Managing the new NIH requirements for clinical trials

As part of an effort to enhance transparency in biomedical research, the National Institutes of Health (NIH) have, over the last few years, announced a series of policy changes related to clinical trials. Though there is still a great deal of uncertainty about which studies do and do not qualify, these changes may have significant consequences for researchers who may not necessarily consider their work to be clinical or part of a trial.

Last September, the NIH announced a series of requirements for studies that meet the agency’s revised and expanded definition of a clinical trials. Soon after, it was revealed that many of these requirements may apply to large swaths of NIH-funded behavioral, social science, and neuroscience research that, historically, have not been considered to be clinical in nature. This was affirmed several weeks ago when the agency released a list of case studies that included a brain imaging study in which healthy participants completed a memory task as an example of a clinical trial.

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NIH’s revised and expanded definition of clinical trials includes many approaches to human subjects research that have historically been considered basic research. (Source)

What exactly constitutes a clinical trial now?

Because many investigators doing behavioral, social science, and neuroscience research consider their work to be basic research and not a part of a clinical trial, it is worth taking a step back to consider how NIH now defines the term.

According to the NIH, clinical trials are “studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.”, In an NIH context, intervention refers to “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.”. Because the agency considers all of the studies it funds that investigate biomedical or behavioral outcomes to be health-related, this definition includes mechanistic or exploratory work that does not have direct clinical implications.

Basically, if you are working on an NIH-funded study that involves biomedical or behavioral variables, you should be paying attention to the new requirements about clinical trials.

What do I need to do now that my study is considered a clinical trial?

If you think your work may be reclassified as a clinical trial, it’s probably worth getting a head start on meeting the new requirements. Here is some practical advice about getting started.

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The new NIH requirements for clinical trials affect activity throughout the lifecycle of a research project. (Source)

Applying for Funding

NIH has specified new requirements about how research involving clinical trials can be funded. For example, NIH will soon require that any application involving a clinical trial be submitted in response to a funding opportunity announcement (FOA) or request for proposal (RFP) that explicitly states that it will accept a clinical trial. This means, that if you are a researcher whose work involves biomedical or behavioral measures, you may have to apply to funding mechanisms that your peers have argued are not necessarily optimal or appropriate. Get in touch with your program officer and watch this space.

Grant applications will also feature a new form that consolidates the human subjects and clinical trial information previously collected across multiple forms into one structured form. For a walkthrough of the new form, check out this video.

Human Subjects Training

Investigators involved in a clinical trial must complete Good Clinical Practice (GCP) training. GCP training addresses elements related to the design, conduct, and reporting of clinical trials and can be completed via a class or course, academic training program, or certification from a recognized clinical research professional organization.

In practice, if you have already completed human subjects training (e.g. via CITI) and believe your research may soon be classified as a clinical trials, you may want to get proactive about completing those couple additional modules.

Getting IRB Approval

Good news if you work on a multi-site study, NIH now expects that you will use a single Institutional Review Board (sIRB) for ethical review. This should help streamline the review process, since it will no longer be necessary to submit an application to each site’s individual IRB. This requirement also applies to studies that are not clinical trials.

Registration and Reporting

NIH-funded projects involving clinical trials must be registered on Clinicaltrials.gov. In practice, this means that the primary investigator or grant awardee is responsible for registering the trial no later than 21 days after the enrollment of the first participant and is required to submit results information no later than a year after the study’s completion date. Registration involves supplying a significant amount of information about a study’s planned design and participants while results reporting involves supplying information about the participants recruited, the data collected, and the statistical tests applied. For more information about Clinicaltrials.gov, check out this paper.

If you believe your research may soon be reclassified as a clinical trial, now is probably a good time to take a hard look at how you and your lab handle research data management.The best way to relieve the administrative burden of these new requirements is to plan ahead and ensure that your materials are well organized, your data is securely saved, and your decisions are well documented. The more you think through how you’re going to manage your data and analyses now, the less you’ll have to scramble to get everything together when the report is due. If you haven’t already, now would be a good time to get in touch with the data management, scholarly communications, and research IT professionals at your institution.

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