2. Agenda 1. Introduce the IRB 2. Define research 3. Discuss protection of human subjects 4. Identify ethics in research, consent 5. Explain what the IRB does 6. Describe how you interact with the IRB 7. Address next steps

3. Introducing the CCGA IRB The Institutional Review Board (IRB): Operates under federal regulations Charged with protecting the rights and welfare of people involved in research Keeps pace with the ever changing environment of human subjects research Facilitates and strengthens human subjects research conducted by investigators (faculty, administrators, staff, & students) at the institution

4. IRB: Role & Responsibility Oversees all research that involves human subjects. Protect the rights & welfare of human subjects recruited to participate in research activities conducted at or on behalf of your institution Responsible for approving and continuingly reviewing all research projects involving human subjects

5. What Do These Studies Have in Common? Were human research participants fully protected? Nuremberg Trials Tuskeegee Syphilis Experiments Wichita Jury Study The Thalidomide Experience Tearoom Trade Study Milgram Studies of Obedience to Authority San Antonio Contraception Study http://www.hhs.gov/ohrp/archive/related.html http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272525/

6. IRB Foundations Mandated by Federal Government: HHS: 45 CFR 46 FDA: 21 CFR 50 & 56 Ethical Guidance: Nuremburg Code Declaration of Helsinki Belmont Report State and local bodies Effective research practice

7. The Challenge of Self-Regulation Each institutional IRB functions independently Federal oversight from the Office of Human Research Protection (OHRP) Defines the Common Rule and implements the regulations (45 Code of Federal Regulations 46, subpart A) The FDA has additional regulations governing new drug and device trials State statutes and local legal counsel

8. What is Research? Regulations define research as …a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Systematic means that research methods are employed to test a hypothesis/propositions and draw conclusions. Generalizable refers to the dissemination of or intent to circulate findings to a scientific or professional audience. This generally includes the following:

9. What is Research? - continued Masters and doctoral theses Presentation at a scientific or professional meeting or conference, including poster presentation and abstract submissions Submission to or publication in a professional or scientific journal Generalizable knowledge is usually that which is disseminated through presentation and/or publication, and placed in the public domain

10. How is a Human Subject defined? Definition of HUMAN SUBJECT according to 45 CFR 46: living individual (s) 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 obtained for this research in a form associable with the individual (that is, the identity of the subject is or may readily be ascertained or associated with information)

11. Vulnerable Populations The IRB is mandated to apply a rigorous evaluation of the risk and benefits of the study, particularly when vulnerable subjects are asked to participate. If more than minimal risk is involved, some degree of benefit is usually required.

12. Vulnerable Populations Children (under 18 years) Cognitively Impaired Pregnant Women Fetuses Human in vitro Fertilization Prisoners

13. What is Minimal Risk? the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45CFR, part 46, secs. 102i and 111)

14. A Few Key Ethical Principles of Human Research Beneficence (i.e., minimize risk & maximize benefits) Justice (i.e., fairness in distribution of risks and benefits) Respect for Persons (i.e., acknowledging autonomy of participants/research subjects)

15. Competing Moral Principles Fulfillment of duties to research subjects Promotion of the general welfare of society through the conduct of research Takes precedence under most Circumstances... Autonomy, privacy Fair treatment Minimize risks Good clinical practice standard Research subjects have a moral responsibility to bear some of the risk in promoting the general welfare of society. Risks are reasonable in proportion to anticipated benefits

16. The Role of Consent Conducting human subjects research in a responsible manner requires that informed consent be obtained from potential subjects. Three of the fundamental components of informed consent are: 1. Give potential subjects adequate information about risks & benefits 2. Decision by subjects to enroll must be voluntary. 3. Subject must be competent to make choice of participation.

