Good Clinical Practice: A Question & Answer Reference Guide - May 2018 - 80

GCP: A Question & Answer Reference Guide
that could result from the disclosures (e.g., unnecessary treatment, subject concern). The National Bioethics
Advisory Commission (NBAC) recommended that such disclosures be made only in "exceptional circumstances,"
and that result disclosures be made only when "a) the findings are scientifically valid and confirmed, b) the findings
have significant implications for the subject's health concerns, and c) a course of action to ameliorate or treat these
concerns is readily available."
In its Institutional Review Board Guidebook, the US Department of Health and Human Services discusses
human genetic research and subjects' access to interim findings, noting that, "IRBs should consider whether the
investigator's approach appropriately balances the risks and benefits involved in providing access to the data.
Subjects should be told, as part of the consent process, whether, when, and what information they will receive. Any
disclosures of genetic information should be accompanied by appropriate counseling by trained genetic counselors.
However, the IRB resolves this question, investigators should explain to prospective subjects the basis according to
which they will decide which data will be disclosed to whom, and when those disclosures will be made."
In January 2011, FDA finalized a new regulation that requires an additional new element be added to the informed
consent form to inform the subject that the aggregate results from the study will be available after the study at www.
clinicaltrials.gov. This new informed consent element is mandatory for all new covered studies commenced after
March 2012. The FDA issued a guidance titled, "Guidance for Sponsors, Investigators, and Institutional Review
Boards: Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)" that addresses what is a
covered study and the specific language required to be added to the informed consent form.
The Center for the Study and Information of Clinical Research Participation (CISCRP) supports informing
research patients of study results. (Getz K, Ouellette E, Simmons D Et al. Providing results to volunteers. Appl. Clin.
Trials 19(10), 52-59 (2010).
2.71 Q. Do requirements exist for inclusiveness in clinical trials and what are the mechanisms for tracking?
A. While the FDA does not have specific regulations mandating diverse patient populations, recent efforts
encourage diversity. Such initiatives include the partnership with Office of Women's Health, the Public Service
Announcements, "Minorities in Clinical Trials" webpage and dedicated patient content on the FDA homepage.
(https://www.gao.gov/assets/680/675712.pdf_)In the recent publication, "2015-2016 Global Participation
in Clinical Trials Report", the FDA highlights trends for inclusion in clinical trials. NIH recently revised its
policy on patient inclusion throughout the lifespan, to encourage trials including children in order to establish
effectiveness of treatments in children. (NIH Policy and Guidelines on the Inclusion of Individuals Across the
Lifespan as Participants in Research Involving Human Subjects https://grants.nih.gov/grants/guide/notice-files/
NOT-OD-18-116.html).
2.72 Q. If a sponsor or institution fails to list a study in ClinicalTrials.gov and does not update the listing are
there any consequences?
A. As of October 2012, the FDA began policing compliance with clinical trial submission requirements for
ClinicalTrials.gov. Under the law that created the requirement for listing clinical trials in 2007, the original
creation and jurisdiction for the database was handled by the National library of Medicine at the NIH. The federal
government has turned jurisdiction for enforcement for compliance with ClinicalTrials.gov to the FDA. The FDA
is now identifying incorrect or fraudulent submissions and seeking out un-submitted trial results. The penalties
could seriously derail your clinical trials.
Civil monetary penalties include any person who fails to properly disclose trial information shall be subject to
a civil monetary penalty up to $10,000. If a violation is not corrected within 30 days following notification-in
addition to the above penalties-persons can be subject to penalties up to $10,000 for each day of the violation after
such period until the violation is corrected.
If your trial is funded in any way by a federal agency, and you fail to properly disclose trial data, you could see
your trial come to a grinding halt.
Section 801 of FDAAA allows for any agency of the HHS, including FDA, NIH, or the Agency for Healthcare
Research and Quality to withhold funding grants for trials currently in progress until disclosure requirements are
met. And, the law allows government agencies to cut off future grants to companies or organizations that it feels
are not in compliance.
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http://www.clinicaltrials.gov http://www.clinicaltrials.gov https://www.gao.gov/assets/680/675712.pdf https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-116.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-116.html http://www.ClinicalTrials.gov http://www.ClinicalTrials.gov http://www.ClinicalTrials.gov

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2018