Informed Consent Documents Editing and Proofreading Services

Nine basic elements of informed consent appear in one federal rule and eight in the other. The Common Rule at 45 CFR 46.116(b) lists nine, with nine more required "when appropriate" under paragraph (c).¹ The Food and Drug Administration's rule at 21 CFR 50.25 lists eight basic elements and six additional ones.² A draft guidance issued jointly by FDA and the Office for Human Research Protections addresses the overlap. That guidance states that "FDA regulated clinical investigations conducted or supported by HHS are subject to both HHS and FDA regulations, per 45 CFR 46.101, 21 CFR 50.1, and 21 CFR 56.101."³

Only one of the two says how the document is arranged

Under 45 CFR 46.116(a)(5)(i), informed consent "must begin with a concise and focused presentation of the key information".¹ That information is the part "most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research."¹ Paragraph (a)(5)(ii) reaches informed consent "as a whole," requiring "information in sufficient detail relating to the research" arranged "in a way that does not merely provide lists of isolated facts".¹ The same sentence names the purpose of that arrangement, "but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate."¹ Nothing in 21 CFR 50.25 states a counterpart.

FDA's draft guidance of March 2024 puts a size on that opening section, recommending it be "relatively short (e.g., generally no more than a few pages)".³ The same guidance adds that "If appropriate, the elements of informed consent that are addressed in the key information section can also be repeated in other parts of the consent form."³ A section the guidance would hold to a few pages, and that may also repeat material appearing later, leaves an editor working on order and placement rather than on volume.

The short form carries a sentence the other version does not

Both rules allow a short form. Under 21 CFR 50.27(b)(2), the short form states "that the elements of informed consent required by § 50.25 have been presented orally to the subject or the subject's legally authorized representative."⁴ The Common Rule's version requires that and one thing more. 45 CFR 46.117(b)(2) asks for that statement and for one more, that the key information "was presented first to the subject, before other information, if any, was provided."⁵ A short form drafted from the FDA text alone carries the first and not the second.

A prohibition worded almost the same way twice

Neither rule allows exculpatory language through which a subject "is made to waive or appear to waive any of the subject's legal rights".⁶ The same sentence bars wording that "releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence."⁶ The two sentences diverge in two places. FDA's reaches consent "whether oral or written," and the Common Rule's says nothing about the form consent takes.⁶ The Common Rule's names "the legally authorized representative" where FDA's says only "the representative."¹ Both bar wording that makes a subject "appear to waive" as well as wording that waives, and both use the same phrase for it.

In November 1996 the Office for Protection from Research Risks issued a letter listing four unacceptable sentences and four acceptable ones.⁷ Among the unacceptable was "I waive any possibility of compensation for injuries that I may receive as a result of participation in this research."⁷ Among the acceptable was "This hospital is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research."⁷ Both describe the same absence of money, and only one asks the subject to give something up.

One passage is supplied word for word

For an applicable clinical trial, 21 CFR 50.25(c) supplies a statement and prints it in full.² The passage is reproduced in the appendix below. What we check is whether it is present and whether it matches the printed text word for word.

What we read, and what the investigator and the board decide

What a risk is, whether an alternative exists, and which procedures are experimental are settled by the investigator, the sponsor, and the reviewing board. We form no medical, scientific, or ethical judgment, and we do not tell a client whether a form satisfies either rule. Which rules reach a study is settled the same way. Anything a client sends is kept in confidence.

The reading we do is confined to the words. A term introduced in the procedures section may or may not keep its meaning in the risks section. A duration stated once and again later may or may not agree with itself. A sentence that could be read as a waiver can be marked for someone qualified to decide.

FDA's Bioresearch Monitoring program gave a final classification to 609 clinical investigator inspections in fiscal year 2024. Of those, 484 were classified no action indicated, 110 voluntary action indicated, and 15 official action indicated.⁸ The program lists six common inspectional observations for clinical investigators, and "Inadequate subject protection; informed consent issues" is the last of the six.⁸ The deck attaches no count to that category, and its label names inadequate subject protection alongside informed consent issues.