17. When is IRB review required? IRB review is required for all human subjects research carried out by CCGA faculty, staff or students: Federally funded research, Research involving FDA regulated products, Research not federally funded or not involving FDA regulated products, i.e. in house studies, research conducted under departmental grants, and unfunded research

18. Review Types & Risk Level Exempt All research procedures must fall into one or more of the exemption categories Do not need to inform IRB of any changes that occur during the course of an exempt study unless the change affects the review level and/or risk to subject Expedited Reviews studies that are no more than minimal risk AND where research procedures fall within one of the expedited categories Full Board Any study that is considered more than minimal risk is reviewed by a fully convened IRB

19. How does the IRB review research? Initial Review – 3 Types: Exempt Expedited Full Board Continuing Review IRB decides renewal term (at least once annually for most ongoing projects) Amendments Significant changes to study: protocol, consent, investigators, publication. Unanticipated Problems Protocol Deviation, Adverse Events, New Information, Subject Complaint Terminations Study end, final report

20. Common Model of Research Review 1. PI writes proposal 2. Scientific review of proposal a. External – e.g., NIH or other sponsor b. b. Internal – Unit-level review c. None – IRB becomes de facto scientific reviewer 3. Submit proposal to IRB 4. Initial IRB review a. Conducted by IRB chair, or committee b. b. May involve input from experts/consultants c. c. May involve communication with other standing committees (COI, bio/radiation safety, etc.) d. d. Communication with PI

21. Model of Research Review cont. 5. Study conducted a. Subjects recruited, consent obtained, enrolled b. PI follows good clinical practice 6. Ongoing administrative review / Review of protocol revisions / Adverse Event reporting 7. PI submits IRB annual report/termination notice 8. IRB close out of study

22. Submission Basics IRB Application (Word document from Website) Informed Consent document Study questionnaires/surveys Certificate of Human Subjects protection training for PIs and key study staff (CITI training) Recruitment materials: ads, radio announcements, brochures (if applicable) Investigational brochure or product labeling (e.g., for drug/device studies, if applicable)

23. Submission Basics cont. HIPAA Authorization or Waiver (if applicable) Conflict of interest documentation (if applicable) For grant funded research: Follow grant application procedures All Submissions Must include : One complete IRB application (including all attachments) submitted electronically, and One complete hard copy (including all attachments) All materials must be submitted directly to the IRB Administrator in Academic Affairs as a complete package Incomplete materials will not be accepted.

24. Helpful Submission Hints Include PI name on all submissions Include fax and email of PI and primary study contact Ensure page numbers are on all documents Update version date on all revised documents (if applicable) Include both versions of revised documents: Copy with changes highlighted or tracked Clean copy with changes incorporated but not highlighted Maintain required frequency of communication with your IRB throughout the life of the study – compliance is required even after receiving IRB approval Finish your IRB paperwork and reporting once study is completed prior to or following annual review

25. Frequently Asked Questions Where should I go if I have questions? Consult the IRB website When do I submit my protocol? How long will the review take? When submission packet is complete, you can submit to IRB for initial review. Allow IRB time to process review packet. Turn around time frame depends upon the type of proposal, when it is submitted, and when the next committee review meeting will convene (typically the last Monday of every month). When should I submit for continuing review? PIs will be notified by IRB when their study is due for continuing review. CRs should be submitted 8 weeks prior to the approval expiration date. What should I do if my approval expires? All study activities should stop (interviews, data collection, recruitment, etc.). If the study expires, you must contact the IRB administrator for further instruction on resubmission.

26. Where is the IRB located? IRB virtual home : http://www.ccga.edu/IRB/http://www.ccga.edu/IRB/ IRB Chair (2012-13), Dr. M. Karen Hambright, Professor of Psychology 214 Academic Commons North College of Coastal Georgia One College Drive Brunswick, GA 31520-3632 USA Office: 912.279.5879 | Fax: 912.279.5878 khambright@ccga.edu IRB Administrator, Ms. Sandra Bunn Coordinator of Faculty and Academic Services College of Coastal Georgia One College Drive Brunswick, GA 31520-3632 USA Office: 912.279.5965 | Fax: 912.279.5721 sbunn@ccga.edu

27. Thank You. 2012-13 Institutional Review Board Questions?