HRPP Policies & Forms

1. HRPP Policies & Forms Created/Revised for AAHRPP

2. Outline • Newly-Created Policies • Revised Policies • Newly-Created Forms • Revised Forms • New Procedures

3. NEWLY-CREATED POLICIES

4. Presidential Policies • Establishment of an Institutional Conflict of Interest Committee • Organizational Official for Human Research Protection Program • Independent Authority of the Institutional Review Boards

5. Newly-created Policy SOP 308 Reporting to Regulatory Agencies & Institutional Officials • Within 30 business days • List of individuals to notify • Contents of the letter

6. Newly-created Policy SOP 406 Determination of Human Research • The investigator has the option of completing the Research Determination Worksheet or contacting the IRB. • IRB Chair determines if activity is research and if the research involves human participants. • If research, requires full submission.

7. Newly-created Policy SOP 411 Suspension or Termination of IRB Approval • Suspension is defined as a temporary or permanent halt to all research activities. • Terminated research is no longer subject to CR.

8. SOP 411 The IRB can suspend or terminate approval of research that: • Is not being conducted in accordance with the IRB’s requirements • Is associated with unexpected serious harm to participants.

9. REVISED POLICIES

10. Revised Policy SOP 104A Conflict of Interest – Investigators Conflict of Interest is an economic interest that could affect or appear to affect the design, conduct, or reporting of the research.

11. Revised Policy SOP 104B Conflict of Interest - IRB Members A conflict of interest arises when an IRB member or consultant holds an economic interest that could affect or appear to affect the design, conduct, oversight or reporting of the research

12. Revised Policy SOP 407 Unanticipated Problems Involving Risks to Participants or Others & Protocol Deviations • SAE’s rolled into this policy • Outside SAE’s reported at the time of CR • Reported within 5 business days • Provides a list of examples • IRB Chair determines if UP • If UP-refer to convened Board for review • Range of possible actions

13. Revised Policy SOP 903 Non-compliance/Scholarly Misconduct • Non-compliance is a proven failure to follow the regulations • Allegation of non-compliance is defined as an unproven assertion of non-compliance

14. SOP 903 Evaluation of Non-compliance • Technical non-compliance • Serious non-compliance • Continuing non-compliance IRB Corrective actions

15. Revised Glossary • Human Participants: DHHS and FDA definition • Guardian definition • Adverse Events-refers to Unanticipated Problems Involving Risks to Participants or Others

16. NEWLY-CREATED FORMS

17. New Forms • Determination of Human Research Worksheet • Conflict of Interest Disclosure Form • Unanticipated Problem Report Form

18. IRB Reviewer Checklists • Required by AAHRPP • Documentation • Provides structured, thorough review • Valuable tool for primary/secondary reviewer presentations

19. IRB Reviewer Checklists • New Study Reviewer Checklist • Full Board Review • Expedited Review • Exempt • Continuing Review Checklist • Modification Checklist • VA Criteria • Waiver of Consent • Vulnerable Populations

20. REVISED FORMS

21. Revised Forms • New Research Project Application • Continuing Review Application • Cell Line Application • Informed consent templates: Main / VA

22. New Procedure Conflict of Interest • IRB reviews COI Disclosure Form • If IRB determines a conflict is manageable, a plan will be provided to Investigator • If a conflict cannot be managed, the research project is not approved

23. Implementation • Date to implement • Process to implement-training

24. Questions? • Read policies • Review forms • Call IRB