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Submit Your Comments About the Informed Consent Process for Clinical Trials by October 26

The Parkinson's Disease Foundation (PDF) encourages the Parkinson's community to submit input for the federal government on an Advance Notice or Proposed Rulemaking (ANPRM) which could affect participants in Parkinson's clinical trials.

Through its Parkinson's Advocates in Research (PAIR) program, PDF Research Advocates are actively collaborating with research professionals, government agencies and private industry to improve the design, conduct and outcomes of Parkinson’s clinical research. So far, 10 of PDF's trained Research Advocates have already submitted their feedback to ensure the safety of future research participants. 

Will you join our advocates and add your voice to this decision? The deadline for community input is Wednesday, October 26.

What is an ANPRM?

An ANPRM allows the government to request public input on proposed changes or additions to rules that explain and expand upon regulations.  A recent ANPRM for Revision to Common Rule was released to request public feedback on how to improve the protection of research participants while facilitating the advancement of science. Two key topics include informed consent and the use of biospecimens. (The Common Rule is the federal policy regarding the protection of research participants.) The government is seeking input on how to streamline informed consent while ensuring that people who participate in research still get the information that is most important to them in deciding when to participate in a study.

PDF will include below instructions from the Parkinson's Action Network (PAN) on submitting comments by Wednesday, October 26. PDF asks community members to note that any comments submitted are not private; they will be published in the Federal Register.


How Do I Submit Feedback? Tips From PAN:

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.

How to Submit Your Comments:

  • Visit this page and click the orange "Submit a Comment" button;
  • Enter your comments into the text box and then click “submit.”  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 consider sending a copy of your submitted comments to PAN by emailing them to Becca O’Connor.

While PAN will submit comments on the ANPRM, 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 opportunity to share ideas on how to make the informed consent process work better for you!  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.

Please consider adding your voice to this important conversation by submitting your comment to HHS by the October 26 deadline!


PAN is the voice of the Parkinson's community in Washington, DC.  In 2011, PDF is supporting PAN with a grant of $200,000.

There are more than 100 PDF Research Advocates working with the Parkinson's Advocates in Research Program. Learn more about their work here.

Source Date: Oct 05 2011