OHRP Guidance

OHRP Guidance

Office for Human Subjects Protections (OHRP) Regulations & Guidance

Click on the following link for the Office for Human Research Protections (OHRP) webpage

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

Code of Federal Regulations - 45 CFR 46

45 CFR 46 consists of Sub-parts A, B, C and D. Sub part A is also known as the "Common Rule".

NEW COMMON RULE CAME INTO EFECT ON JULY 19, 2018 AND JANUARY 19, 2019

FAQ regarding updates to common rule 
OHRP currently has many helpful FAQ sections covering all the new updates to 45 CFR 46 that took effect in January 2019. Below is a link to the FAQ. 
 
OHRP New Common Rule FAQ
 
Keep a look out on our website, as we will be periodically updating our own guidance pages to reflect these new FAQ and OHRP guidance's regarding the Updated Common Rule 

Expedited Categories of Research
Categories of research that may be reviewed by the Institutional Review Board (IRB) through Expedited review procedures.
 

Consent forms for Clinical Trials
The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame.  The consent form must have been used in enrolling participants in order to satisfy this new provision. A link to detailed step for this requirement can be found here: Clinical Trial Informed Consent Posting

 

OHRP Guidance by Topic

OHRP has published a variety of policy and regulatory guidance materials to assist the research community in conducting ethical research that is in compliance with the HHS regulations. These include guidance documents and frequently asked questions (FAQs) addressing various topics, findings in the form of OHRP letters addressing regulatory issues, and other media including decision tree graphics and educational videos.   

Policies and Guidance webpage


OHRP Commonly Used Links