IRB Tutorial CLICK HERE

1. IRBTutorial CLICK HERE

2. Institutional Review BoardTutorial for Faculty & Staff

3. The College of New JerseyInstitutional Review Board • What is the IRB? • What is its purview? • How do I receive IRB approval for conducting human subjects research?

4. The College of New JerseyInstitutional Review Board • What is the IRB? • What is its purview? (or, what is human subjects research?) • How do I receive IRB approval for conducting human subjects research?

5. The College of New JerseyInstitutional Review Board • Established to protect rights and welfare of human subjects in research in accordance with Federalwide Assurance (FWA00004576) • Must meet federal guidelines as specified in Title 45 Code of Federal Regulations Part 46. • Charged with responsibility and authority to approve, require modifications in, halt unapproved or non-compliant research.

6. The College of New JerseyInstitutional Review Board • What is the IRB? • What is its purview? (or, what is human subjects research?) • How do I receive IRB approval for conducting human subjects research?

7. As a rule of thumb, IF . . . • Is the activity a systematic investigation designed to develop or contribute to generalizable knowledge? [45 CFR 46.102(d)] • Does the research involve obtaining information about living individuals? [45 CFR 46.102(f)] • Does the research involve intervention or interaction with the individuals? [45 CFR 46.102(f)(1),(2)] • . . .THEN your scholarly activity falls under the purview of 45 CFR part 46

8. Additional guidelines and regulations can be found in IRB policy manual. source: http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm

9. The College of New JerseyInstitutional Review Board • What is the IRB? • What is its purview? (or, what is human subjects research?) • How do I receive IRB approval for conducting human subjects research?

12. Workflow Overview PI Receives Training PI Submits Proposal Notification sent to PI & IRB IRB Reviews Proposal PI Reviews Feedback Notification sent to PI if revisions are required Notification sent to IRB if revisions are made IRB Approval PI Submits Report Notification sent to PI & IRB Notification sent to PI & IRB

13. Workflow Process STEP 1: PI Receives Training Online & Retains Certificate Principal investigators and student investigators are required to undergo online training and obtain NIH certification in conducting research involving human subjects. This certification must be renewed every three years. STEP 2: PI Generates Consent Document Effective August 2010, principal investigators are required to generate and upload consent documents using the eConsent form available on the eIRB system. STEP 3: PI Submits Proposal PI will login into the eIRB System and submit proposal (e.g. includes online application, eConsent, and supporting materials). Once the chair assigns the proposal to IRB reviewers, the PI will receive an e-mail notification that the proposal is in review. STEP 4: IRB Evaluates Proposal and Responds to PI IRB reviewers will read your proposal and provide feedback within the system. The PI will receive an e-mail notification if revisions are required.

14. Workflow Process STEP 4: PI Reviews Feedback and Addresses Concerns (if any) The PI will login into the eIRB System and respond to feedback by updating supporting materials or the application. The IRB reviewers will receive e-mail notifications when the proposal has been updated. Once the PI has addressed all of the concerns, IRB reviewers will recommend the proposal for approval. STEP 5: IRB Approves Proposal and PI Begins Research The IRB Chair approves the proposal and sets the expiration date for the protocol. The PI will receive an e-mail notification that the proposal is approved. Approval is granted on the condition that any deviation from the protocol will be submitted for separate approval in the eIRB System. STEP 6: PI Submits Annual Report and Renews Proposal to Continue Research Approval is valid until the expiration date of your protocol. You are required to apply for a renewal at least 45 days before the expiration date for as long as the study is active.

15. AGAIN, first decide: Is your scholarly activity research involving human subjects, as codified under 45 CFR 46.101?

16. THEN decide: What TYPE of research is it?

19. As a rule of thumb, IF . . . • conducted in established or commonly accepted educational settings, involving normal education practices • use of educational tests, survey procedures, interview procedures, or observation of public behavior • collection or study of existing data, documents, records, or pathological or diagnostic specimens • studying, evaluation, or examining public benefit or service programs • taste and food quality evaluation or consumer acceptance studies • . . .THEN your human subjects research falls under exempt category. [45 CFR part 46.101(i), 45 CFR part 46.401(b)]

20. Additional guidelines and regulations regarding exemptions can be found in IRB policy manual. http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm

22. As a general rule of thumb, EXPEDITED research categories may include • Collecting data from subjects 18 or older using non-invasive procedures routinely employed in clinical practice. • Moderate exercise by healthy volunteers. • Study of existing data, documents, records, pathological specimens, or diagnostic specimens. • Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory or test development. • REFER TO THE POLICY MANUAL FOR DETAILED LIST OF RESEARCH CATEGORIES and EXCEPTIONS

24. As a general rule of thumb, following categories fall under FULL BOARD review • Research characteristic: • 1.Procedure may result in greater than minimal risk • Participant characteristics: • Children under the age of 18 • Pregnant women • Prisoners • Individuals with cognitive impairments • Senior citizens. • REFER TO THE POLICY MANUAL FOR DETAILS

25. Step 3: Submit the IRB proposal, following the step-by-step instructions.

26. Helpful Hint: Complete all forms and documentation prior to submitting the IRB proposal.

27. Helpful Hint: Use the sample forms that have been provided for you as you gather documentation.

28. IRB Protocol Review Standards [45 CFR 46.111] • Proposed research design is scientifically sound and will not unnecessarily expose subjects to risk. • Risks to subjects are reasonable in relations to anticipated benefits to subjects and the importance of knowledge that may reasonably be expected to result. • Subjects selection is equitable. • Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence. • Informed consent is obtained from research subjects. • Risks to subjects are minimized. • Subjects privacy and confidentiality are maximized.

29. Informed Consent [45 CFR 46.116 (a) through (f)] • Some common mistakes and missing elements: • A statement that the study involves research and explanation of the purpose of the research. • Description of: duration, procedures , risks , benefits. • Statement describing confidentiality of records. • Contact info about the research and participant rights, including contact info for IRB chair for additional questions and concerns. • Statement that participation is voluntary and that refusal or termination of participation will not result in penalty or harm. • Parental permission and child assent for Ss under 18. • REFER TO THE POLICY MANUAL FOR DETAILS

31. The College of New JerseyInstitutional Review Board • Thank you! • www.tcnj.edu/~irb