NIH Proposed Changes to Informed Consent: A Patient’s Perspective

jeri-homeAlthough I am Director of Patient Initiatives at HealthiVibe, I am also a patient advocate with a passion for clinical trial participation. So I’m switching hats today in order to share a recent experience with you.

The National Institutes of Health (NIH) is planning to make some changes to the Common Rule which governs the ethical treatment of clinical trial participants who take part in federally funded studies. As part of due process, they have issued a Notice of Proposed Rule-Making (NPRM) which gives a heads up to the general public that changes will be taking place, inviting public comment.

I was invited to give the patient perspective on the proposed changes in a “town hall” meeting took place on 11/18/15 in Philadelphia, the final of four such meetings that were streamed live from various locations across the country. I was the only “layperson” to speak at any of the meetings which was slightly intimidating. But for someone who is so passionate about bringing the patient perspective to clinical trial design, it was the chance of a lifetime. I was honored to be invited.

In the video below I shared my thoughts on what would make the Informed Consent not only patient-friendly, but, if thoughtfully design, could become a trial-long guide for study participants. You can find the full video of the entire event, complete with a lively panel discussion at the end here.


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