Make Your Voice Heard: Tell NIH You Oppose the Classification of Basic Human Subjects Research as Clinical Trials

Make Your Voice Heard: Tell NIH You Oppose the Classification of Basic Human Subjects Research as Clinical Trials

The US National Institutes of Health (NIH) is still at it: If you’ve been following along, you know that NIH has been attempting to classify basic behavioral science research as clinical trials. Just on principle, this reclassification is offensive. But there are practical implications as well. Among other things, psychological scientists funded by NIH will have to satisfy many additional rules and regulations that may make sense for true clinical trials—but not for basic research. And NIH has tried to justify this move by connecting it to efforts to increase registering and reporting of research studies. Simply put, this makes no sense.

APS and many other scientific and academic organizations and thousands of individual scientists were unanimous in telling NIH that they opposed the definition. But NIH was unreceptive to the community’s concerns and continued to move ahead with implementing the objectionable redefinition amid widespread confusion within and outside NIH about its purpose.

At a loss, APS and other groups turned to Congress to express our disappointment with NIH’s policy changes; Congress, recognizing our concerns were valid, instructed NIH to delay its policies and consult with the scientific community.

And that’s where we are now. At the direction of Congress, NIH has issued a Request for Information (RFI) asking the community to weigh in on a number of questions related to basic behavioral science. The title would lead you to believe that that the focus of the RFI is on registration and reporting, but you’ll see that NIH has used the RFI to double down and is treating the redefinition of basic research as clinical trials as a done deal.

Act Now—Numbers Matter

NIH needs to hear from individual scientists like you that basic human subjects research should not be classified as clinical trials.

APS has weighed in, and you can read our response to NIH’s RFI below (as well as in PDF format by clicking here). Feel free to use it as a model for your own RFI response; the bottom line is that it is critically important to let NIH know you do not accept a redefinition of basic research with human subjects as clinical trials.

To respond individually to NIH’s RFI, you should:

  1. Read APS’s response to NIH’s RFI, shown below
  2. Click this link to access NIH’s RFI—don’t be distracted by the title, which only captures part of the broader issues raised by the RFI
  3. Enter your comments into whichever individual comment boxes that you feel you are able to address
  4. Submit the RFI form prior to November 12, 2018, 11:59 PM EDT
  5. Encourage your colleagues to weigh in as well
  6. Feel free to share your response with APS by emailing it to aps@psychologicalscience.org with the subject line “NIH RFI.”

After submitting your response to NIH’s RFI, treat yourself to “The Basic Research Blues,” a song on this issue written and performed by Sarah Brookhart, APS Executive Director. You may even want to do your own version of the song—be sure to share it with APS if you do!

Click this link to access NIH’s RFI.

Below follows APS’s response to the NIH RFI on clinical trials.


 

Association for Psychological Science

Response to NIH NOT-OD-18-217 Request for Information

The US National Institutes of Health (NIH) is attempting to classify basic behavioral science and other basic research with human subjects as clinical trials. Per a directive from Congress, NIH has delayed implementation of the new definition and has released a Request for Information (RFI) inviting members of the scientific community to offer feedback on a series of topics. Although the title of the RFI implies that it is solely about registration and reporting, there’s something much larger at stake—the way that basic research with human subjects is recognized at NIH.

The Association for Psychological Science (APS) opposes NIH’s efforts to classify basic research with human subjects as clinical trials, and it has told NIH this in its response to the RFI, submitted on October 11, 2018. You can read APS’s response to the RFI topics below. The plain text indicates the topic prompt appearing in the NIH RFI, and the boxed, outlined text shows APS’s response.


 

RFI Topic: Specific examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov, including specific reasons for these challenges (e.g., specific data elements)

APS: The questions in this RFI assume that the scientific community accepts NIH’s redefinition of basic research with human subjects as clinical trials and that such basic research should be subject to identical registering and reporting standards as clinical trials. The Association for Psychological Science (APS) does not agree with this assumption, and neither does the basic human subjects research community, evidenced by the strong and unanimous opposition to this redefinition previously conveyed to NIH by thousands of individual scientists and numerous scientific and academic organizations in addition to APS.

Clinical trials and basic research with human subjects are recognized across all of science as distinct spheres, involving different methods and designs, terminologies, publication outlets, and, importantly, different best practices for registration and reporting. Critically, ClinicalTrials.gov was not designed with basic research with human subjects in mind and is not an appropriate platform for registering and reporting these types of studies.

APS urges NIH to evaluate existing platforms for reporting basic research with human subjects and/or consider establishing a new platform that is appropriate for these types of studies, rather than attempting to retrofit ClinicalTrials.gov for this purpose. Forcing basic research to fit a mold designed for clinical trials disregards the immutable differences between these types of studies.

