Page Comparison

Versions Compared

Key

This line was added.
This line was removed.
Formatting was changed.

Comment: Reverted from v. 235

...

Usa div

class	grid-row

Usa div

class	grid-col-4

Div

class	panel-top sans-heading

Usa div

class	grid-row

100 Series - Institutional Authorities and Requirements

Usa div

class	grid-col-1

Usa div

class	grid-col-7

100 - NIH HRPP

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

Report Table

injected	true
displayTitles	false

page:attachments

100attachment:labels100

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence100INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

101 - Organizational Structure of OHSRP

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

Report Table

injected	true
displayTitles	false

page:attachments

101attachment:labels101

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence101INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

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)

Report Table

injected	true
displayTitles	false

page:attachments

102attachment:labels102

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence102INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

Info

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)

Report Table

injected	true
displayTitles	false

page:attachments

103attachment:labels103

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence103INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

104 - Research-Related Subject Complaints

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

Report Table

injected	true
displayTitles	false

page:attachments

104attachment:labels104

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence104INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

105 - IRB Reliance and Collaborative Research

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

Report Table

injected	true
displayTitles	false

page:attachments

105attachment:labels105

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence105INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

106 - Ancillary Reviews

106 - Policy - Ancillary Reviews (Printer friendly version available)

Report Table

injected	true
displayTitles	false

page:attachments

106attachment:labels106

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence106INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

107 - Privacy and Confidentiality

107 - Policy - Privacy and Confidentiality (Printer friendly version available)

Report Table

injected	true
displayTitles	false

page:attachments

107attachment:labels107

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence107INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

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)

Report Table

injected	true
displayTitles	false

page:attachments

108attachment:labels108

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence108INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

Anchor
policy109
policy109
109 - Coverage Under the NIH FWA

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

Report Table

injected	true
displayTitles	false

page:attachments

109attachment:labels109

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence109INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

...

Usa div

class	grid-row

Usa div

class	grid-col-4

Div

class	panel-top sans-heading

200 Series - IRB Authorities and Requirements

Usa div

class	grid-col-1

Usa div

class	grid-col-7

200 - IRB Scope and Authority

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

Report Table

injected	true
displayTitles	false

page:attachments

200attachment:labels200

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence200INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

201 - IRB Membership and Composition

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

Report Table

injected	true
displayTitles	false

page:attachments

201attachment:labels201

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence201INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

202 - Board Member Financial Conflict of Interest

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

Report Table

injected	true
displayTitles	false

page:attachments

202attachment:labels202

Attachment Name

httpsattachment:download pathhttps://irbo.nih.gov/confluence202INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

203 - Support of IRB Operations

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

Report Table

injected	true
displayTitles	false

page:attachments

203attachment:labels203

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence203INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

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)

Report Table

injected	true
displayTitles	false

page:attachments

204attachment:labels204

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence204INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

205 - Requirements for IRB Submissions

205 - Policy - Requirements for IRB Submissions (Printer friendly version available)

Report Table

injected	true
displayTitles	false

page:attachments

205attachment:labels205

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence205INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

206 - Maintenance of Records

206 - Policy - Maintenance of Records (Printer friendly version available)

Report Table

injected	true
displayTitles	false

page:attachments

206attachment:labels206

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence206INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

207 - Public Health Emergency Research Review Board

207 - Policy - Public Health Emergency Research Review Board (Printer friendly version available)

Report Table

injected	true
displayTitles	false

page:attachments

207attachment:labels207

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence207INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

...

Usa div

class	grid-row

Usa div

class	grid-col-4

Div

class	panel-top sans-heading

300 Series - Investigator Responsibilities

Usa div

class	grid-col-11

Usa div

class	grid-col-7

300 - Investigator Responsibilities

300 - Policy - Investigator Responsibilities (Printer friendly version available)

Report Table

injected	true
displayTitles	false

page:attachments

attachment:labels300policy

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence300INLINE

%attachment:file name%

There are Currently No Attachments

Report Table

injected	true
displayTitles	false

page:attachments

attachment:labels300

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence300INLINE

%attachment:file name%

There are Currently No Attachments

301 - Informed Consent

301 - Policy - Informed Consent (Printer friendly version available)

Report Table

injected	true
displayTitles	false

page:attachments

attachment:labels301

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence301INLINE

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

302 - Recruitment and Compensation

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

Report Table

injected	true
displayTitles	false

page:attachments

attachment:labels302

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence302INLINE

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

303 - Intramural Research Program Telehealth Requirements

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

Report Table

injected	true
displayTitles	false

page:attachments

attachment:labels303

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence302INLINE

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

Usa div

class	grid-row

Usa div

class	grid-col-4

Div

class	panel-top sans-heading

400 Series - Regulatory Protections for Vulnerable Populations

Usa div

class	grid-col-1

Usa div

class	grid-col-7

400 - Research Involving Pregnant Women, Fetuses, and Neonates

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

Report Table

injected	true
displayTitles	false

page:attachments

400attachment:labels400

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence400INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

401 - Research Involving Prisoners

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

Report Table

injected	true
displayTitles	false

page:attachments

401attachment:labels401

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence401INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

402 - Children in Research

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

Report Table

injected	true
displayTitles	false

page:attachments

402attachment:labels402

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence402INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

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)

Report Table

injected	true
displayTitles	false

page:attachments

403attachment:labels403

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence403INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

404 - Research Involving NIH Staff

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

Report Table

injected	true
displayTitles	false

page:attachments

404attachment:labels404

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence404INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

...

Usa div

class	grid-row

Usa div

class	grid-col-4

Div

class	panel-top sans-heading

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

Usa div

class	grid-col-1

Usa div

class	grid-col-7

500 - Research Involving Drugs, Biological, and Nutritional Products

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

Report Table

injected	true
displayTitles	false

page:attachments

500attachment:labels500

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence500INLINEattachment:download pathINLINE

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

501 - Research Involving FDA Regulated Devices

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

Report Table

injected	true
displayTitles	false

page:attachments

501attachment:labels501

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence501INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

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)

Report Table

injected	true
displayTitles	false

page:attachments

502attachment:labels502

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence502INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

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)

Report Table

injected	true
displayTitles	false

page:attachments

503attachment:labels503

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence503INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

...

Usa div

class	grid-row

Usa div

class	grid-col-4

Div

class	panel-top sans-heading

700 Series - International Research Requirements

Usa div

class	grid-col-1

Usa div

class	grid-col-7

700 - International Research

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

Report Table

injected	true
displayTitles	false

page:attachments

700attachment:labels700

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence700INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

...

Usa div

class	grid-row

Usa div

class	grid-col-4

Div

class	panel-top sans-heading

800 Series - Compliance and Research Event Reporting Requirements

Usa div

class	grid-col-1

Usa div

class	grid-col-7

801 - Reporting Research Events

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

Report Table

injected	true
displayTitles	false

page:attachments

801attachment:labels801

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence801INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

802 - Non-Compliance in HSR

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

Report Table

injected	true
displayTitles	false

page:attachments

802attachment:labels802

Attachment Name

attachment:download pathhttps://irbo.nih.gov/confluence802INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

...

Versions Compared

Old Version 236

New Version 237

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