A general requirement for the informed consent form is that it may not include

Except as provided in ß50.23, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

The study team make sure that technical and scientific terms are adequately explained or that common terms (lay language terms) are substituted. The informed consent document should properly translate complex scientific concepts into simple concepts that the typical subject can read and comprehend.

Although not prohibited by the FDA regulations, use of the wording, "I understand..." in informed consent documents may be inappropriate as many prospective subjects will not "understand" the scientific and medical significance of all the statements. Consent documents are more understandable if they are written just as the clinical investigator would give an oral explanation to the subject, that is, the subject is addressed as "you" and the clinical investigator as "I/we." This second person writing style also helps to communicate that there is a choice to be made by the prospective subject. Use of first person may be interpreted as presumption of subject consent, i.e., the subject has no choice. Also, the tone of the first person "I understand" style seems to misplace emphasis on legal statements rather than on explanatory wording enhancing the subject's comprehension.

Subjects are not in a position to judge whether the information provided is complete. Subjects may certify that they understand the statements in the consent document and are satisfied with the explanation provided by the consent process (e.g., "I understand the statements in this informed consent document)." They should not be required to certify completeness of disclosure (e.g., "This study has been fully explained to me," or, "I fully understand the study.")

Consent documents should not contain unproven claims of effectiveness or certainty of benefit, either explicit or implicit, that may unduly influence potential subjects. Overly optimistic representations are misleading and violate FDA regulations concerning the promotion of investigational drugs [21 CFR 312.7] or investigational devices [21 CFR 812.7(d)] as well as the requirement to minimize the possibility of coercion or undue influence [21 CFR 50.20

Significant Differences in FDA and DHHS Regulations related to Research Consent

 

 DHHSFDAWaiver of Parent/Guardian Permission in Minimal Risk Studies (45.404)For minimal risk studies involving children, the IRB may waive the requirement for consent if the research meets the criteria of 46.116(d) or is designed for conditions or a population for which parent/guardian permission is not a reasonable requirement to protect the subjects (examples include neglected and abused children).Waiver of parental permission is not allowed for FDA regulated research.Waiver of Parent/Guardian Permission in studies posing more than minimal risk to subjects and offering direct benefit to children participating. (45.405)For benefit studies with more than minimal risk involving children, the IRB may waive the requirement for consent if the research is designed for conditions or a population for which parent/guardian permission is not a reasonable requirement to protect the subjects (examples include neglected and abused children).Waiver of parental permission is not allowed for FDA regulated research.Waiver of Parent/Guardian Permission in Studies – a minor increase over minimal risk and no benefit to children participants (45.406)For studies not offering the prospect of direct benefit and that involve only a minor increase over minimal risk involving children, the IRB may waive the requirement for consent ONLY IF the research is designed for conditions or a population for which parent/guardian permission is not a reasonable requirement to protect the subjects (ex. include neglected and abused children). If parental permission is sought, both parents must provide consent (some exceptions.)Waiver of parental permission is not allowed for FDA regulated research.Dating consent formsDHHS regulations do not explicitly require consent forms to be dated.FDA explicitly requires that consent forms be dated as well as signed by the subject or the subject's legally authorized representative. 50.27(a)Waiver of Documentation of Informed ConsentDHHS allows for waiver or alteration of the requirement for a signed informed consent document in certain minimal risk studies and when the principal risk is a breach of confidentiality.FDA does not permit waiver of documentation. Obtaining informed consent is “deemed feasible” except in two situations (clinical emergency and emergency research. 21 CFR 50.23, 50.24. Waiver of Informed Consent/Consent not RequiredWaiver permitted under 46.116(d) if:

• The research involves minimal risk
• The waiver will not adversely affect the rights and welfare of subjects
• The research could not practicably be carried out w/out the waiver
• Where appropriate, subjects will be provided w/ additional information

Exceptions to informed consent requirements 21 CFR 50.23:

• Subject is confronted with life-threatening situation necessitating use of test article
• Informed consent not possible because of an inability to communicate with, or obtain legally effective IC from the subject
• No time to obtain consent from LAR
• No alternative method of approved therapy available that provides equal or greater likelihood of saving subject’s life
• IRB approves emergency research without requiring IC. 21 CFR 50.24

Costs of ResearchInformed consent document must include disclosure of any “additional costs to the subject that may result from participation in the research.” 46.116(b)(3)

• Disclosure of “additional costs” in the IC document
• Costs of IND product are not chargeable to the subject without FDA permission
• Costs of IDE product are chargeable to the subject, and are controlled by regulation.

Inspection of Study RecordsDHHS reserves the right to inspect records of studies it funds at a reasonable time and in a reasonable manner; it does not require that subjects provide informed consent for that inspection.FDA explicitly requires that subjects be informed that FDA may inspect the records of the study because FDA may occasionally examine a subject's medical records when they pertain to the study. 50.25(a)(5)

 

THE MOST COMMON REASON FOR DELAY OF APPROVAL OF A PROTOCOL IS AN IMPROPERLY PREPARED CONSENT FORM - EITHER CONTAINING INCOMPLETE INFORMATION OR UNINTELLIGBLE, COERCIVE OR CONFUSING LANGUAGE. 

Which information is not required in the written informed consent form?

What general information are included for required informed consent?

Which of the following is not part of informed consent?

What are the 3 general principles of consent?