RFI Topic: Strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants

APS: A wide variety of platforms exists for timely registration and reporting of basic research with human subjects. As one example, APS advises its journal submitters to visit the Registry of Research Data Repositories (re3data.org) to find the right repository for their data. We have found that setting expectations for data and materials reporting and registration and letting researchers use the platform that is right for them has been effective in encouraging increased registration and reporting. Alternatively, NIH could develop a new portal for registration and reporting of the outcomes and findings of basic research, including basic research with human subjects.

We recommend that NIH consult APS’s current initiatives supporting transparent reporting and registration of basic research with human subjects. Further information is available on our website (https://www.psychologicalscience.org/publications/open-science). Preliminary evidence (e.g., Kidwell et al., 2016, PLOS Biology; Giofrè, Cumming, Fresc, Boedker, & Tressoldi, 2017, PLOS One) suggests that APS policies introduced in 2014 are linked with improved rates of reporting within our journals. We have since seen similar organizations adopt similar policies modeled after our own.

Given our experience in encouraging registration and reporting, we further recommend that NIH undertake a comprehensive, broad survey of the basic human subjects research community to determine what platforms currently are being used for the purposes of registering and reporting research. This survey should not be connected to current NIH clinical trials definitions and policies, which we believe to be a separate topic. A panel of experts should be convened to determine the criteria for assessing these platforms, and the quality of the platforms should be thoroughly examined. APS would be willing to facilitate a convening of such a panel. The results of this survey should be made publicly available at the earliest opportunity.

RFI Topic: Additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants

APS: As noted in our response to the first prompt, we do not believe that ClinicalTrials.gov is an appropriate platform for registering and reporting basic research with human subjects, given that APS and the basic human subjects research community do not agree that basic research should be subject to the current clinical trials policies at NIH.

We are willing to engage in a discussion about appropriate data elements for inclusion in existing platforms for reporting basic research findings, or about elements for inclusion in potential new platforms that are appropriate for basic research with human subjects.

Fundamentally, APS believes that the question of which data elements are appropriate for reporting and registration of basic research with human subjects is entirely separate from the issue of whether basic research with human subjects should be classified as clinical trials. As always, APS is supportive of efforts to strengthen registration and reporting of basic research with human subjects, which we believe is a core aspect of ensuring rigorous and reproducible science.

RFI Topic: Other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

APS: It is inappropriate to address this question in the context of this RFI, which needlessly combines the question of whether basic research with human subjects should be defined as clinical trials—which APS and the entire basic research community opposes—with recommended reporting and registration standards for basic science research. Please see our answers to the second and third prompts for more.

RFI Topic: Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants

APS: NIH must halt its efforts to define basic research with human subjects as clinical trials. The basic human subjects research community, academic institutions and organizations, and other groups are unanimous in opposing this definition. It is entirely unclear to APS and the community why NIH is persisting in its efforts, especially given that including basic research with human subjects in the definition of clinical trials will not solve the problem of the underreporting and lack of registration of true clinical trials.

Moreover, APS requests that NIH’s clinical trials definition and associated policies, case studies, and other guidance be reverted to their 2014 status, prior to the introduction of the expanded definition of clinical trials to include basic research with human subjects, and not permit directly or indirectly by implication or reference a definition of clinical trials that includes basic research with human subjects. The definition of clinical trials must be clear so as to not automatically classify basic research with human subjects as clinical trials.

As noted by Congress in its message to NIH, “Fundamental research is critical to the NIH mission and of value to the public, and there is concern that policy changes could have long-term, unintended consequences for this research.” We agree with this assessment and ask that NIH make a fresh start and engage in a process that is focused on designing policies that are appropriate for basic research with human subjects to meet the goals that we share with NIH with regard to ensuring transparency and rigor in research.

Comments

Classification of Basic Human Subjects Research as Clinical Trials will have drastic effects on basic research as well as the education of undergraduate and graduate students. Please do not do this!

I have a feeling they do not care what we (scientists) or congress say. They decided what they want from the start and that’s it. Not scientific of course, but that’s what they have become.

This is dumb. You should already know that these two things are not equivalent. Stop it NIH. Don’t be a jerk.

Basic research with human subjects is methodologically and conceptually distinct from clinical trials. Basic research should not be subject to the same registering and reporting standards as clinical trials. Clinical trials and basic research with human subjects are recognized across all of science as distinct spheres, involving different methods and designs, terminologies, publication outlets, and different best practices for registration and reporting. ClinicalTrials.gov was not designed for basic research with human subjects and is not an appropriate platform for registering and reporting these types of studies. Forcing basic research to fit a mold designed for clinical trials disregards the important differences between these types of studies and imposes unnecessary burdens on scientists who conduct basic research with human subjects. The proposed changes requiring registering and reporting this type of research in ClinicalTrials.gov will hamper important advances in our understanding of human health and well-being.

