[CarolynS]

Deadline Approaching! Submit Comments on the Clinical Trial
Informed Consent Process by Wednesday, October 26!

The U.S. Government has rules and policies in place that are intended to protect individuals who participate in clinical trials. In July, the U.S. Department of Health and Human Services (HHS) announced that it is evaluating these rules. Among the many things being considered are ways to improve the informed consent process. Click here to read the Advanced Notice of Proposed Rulemaking (ANPRM).

HHS has received feedback that the packet of forms and documents given to patients at the informed consent stage of a clinical trial can be lengthy and confusing. It is seeking feedback on ways to improve and streamline the materials participants receive to ensure that the best information for making decisions is included.

PAN has submitted comments (click here to read) on the ANPRM, and we also strongly encourage those of you who have participated in clinical trials to take advantage of this opportunity to share your valuable insights. This is your chance to share ideas on how to make the informed consent process work better! We encourage you to be candid in your remarks and to share creative ideas for improving the process. This is a great opportunity to be heard – each comment will be recorded.

How to Submit Your Comments:

Visit this page and click the orange "Submit a Comment" button:
http://www.regulations.gov/#!documentDetail;D=HHS-OPHS-2011-0005-0001

Enter your comments into the text box and then click “submit.” [Using a Word document is a good idea so that you have plenty of time to consider your comments before submitting them. The submission system only allows 20 minutes to complete the submission.] Specific issues you may wish to address:

What factors contribute to the excessive length and complexity of informed consent forms, and how might they be addressed?

What additional information, if any, should be required by the regulations to assure that consent forms appropriately describe to study participants, in concise and clear language, alternatives to participating in the research study and why it may or may not be in their best interests to participate? What modifications or deletions to the required elements would be appropriate?

What modifications would improve the quality of consent forms?

Should the regulations require, for certain types of studies, investigators assess how well potential study participants comprehend the information provided to them before they are allowed to sign the consent form?

Would informed consent be improved if the regulations included additional requirements regarding the consent process, and if so, what should be required? For example, should investigators be required to disclose in consent forms certain information about the financial relationships they have with study sponsors?

Please send a copy of your submitted comments to Parkinson's Action Network (PAN) by emailing them to Becca O’Connor.

Please consider adding your voice to this important conversation by submitting your comments to HHS by the October 26 deadline! PAN appreciates your time and will keep you informed of next steps.