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HRPP Policy & Guidelines

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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.

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001- Policy - NIH Human Research Protection Program (HRPP) Policy Development

General and Structural Changes to the NIH HRPP Policies

NIH IRP Human Research Protection Program (HRPP) Policy Glossary

Info

title	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. 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).

How to request an archived policy:

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.

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100 Series - Institutional Authorities and Requirements

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100 - NIH HRPP

100 - Policy - NIH HRPP (Printer friendly version available)

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101 - Organizational Structure of OHSRP

101 - Policy - Organizational Structure of OHSRP (Printer friendly version available)

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102 - Investigator Conflict of Interest and Government Royalties

102 - Policy - Investigator Conflict of Interest and Government Royalties (Printer friendly version available)

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title	COI Certifications and Guide

For the COI Certifications and Guide please navigate to this page.

103 - Education Program

Formerly Policy number 201

103 - Policy - Education Program (Printer friendly version available)

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104 - Research-Related Subject Complaints

104 - Policy - Research-Related Subject Complaints (Printer friendly version available)

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105 - IRB Reliance and Collaborative Research

105 - Policy - IRB Reliance and Collaborative Research (Printer friendly version available)

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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)

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108 - OHSRP Quality Assurance and Quality Improvement Program

108 - Policy - OHSRP Quality Assurance and Quality Improvement Program (Printer friendly version available)

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109 - Coverage Under the NIH FWA

109 - Policy - Coverage Under the NIH FWA (Printer friendly version available)

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200 Series - IRB Authorities and Requirements

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200 - IRB Scope and Authority

200 - Policy - IRB Scope and Authority (Printer friendly version available)

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201 - IRB Membership and Composition

201 - Policy - IRB Membership and Composition (Printer friendly version available)

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202 - Board Member Financial Conflict of Interest

202 - Policy - Board Member Conflict of Interest (Printer friendly version available)

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203 - Support of IRB Operations

203 - Policy - Support of IRB Operations (Printer friendly version available)

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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)

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300 Series - Investigator Responsibilities

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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 and Compensation

302 - Policy - Subject Recruitment and Compensation (Printer friendly version available)

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303 - Intramural Research Program Telehealth Requirements

303 - Intramural Research Program Telehealth Requirements (Printer friendly version available)

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400 Series - Regulatory Protections for Vulnerable Populations

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400 - Research Involving Pregnant Women, Fetuses, and Neonates

400 - Policy - Research Involving Pregnant Women, Fetuses, and Neonates (Printer friendly version available)

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401 - Research Involving Prisoners

401- Policy - Research Involving Prisoners (Printer friendly version available)

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402 - Children in Research

402- Policy - Research Involving Children (Printer friendly version available)

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403 - Research with Subjects Lacking Capacity to Consent

403 - Policy - Research with Subjects Lacking Capacity to Consent (Printer friendly version available)

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404 - Research Involving NIH Staff

404-Policy-Research Involving NIH Staff as Subjects (Printer friendly version available)

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500 Series - FDA Requirements for Human Subjects Research and Data and Safety Monitoring

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500 - Research Involving Drugs, Biological, and Nutritional Products

500 - Policy - Research Involving Drugs, Biological, and Nutritional Products (Printer friendly version available)

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501 - Research Involving FDA Regulated Devices

501 - Policy - Research Involving FDA Regulated Devices (Printer friendly version available)

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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)

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503 - Data and Safety Monitoring

503 - Policy - Data and Safety Monitoring (Printer friendly version available)

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700 Series - International Research Requirements

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700 - International Research

700 - Policy - International Research (Printer friendly version available)

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800 Series - Compliance and Research Event Reporting Requirements

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801 - Reporting Research Events

801 - Policy - Reporting Research Events (Printer friendly version available)

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802 - Non-Compliance in HSR

802 - Policy - Non-Compliance in HSR (Printer friendly version available)

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Common Rule Bulletins

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Info

title	Policy and Accreditation

For more information, please visit the OHSRP Policy and Accreditation page here.

Versions Compared

Old Version 226

New Version 227

Key

HRPP Policy & Guidelines

100 Series - Institutional Authorities and Requirements

100 - NIH HRPP

101 - Organizational Structure of OHSRP

102 - Investigator Conflict of Interest and Government Royalties

103 - Education Program

104 - Research-Related Subject Complaints

105 - IRB Reliance and Collaborative Research

106 - Ancillary Reviews

107 - Privacy and Confidentiality

108 - OHSRP Quality Assurance and Quality Improvement Program

Anchorpolicy109policy109109 - Coverage Under the NIH FWA

200 Series - IRB Authorities and Requirements

200 - IRB Scope and Authority

201 - IRB Membership and Composition

202 - Board Member Financial Conflict of Interest

203 - Support of IRB Operations

204 - Levels of IRB Review and Criteria for IRB

205 - Requirements for IRB Submissions

206 - Maintenance of Records

207 - Public Health Emergency Research Review Board

300 Series - Investigator Responsibilities

300 - Investigator Responsibilities

301 - Informed Consent

302 - Recruitment and Compensation

303 - Intramural Research Program Telehealth Requirements

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 Series - FDA Requirements for Human Subjects Research and Data and Safety Monitoring

500 - Research Involving Drugs, Biological, and Nutritional Products

501 - Research Involving FDA Regulated Devices

502 - Expanded Access, Including Emergency Use of Investigational Drugs, Biologics, and Medical Devices (Test Articles)

503 - Data and Safety Monitoring

700 Series - International Research Requirements

700 - International Research

800 Series - Compliance and Research Event Reporting Requirements

801 - Reporting Research Events

802 - Non-Compliance in HSR

Common Rule Bulletins

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109 - Coverage Under the NIH FWA