US plans to require trial consent publication

By Fiona BARRY

- Last updated on GMT

US plans to require trial consent publication

Related tags Informed consent

The US government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human Services (HHS).

If passed, the changes to the Common Rule (also known as the Federal Policy for the Protection of Human Research Subjects) would include a one-time posting requirement for the consent forms for clinical trials, so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.​”​ The documents will be published after trial enrolment has closed.  

Additionally, consent forms would be shortened, with extra information available in appendices:

Consent forms would no longer be able to be unduly long documents, with the most important information often buried and hard to find.

They would need to give appropriate details about the research that is most relevant to a person's decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information.

Proprietary information

Most pharma companies have yet to respond to the planned changes, although BIO (Biotechnology Industry Organization) and PhRMA (Pharmaceutical and Research Manufacturers of America) say they “applaud​” HHS for trying to modernise the Common Rule and have asked for a two-month extension to the December 7 comment deadline.  

A clinical trials expert told he expects the pharma industry to request the final rule to allow redactions of parts of consent with proprietary information.   

David Borasky, a VP at the institutional review board Copernicus Group IRB, told us he also has concerns that publishing consent documents alone “won’t tell you the whole story​” about the consent “process​” and may pose some challenges with increased uptake of electronic consent forms.

Timeline: six months?

It is possible HHS and a coalition of other government departments may decide whether to make their proposals a final rule within six months. The agency “seems under pressure to publish before the end of the Obama administration,​” Borasky told us; incoming governments of either party tend to temporarily halt many planned regulations.

The FDA is not involved in rewriting the Common Rule but has said if the changes pass it will issue its own Notice of Public Rule-Making as similar as possible to HHS’s.

Related news

Related products

show more

How a Clinical MDR Helps with Data Quality

How a Clinical MDR Helps with Data Quality

Formedix | 16-Jan-2023 | Technical / White Paper

This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to...

Optimizing Adherence in DCTs

Optimizing Adherence in DCTs

PPD - Decentralized Clinical Trials | 12-Jan-2023 | Technical / White Paper

Prioritizing greater patient-centricity and creating an opportunity to reach unprecedented patient groups, decentralized and hybrid clinical trials are...

PPD is Supporting Complex EU DCTs

PPD is Supporting Complex EU DCTs

PPD - Decentralized Clinical Trials | 05-Jan-2023 | Technical / White Paper

PPD supports European DCTs and clinical trial sponsors with a holistic and comprehensive approach

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 14-Dec-2022 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Related suppliers

Follow us


View more