed as one of the categories in the regulations' list of procedures that qualify for an expedited review process. The research categories that may qualify for an expedited review process are listed below. Additional information may be found at: http://www.hhs.gov/ohrp/policy/exprev.html, http://www.hhs.gov/ohrp/policy/expedited98.html or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm119074.htm. The investigator must be aware of the following information regarding expedited research: The categories in the expedited research list apply regardless of the age of subjects, except as noted. 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 in terms of 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. The expedited review procedure may not be used for classified research involving human subjects. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened (full board)--utilized by the IRB. Categories one (1) through seven (7) below pertain to both initial and continuing IRB review. The list of research categories eligible for an expedited review: (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. (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 children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with

7 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 gumbase 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). (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.

8 (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 (c) where the remaining research activities are limited to data analysis. (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. *The final decision on whether an expedited review process may be used rests with the IRB. D- IS YOUR STUDY A CLINICAL TRIAL?

Use the following four questions to determine the difference between a clinical study and a clinical trial: 1. Does the study involve human participants? 2. Are the participants prospectively assigned to an intervention? 3. Is the study designed to evaluate the effect of the intervention on the participants? 4. Is the effect being evaluated a health-related biomedical or behavioral outcome? If the answers to the above 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…

 You are studying healthy participants  Your study does not have a comparison group (e.g., placebo or control)  Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug  Your study is utilizing a behavioral intervention

NOTE: Studies intended solely to refine measures are not considered clinical trials. Studies that involve secondary research with biological specimens or health information are not clinical trials. YOU MUST REGISTER YOUR CLINICAL TRIAL AT CLINICAL TRIALS.GOV TO BE IN COMPLIANCE. Go to: https://clinicaltrials.gov/ct2/manage-recs/how-register (CONTACT IRB CHAIR TO BEGIN THIS PROCESS)

9 In the judgment of the Principal Investigator, this research qualifies for which of the following

__ Exempt __ Expedited __ Full Board Review*

*If research study is a clinical trial and requires full board review, the Good Clinical Practice (GCP) guidelines must be adhered to including GCP training demonstrated by all on protocol by completion of CITI modules. (Good Clinical Practice (GCP) is the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides regulators assurance that data are reported, results are credible and accurate, and that the rights, confidentiality, and well-being of trial subjects, are protected.)

Research Category Check all categories that apply:

__ Education Research __ Gene Transfer Research __ Survey/Interview __ Medical Records __ Audio/Video Recording __ Stem Cell Research __ Oral History __ Medical Imaging __ Internet-based __ Human/Animal Tissue __ Analysis of Existing Data __ Animal Research __ International Research __ Pathogens __ Other (specify) __ Hazardous Substances __ Controlled Substances

1 0

Is the study investigator-initiated? YES __ N O___

If funded, please list funding agency and award dates and number

III. DESCRIPTION OF HUMAN SUBJECT SAFEGUARDS AND RIGHTS

A. Risks/Benefits to Participants 1. Identify possible psychological or physical risks* or discomforts to participants and safeguards put in place to lessen possible risks. (These may be of a physical, psychological, social or legal nature. If subjects are vulnerable populations or if risks are more than minimal, please describe in detail what additional safeguards will be taken AND FULL BOARD REVIEW IS REQUIRED.)

* The regulatory definition of "minimal risk" is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

10 2. Identify the benefits to the SUBJECT:

3. Do benefits outweigh risks in your opinion? __ Yes __ No

4a. Are there potential legal risks to the Principal Investigator or to the College? __ Yes __ No

B. Collection of data (provide a chart if more than one visit per subject) 1. Where will it take place? (Institutions(s) and locations within institution(s))

2. When will it take place? (Date(s)) Period of time needed (days/weeks/months) Length of time needed (minutes/hours)- for each visit AND total per subject (INCLUDE A FLOWCHART OUTLINING SUBJECT BURDEN IF MORE THAN ONE VISIT).

10 3. Name of Instrument to be used (if standardized):

Where available:

If not standardized instrument, attach instrument.

