Clinical Researcher—November 2021 (Volume 35, Issue 8)

CHAIR’S MESSAGE

Erika Stevens, MA, 2021 Chair of the Association Board of Trustees for ACRP

How can ACRP impact research integrity?

Maintaining research integrity is a complicated process in clinical research. While regulations require protection of human subjects{1} and demand good clinical practice (GCP) in clinical research,{2} oversight of these activities in the United States sits with the U.S. Food and Drug Administration (FDA).{3}

The National Institutes of Health defines research integrity as performing research with verifiable methods and result reporting with adherence to regulations.{4} The Office of Research Integrity provides further clarification on shared scientific principles in the conduct of research to include honesty, objectivity, accuracy, and efficiency.{5} Noncompliance with federal regulations found through FDA inspections are classified as “No Action Indicated,” “Voluntary Action Indicated,” or “Official Action Indicated.”{6}

Despite the regulations, potential inspections, and penalties, research misconduct exists in the clinical research industry. Research misconduct includes “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”{7} The Code of Federal Regulations established a final rule on research misconduct in 2005{8}; the possible administrative sanctions include debarment from federal funding and required corrective actions, inclusive of certification of research.{9}

While the FDA has oversight of inspections through the Department of Health and Human Services, the Office of Inspector General identified issues with FDA’s ability to adequately oversee safety inclusive of biologics: “Ensuring that participants in clinical trials are protected from significant risk presents an additional challenge to the Department both during the initial approval process and after drugs, devices, and biologics are approved by FDA when post-marketing trials are conducted.”{10} Unfortunately, even when reporting of misconduct to FDA occurs, the agency may not have the required resources to respond. For example, in September 2020, a report filed with the agency indicated several concerns from a research organization participating in COVID-19 trials.{11}

ACRP provides simulated GCP training to support researchers’ adherence to the regulations.{12} Further, ACRP offers pathways to certification for clinical research coordinators (CCRC), clinical research associates (CCRA), principal investigators (CPI), and ACRP certified professionals (ACRP-CP), and provides subspeciality designations for those working in the medical device (ACRP-MDP) and project management (ACRP-PM) arenas.{13} ACRP continues to be at the forefront in clinical research training and certification, and strives toward meeting its mission of “promoting excellence in clinical research” and its vision for clinical research to be “performed responsibly, ethically, and professionally everywhere in the world.”{14}

I wish you all the best jusqu’a la prochaine fois (until the next time),

References 

1. https://www.ecfr.gov/on/2018-07-19/title-45/subtitle-A/subchapter-A/part-46
2. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1
3. https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection
4. https://grants.nih.gov/policy/research_integrity/what-is.htm
5. https://ori.hhs.gov/education/products/RCRintro/index.html
6. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspections-database-frequently-asked-questions#classification
7. https://ori.hhs.gov/content/chapter-2-research-misconduct-federal-policies
8. https://ori.hhs.gov/public-health-service-phs-policies-research-misconduct-%E2%80%93-42-cfr-part-93-%E2%80%93-june-2005
9. https://ori.hhs.gov/federal-research-misconduct-policy
10. https://oig.hhs.gov/reports-and-publications/top-challenges/2011/issue12.asp
11. https://www.bmj.com/content/375/bmj.n2635
12. https://acrpnet.org/courses/good-clinical-practice-gcp-simulation/
13. https://acrpnet.org/certifications/
14. https://acrpnet.org/wp-content/uploads/dlm_uploads/2020/01/Mission-Vision-Goals.pdf