HRPP Policies & Forms Created/Revised for AAHRPP

Outline Newly-Created Policies Newly-Created Policies Revised Policies Revised Policies Newly-Created Forms Newly-Created Forms Revised Forms Revised Forms New Procedures New Procedures

NEWLY-CREATED POLICIES

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

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

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

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

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

REVISED POLICIES

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.

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

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

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

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

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

NEWLY-CREATED FORMS

New Forms Determination of Human Research Worksheet Determination of Human Research Worksheet Worksheet Conflict of Interest Disclosure Form Conflict of Interest Disclosure FormForm Unanticipated Problem Report Form Unanticipated Problem Report FormForm

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

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

REVISED FORMS

Revised Forms New Research Project Application New Research Project ApplicationApplication Continuing Review Application Continuing Review ApplicationApplication Cell Line Application Cell Line ApplicationApplication Informed consent templates: Informed consent templates: MainMain / VA VA MainVA

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

Implementation Date to implement Date to implement Process to implement-training Process to implement-training

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