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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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Common Rule Bulletin #1: Key Information

Common Rule Bulletin #3: Biospecimens/Data Requirements in ICF

Common Rule Bulletin #4: The "Reasonable Person" Standard in ICF

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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Humanitarian Use Device FAQs

ForHumanitarian Use Device (HUD) FAQs please navigate to this page

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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Versions Compared

Old Version 237

New Version 238

Key

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

Anchor
policy109
policy109
109 - Coverage Under the NIH FWA