Share Your Ideas to Foster Research Integrity and the Responsible Conduct of Research

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We all have a vested interest in maintaining the integrity of biomedical research. It is critically important to do so, after all, so the public can trust the resulting scientific findings. These posts from 2020, 2019, and 2018 highlight a few ways NIH works toward this goal of an environment promoting integrity and discouraging misconduct (check out this NIH All About Grants podcast for more on this).

Now it’s your turn to share some ideas. Our colleagues with the HHS Office of Research Integrity (ORI) recently published a Request for Information seeking your input. The feedback they receive will be invaluable for conducting future outreach and developing educational resources for the research community. In particular, feedback is sought on:

  • Using Training and Education to Foster Research Integrity
  • Administering research integrity and Responsible Conduct of Research programs
  • Training Sessions on research integrity and Responsible Conduct of Research.

Maybe your institution has practices that foster such a climate? Perhaps you have seen challenges administering the programs faced head-on, which made a noticeable difference? Or even participated in interactive, thought-provoking training efforts and feel the structure and topics may be applicable for others to meet their teaching needs? Figured out metrics to measure their effectiveness?

ORI wants to know! Comments are welcomed to OASH-ORI-Public-Comments@hhs.gov by December 18, 2020. Be sure to include “RCR RFI” in the email subject line.

5 Comments

  1. Congratulations to my American Scientific Experts for propeling the idea of ethical research for promoting high quality, strategic and pragmatic research on a global platform.

    Dr. Saumya Pandey (M.Sc., Ph.D.) would like to further provide her expert opinion:

    1. Emerging and established scientists with proven excellence in translational research and health sciences as evident in senior/first-authorships in peer-reviewed journals should undergo mandatory rigorous advanced research training in Bioethics, Scientific Integrity and Responsible Conduct of Research.

    2. Distinguished lectures by internationally-acclaimed scientists/clinical researchers emphasising the significance of academic authorship in research, financial/personal conflict of interest and dynamic collaborative research adhering to ethical guidelines as per the stringent American federal research statutes.

    3. With my most recent professional achievement as an Abstract-presenter at the American Society of Reproductive Medicine-ASRM 2020, I would like to add that fertility-reproductive medicine, one of my clinical research areas of special interest, certainly warrants relatively more stringent data-sharing/data-management protocols, especially involving multicentric-multiethnic pooled population subsets with asymptomatic-borderline-symptomatic infertility-either Mycobacterium tuberculi-mediated female infertility, tobacco-mediated male/female infertility; scientifically sound, ethical research involving eligible human subjects should adhere to core tenets of bioethics with written informed consent of study-participants.
    Moreover, international collaborations viz. pooled clinical samples-American+Asian Indian-North+South Indian subsets of infertility cases and controls, should be stringently monitored for compliance issues, international country-study site specific medical research ethics/approval mandates, by a special surveillance/medical research vigilance team at the federal offices.

    4. To ensure highest-quality research, investigators demonstrating scientific competence with at least 10 senior/first authorship publications should be screened/shortlisted for project-proposal-submissions; with my meticulous 50 first authorships in leading peer-reviewed journals, I would ambitiously, strategically and deservingly be proud to be an academically accomplished Project-proposal Grant Reviewer at the NIH Grants Offices, USA so as to effectively identify competent investigators vying for American federal fund support, and emphatically disseminate the global significance of ethics-based medical research. Further, IRB approval numbers for human/animal research should be provided in scientific research reports and publications.

    5. Curriculum vitae with at least 10 senior authorships of investigators without marital status-gender-ethnicity bias, should be strictly reviewed prior to expert-panel scientific review board-meetings for consideration/review of eligible investigators’-pilot proposals in myriad burning areas of research.

  2. 1. Science grows-Many current reviewers have very narrow knowledge and training and when they are put in a position to evaluate, they are limited by their minds. For example, excessive focussing on molecular biology and have very little knowledge of pathology or biochemistry could bias a reviewers mind. There is no hierarchy in science. An application that studies a basic metabolic reaction is not inferior to an exercise in molecular biology involving creating new genes or altering them.
    2. The reviewers (instead of primary/secondary/tertiary) should be Senior, Junior, learner characteristics.
    3. For every application, there should be a “for” and “against”-mnot strengths and weaknesses pointed out by the same reviewer.
    4. Often reviewers give great scores independent of the negative weak points. The SRO asked the reviewers simply to tone down the criticism. And the reviewers takes out a couple of negatives. This is “altering” the “score”.
    5. Minor or major weakness are very descriptive. There should be explanations as to what qualifies for a minor and major strengths and weaknesses. A friendly reviewers could see major weakness as a minor point and would argue so. One the other hand, a lack of description of a buffer composition could cost one a grant, if the reviewers is unfavorable (it happened to me).
    6. Believe it or not-there is racism in the review process. This leads to behind the scene manipulations, SROs acting in unprofessional manner, and grouping. Believe me, most often birds of the same feathers don’t flock together. A chines reviewers is often not fair to a Chinese applicant, and an Indian reviewer is not fair to an Indian application, One of my Indian friend sometime back remarked that it is better not to send to a study section with an Indian chief, because he would go out of the way to be “fair” and hurt you. The other side also true., In have seen SROs, not just of one race or color, having secret meetings with applicants in conferences and gatherings.
    7. Believe me; even the order in which a grant is discussed has an effect on the score or participation by other members in a panel. Reviewers, despite strict recommendations, would like to get their applications done with. They book their travel early, finish and leave. Those applications that are often reviewed later often have a miserable time at the review.
    8. NIH should give the review panel courses on the art of listening and the art of speaking. I am not referring to accent and understandability. I am talking about patience, comprehension, clearly verbalizing etc.
    6.

  3. There is a lack of bioethics follow through at the institutional level. Institutional processes to ensure research ethics compliance are non existent and/or toothless. Senior faculty sometimes practice a “looser” bioethics standard in their science derived from their long-ago training. MDs doing bench science are not held to the same bioethics standard as PhD researchers. Authorship practices vary widely among MDs as compared to PhDs. The NIH should require all US institutions to have a bioethics office, to have clearly stated standards for research ethics and authorship, and should have the power to review and address complaints. Bioethics should also be shown to be considered when institutions hire and promote faculty.

  4. I absolutely agree with Karen. In the olden days an MD obtained a PhD after working for several years in the laboratory. Now the MD, PhD programs offer a 2 year consolidated degrees. Total waste, except from the perspective of clinicians who want to eliminate then PhD track and have only MD PhDs perform research. There are hardly a few successful MDs performing research. Their standards of research is below par-little or no statistics, no repetition or validation of studies, multiple bugs authorships, not much thought processes or IRB or IACUC, very little literature knowledge…it is just a waste of time. On the other hand, the PhDs have no concept of disease process, physiology, interventions or even rudimentary knowledge of anatomy. These two are parallel tracks and most attempy=ts to bring them together have ended up in failure.
    The K awards are a joke. Most institutions don’t allow their faculty to commit to research at 75%. We usually end up with mediocre talents.

  5. NIH should make it mandatory for all applicants to list in their biosketches, JITs and RPPRs, any research papers or conference proceedings where the
    applicants are either senior authors or first authors were retracted, withdrawn or under investigation for data integrity. Currently, there is no way for either reviewers or NIH to know this information unless they are proactively look for such information. This simple requirement by NIH from grantees will bring about the necessary attention and bring about responsible conduct in all parties involved when everyone knows that there are consequences to irresponsible conduct of research especially with respect to funding. If NIH study sections will take into account the credibility of past research while making decisions regarding future funding, this will create additional incentives for being more responsible for assembling and reporting data.

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