Policies & Guidance
During 2019 and 2020, NIH is transitioning from Human Subjects Protections Program (HRPP) Standard Operating Procedures (SOPs) to HRPP policies. These policies are applicable to NIH clinical investigators, non-NIH clinical investigators when relying upon the NIH IRB, to NIH IRB operations, and to the NIH IRB when it is the Reviewing IRB. These policies also apply when the NIH IRB is acting as the Public Health Emergency Research Review Board (PHERRB) for the United States. These pages contain the currently implemented policies of the NIH Intramural Research Program. Also contained within these pages are supplemental guidelines and tools to aid investigators and research teams with the implementation of these policies.
Policies
The NIH Human Research Protection Program (HRPP) Policies are under development. The implemented policies appear below under policy groupings organized by topic. Upon implementation the remaining policies will appear below in under the topic groupings. Until the policies are implemented, the HRPP Standard Operating Procedures (SOPs) remain in effect. Please view the overview of General and Structural Changes to the NIH HRPP Policies if you are so inclined.
Policy 001 - NIH Human Research Protection Program (HRPP) Policy Development
General and Structural Changes to the NIH HRPP Policies
Policy page update
The official repository for the HRPP policies is in the OMA Manual Chapter (MC) system. Manual Chapter 3014 is a chapter within the Intramural Policy Series 3000. The MC 3014 contains the HRPP policies which can be found here: https://policymanual.nih.gov/3014. Note that we are in the process of replacing the policy PDFs with links to the published policies within MC 3014. In MC 3014, you will notice a slight difference in the policy numbering to reflect the MC under which the policies fall, (e.g., Policy 100, will be listed as Policy 3014-100 in the MC). The HRPP policy glossary is also published in MC 3014 and each policy lists the defined terms in Section D and a link to the policy glossary is provided there.
100 Series - Institutional Authorities and Requirements
100 - NIH HRPP
- 100 - Policy - NIH HRPP (Printer friendly version available)
101 - Organizational Structure of OHSRP
- 101 - Policy - Organizational Structure of OHSRP (Printer friendly version available)
102 - Investigator Conflict of Interest and Government Royalties
103 - Education Program
Formerly Policy number 201
- 103 - Policy - Education Program (Printer friendly version available)
104 - Research-Related Subject Complaints
- 104 - Policy - Research-Related Subject Complaints (Printer friendly version available)
105 - IRB Reliance and Collaborative Research
- 105 - Policy - IRB Reliance and Collaborative Research (Printer friendly version available)
106 - Ancillary Reviews
- 106 - Policy - Ancillary Reviews (Printer friendly version available)
107 - Privacy and Confidentiality
- 107 - Policy - Privacy and Confidentiality (Printer friendly version available)
108 - OHSRP Quality Assurance and Quality Improvement Program
- 108 - Policy - OHSRP Quality Assurance and Quality Improvement Program (Printer friendly version available)
109 - Coverage Under the NIH FWA Assurance
- 109 - Policy - Coverage Under the NIH FWA Assurance (Printer friendly version available)
200 Series - IRB Authorities and Requirements
200 - IRB Scope and Authority
- 200 - Policy - IRB Scope and Authority (Printer friendly version available)
201 - IRB Membership and Composition
- 201 - Policy - IRB Membership and Composition (Printer friendly version available)
202 - Board Member Financial Conflicts of Interest
- 202 - Policy - Board Member Conflict of Interest (Printer friendly version available)
203 - Support of IRB Operations
- 203 - Policy - Support of IRB Operations (Printer friendly version available)
204 - Levels of IRB Review and Criteria for IRB
- 204 - Policy - Levels of IRB Review and Criteria for IRB (Printer friendly version available)
205 - Requirements for IRB Submissions
- 205 - Policy - Requirements for IRB Submissions (Printer friendly version available)
206 - Maintenance of Records
- 206 - Policy - Maintenance of Records (Printer friendly version available)
207 - Public Health Emergency Research Review Board
- 207 - Policy - Public Health Emergency Research Review Board (Printer friendly version available)
300 Series - Investigator Responsibilities
300 - Investigator Responsibilities
- 300 - Policy - Investigator Responsibilities (Printer friendly version available)
301 - Informed Consent
- 301 - Policy - Informed Consent (Printer friendly version available)
302 - Recruitment Compensation
- 302 - Policy - Subject Recruitment and Compensation (Printer friendly version available)
400 Series - Regulatory Protections for Vulnerable Populations
400 - Research Involving Pregnant Women, Fetuses, and Neonates
401 - Research Involving Prisoners
402 - Children in Research
403 - Research with Subjects Lacking Capacity to Consent
404 - Research Involving NIH Staff
500 - FDA Requirements for Human Subjects Research and Data and Safety Monitoring
500 - Research Involving Drugs, Biological, and Nutritional Products
- 500 - Policy - Research Involving Drugs, Biological, and Nutritional Products (Printer friendly version available)
501 - Research Involving FDA Regulated Devices
- 501 - Policy - Research Involving FDA Regulated Devices (Printer friendly version available)
502 - Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Articles)
- 502 - Policy - Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Articles) (Printer friendly version available)
503 - Data and Safety Monitoring
- 503 - Policy - Data and Safety Monitoring (Printer friendly version available)
700 Series - International Research Requirements
700 - International Research
- 700 - Policy - International Research (Printer friendly version available)
800 Series - Compliance and Research Event Reporting Requirements
801 - Reporting Research Events
- 801 - Policy - Reporting Research Events (Printer friendly version available)
802 - Non-Compliance in HSR
- 802 - Policy - Non-Compliance in HSR (Printer friendly version available)
Active HRPP Policies (SOPs)
Active
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