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 Home      /      Policy      /      HRPP Policies

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.


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

General and Structural Changes to the NIH HRPP Policies


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titlePolicy 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.



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100 Series - Institutional Authorities and Requirements

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100 - NIH HRPP

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101 - Organizational Structure of OHSRP

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102 - Investigator Conflict of Interest and Government Royalties

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103 - Education Program

Formerly Policy number 201

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104 - Research-Related Subject Complaints

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105 - IRB Reliance and Collaborative Research

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106 - Ancillary Reviews

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107 - Privacy and Confidentiality 

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108 - OHSRP Quality Assurance and Quality Improvement Program 

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109 - Coverage Under the NIH FWA Assurance

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200 Series - IRB Authorities and Requirements

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200 - IRB Scope and Authority

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201 - IRB Membership and Composition

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202 - Board Member Financial Conflict of Interest

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203 - Support of IRB Operations

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204 - Levels of IRB Review and Criteria for IRB

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205 - Requirements for IRB Submissions

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206 - Maintenance of Records 

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207 - Public Health Emergency Research Review Board

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300 Series - Investigator Responsibilities

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300 - Investigator Responsibilities

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301 - Informed Consent

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302 - Recruitment Compensation

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400 Series - Regulatory Protections for Vulnerable Populations

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400 - Research Involving Pregnant Women, Fetuses, and Neonates

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401 - Research Involving Prisoners

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402 - Children in Research

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403 - Research with Subjects Lacking Capacity to Consent

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404 - Research Involving NIH Staff

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

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500 - Research Involving Drugs, Biological, and Nutritional Products

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501 - Research Involving FDA Regulated Devices 

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

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503 - Data and Safety Monitoring 

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700 Series - International Research Requirements

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700 - International Research 

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800 Series - Compliance and Research Event Reporting Requirements

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801 - Reporting Research Events

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802 - Non-Compliance in HSR

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Anchor
SOPs
SOPs
HRPP Policy Memoranda

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Guidance


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Regulations and Ethical Guidance

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Food and Drug Administration (FDA)

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Common Rule Bulletins

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Other Guidance Documents

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