FAQ - Informed Consent Issues
Is an English consent document OK when enrolling non-English-speaking subjects?
Study subjects are given a copy of the consent to be used as a reference document to reinforce their understanding of the study and, if desired, to consult with their physician or family members about the study.
In order to meet the requirements of 21 CFR 50.20, the consent document must be in language understandable to the subject. When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English.
However, when the majority of anticipated study subjects are non-English-speaking people, and it is anticipated that the consent interviews are likely to be conducted in a language other than English, the PI should submit a translated consent form for IRB review.
A copy of the translated consent document must be given to each appropriate subject. While a translator may be used to facilitate conversation with the subject, routine ad hoc translation of the consent document may not be substituted for a written translation.
If the anticipated study population will only include a few non-English-speakers, a short form may be used to obtain informed consent. See: About Short Forms
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Who should be listed on the consent form as the contact to answer questions?
21 CFR 50.25(a)(7) requires contacts for questions about the research, the research subject's rights, and in case of a research-related injury. It does not specify whom to contact. The same person may be listed for all three. However, FDA and most IRBs believe it is better to name a knowledgeable person other than the clinical investigator as the contact for study subject rights. Having the clinical investigator as the only contact may inhibit subjects from reporting concerns and/or possible abuses.
Standard language for subjects in studies being conducted at the University of Minnesota Medical Center, Fairview:
“If you have any questions or concerns regarding the study and would like to talk to someone other than the researcher(s), you are encouraged to contact the Fairview Research Helpline at telephone number 612-672-7692 or toll free at 866-508-6961. You may also contact this office in writing or in person at University of Minnesota Medical Center, Fairview-Riverside Campus, #815 Professional Building, 2200 Riverside Avenue, Minneapolis, MN 55454.”
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Who should be present when the informed consent interview is conducted?
FDA does not require a third person to witness the consent interview unless the subject or representative is not given the opportunity to read the consent document before it is signed; see 21 CFR 50.27(b). The person who conducts the consent interview should be knowledgeable about the study and able to answer questions.
FDA does not specify who this individual should be. Some sponsors and some IRBs require the clinical investigator to personally conduct the consent interview. However, if someone other than the clinical investigator conducts the interview and obtains consent, this responsibility should be formally delegated by the clinical investigator and the person so delegated should have received appropriate training to perform this activity.
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Must a witness observe the entire consent interview or only the signature of the subject?
FDA does not require the signature of a witness when the subject reads and is capable of understanding the consent document, as outlined in 21 CFR 50.27(b)(1). When the subject has no opportunity to read the consent document to verify the accuracy and completeness of the information provided, the signature of a witness is required (21 CFR 50.27(b)(2)).
The intended purpose is to have the witness present during the entire consent interview and to attest to the accuracy of the presentation and the apparent understanding of the subject. If the intent of the regulation were only to attest to the validity of the subject's signature, witnessing would also be required when the subject reads the consent.
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How is substituted informed consent obtained?
Alternatives to obtaining informed consent from the subject immediately before the start of the trial include:
- prior written consent from the subject,
- surrogate consent from a legally authorized representative,
- durable power of attorney, and
- proxy.
Alternatives 1 and 2 are provided for in the regulations and are appropriate. Alternatives 3 and 4 allow a designated individual to provide consent for a patient with regard to health care decisions. When these alternatives are considered, the IRB must assure itself that applicable state law applies to obtaining informed consent for subjects participating in research as well as for patients who require health care decisions.
Bottom line: Are individuals who have durable power of attorney or have proxy status able to provide consent for participation in research or are their actions limited to health care decisions?
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Who must sign the consent form?
21 CFR 50.27 requires that the written consent form approved by the IRB be signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.
It is the IRB's expectation that the person obtaining consent (sometimes the PI, sometimes a trained delegate), will also sign and date the form, attesting to the informed consent conversation. The PI should sign the form only if he or she was present for the consent interview.
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How do you obtain consent from someone who speaks and understands English but cannot read?
Illiterate persons may have the consent read to them and "make their mark." The 21 CFR 50.27(b)(2) requirements for signature of a witness to the consent process and signature of the person conducting the consent interview must be followed, although a special "short form" consent need not be prepared.
Clinical investigators should be cautious when enrolling subjects who may not truly understand what they have agreed to do.
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