Human Research Protection Program Policies
Policies that do not have links are being revised.
| I. IRB Authority and Institutional Commitment |
|
|
|
|
| II. Investigator Responsibilities |
|
|
|
|
|
|
|
|
|
|
| III. Committee Roles and Responsibilities |
|
|
|
|
| IV. Research Review Procedures |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| DOHP 400-4.12-07 Recruitment / Advertising |
| DOHP 400-4.15-08 Monitoring of the Informed Consent Process |
| V. Informed Consent Process |
|
|
|
|
| DOHP 400-5.3-07 Waiver and Alteration of Informed Consent |
| DOHP 400-5.4-07 Asset/Dissent by Children or Cognitively Impaired Adults |
| DOHP 400-5.5-07 Approval and Expiration Dates on Informed Consent Documents |
| VI Research Involving Vulnerable Populations |
| DOHP 400-6.1-07 Special Categories of Research: Pregnant Women, Fetuses, Neonates |
| DOHP 400-6.2-07 Special Categories of Research: Prisoners |
| DOHP 400-6.3-07 Special Categories of Research: Children |
| DOHP 400-6.4-07 Special Categories of Research Cognitively Impaired Participants |
| VII Use of Investigational Drugs, Biologics, and Devices |
| DOHP 400-7.1-07 Investigational Drugs and Biologics |
| DOHP 400-7.2-07 Investigational Devices |
|
|
| VIII Documentation of Research Review Activities |
| DOHP 400-8.1-07 IRB Office Records |
| IX Education and Outreach |
|
|
| DOHP 400-9.5-07 Responding to Participant Inquires |
| X Addressing Allegations and Findings of Non-Compliance |
| DOHP 400-10.2-07 Administrative Hold, Suspension, or Termination of IRB Approval |
| DOHP 400-10.3-07 Investigating any Noncompliance, Serious or Continuing Noncompliance |
| XI Definitions |
| DOHP 400-11.1-08 Development and Approval and Maintenance of Policies |
| DOHP 400-11.2-08 IRB Membership Roster |
| DOHP 400-11.3-08 Definitions |