Health and Human Services Homepage

  U.S. Department of Health and Human Services | National Institutes of Health

Versions Compared

Old Version 239

changes.mady.by.user Pauly, Kelly (NIH/OD) [E]

Saved on

compared with

New Version Current

changes.mady.by.user Pauly, Kelly (NIH/OD) [E]

Saved on

Key

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

...

Usa div
classgrid-row
Usa div
classgrid-col-4
Div
classpanel-top sans-heading
Usa div
classgrid-row

100 Series - Institutional Authorities and Requirements

Usa div
classgrid-col-1


Usa div
classgrid-col-7

100 - NIH HRPP

100 - Policy - NIH HRPP (Printer friendly version available)
Report Table
injectedtrue
displayTitlesfalse



page:attachments

100attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence100INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size


101 - Organizational Structure of OHSRP

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

Report Table
injectedtrue
displayTitlesfalse
page:attachments

101attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

102attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence102INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

Info
titleCOI 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
injectedtrue
displayTitlesfalse
page:attachments

103attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

104attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

105attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

106attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

107attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

108attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

109attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence109INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments





Usa div
classgrid-row
Usa div
classgrid-col-4
Div
classpanel-top sans-heading

200 Series - IRB Authorities and Requirements

Usa div
classgrid-col-1


Usa div
classgrid-col-7

200 - IRB Scope and Authority

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

Report Table
injectedtrue
displayTitlesfalse
page:attachments

200attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

201attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

202attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

203attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence203INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments


204 -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
injectedtrue
displayTitlesfalse
page:attachments

204attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

205attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

206attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

207attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence207INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments





Usa div
classgrid-row
Usa div
classgrid-col-4
Div
classpanel-top sans-heading

300 Series - Investigator Responsibilities

Usa div
classgrid-col-1


Usa div
classgrid-col-7

300 - Investigator Responsibilities

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

Report Table
injectedtrue
displayTitlesfalse
page:attachments

300policyattachment:labels

Attachment Namehttps://irbo.nih.gov/confluence300INLINEattachment:download path

%attachment:file name%

There are Currently No Attachments

Report Table
injectedtrue
displayTitlesfalse
page:attachments

300attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence300INLINEattachment:download path

%attachment:file name%

There are Currently No Attachments


301 - Informed Consent

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

Report Table
injectedtrue
displayTitlesfalse
page:attachments

301attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence301INLINEattachment:download path

%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
injectedtrue
displayTitlesfalse
page:attachments

302attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence302INLINEattachment:download path

%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
injectedtrue
displayTitlesfalse
page:attachments

303attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence302INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments





Usa div
classgrid-row
Usa div
classgrid-col-4
Div
classpanel-top sans-heading

400 Series - Regulatory Protections for Vulnerable Populations

Usa div
classgrid-col-1


Usa div
classgrid-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
injectedtrue
displayTitlesfalse
page:attachments

400attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

401attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence401INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments

size


402 - Children in Research

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

Report Table
injectedtrue
displayTitlesfalse
page:attachments

402attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

403attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

404attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence404INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments





Usa div
classgrid-row
Usa div
classgrid-col-4
Div
classpanel-top sans-heading

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

Usa div
classgrid-col-1


Usa div
classgrid-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
injectedtrue
displayTitlesfalse
page:attachments

500attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence500INLINEattachment:download path

%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
injectedtrue
displayTitlesfalse
page:attachments

501attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

502attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

503attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence503INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments




Usa div
classgrid-row
Usa div
classgrid-col-4
Div
classpanel-top sans-heading

700 Series - International Research Requirements

Usa div
classgrid-col-1


Usa div
classgrid-col-7

700 - International Research 

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

Report Table
injectedtrue
displayTitlesfalse
page:attachments

700attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence700INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments




Usa div
classgrid-row
Usa div
classgrid-col-4
Div
classpanel-top sans-heading

800 Series - Compliance and Research Event Reporting Requirements

Usa div
classgrid-col-1


Usa div
classgrid-col-7

801 - Reporting Research Events

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

Report Table
injectedtrue
displayTitlesfalse
page:attachments

801attachment:labels

Attachment Namehttps://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
injectedtrue
displayTitlesfalse
page:attachments

802attachment:labels

Attachment Namehttps://irbo.nih.gov/confluence802INLINEattachment:download path

%attachment:file name%

Sizereport-size

attachment:nice file size

There are Currently No Attachments



Info
titlePolicy and Accreditation

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

...