The National Institutes of Health (NIH) has updated its definition and procedures for NIH-funded clinical trials research. The definition of a clinical trial has been expanded and now contains research on behavioral outcomes. They have also added a requirement for the use of a single IRB (sIRB) for multi-site studies
NIH Definition of “Clinical Trials”
NIH defines a clinical trial as:
"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 evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
Prospectively assigned refers to a predefined process specified in an approved protocol that stipulates assignment to one or more arms of a clinical trial.
Intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.
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.
Review this flyer for help in determining if your study qualifies as an NIH-funded clinical trial. This interactive tool will walk you through determining if your human subjects research is a clinical trial.
Studies that propose to conduct a clinical trial at the time of the application submission must include with the application:
- Protection of Human Subjects section that describes all of the human subjects components of the study
- Data and Safety Monitoring Plan (DSMP), which may involve the creation of a Data and Safety Monitoring Board (DSMB) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for NIH-Defined Phase III clinical trials
- Inclusion of Women and Minorities
- PHS Inclusion Enrollment Report(s)
- Inclusion of Children
NIH is launching a series of initiatives to enhance the accountability and transparency of clinical research. These initiatives target key points along the entire clinical trial lifecycle, from concept to results reporting. The Research Methods Resources website provides investigators with important research methods resources to help them satisfy these new requirements.
Single IRB (sIRB) Requirement
NIH has instituted a single IRB requirement. All domestic sites participating in multi-site studies involving non-exempt human subjects research funded by NIH must use a single Institutional Review Board (sIRB). The goal of this policy is to enhance and streamline the IRB review process for multi-site research without compromising ethical principles and protections for human research participants.
How does NIH define “multi-site” research?
NIH defines a multi-site study as one that uses the same protocol to conduct human subjects research at more than one site. So the same protocol is being conducted at multiple locations. A site is considered to be conducting human subjects research if it is "engaged" in the research. There are some exceptions to this, but in general, an institution is engaged in research when:
- It is the grantee institution, directly receiving an award from NIH, even if all of the human subjects activities are being carried out at other sites.
- Its employees or agents interact or intervene with human subjects by manipulating their environment or by performing invasive or noninvasive procedures.
- Its employees or agents obtain informed consent from human subjects
- Its employees or agents receive identifiable private information or identifiable biological specimens.
A more detailed explanation of when institutions are engaged in research can be found at OHRP’s website.
At this time RIT is unable to act as the relying IRB for multi-site research review requiring an sIRB; please contact the HSRO office if you will be engaging in research that requires sIRB review.
In addition to the definition update and changes to human subjects protections review, NIH is also requiring additional training in the form of Good Clinical Practice and an expectation that all trials will be registered on ClinicalTrials.gov.
Good Clinical Practice Training
NIH requires all staff and investigators involved in the conduct, oversight, and management of NIH-funded clinical trials to be trained in Good Clinical Practices (GCP). GCP training is available through RIT’s CITI program. At this time see the HSRO Training page for information on adding the GCP module to your CITI account. In the future there may be other portals or procedures determined by RIT’s Sponsored Research Services.
Registering Studies with ClinicalTrials.gov
NIH funded clinical trials must register with clinicaltrials.gov. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
To ensure compliance with the NIH policy, RIT requires that:
- Clinical trials are registered at ClinicalTrials.gov at the time of IRB review.
- Results information from clinical trials is submitted to ClinicalTrials.gov not later than one year after the trial's primary completion date (i.e., the date of final data collection for the primary outcome measure).
- Consent forms include the following text: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."
NIH funding proposals are required to include a plan outlining how applicants will comply with the policy. We recommend that the following text be used to describe the plan: "In compliance with NIH policy, this clinical trial will be registered with ClinicalTrials.gov. Registration will occur at the time of IRB review and results information will be submitted not later than one year after the trial's primary completion date. Additionally, the relevant informed consent documents will include a specific statement relating to posting of the clinical trial information at ClinicalTrials.gov."