04 August 2011

New Rules Proposed for Studies and Researchers

This is somewhat like rules to protect the rule breakers. Yes, a little extreme, but when it comes to the government writing rules, this includes everyone but those in the government. The largest abuser of human subjects is the Veterans Administration which seemingly gets to do what it wants to abuse veterans in trails and studies.  But this is just my view of existing rules and the new rules being proposed.

The article in the New England Journal of Medicine (NEJM) lays out the history of the current rules first. Then it discusses the process of revising the current rules and the place to view the proposed new rules. While the responsibility of enforcing the rules rests with about 14 different federal departments and the Food and Drug Administration has similar but not identical regulations.

Most of the identification and investigation still rests with institutional review boards (IRBs), but as directed by the different federal departments for oversight. These IRBs need to be freed of some burdens to be able to their duties more effectively.

Two important items for discussion and potential revision of the rules (very much needed) is the exempt category and enhancing protections for research participants.  Many studies continue to have the risk of having private information and inappropriate information released to the public. The proposal of having these studies in the exempt category fall under the rules of the Health Insurance Portability and Accountability Act (HIPAA) is one of the better proposed rule changes.

The enhancing protections for research participants topic has many good suggestions and all need consideration. Briefly they are closing the gap that some studies use to bypass federal oversight, consolidation of reporting requirements of adverse events, revising informed consent documents to eliminate lengthy legal boilerplating, and making them more readable for knowledgeable informed consent, and finally rules about biospecimens – their control and use.

The one area I have not found any concern about are for regarding human participants is the Veterans Administration. Since they are a government entity, they do not seem the have an IRB to review their activities or any agency to discipline them for their rule violations. Therefore this is an area that needs attention and the Secretary of Defense needs to be able to empower a board of review for the Veterans Administration's abuse of our veterans. Yes, the Department of Defense (DOD) and the Department of Veterans Affairs (DVA) have some reporting requirements for adverse events, but there seems to be no oversight or requirements for failure to report.

The authors do state that some reforms are needed now with the growing body of human participants and new types of research. They appropriately warn that these reforms should not be delayed for another 20 years.

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