WakeForestUniversity Health Sciences

Guidance Document on Informed Consent

Informed consent is one of the primary ethical principles of human subjects research and is required by both FDA (21 CFR 50) and OHRP regulations (45 CFR 46).

Definitions:

Investigator:An individual who is ultimately responsible for the overall supervision and conduct of the research study and is CITI certified.

Designee:An individual who is listed as a study team member in e-IRB, is CITI certified, is knowledgeable about the study, and is delegated the task of obtaining consent by the investigator.

LAR (Legally Authorized Representative): An individual authorized to consent on behalf of a potential research subject.

Witness:An impartial adult who witnesses the consent process

Informed consentis a process that occurs between theinvestigator, or designated study team member, and the potential research subject. The consent process is divided into three main parts:

Written Consent Process

  1. Explanation of the Study
  • The investigator, or designee, provides a verbal explanation of the rationale, procedures, and risks and benefits of the study to the potential subject and gives the potential subject an opportunity to ask questions. This is usually done face-to-face, but with IRB permission may be conducted over the telephone.
  • The potential subject is provided with a copy of the written consent form, and is given sufficient time to read the consent and make a decision whether or not to participate. “Sufficient time” can range from hours to days, depending on the complexity of the study, the length of the consent, and the individual’sreading skills.
  • After allowing sufficient time to read the consent, the investigator, or designee, meets with the potential subject and answers any additional questions he/she may have.
  1. Subject Comprehension

The investigator, or designee, has the responsibility for ensuring that a potential subject understands the potential risks and benefits of the research study, the alternatives to participating, his right to withdraw from the study at any time, and the procedures for doing so. The consenter should not only answer questions, but also ask questions to assess subject comprehension. Asking questions can:

  • Further the consent discussion
  • Encourage the potential subject to think more carefully about the study
  • Help the consenter determine if the potential subject adequately understands the research risks/benefit

Open-ended questions provide the consenter with a better understanding of the potential subjects’ comprehension and cannot be answered by a simple “yes” or “no.” Examples of open-ended questions include:

  • “Describe in your own words the purpose of this study”
  • “Could you please explain to me what you think the study is asking you to do?”
  • “What do you think is the possible benefit to participating in this study? What are the possible risks?”
  • “Can you describe the alternatives to participating in this study?”
  • “What more would you like to know?”

Closed ended questions do not further the consent discussion and should be avoided. Examples include:

  • “Do you have any questions?”
  • “Do you understand?”
  • “Do you understand that this study involves some risk?”
  1. Required Signatures

Once a potential subject has had his /her questions answered and agrees to participate in the research study:

  • The subject, or legally authorized representative (LAR) should personally sign and date the consent form (see below)
  • The investigator, or designee, should sign and date the consent form
  • The signature of a witness is NOT required unless the subject or LARcannot read the consent form before it is signed.

Who Can Serve As an LAR?

The WFUHS IRB prescribes who can be an LAR, in the following order:

  1. Legal guardian
  2. Health care agent named under a health care power of attorney
  3. Spouse
  4. Adult son and/or daughter
  5. Parent
  6. Adult brother and/or sister
  7. Uncle and/or aunt
  8. Other adult relative

A legally authorized representative (LAR) may sign for the subject if:

  • The subject is incompetent
  • The subject is unable to provide consent (e.g. unconscious)
  • The subject is a minor (under the age of 18) and is not emancipated.
  • The IRB has granted approval for the use of an LAR to consent for research subjects as outlined in the IRB application.

The relationship of the LAR to the research subject must be indicated on the consent form.

In situations in which an LAR has signed the consent for a subject who was temporarily unable to sign for himself (e.g., due to unconsciousness or a similar state) the research subject should be informed of the research study at the earliest possible time and given the opportunity to sign the consent form themselves, or to decline and terminate their participation.

