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# Praise, Suggestions for Informed Consent Guide
- URL: https://www.fdaweb.com/praise-suggestions-for-informed-consent-guide/
- Published: 2024-05-02T12:00:00.000Z
- Updated: 2026-09-14T14:29:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156901

Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the flexible and innovative approach outlined in an FDA draft guidance on key information and facilitating understanding in informed consent. A PhRMA comment [letter](https://www.regulations.gov/comment/FDA-2022-D-2997-0065?ref=fdaweb.com) urges FDA and the HHS Office for Human Research Protections (OHRP) “to continue to embrace flexibility and recognize that lengthy informed consent documents are generally unnecessary and, in many circumstances, can be counterproductive to the intended purpose of informed consent.” It recommends that the guidance expressly state that only the most significant aspects of each of the seven recommended topics identified in the draft may be necessary in the Key Information.

PhRMA provides additional comments on the Key Information section and says FDA and OHRP should clarify the included example and provide additional examples of key information.

The association says it supports the draft’s recommended plain language and tiered approaches to informed consent forms.

In its [comment](https://www.regulations.gov/comment/FDA-2022-D-2997-0057?ref=fdaweb.com), the Association for Clinical Oncology “applauds FDA for its continuous efforts to provide multiple strategies for clinical studies that are consistent with the revised HHS Common Rule.” The letter says the association is pleased that FDA provided several examples of how to facilitate participants’ understanding to appropriately assess the reasons why one may or may not want to participate in a study.

EMD Serono [says](https://www.regulations.gov/comment/FDA-2022-D-2997-0068?ref=fdaweb.com) the draft “is an excellent opportunity for study sponsors to revisit their current practices from a patient perspective, aiming at the provision of all essential information in a clear and unequivocal way without causing confusion to patients or caregivers.” The letter also includes specific line-by-line comments.

[Otsuka](https://www.regulations.gov/comment/FDA-2022-D-2997-0064?ref=fdaweb.com) and [Moderna](https://www.regulations.gov/comment/FDA-2022-D-2997-0041?ref=fdaweb.com) gave line-by-line comments.