4. Describe methodology to be used (specific protocol design of study):

10 5. Population, including number of subjects (e.g., justification for number of subjects- power analysis, pilot study explanation, saturation rationale), inclusion/exclusion criteria, age of subjects:

The study population may include (check all categories which may be included, by design or incidentally) *: Minors Students Pregnant women Low Income Persons Women of Childbearing Age Minorities Institutionalized Persons (Includes Incompetent Persons (or those with prisoners) diminished capacity Other (specify)

10 *[NOTE: IF ANY STUDY SUBJECTS ARE CONSIDERED VULNERABLE BY THE FEDERAL GOVERNMENT, PLEASE EXPLAIN ADDITIONAL MEASURES YOU ARE TAKING TO PROTECT THEIR RIGHTS.]

ALSO, IF you are including children, ASSENT must be addressed- https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/children- research/index.html If you are including Incompetent Person then LEGAL AUTHORIZED REPRESENTATIVE must be addressed- https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html .

How are subjects recruited and selected (describe recruitment process)? [ATTACH RECRUITMENT INFORMATION/FLYER]

What incentives will be offered, if any?

Are you associated with the subjects (e.g., your students, employees, patients)? Yes No __ _

If yes, please explain the nature of the association and what measures you are taking to protect subjects’ rights, including safeguards against any coercion.

Will subjects be minors (under 18) or otherwise not fully competent to consent? Yes ____ * No ___ *If yes, explain safeguards in place, and identify the consent process that will be used in accordance with CFR guidelines (https://www.hhs.gov/ohrp/regulations-and- policy/guidance/vulnerable-populations/index.html

Will this research be conducted with subjects who reside in another country, or who reside in the U.S. but in a cultural/ethnic context different from traditional U.S. society/culture (including non-English language speakers)? ___ Yes* ___ No

*If yes, explain, and required cultural attestation and approval of local human subject’s research ethics board required (https://www.hhs.gov/ohrp/international/index.html )

13 * Additionally, will there be any corresponding complications in your ability to minimize risks to subjects, maintain their confidentiality and/or assure their right to voluntary informed consent? ___ Yes* ___ No * If yes, what are these complications and how will you resolve them?

C. Informed Consent

1. Describe how and to what extent participants will be informed about the research before they give their consent. Please attach a copy of the informed consent letter you will use based on the Molloy College Informed Consent template. (It should be at the 8th grade reading level, or lower as dictated by the needs of the subjects.). IF MINORS ARE PARTICIPANTS- ASSENT APPROPRIATE FOR AGE GROUP MUST BE ADDRESSED. Informed consent is a process, and must include basic elements of

2. Are you requesting a waiver of consent, if yes, why? Yes No

15 3. Are you requesting a waiver of documentation of informed consent, if yes, why? Yes No

4. Does your investigation involve incomplete disclosure of the research purpose or deception of subjects? ___ Yes ___ No

[NOTE: DESCRIBE ANY DECEPTION, IF ANY, TO BE USED WITH HUMAN SUBJECTS.] If yes, be sure to include rationale and copies of your debriefing procedures for subjects.

5. If this study involves more than one interaction, describe how ongoing inform consent will be maintained at each visit.

6. Indicate how subjects can, if they wish, withdraw from the study. [IF PROCEDURES ARE POTENTIALLY HARMFUL, DESCRIBE ARRANGEMENTS FOR MEDICAL REFERRAL OR OTHER ASSISTANCE. IF EXPECTED CULTURAL OR LANGUAGE PROBLEMS, DESCRIBE PROVISIONS TO BE MADE FOR CONSENT.]

17 D. Privacy/Confidentiality

1. Does the project involve protected health information (PHI) as defined by the Health Insurance Portability and Accountability Act (HIPAA) or protected information as defined by Title 34, Part 99--Family Educational Rights and Privacy(FERPA)?

Yes No

If yes, upload a list of HIPAA and/ or variables being collected and data de-identification and protection plan (https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de- identification/index.html#protected ) (https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5&node=34:1.1.1.1.33 )

NOTE: Consent will be needed for access to HIPAA or FERPA protected data.

2. Describe whether the research will involve observation or intrusion in situations where subjects have a reasonable expectation of privacy (where, how, and when will research occur).

3. If records are to be examined, has appropriate permission been sought, provide 18 documentation of approval (describe permissions obtained from [who, when, what specific records] if applicable)?

4. Specify how subjects’ anonymity will be achieved and/or how confidentiality will be maintained. His should include plan for anonymity or confidentiality during interactions with subjects AND additional data protection plan addressed. Data acquisition, storage, transfer, dissemination, and destruction plan must be addressed. See Molloy College suggestions for data protection plan posted on IRB website.

