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Research Involving Human Subjects

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  Protecting Human Research Participants This course has been retired as of September 26, 2018. Archived course materials are available as a reference.
  Certificate of Confidentiality CoCs are issued by the NIH to protect the privacy of subjects by allowing investigators and institutions to refuse the release of identifying information of subjects involved in research.
  Clinical Trials Learn what is required of a study considered to be a clinical trial.
  Inclusion To ensure that individuals (such as women, children, and minorities) are included in clinical research in a manner that is appropriate to the scientific question under study.
  Glossary List of the commonly used terms.
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I am an Investigator

Those in the process of applying for a grant, cooperative agreement or R&D contract. This includes those submitting an SBIR/STTR application. Those who have submitted an application. Those who have been funded. 

I am at an Institution

Institutional officials and administrators, IRB administrators and members.

About Peer Review

Learn about the review of human subjects during the peer review process. Applicants can get a better idea of what peer reviewers look for in the application and Protection of Human Subjects section. Peer Reviewers can find guidance for reviewing the human subjects research plan.

I have a Special Award

Human Subjects information for specific NIH award types.

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Recent news

The Final Rule to delay the general compliance date of the Revised Common Rule was announced by the Office of the Federal Register on June 18, 2018 (https://www.federalregister.gov/documents/2018/06/19/2018-13187/protection-of-human-subjects-delay-of-general-compliance-date), and published in the Federal Register on June 19, 2018. The Final Rule delays the implementation of the 2018 revisions to the policy from July 19, 2018 to January 21, 2019, while allowing the following three burden-reducing provisions to be implemented during the delay period:

1) The revised definition of “research,” which deems certain activities not to be research;

(2) The allowance for no annual continuing review of certain categories of research; and

(3) The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.

The Notice of Proposed Rulemaking (NPRM) to delay for an additional 6 months ((July 19, 2018 until January 21, 2019)) the general compliance date of the revisions to the Common Rule that was put on public display yesterday by the Office of the Federal Register (see April 19, 2018 listserv announcement about that here: https://www.hhs.gov/ohrp/announcement-nprm-revisions-common-rule.html) was published in today’s edition of the Federal Register. To access the NPRM Federal Register Notice, click here. 

To be assured consideration, comments on the NPRM must be received no later than 11:59 p.m. Eastern Standard Time on May 21, 2018. To submit comments during the open comment period or browse posted comments, click here.

The Interim Final Rule to delay revisions to the Common Rule that was put on public display by the Office of the Federal Register last week (see January 17, 2018 listserv announcement about that here: https://www.hhs.gov/ohrp/interim-final-rule-common-rule.html) was published in yesterday’s edition of the Federal Register. To access the IFR Federal Register Notice, go here: https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/pdf/2018-00997.pdf. To be assured consideration, comments on the IFR must be received no later than 11:59 p.m. Eastern Standard Time on March 19, 2018. To submit comments during the open comment period or browse posted comments, go here: https://www.regulations.gov/document?D=HHS-OPHS-2017-0001-0001.

This delay does not impact any NIH-specific policies, such as the implementation of the NIH's Single IRB Policy, which is effective for research applications submitted for due dates on or after January 25, 2018.

A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html.

New Human Subjects Tools

  • Preparing the Human Subjects Section - Have you seen the new PHS Human Subjects and Clinical Trials Information Form? Are you working on human subjects research or human specimens or data? Should you submit a Data and Safety Monitoring Plan? This presentation simplifies the human subjects scenarios used to describe the different options for human subjects in research. Find the scenario that best describes your research to determine what information is needed with your NIH application. This guide has been updated for the new form, additional requirements for clinical trials, and specific information for career development (K), fellowship (F), and training (T) applications.
     
  • Human Subjects Infographic - This one-page infographic is a guide to defining human subjects research at the NIH. It summarizes human subjects research, what you will need for your NIH application and what you will need if you are funded. This will be updated with the implementation of the Revised Common Rule.
     
  • Exemptions Infographic - This one-page infographic is a guide to simplify the 3 human subjects research exemptions most commonly used at the NIH. It summarizes Exemptions 1, 2 and 4 providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and things one must consider when engaged in exempt human subjects research. This will be updated with the implementation of the Revised Common Rule.
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    Am I doing Human Subjects Research? Questionnaire

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