Informed Consent: BISA Submits Comments On FDA Draft Guidance
The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) announced a call for comments on the current draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent.”
The call for public comments on the draft guidance is intended to improve the informed consent process.
“The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA’s proposed rule,” according to the FDA.
The deadline to submit public comments is April 30, 2024, including the docket number: FDA-2022-D-2997.
Key Information and Facilitating Understanding in Informed Consent
Guidance for Sponsors, Investigators, and Institutional Review Boards
BISA advocates Maria Gmitro and Jennifer Cook submitted comments to the agency on April 22, 2024.
BISA submitted the following letter:
Dear U.S. Food & Drug Administration,
Thank you for the opportunity to comment on the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) current draft guidance entitled “Key Information and Facilitating Understanding in Informed Consent docket FDA-2022-D-2997.
My name is Maria Gmitro and I am a Board Certified Patient Advocate with a Master’s Degree in Instructional/Educational Technology. I am president and founder of Breast Implant Safety Alliance (BISA). Our mission is to raise awareness, optimize outcomes, and ensure informed consent for patients considering breast implant surgery. BISA provides balanced, science-backed education, resources, and outreach to support empowered, informed healthcare decisions.
Protecting a patient’s right to informed consent is a core part of BISA’s mission. We believe using plain language is crucial to facilitate a patient or consumer’s understanding.
BISA reviewed the current draft form and I am submitting the following comments on behalf of our organization:
The current draft guidance addresses the need to use simple language and to explain/define technical, scientific, and medical terms. BISA believes it also may be helpful to additionally recommend that key terms that are subject to multiple meanings also be defined. Defining key terms in the document that are subject to multiple meanings can avoid potentially misleading prospective subjects. One example of a key word subject to multiple meanings would be the word "evidence." For example, this document from the CDC recognizes that "[e]vidence is defined in many different ways."
Here is the portion of the guidance where simple language and the recommendation to define terms is addressed (emphasis added):Page 13, lines 406-409
We recommend following plain language principles for the entire consent form.38 Plain language principles generally involve a combination of text based and visual approaches (e.g., pictures and diagrams), including organizing information with the most important points first, breaking complex information into understandable groups, using simple language, and defining technical terms. 39
Page 14, lines 443-445
3. Understandable Language
Information should be presented in plain language and at a level prospective subjects would likely comprehend; explanations should be included for scientific and medical terms. 41
Thank you for your consideration and your continued work toward improving the informed consent process.
SourcesFederal Plain Language Guidelines
Warmly,
Maria Gmitro, BCPA
President & Founder
Breast Implant Safety Alliance (BISA)
bisanonprofit.org
About Breast Implant Safety Alliance: BISA is a 501(c)3 women-owned nonprofit, patient-centered organization dedicated to improving breast implant safety and awareness—through direct collaboration with consumers, medical professionals, manufacturers, regulators, and advocates. BISA is a 100% volunteer organization not funded by implant manufacturers.
Media Contact: Maria Gmitro | maria@bisanonprofit.org | 843.501.6873