ACS CAN Files Comments on the Use of Human Subjects in Clinical Trials

Today the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), submitted comments to HHS and the FDA in response to the proposed rule to modify the Common Rule, which governs the treatment of human subjects in clinical trials funded by more than 15 federal agencies. The Common Rule was developed in the 1970s following the disclosure that African American men in Tuskegee, Alabama were intentionally infected with syphilis and then left untreated.

The Society and ACS CAN believe that modifications to the Common Rule are essential to achieving two critical goals: 1) streamlining the clinical trials research process so that they stand the best possible chance of yielding groundbreaking discoveries that could save lives, and 2) ensuring that patients who participate in clinical trials receive the highest quality care, are fully informed about what their participation entails, and are protected from potential privacy violations. The comments submitted by the Society and ACS CAN focus on the following areas:

Institutional Review Boards (IRBs) -- Under current regulations, every recipient of federal funding for a clinical trial must set up a separate IRB to ensure that the research meets ethical guidelines. The Society and ACS CAN strongly support the FDA's proposal to require only one IRB of record for multi-site clinical trials. Having one IRB for multi-site trials would increase efficiencies in large-scale research projects and reduce the start-up time for such projects by an estimated four months. We also support changes that will increase the efficiency and effectiveness of IRBs.

Patient privacy -- The Society and ACS CAN support the HHS proposal to apply the HIPAA Privacy Rule standards to research studies to best protect the privacy and confidentiality of cancer patients’ identifiable health information.

Biospecimens -- The Society and ACS CAN agree with the proposal that written consent be required for the use of biospecimens collected for clinical purposes and later used for research purposes. We also support the proposal that any consent for the future use of a research subject’s biospecimens cover all biospecimens collected for that purpose. Allowing broad consent for the use of patient biospecimens would prevent researchers from having to repeatedly receive consent from patients who provide multiple samples at a hospital or institution.

Applying regulations to all agencies -- The Society and ACS CAN support the proposal to harmonize the Common Rule and FDA regulations governing human subject research across all federal agencies, thereby minimizing confusion and improving compliance.

A full copy of the comments can be viewed here.