Basic Research is NOT “clinical trials”. A clinic provides treatment for disease or disorder. Basic research investigates phenomena- it does not provide clinical treatment.

There is a lot of basic human research to be done–it is not at all equivalent to clinical research trials and should not be subject to the same requirements.

Filled out the form and posted it on LinkedIn.

This change will not lead to improvement in transparency or accountability. It will inhibit basic research by adding to the costs for training, time reporting. It will muddy the waters for people looking for clinical trials to participate in for treatment. The change will make the word “clinical” meaningless.

The general public often holds the common misconception that Psychology is synonymous with Clinical Psychology. But the NIH should not hold such a naive understanding of Psychology that it also is subject to that misconception.

Psychology is the broader discipline that includes the basic science that investigates the nature of thinking and behavior. It examines the factors that underlie normal processes. In doing so, it also sometimes illuminates ways in which those processes can go wrong and result in abnormal behavior and thinking. Then the application of that knowledge is Clinical Psychology.

In other disciplines a similar relationship between an underlying science and the application of the science to solving clinical problems exists. In physical medicine the sciences of Chemistry and Biology underlie the practice of Physicians. A research study in chemistry could examine how some chemicals combine to form other chemicals. Perhaps the new chemical could then be considered as one constituent in a new medication. But would the NIH consider the original research on how chemicals combine a clinical trial? Certainly not.

Similarly, studies on how normal memory works have led to applications to the collection of eyewitness testimony. But should the NIH consider the original research on how normal memory works clinical trials? Certainly it should not.

In medicine, the sciences that underlie medical practice go by names other than “Medicine.” They are called Chemistry and Biology. Just because the science that underlies the practice of Clinical Psychology goes by the name of “Psychology” does not mean that it is synonymous with Clinical Psychology. Indeed the organization that was formerly called “The American Psychological Society” renamed itself “The Association for Psychological Science” to emphasize the distinction.

Psychological science involving human subjects is a broad field. Much of this research attempts to understand the mechanisms by which humans respond to their physical and social environments, or the processes by which these mechanisms develop. Some modest fraction of this research focuses on difficulties in these mechanisms; for this fraction clinical trials may be an appropriate research method. But for the vast majority of research on the development and expression of normal human cognitive and emotional processes, clinical trials make no sense, and an attempt to force the research into this mold seems bizarre and counterproductive.

Please duplicate Robert Ryan 10/15/18, omitting the last sentence.

There are many basic science questions that are not clinical trials. These include basic studies on sensation and perception (psychophyics, illusions, etc), human factors studies (e.g., driver performance), learning and attention (cognitive/connectionist modeling), psychometrics (e.g., developing improved methods of predicing workplace performance), to name a few. Equating basic research studies with clinical trials is ridiculous on the face of it.

There are tens of thousands of neuroscience studies published every year that are based on the examination of the human brain. This NIH proposal would make such studies, particularly those done with non-invasive approaches, e.g. brain-imaging studies, very onerous to conduct. Why throw such great obstacles on basic science? Indeed, most psychology studies are also conducted with human subjects. It seems absurd to subject studies on memory or cognition in general to such strict requirements. We should be trying to facilitate scientific work. Care must be taken when there could be adverse consequences, and the studies should meet appropriate guidelines to that effect. But in an overwhelming number of studies, the risks are minimal or even non-existing.

AGREE:
“The general public often holds the common misconception that Psychology is synonymous with Clinical Psychology. But the NIH should not hold such a naive understanding of Psychology that it also is subject to that misconception.

Psychology is the broader discipline that includes the basic science that investigates the nature of thinking and behavior. It examines the factors that underlie normal processes. In doing so, it also sometimes illuminates ways in which those processes can go wrong and result in abnormal behavior and thinking. Then the application of that knowledge is Clinical Psychology.

In other disciplines a similar relationship between an underlying science and the application of the science to solving clinical problems exists. In physical medicine the sciences of Chemistry and Biology underlie the practice of Physicians. A research study in chemistry could examine how some chemicals combine to form other chemicals. Perhaps the new chemical could then be considered as one constituent in a new medication. But would the NIH consider the original research on how chemicals combine a clinical trial? Certainly not.

Similarly, studies on how normal memory works have led to applications to the collection of eyewitness testimony. But should the NIH consider the original research on how normal memory works clinical trials? Certainly it should not.

In medicine, the sciences that underlie medical practice go by names other than “Medicine.” They are called Chemistry and Biology. Just because the science that underlies the practice of Clinical Psychology goes by the name of “Psychology” does not mean that it is synonymous with Clinical Psychology. Indeed the organization that was formerly called “The American Psychological Society” renamed itself “The Association for Psychological Science” to emphasize the distinction.”

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