A third party may be involved in the consent process as either a witness or a surrogate decision-maker. A witness observes the consent process and attests that the oral presentation of information made by the investigator is consistent with the disclosures made in the informed-consent document. A witness may also help the potential subject to understand the presented information so that he or she can make an informed decision regarding participation. A surrogate decision-maker acts for the potential subject and actually decides if the potential subject will participate in the study.
Third Party as Witness
Although Common Rule and U.S. Food and Drug Administration (FDA) regulations do not require the signature of a witness on the consent document (when a competent individual is the subject), the institution, state, or IRB may require this signature. For those protocols approved at Yale School of Medicine and Yale School of Nursing requiring written consent, the signature of the member of the research team who obtains consent is also required. Note that for protocols approved by the Human Subjects Committee (the IRB for the Faculty of Arts and Sciences) the signature of the principal investigator is not required on the consent forms. The Yale University Human Investigation Committee (HIC) protocol application form asks the investigator to list those personnel who will be involved in the consent process with subjects. These individuals should be listed on the protocol as co-investigators or study personnel. To meet the requirements for being listed as consent personnel, these individuals must have completed their IRB training, as well as Health Insurance Portability and Accountability Act (HIPAA) training.
The signature of a witness is required under federal policy when the IRB authorizes the use of a short-form written consent. In this case, the IRB approves a written summary of the oral presentation along with an abbreviated consent form that is signed by the investigator and a witness, attesting to the oral presentation of the consent information. An example of when the short-form consent/witness consent process may be used is when (as an interim measure) non-English-speaking subjects are being recruited and a translated consent form is not available. In this case, federal regulations require that the witness (who may also be the translator) do the following: (a) observe the oral presentation, (b) sign a copy of the summary of the oral presentation, and (c) sign the short-form consent document. The investigator signs a copy of the summary. The subject signs only the short-form and should receive a copy of both the short form and the summary. Please note that a full consent form translated into the subject’s native language is always preferable. The IRB must approve all translations of consent forms before they can be used.
During the consent process for certain types of vulnerable subjects where undue influence may be a concern (such as the physician-investigator negotiating consent with his or her terminally ill or seriously ill patient), the addition of a witness to the consent process may be appropriate. The President’s Commission favors employment of a third-party observer for some types of research, such as research involving persons institutionalized as mentally infirm or persons who are severely physically or mentally ill, but the need for such third parties is left to the discretion of the IRB in all other cases. The IRB may request the involvement of a third-party observer by suggesting a consultation or by officially requesting the presence of an overseer of the consent process.
The investigator should consider the goal of the “process of witnessing” when deciding who is an appropriate witness. The role of the witness is to be present while the investigator provides the prospective subject with a complete and meaningful disclosure of information about the research so that the subject can make an informed decision that is free of undue influence. With this objective in mind, the witness or third-party observer may be a spouse or partner, a family member, or a consent monitor. A consent monitor is an impartial person who understands the risks and benefits of the research, such as an IRB member or IRB staff member; a research subject advocate; or a patient advocate. All General Clinical Research Centers must include funding for the position titled research subject advocate. The primary role of the research subject advocate is to ensure that studies conducted at the General Clinical Research Centers are designed and conducted safely and ethically, with protection of human subjects accorded the highest priority. The requirement for a witness should not be taken lightly. The presence of a witness might be construed by the subject as an invasion of his or her privacy or a suggestion that his or her judgment is questioned. Therefore, depending on the circumstances, it may be appropriate for the subject to select the witness. Witnesses who are family members or next of kin may have knowledge of the potential subject’s preferences and therefore be better able to advise them regarding participation in research.
The IRB may request that an investigator use an independent overseer, a special type of consent monitor. The independent overseer has special qualifications and typically is a physician or another health care practitioner who is capable of determining whether the potential subject’s physical and/or psychological condition will allow him or her not to be influenced or coerced during the consent negotiations. In addition, the independent overseer often evaluates whether the prospective subject possesses sufficient cognitive function to comprehend the information presented during the consent process. When possible, the independent overseer should be familiar with the prospective subject’s medical or psychiatric condition. An example of when an IRB might request the participation of an independent overseer as a witness is when there is a significant opportunity for therapeutic misconception, i.e., when the subject holds the mistaken belief that the research is recommended and will be of direct benefit to their clinical situation, (e.g., a physician investigator is obtaining consent from a terminally ill patient to participate in a Phase I clinical trial).
Third Party as Surrogate Decision-Maker for the Research Subject
When a potential subject is not competent to give informed consent, a surrogate decision-maker may provide consent under certain circumstances. The literature on this topic addresses legal and ethical questions for the investigator and the IRB. These questions have to do with the choice of a surrogate decision-maker. Federal law recognizes and allows surrogate decision-makers in the consent process, but defers to state law to define the “legally authorized representative” who may give permission or “consent” for the subject.
Investigators should consult the law of the state in which the research will be approved to take place, in addition to their individual IRB policies. The state of Connecticut law is silent on the designation of legally authorized representatives for the purpose of consenting to medical research. Therefore, the medical model for consent with regard to clinically indicated procedures is generally followed. This model recognizes the durable power of attorney for health care, next of kin, and legal (court-appointed) guardians or conservators. Furthermore, the decision to obtain permission for research purposes from an informally appointed surrogate (e.g., next of kin, not a court-appointed guardian or agent under a durable power of attorney for health care) should be based on three factors: (a) the risk of harm, (b) the probability of direct benefit to the subject, and (c) the implication of delaying study participation for the time it would take to appoint a legal guardian. Investigators should note that Connecticut state statutes explicitly prohibit court-appointed guardians of mentally retarded individuals from having the authority to grant permission for their wards to participate in research unless stringent terms and conditions are met. Please see Module 7 for more information regarding obtaining consent from decisionally impaired individuals.