Who is a Witness

A witness is an impartial adult, such as one who is not a study team member or family member of the subject. A witness is required in those instances where the subject is unable to read the consent form themselves (e.g. illiterate, blind, etc.) and the consent form must be read aloud to the subject. The impartial witness must be present for the entire consent process and sign the consent document. The witness’sdated signature attests to the accuracy of the presentation and the apparent understanding of the subject. A witness is not necessary when the subject reads and is capable of understanding the consent document.

When to Reconsent

Federal Regulations require that subjects be provided with significant new information or findings developed during the course of the research, which could affect a subject’s willingness to continue participation [45 CFR 46.116(b)(5) and 21CFR50.25(b)(5)]. The IRB may require all previously enrolled subjects to be provided with new information concerning these findings.

The following are examples of situations that could require the investigator to provide new information to the study participants, consistent with 45 CFR 46.116(b)(5) or 21CFR50.25(b)(5):

  • Any changes to the protocol that could affect a subject’s willingness to participate in the research.
  • Availability of new information about the study interventions that could affect a subject’s willingness to participate in the research.
  • Identification of previously unknown risks or risks that are found to occur with greater frequency or severity than originally described.
  • Changes in the costs to the subjects or available compensation
  • Receipt of new information about the availability or effectiveness of alternative treatments that could affect a subject’s willingness to participate in the entire research study or a particular study arm

How to Consent Non-English-Speaking Subjects

To meet the requirements of 21 CFR 50.20, the informed consent document should be in a language understandable to the subject (or LAR). When the study anticipates enrolling non-English speaking subjects, the consent document should be translated and submitted to the IRB for review and approval prior to use to ensure that the translation is correct. As required by 21 CFR 50.27, a copy of the consent form must be given to each subject. In the case of non-English speaking subjects, this would be the translated document or the short form consent document (both of which require prior IRB approval). Subjects cannot waive their right to receive a translated informed consent document. While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation is not a substitute for a written translation.

How to Consent English-Speaking Subjects Unable to Read and/or Write

Illiterate persons who understand English may have the consent read to them and “make their mark,” if appropriate under applicable state law. For those individuals who can understand and comprehend spoken English, but are physically unable to talk or write, they can be entered into a study if they are competent and able to indicate approval or disapproval by other means:(1) the individualshould be able to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) be able to indicate approval or disapproval to study entry. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.

Telephone consent

Verbal consent does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document, as outlined in 21 CFR 50.27(a). It is acceptable, however, to first send the consent document to the subject or LAR by mail, e-mail, or facsimile, and thereafter conduct the consent interview by telephone at a time when the subject or LAR can read the consent as it is discussed. After all the subjects or LAR's questions have been addressed, if s/he agrees, s/he can sign the consent and return the signed document to the clinical investigator. Prior IRB approval should be obtained to conduct the consent process in this manner.

IMPORTANT NOTES:

  • English-speaking subjects who are unable to read and write must not be confused with non-English speaking subjects who are able to read and write in another language. A certified translation of the English consent form must be used to consent non-English speaking subjects.
  • It is the investigator’s responsibility to judge the subject’s comprehension of the consent information including the understanding that participation is voluntary and that the subject has the right to withdraw at any time during the study. If the investigator doubts the subject’s consent comprehension, he/she should not enroll the subject in the study.
  • Unapproved (unstamped) consent forms should not be used
  • Expired consent forms should not be used. The approval and expiration date within the IRB stamp on the consent document should be confirmed prior to use.
  • Changes will be made to the informed consent document during the course of the study. It is the Investigator’s responsibility to ensure that the individual signs the latest version of the consent document
  • The English consent form should not be verbally interpreted into other languages. Investigators must use an IRB-stamped, translated consent form or the short form consent process (requires prior IRB approval).
  • The subject should always be provided with a copy of the signed consent form to use as a reference for emergency contact information, scheduling of procedures, etc.
  • To further document and facilitate clarification of any future questions regarding the consenting process, the investigator should consider including the following information in a clinic chart/progress note/other source document: that XX study was explained, questions were answered (if any), subject agreed to participate and signed the consent form, and a copy of the signed consent form was given to subject. This note should be signed and dated by the person obtaining consent.

Version 1.27.11