Protecting Human Participants in Research orip.syr/humanresearch.html

1. Protecting Human Participantsin Researchhttp://orip.syr.edu/humanresearch.html Office of Research Integrity and Protections (ORIP) Jeanne Diederich IRB Administrator

2. What Is the Institutional Review Board and what is it’s role?

3. Composition of the IRB The IRB must be comprised of at least 5 members from relevant academic disciplines and include at least one non-affiliated community member.

4. Role of the IRB • The role of the IRB is to protect human subjects participating in research. • The IRB is charged to review ALL projects involving human subjects for compliance with institutional, state, local and federal laws as well as the ethical principals contained in the Belmont Report.

5. Federal Wide Assurance • Receiving federal funds creates an obligation that the recipient (SU) will assure that people participating in research are: • Protected from excessive risk/harm (Beneficence) • Participate voluntarily (Autonomy) • Selected equitably (Justice) • In the FWA, the institution pledges to follow certain ethical principles (Belmont Report) and federal regulations (45 CFR 46-Part A). • Regardless of Whether the Research is Funded or Not • Plus – it’s the right thing to do…

6. The Belmont ReportBasic Ethical Principles • Respect for Persons • Beneficence-(1)do not harm and (2) maximize possible benefits and minimize possible harms. • Justice- fair procedures and outcomes in the selection of research subjects

7. Federal Policy for the Protection of Human Subjects Common Rule45 CFR 46 (Part A) Regulations for: • The definition of research • IRB membership • IRB functions and operations • IRB review of research • Criteria for IRB approval of research • IRB’s authority to suspend or terminate approval of research • IRB records • General requirements for informed consent • Documentation of informed consent

8. Definition of Human Subjects Research as defined in 45 CFR 46 • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. • Human subject means 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.

9. Categories of IRB Review • Exempt • Expedited • Full Board

10. Exempt Review • Exempt • Some studies meet the definition of human subjects research but may qualify for exemption under one or more of the 6 categories defined by the Federal Regulations. • Examples: anonymous surveys, existing data that is publicly available, and research conducted in established or commonly accepted educational settings involving normal educational practices • Exemption must be determined by the IRB, not the investigator (must submit and exempt application)

11. Exempt Review Process Exempt applications are reviewed by the ORIP Director, Tracy Cromp. Turn around time for review is approximately 5-7 business days. There are no deadlines for exempt applications. Allow a minimum of 4 weeks for the review process. Exempt studies are authorized for a period of 5 years.

12. Expedited Review • Expedited • 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 9 categories defined by the Federal Regulations. • May be reviewed by one member of the IRB, usually the IRB Chair unless additional expertise is needed.

13. Expedited Review-con’t • Common examples of expedited research: • Research on individual or group characteristics or behavior • Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. • Collection of data through noninvasive procedures routinely employed in clinical practice (moderate exercise, blood pressure screening, muscular strength and flexibility testing, and body composition assessment)

14. Expedited Review Process Turn around time for review is approximately 7-10 business days. There are no deadlines for expedited applications. Allow a minimum of 4 weeks for the review process. Expedited studies are approved for a period of one year, (unless the IRB determines more frequent review is necessary) and are renewable for up to 7 years.

15. Full Board Review • The research involves greater than minimal risk: Harm or discomfort > those encountered in daily life • Potential illegal behavior • Under age drinking • Child abuse or neglect • Sensitive topics that could be damaging to participants • Disclosure of medical status • Sexual Behavior • The research involves a population requiring FBR • Legally restricted participants

16. Full Board Review Process Full board applications must be reviewed at a convened meeting of the IRB with a majority of IRB members in attendance. There is a hard deadline for full board applications. Full board applications must be received two weeks prior to the scheduled IRB meeting. The IRB meets monthly except during the month of July. The meeting schedule is posted on our website.

17. Full Board Review Process-con’t Allow a minimum of 8 weeks for the full board review approval process. Full board applications can be approved for up to 365 days from the date of review (unless the IRB determines more frequent review is necessary) and are renewable for up to 7 years.

18. Application Content • Purpose of Research (Rationale or research question) • Approach/Method –What are you going to do and what is going to happen to the subject? • Qualifications of the Researchers • Characteristics of the Subject population to be Recruited • Special Groups Involved in Research • Type of Informed Consent to Be Obtained • Precautions to Ensure Privacy and Confidentiality • Risks to Subjects (physical, psychological, financial, etc.) and how the risks will be managed. • Benefits to Subjects and Society at Large - How Do the Benefits Outweigh the Risks?

19. Application Content-con’t • All applications should be completed under the guidance of the student’s faculty advisor and reviewed by the faculty advisor prior to submission. • The application must be signed by the faculty advisor and the student .

20. Informed Consent • Required elements include (are not limited to): • Statement – that the study involves “research” • Purpose of Research • Procedures involved in the Research • Duration of Involvement in the Research • Participation is Voluntary-Right to withdraw at anytime without Penalty • Right to confidentiality • Risks and Benefits • Who to Contact for More Information or Questions • Who to Contact if a Participant is Harmed or Has Concerns

21. Informed Consent-con’t • Use everyday language appropriate to potential participant (readable and clear) • On SU Letterhead • Title of Research • Signature lines • Sample available at http://orip.syr.edu/IRBInstructions.htm • Keep signed documents for at least 3 years after the study has closed

22. Outcomes of Review • Once your application has been submitted, the IRB can: • Approve • Request modification(s) or additional information • Disapprove • Re-Categorize the research as Exempt, Expedited or Full

23. Training Requirements • CITI Training is required for all Expedited and Full Board Applications. • All persons listed in the protocol application that will have direct contact with participants and or identifiable human participant data are required to complete the CITI training appropriate to their role in the research. • No Expedited or Full Board studies will be approved until CITI training requirements are satisfied.

24. Amendments • Needed whenever anything changes in materials originally submitted (the “protocol”) • Cannot implement change to the protocol without prior IRB review/approval. - Exception: if the change is essential to protect human participants from harm

25. Reminders…. • No human subjects research can be conducted without IRB approval or exemption • Collaborative IRB Training Initiative (CITI) is required by all individuals actively engaged in the research (not required for exempt research) • Full board and expedited applications can be approved for up to 365 days (unless IRB determines more frequent review is necessary). • Allow enough time for your application to be approved, it can take up to two months if revisions are needed.

26. Where do I go for help? • The Office of Research Integrity and Protections: 121 Bowne Hall Phone Number: 443-3013 Email: orip@syr.edu