Full access
Government News
Published Online: 2 September 2011

Research Regulation Changes Could Make Process More User Friendly

Publication: Psychiatric News
Volume 46, Number 17
https://doi.org/10.1176/pn.46.17.psychnews_46_17_4_2
PDF/EPUB
The Department of Health and Human Services' proposed changes to the "Common Rule" governing human research aim to accomplish the following:
Establish for all of the U.S. sites in a multisite study a single Institutional Review Board (IRB) of record. Under the current Common Rule, an IRB at each institution involved in a study has to approve the research.
Tailor administrative and reporting requirements to the level of risk to humans involved in biomedical research and expand the number of trials that can be expedited without IRB oversight.
Provide greater specificity about how consent forms should be written and what information they should contain, so they can be shorter and more user friendly.
Establish a single Web site where adverse events can be reported electronically, thus meeting all federal reporting requirements, with the resulting data being stored in a single database and reporting requirements across federal agencies harmonized.

Information & Authors

Information

Published In

Go to Psychiatric News
Psychiatric News
Volume 46 • Number 17 • September 2, 2011
Pages: 4

History

Published online: 2 September 2011
Published in print: September 2, 2011

Authors

Metrics & Citations

Metrics

Citations

Export Citations

If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download.

For more information or tips please see 'Downloading to a citation manager' in the Help menu.

Format
Citation style
Style
Copy to clipboard
Tips for downloading citations

There are no citations for this item

View Options

View options

PDF/ePub

View PDF/ePub

Get Access

Login options

Already a subscriber? Access your subscription through your login credentials or your institution for full access to this article.

Personal login Institutional Login Open Athens login

Not a subscriber?

Subscribe Now / Learn More

PsychiatryOnline subscription options offer access to the DSM-5-TR® library, books, journals, CME, and patient resources. This all-in-one virtual library provides psychiatrists and mental health professionals with key resources for diagnosis, treatment, research, and professional development.

Need more help? PsychiatryOnline Customer Service may be reached by emailing [email protected] or by calling 800-368-5777 (in the U.S.) or 703-907-7322 (outside the U.S.).

Media

Figures

Other

Tables

Share

Share

Share article link

Share

×

As described within the American Psychiatric Association (APA)'s Privacy Policy and Terms of Use, this website utilizes cookies, including for the purpose of offering an optimal online experience and services tailored to your preferences. Please read the entire Privacy Policy and Terms of Use. By closing this message, browsing this website, continuing the navigation, or otherwise continuing to use the APA's websites, you confirm that you understand and accept the terms of the Privacy Policy and Terms of Use, including the utilization of cookies.