HRPP Policy Memoranda
HRPP Policies
During 2019 and 2020, the NIH Intramural Program (IRP) transitioned from Human Subjects Protections Program (HRPP) Standard Operating Procedures (SOPs) to HRPP policies. (See General and Structural Changes to the NIH HRPP Policies for more information.) These policies are applicable to NIH clinical investigators, non-NIH clinical investigators when relying upon the NIH IRB, to the Office of IRB Operations (IRBO), 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. Additional supplemental educational materials are provided below each policy link to aid investigators and research teams with the implementation of these policies.
001- Policy - 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. 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 system). The HRPP policy glossary is also published in MC 3014 and each policy lists the defined terms in Section D with a link to the policy glossary is provided there.
OMA is the official HRPP standard operating procedure (SOP) and policy archive for the HRPP policies. To request a copy of an archived SOP or policy email a request to: PolicyManual@nih.gov.
100 Series - Institutional Authorities and Requirements
100 - NIH HRPP
100 - Policy - NIH HRPP (Printer friendly version available) |
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There are Currently No Attachments
101 - Organizational Structure of OHSRP
- 101 - Policy - Organizational Structure of OHSRP (Printer friendly version available)
There are Currently No Attachments
102 - Investigator Conflict of Interest and Government Royalties
- 102 - Policy - Investigator Conflict of Interest and Government Royalties (Printer friendly version available)
There are Currently No Attachments
103 - Education Program
Formerly Policy number 201
- 103 - Policy - Education Program (Printer friendly version available)
There are Currently No Attachments
104 - Research-Related Subject Complaints
- 104 - Policy - Research-Related Subject Complaints (Printer friendly version available)
There are Currently No Attachments
105 - IRB Reliance and Collaborative Research
- 105 - Policy - IRB Reliance and Collaborative Research (Printer friendly version available)
There are Currently No Attachments
106 - Ancillary Reviews
- 106 - Policy - Ancillary Reviews (Printer friendly version available)
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107 - Privacy and Confidentiality
- 107 - Policy - Privacy and Confidentiality (Printer friendly version available)
There are Currently No Attachments
108 - OHSRP Quality Assurance and Quality Improvement Program
- 108 - Policy - OHSRP Quality Assurance and Quality Improvement Program (Printer friendly version available)
There are Currently No Attachments
109 - Coverage Under the NIH FWA Assurance
- 109 - Policy - Coverage Under the NIH FWA Assurance (Printer friendly version available)
There are Currently No Attachments
200 Series - IRB Authorities and Requirements
200 - IRB Scope and Authority
- 200 - Policy - IRB Scope and Authority (Printer friendly version available)
There are Currently No Attachments
201 - IRB Membership and Composition
- 201 - Policy - IRB Membership and Composition (Printer friendly version available)
There are Currently No Attachments
202 - Board Member Financial Conflict of Interest
- 202 - Policy - Board Member Conflict of Interest (Printer friendly version available)
There are Currently No Attachments
203 - Support of IRB Operations
- 203 - Policy - Support of IRB Operations (Printer friendly version available)
There are Currently No Attachments
204 - Levels of IRB Review and Criteria for IRB
- 204 - Policy - Levels of IRB Review and Criteria for IRB (Printer friendly version available)
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205 - Requirements for IRB Submissions
- 205 - Policy - Requirements for IRB Submissions (Printer friendly version available)
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206 - Maintenance of Records
- 206 - Policy - Maintenance of Records (Printer friendly version available)
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207 - Public Health Emergency Research Review Board
- 207 - Policy - Public Health Emergency Research Review Board (Printer friendly version available)
There are Currently No Attachments
300 Series - Investigator Responsibilities
300 - Investigator Responsibilities
- 300 - Policy - Investigator Responsibilities (Printer friendly version available)
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301 - Informed Consent
- 301 - Policy - Informed Consent (Printer friendly version available)
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302 - Recruitment Compensation
- 302 - Policy - Subject Recruitment and Compensation (Printer friendly version available)
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400 Series - Regulatory Protections for Vulnerable Populations
400 - Research Involving Pregnant Women, Fetuses, and Neonates
- 400 - Policy - Research Involving Pregnant Women, Fetuses, and Neonates (Printer friendly version available)
There are Currently No Attachments
401 - Research Involving Prisoners
- 401- Policy - Research Involving Prisoners (Printer friendly version available)
There are Currently No Attachments
402 - Children in Research
- 402- Policy - Research Involving Children (Printer friendly version available)
There are Currently No Attachments
403 - Research with Subjects Lacking Capacity to Consent
- 403 - Policy - Research with Subjects Lacking Capacity to Consent (Printer friendly version available)
There are Currently No Attachments
404 - Research Involving NIH Staff
- 404-Policy-Research Involving NIH Staff as Subjects (Printer friendly version available)
There are Currently No Attachments
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)
There are Currently No Attachments
501 - Research Involving FDA Regulated Devices
- 501 - Policy - Research Involving FDA Regulated Devices (Printer friendly version available)
There are Currently No Attachments
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)
There are Currently No Attachments
503 - Data and Safety Monitoring
- 503 - Policy - Data and Safety Monitoring (Printer friendly version available)
There are Currently No Attachments
700 Series - International Research Requirements
700 - International Research
- 700 - Policy - International Research (Printer friendly version available)
There are Currently No Attachments
800 Series - Compliance and Research Event Reporting Requirements
801 - Reporting Research Events
- 801 - Policy - Reporting Research Events (Printer friendly version available)
There are Currently No Attachments
802 - Non-Compliance in HSR
- 802 - Policy - Non-Compliance in HSR (Printer friendly version available)
There are Currently No Attachments
Guidance
Regulations and Ethical Guidance
Food and Drug Administration (FDA)
Common Rule Bulletins
Other Guidance Documents
There are Currently No Attachments
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