Re-envisioning the Federal Policy for the Protection of Human Subjects


A major change is underway regarding the Federal Policy for the Protection of Human Subjects.

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies recommended a Notice of Proposed Rulemaking (NPRM) that was published on September 8th in the Federal Register. The NPRM details the proposition to improve upon and strengthen—largely through modernization and simplification—the Federal Policy in order to offer better protection for human subjects before, during, and after enrollment in a clinical trial. The NPRM also focuses on the benefits and values of research, while aiming to ameliorate the burden and ambiguity on behalf of the investigators.

One of the main issues being discussed is informed consent. Informed consent, in relation to a clinical trial, is the ability for a patient to make an informed decision with the full knowledge of the risks and benefits of the treatment or trial. The goal of these proposed changes to the rules regulating informed consent will be to ensure that the overall process of, for example, consenting to participating in a clinical trial will be less hassle for the participant. Clearly defining the intentions—including risks and benefits—of the trial in documents that are navigable and where the critical information is apparent, is just one of the ways in which consent forms will be made more accessible to the reader. The informed consent forms (ICFs) would be catered more specifically to the person reading the form, so the material contained within the ICF would highlight key information that is the most significant to the person’s decision to participant in the study. All ICF’s will have to adhere to a one-time posting requirement, so those drafting the ICF’s would do so knowing that the public can access the document. These proposed changes will take the ICF’s into a more public sphere of scrutiny.

An attempt to match the level of review to the seriousness of the risks is also being greatly considered by the NPRM. Subjects that are enrolling in clinical trials where the research presents a greater risk will be assured that the research has undergone more intensive evaluation than research that does not pose as great a risk. In accordance with these considerations, the NPRM strives to update any and all outdated regulatory standards. This is crucial to a patient’s understanding of the ICF, since outdated standards can prove overwhelming, distracting, and a waste of careful consideration on the patient’s behalf. An increase in the benefits of a study’s research can be achieved through the implementation of these new and necessary standards of practice.

Some of the results from these changes are that studies that currently require IRB review would become exempt, and those that already have an exempt status could be considered not to need any further review—either administrative or from the IRB. A “decision tool” that will determine whether a study can be classified as exempt or not will be created that can be used by investigators. For more detailed information on the NPRM proposals, please visit

These modifications and proposals, above all else, have been developed in order to continue to uphold the Federal Policy’s ethical principles. If interested in learning more about the proposed changes affecting the regulations for human subject research and protections, the Office for Human Research Protections (OHRP) is holding a session on behalf of Irene Stith-Coleman on Wednesday, September 15th at the Global Center for Health Innovations in Cleveland, Ohio. You can register now at the Forum website at The conference organizer is Carrie O’Neill and she can be reached at Space is limited, so do not hesitate to learn more about the collaborative innovations in human subject research!

Let us know your thoughts on this and other topics to LinkedIn by posting within the Quality Systems for Clinical Research Sites group. We would like you to join this group.