Human Studies

Human Studies

HUMAN RESEARCH PROTECTION PROGRAM

Guidance and Forms

All research protocols involving human participants within the jurisdiction of the University IRB must undergo an appropriate level of review by that IRB. The initiation of a review of a research protocol involving human participants occurs following submission of an application by the PI to the IRB.

POLICY MANUAL  

IRB Committee Member Disclosure Form

                                                                           

IRB FORMS & TEMPLATES  

 

OHRP GUIDELINES
 

RELATED GUIDELINES
HIPAA Privacy Rule
Office of Compliance
World Medical Association  (Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects),
The Council for International Organizations of Medical Sciences (International Ethical Guidelines for Biomedical Research Involving Human Subjects)

 

Federal Excluded Parties List System (EPLS)

HHS (OIG) List more detailed Excluded Parties System

Disqualified and Restricted Investigators

Debarment List

Assurances

Federalwide Assurance (FWA) ID # FWA00005002, expires 1/31/2017  (FWA replaces the General Assurance for Human Subjects)

Registration of the IRB with US Department of Health and Human Services (OHRP and FDA)
     #IRB00000293 (expires 10/23/12)

HUMAN RESEARCH PROTECTION PROGRAM

Guidance and Forms

All research protocols involving human participants within the jurisdiction of the University IRB must undergo an appropriate level of review by that IRB. The initiation of a review of a research protocol involving human participants occurs following submission of an application by the PI to the IRB.

POLICY MANUAL  

IRB Committee Member Disclosure Form

                                                                           

IRB FORMS & TEMPLATES  

 

OHRP GUIDELINES
 

RELATED GUIDELINES
HIPAA Privacy Rule
Office of Compliance
World Medical Association  (Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects),
The Council for International Organizations of Medical Sciences (International Ethical Guidelines for Biomedical Research Involving Human Subjects)

 

Federal Excluded Parties List System (EPLS)

HHS (OIG) List more detailed Excluded Parties System

Disqualified and Restricted Investigators

Debarment List

Assurances

Federalwide Assurance (FWA) ID # FWA00005002, expires 1/31/2017  (FWA replaces the General Assurance for Human Subjects)

Registration of the IRB with US Department of Health and Human Services (OHRP and FDA)
     #IRB00000293 (expires 10/23/12)