HHS Announces New Rules to Protect Clinical Trial Participants
On September 2, 2015, the Department of Health and Human Services (HHS) announced changes to a 1991 Common Rule governing the protection of human participants in clinical research. The changes include:
- Informed consent documents will have to highlight important information in a more condensed and readable format
- The storage and use of biospecimens in secondary research will require written consent from the patient
- Most multisite research studies will be required to use a singular IRB
- There will be simplified standards for oversight of low-risk research studies
Some experts see the change as aligning with the goals of a federal push for precision medicine. Others are worried that the rule governing biosamples could slow down important research initiatives.
How do you feel about the new rule requiring informed consent for the use of biosamples in secondary research?
For more information about what sites need to know about IRBs and inspections, watch our webinar on-demand!
Also Read: Patient-Funded Trials: Are They Ethical?