The Common Rule Redefined?

-Solomon Sackitey

The United States Health And Human Services has, on July 22, 2011, published for public comments, proposed rule changes for protecting human subjects in medical research. This vision has long been overdue in view of the rapid technological, regulatory and scientific advancements taking place globally.

Whilst the changes under consideration  focus mostly on the domestic front, it is not clear how they will impact the International Compilation of Human Subject Protections and the Office for Human Research Protections (OHRP)’s international outreach initiatives.

This aspect needs to be addressed clearly because it would take out the guesswork from studies done outside the United States where language and culture are big issues. Terminologies need to be clearly defined and allow for proper translations into the local languages in order to help citizens of those nations to make informed decisions prior to participating in human subject research studies.

Comments about the proposed changes will go a long way in bringing about the much-needed improvements while attracting and retaining research volunteers. What is your take on this proposal?

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