LBDA

Advocacy in Action: LBDA Voices Support for New NIH Policy

Advocacy in Action: LBDA Voices Support for New NIH Policy

Federal regulations for all medical research requires that each study is ethically reviewed to ensure the protection of its human subjects. Each organization that does medical research must have an Institution Review Board (IRB) for this purpose. LBDA has joined its voice with eighty-six other organizations via Leaders Engaged on Alzheimer’s Disease (LEAD), in support of a newly proposed policy by the National Institute of Health to allow for a single IRB of record for multi-site studies.

When the regulation was originally published, most clinical research was conducted at a single institution. Over time, the research landscape evolved and many studies are now collaborations across a multiple sites. Each site was still required to obtain approval from its institution’s IRB. This caused delays in research as well as duplication of effort and cost.

The draft NIH policy proposes that all NIH-funded, multi-site studies in the United States should use a single IRB. There are exceptions however, in the case where local IRB review is required to meet the needs of specific populations or when required by federal, state or tribal laws or regulations.

Because of the high rate of underdiagnosis of Lewy body dementia, many LBD research studies require collaborative across multiple sites. LBDA supports the use of a single IRB as it will aid in eliminating bureaucratic delays and increasing cost efficiency at research institutions.

Read the letter of support submitted by the LEAD Coalition during the public comment process.

Federal regulations for all medical research requires that each study is ethically reviewed to ensure the protection of its human subjects. Each organization that does medical research must have an Institution Review Board (IRB) for this purpose. LBDA has joined its voice with eighty-six other organizations via Leaders Engaged on Alzheimer’s Disease (LEAD), in support of a newly proposed policy by the National Institute of Health to allow for a single IRB of record for multi-site studies.

When the regulation was originally published, most clinical research was conducted at a single institution. Over time, the research landscape evolved and many studies are now collaborations across a multiple sites. Each site was still required to obtain approval from its institution’s IRB. This caused delays in research as well as duplication of effort and cost.

The draft NIH policy proposes that all NIH-funded, multi-site studies in the United States should use a single IRB. There are exceptions however, in the case where local IRB review is required to meet the needs of specific populations or when required by federal, state or tribal laws or regulations.

Because of the high rate of underdiagnosis of Lewy body dementia, many LBD research studies require collaborative across multiple sites. LBDA supports the use of a single IRB as it will aid in eliminating bureaucratic delays and increasing cost efficiency at research institutions.

Read the letter of support submitted by the LEAD Coalition during the public comment process.