NIH Requirements for Human Subject Research

NIH Human Subject & Clinical Trial Requirements

Identifying whether the NIH considers your study to be a clinical trial impacts whether you need to: respond to a clinical trial-specific FOA, address additional review criteria specific for clinical trials, or register and report your clinical trial in ClinicalTrials.gov.
 

Changes that apply to all human subject research:

  • Application Form E for human subjects research
  • Policy for using a single IRB for multi-site research
  • Certificates of confidentiality for all NIH funded research that uses identifiable sensitive information

Changes that apply specifically to clinical trials:

  • Training requirements in Good Clinical Practice
  • Clinical trial related changes to Funding Opportunity Announcements (FOA) 
  • Clinical trial FOA specific review criteria
  • Improving the regulation and reporting procedures for NIH-funded clinical trials in clinicaltrails.gov. 

The NIH defines a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evluate the effects of those interventions on health-related biomedical or behavioral outcomes.

The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

A “health-related biomedical or behavioral outcome” is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects biomedical or behavioral status or quality of life.  Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological neurodevelopmental parameters (e.g., mood management interventions for smokers; reading comprehension and/or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and positive or negative changes to quality of life. 

FAQs
Case Studies
Decision Tree

The PHS Human Subjects and Clinical Trials Information form is used to collect information on human subjects research, clinical research, and/or clinical trials, including study population characteristics, protection and monitoring plans, and a protocol synopsis.

This form accommodates the full spectrum of all types of clinical trials, including, but not limited to, behavioral, exploratory/development, mechanistic, pilot/feasibility, early phase, efficacy, effectiveness, group-randomized, and others.

The most significant change with the new FORMS-E Application Package is the addition of a new PHS Human Subjects and Clinical Trials Information form. This form consolidates human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms. The form collects information on human subjects and clinical trials at the study level.

  • Leads applicants through the human subject and clinical trial information collection requirements
  • Expands the use of discrete form fields to capture clinical trial information to provide the level of detail needed for peer review
  • Presents key information to reviewers and agency staff in a consistent format
  • Aligns with ClinicalTrials.gov (where possible) and positions the NIH for future data exchange with ClinicalTrials.gov

The new form collects key elements from the protocol.  As a result, the appendix policy has been updated so that you may only include the protocol in your application if explicitly required by the FOA.

Application Form Instructions
Example Form
Video – Completing the Form

Historically, in many multi-site studies, each site has its own IRB which conducts an independent review of studies involving human research participants. The use of a single IRB of record for multi-site studies that are conducting the same protocol will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites.

The goal of this policy is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants.

Single IRBs are NOT applicable for Career Development (K), Research Training (T), or Fellowship (F) calls.

Emory IRB Guidance

Certificates of Confidentiality (CoC) protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations. NIH funded researchers are automatically issued a CoC through their award. 

The updated policy:

  • Eliminates the need for NIH funded investigators to apply for a CoC
  • Enhances the privacy protections of individuals participating in NIH-funded research
  • Requires investigators to only disclose information under specific circumstances
  • Applies to NIH awards funded wholly, or in part, by NIH
  • Disclosure restrictions also apply to anyone who receives a copy of identifiable sensitive information protected by the policy, even if they are not funded by NIH
  • CoC is issued as a term and condition of award (no physical certificate)

FAQs
Suggested Consent Language Describing the CoC Protections

All investigators and clinical trial staff involved in a NIH funded clinical trial must complete Good Clinical Practice Training (GCP). The principles of GCP help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.  

GCP training aims to ensure that:

  • The rights, safety, and well-being of human subjects are protected
  • Clinical trials are conducted in accordance with approved plans with rigor and integrity
  • Data derived from clinical trials are reliable

Emory investigators should complete training through CITI.  Documentation of the training should be maintained and refreshed every three years.

CITI Training 

All NIH-funded clinical trials are expected to register and submit results information to as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals. This website provides resources for understanding and complying with this NIH policy and the federal regulations.

Investigators must ensure that the responsible entity registers the clinical trial no later than 21 days after enrolling the first subject.  Information must be updated every 12 months.  A summary report must be uploaded no later than a year after the trial completion date.

Clinicaltrials.gov    

NIH requires that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The purpose of this policy is to improve our ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.  FOAs have been updated to specify the allowability of clinical trials in Section II. Award Information. In addition, FOAs that allow clinical trials will include “Clinical Trial Required” or “Clinical Trial Optional” in the FOA title. 

Fellowship & Training FOAs do NOT include a clinical trials allowability indicator in the title. These FOAs are always “Clinical Trial Not Allowed” so there is no need to differentiate FOAs.

In Spring 2018, the search feature of the NIH Guide for Grants and Contracts will be enhanced to include clinical trial allowability as a search criteria. In the meantime, you can include "optional" and "required" as terms in the "Search Title" box of the NIH Guide to Grants and Contracts advanced search.

In order to ensure the NIH is funding the most rigorous and impactful science, additional review criteria for clinical trials has been added to the FOAs.  Additional criteria includes:

Scored Review Criteria

  • Significance
  • Investigator 
  • Innovation
  • Approach
  • Environment

Additional Review Criteria

  • Study Timeline & Milestones

More information - Clinical Trials
More information - Career Development Awards