19 "DEFINITIONS OFTEN USED IN DATA PROTECTION PLANS:"

What is the difference between the terms coded, de-identified, and anonymous?

 Coded: Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s); but the original identifiers are retained in such a way that they can be traced back to the source(s) by someone with the code. Note: A code is sometimes also referred to as a “key,” “link,” or “map.”  De-identified: All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). Note: For purposes of HRPP policy, protected health information is de- identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule). For more information, including the list of identifiers that must be removed to de-identify health information, see HIPAA and Human Subjects Research.  Anonymous data: Unidentified (i.e., personally identifiable information was not collected, or if collected, identifiers were not retained and cannot be retrieved); information or materials (e.g., data or specimens) that cannot be linked directly or indirectly by anyone to their source(s).

E. Use of data

1. Describe how data will be used, stored, disseminated, and disposed.

20 2. Will subjects be given research results if they so request? Yes No

[ANY FINANCIAL INTEREST IN THE RESEARCH? IF SO, BRIEFLY EXPLAIN AND ATTACH A STATEMENT TO BE DISTRIBUTED. ADDITIONALLY, CONFLICT AND POTENTIAL CONFLICT OF INTERESTS WILL NEED TO BE DECLARED- CONTACT IRB CHAIR]

III. Please submit electronic documents with all components of:

A. Proposal form (this application) B. Proposal Protocol (specific protocol details- USE THE KEY ELEMENTS OF A RESEARCH PROTOCOL IN THIS APPENDIX on Pages 15- 16 as a guide for elements to include) [The Proposal Protocol is a proposal that includes specifics about the research protocol such as how the applicant will recruit and enroll subjects such as contact letters, the data collection procedures such as location, and assurances of human subject protection]. This is a more detailed version of the protocol than the Abstract and information contained within the application (proposal form) C. Research tool(s) D. Consent form and recruitment letter

All applications must be submitted as one hard copy and one e-copy, submitted to the email addresses of the Co-Chairpersons of the IRB, or directly to the Molloy College IRB email address ([email protected]).

Signature(s) of investigator(s) Date: (Electronic signature with email acceptable):

21 APPENDIX

KEY ELEMENTS OF A RESEARCH PROTOCOL for EXECUTIVE SUMMARY and IRB APPLICATION. (Elements of Protocol should be aligned with the Consent Form).

What is a research protocol? It is the formal design or plan of an experiment or research activity. It is the plan submitted to an Institutional Review Board for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on collected data. If your research protocol is NOT a CLINICAL research protocol, the following information is still applicable except perhaps stopping rules or discontinuation criteria and hypotheses for qualitative design. A Molloy College research protocol should include the following:

1. Executive Information a. Protocol title, version number and version date b. Name and address of principal investigator c. Site(s) where study will be performed

2. Background/Rationale/Literature Review - basis for doing the clinical research study.

3. Hypothesis/Key Questions - the hypothesis being evaluated; the key questions being asked in the research study.

4. Research Objectives and Purpose - an extension of the hypothesis/key questions--can be combined. Describe what procedures and research interventions are is being conducted at Molloy College.

5. Research Methods Study Design (includes some or all of the following) Primary and secondary endpoints Type/design of the study (double-blind, placebo-controlled, etc.) Measures taken to avoid/minimize bias (randomization, blinding) Study treatments or interventions Expected duration of subject participation; what is done and when Stopping rules or discontinuation criteria

6. Selection and Withdrawal of Subjects Inclusion criteria (include age range when subjects are being enrolled/consented) Exclusion criteria Withdrawal criteria (if applicable) Recruitment Plan (if subjects are enrolled/consented) [age range, number of subjects at Molloy College and all sites, list of all projects sites where subjects will be recruited) Consenting Procedure (location, who will consent subjects, etc.) Subject Compensation

7. Efficacy Assessment

8. Risk

9. Benefit

10. Safety Assessment – including recording adverse events

11. Statistical Analysis Statistical methods including interim analysis if appropriate Number of subjects to be enrolled Rationale for choice of sample size (power calculation and clinical justification) Level of significance to be used Criteria for terminating the study Procedures for reporting deviations from the original plan Selection of subjects for inclusion in the analysis

12. Anticipated Results and Potential Pitfalls

13. Discussion of Next Steps

14. Scientific References/Bibliography