Bioethics Blogs

Final Rule: HHS and NIH’s New Information Requirements for Clinical Trials: Is More Information Beneficial and For Whom?

By Jorge Luis Rivera-Agosto

On September 16, 2016, the U.S. Department of Health and Human Services (HHS) presented a final rule, in conjunction with a complementary policy of the National Institutes of Health (NIH), amending Tile 42, Chapter 1 of the Code of Federal Regulations[1]. This final rule will bring about a new era for the different stakeholders in the health care industry: patients, providers, researchers and our government[2]. It represents a big step toward increased access to information about certain clinical trials, a topic that affects subjects’ informed consent directly. The regulation’s aim is to specify “how data that were collected and analyzed in accordance with a clinical trial’s protocol are submitted to ClinicalTrials.gov”. As such, it does not create new requirements on data, design, or conduct of clinical trials[3].

All stakeholders in the field of research ethics have engaged in continuous debate regarding the need for “increased access to information about clinical trials”[4]. The lack of publications[5] (researchers that don’t publish their findings for a variety of reasons such as that their data won’t be of benefit to the whole community) of clinical trials and biased literature[6],[7] (when researchers publish positive rather than negative findings) concerning clinical trials outcomes are major concerns. The problems previously mentioned are what this regulation tackles.

First, Section 11.22 of the final rule explains which clinical trials must be registered in the webpage. It states that all clinical trials initiated after September 27, 2007, or any clinical trial initiated before or continued after such date, must figure in ClinicalTrials.gov[8].

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.