UTHSC Institutional Review Board (IRB) Informed Consent UTHSC Institutional Review Board (IRB)

Session Overview Process and Documentation Vulnerable Populations Informed Consent of Non-English Speakers Illiterate Subjects Alteration/Waiver of Informed Consent

Informed Consent Process Informed Consent is not just a form; it is an ongoing process of information exchange that may include: Recruitment materials; An ongoing, open discussion of the research study, including risks, benefits, procedures, and alternatives, appropriate to the subject and the study; Ample opportunity for the subject to ask questions and to have them answered; An explanation that the subject’s participation is voluntary and that the subject can decline to participate; Formally obtaining the subject’s consent or dissent; and Documentation of the consent process

Recruiting Study Subjects FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process Advertisements should be reviewed & approved by the IRB as part of the package for initial review; however, if a researcher decides at a later date to advertise for subjects, the advertising may be submitted for IRB review & approval FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine eligibility and interest

Informed Consent Document A statement that the study involves research An explanation of the purposes of the research The expected duration of the subject's participation A description of the procedures to be followed Identification of any procedures which are experimental A description of any reasonably foreseeable risks or discomforts to the subject

Informed Consent Document A description of any benefits to the subject or to others which may reasonably be expected from the research A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained Research, Rights or Injury: An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled

Additional Elements A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent Any additional costs to the subject that may result from participation in the research The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject The approximate number of subjects involved in the study

Informed Consent Document Must be written in “lay language” (i.e., understandable to the people being asked to participate) Use of the scientific jargon and legalese is not appropriate Do not use the first person (e.g., “I understand that…”) If the document is ungrammatical, it does not communicate; if it does not communicate, it cannot serve its purpose The written presentation of information is used to document the basis of consent and for the subject’s future reference

Documentation of Informed Consent Informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative (LAR) A copy of the consent document must be given to the subject or (LAR) The original signed consent form should be retained in the research record If applicable, a copy of the consent form should be included in the subject’s medical record Document the proceedings of the informed consent interview in the research record (sample on IRB website)

Legally Authorized Representative (LAR) When prospective subjects lack adequate decision making capacity, investigators may not involve them in clinical research without the legally effective informed consent of the subject’s legally authorized representative (LAR). The LAR must be an adult who has exhibited special care and concern for the subject, who is familiar with the subject’s personal values, who is reasonably available, and who is willing to serve. No person who is identified in a protective order or other court order that directs that person to avoid contact with the subject shall be eligible to serve as the subject’s LAR. Identification of an LAR should normally be made using the following order of descending preference: conservator; guardian; attorney-in-fact; subject’s spouse, unless legally separated; the subject’s adult child; the subject’s parent; the subject’s adult sibling; any other adult relative of the subject; or any other adult who is familiar with the patient’s personal values, who is reasonably available, and who is willing to serve as LAR.

Legally Authorized Representative (LAR) If the LAR loses the legal right to consent for the subject while the subject is participating in a research study (e.g., loss of Power of Attorney over healthcare), a new LAR must be identified and consented for the subject’s continued participation in the study. When consent has been obtained from the LAR due to the incompetence of the subject at the time of entry in a study, and the subject regains competence during study participation, then the principal investigator or designee must secure the subject’s non-objection to continued participation in the study.

Legally Authorized Representative (LAR) Adults who have the capacity to consent during study enrollment, but who may lose the capacity to consent at some point during study participation (due to Alzheimer’s disease for instance) can name a future LAR upon study enrollment. This should be done in writing, such as on a healthcare proxy form, and be kept with the subject’s research record. At the time when the investigator determines the subject has lost the capacity to continue to consent to study participation, the designated LAR should be consented. If a research study will include the use of adults who do not have the capacity to consent, assent of the adult subject should be obtained if possible and documented on the adult assent discussion page of the consent form.

Legally Authorized Representative (LAR) Appropriate signature line(s) on the UTHSC informed consent document: Appropriate initial lines on the UTHSC informed consent document:

Pediatric Assent Assent is a child’s affirmative agreement to participate in a research study A child’s passive resignation to submit to an intervention or procedure must not be considered assent The assent process should be developmentally appropriate give the ages and other characteristics of the children to be approached and provide opportunities for children to express and discuss their willingness or unwillingness to participate

Pediatric Assent Documentation of assent, varies by age of the minor: Research with very young children (<8 years old) requires only that parental permission is secured and that appropriate information is given to the minor about the research in the same way that procedures would ordinarily be explained to a young child. For minors between the ages of 8–13, documentation of assent to participate is required using a “short form” assent document. The “short form” assent document will be attached as the last page of the consent form. For older adolescents (age ≥14 years), a single consent form that both the minor and the parents sign is adequate unless the Committee has specified differently in the approval letter.

Pediatric Assent If a minor between the ages of 14 and 17 is cognitively capable of assenting to his/her participation in the research study but cannot physically sign the assent line on the consent page (e.g., due to paralysis), he/she can verbally indicate that he/she assents and can have his/her LAR sign the assent line for him/her. This situation should be explained and documented in the assent/consent discussion notes in the research record

Pediatric Assent When a child subject turns 8 years old while participating in a research study, then the documentation of assent is required utilizing the “short form” assent document When a child subject reaches the age of majority while enrolled in research study, then the subject should re- consented as an adult. If the parent loses parental rights or a legal guardian loses guardian rights while the child is participating in a research study, a new LAR must be identified and consented for the child’s continued participation in the study.

Pediatric Assent Appropriate signature line(s) on the UTHSC informed consent document: Appropriate initial lines on the UTHSC informed consent document: Include the “short form” assent document as the last page of the consent form if the research study includes subjects 8-13 years of age

Assent Discussion for Subjects 8-13 Years of Age Assent Obtained Date and time of assent Minor Subject’s name, date of birth, and signature Signature of person obtaining assent Assent Not Obtained, but Minor Subject was Enrolled Assent of the minor subject was NOT obtained for the following reason: Minor is cognitively or emotionally unable to participate in an assent discussion (e.g., minor has either a psychiatric or developmental disorder; minor received narcotics within the last 4 hours; minor is sedated; etc.). Minor refused to provide assent; however, the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well being of the minor and is available only in the context of the research [45 CFR 46.408(a)]. Assent was Obtained, but Minor Subject was Unable to Sign The minor assented to participation, but has an incapacity that prevents applying a signature (e.g., the subject’s dominant hand is incapacitated, the subject is illiterate, etc.) The assenting subject’s inability to sign the assent document has been duly noted in the research record.

Children who are Wards of the State Children who are Wards of the State or any other agency, institution, or entity can be included in research involving greater than minimal risk with no prospect of direct benefit or Research not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate serious problems affecting the health or welfare of children only if such research is related to their status as wards; or the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. If research is approved under this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child’s participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

Inclusion of Prisoners Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration; however, individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners Individuals with psychiatric illnesses who have been committed involuntarily to an institution as an alternative to a criminal prosecution or incarceration; however, individuals who have been voluntarily admitted to an institution for treatment of a psychiatric illness, or who have been civilly committed to non- penal institutions for treatment because their illness makes them a danger to themselves or others, are not prisoners. Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners. Probationers and individuals wearing monitoring devices are generally not considered prisoners; however, situations of this kind frequently require an analysis of the particular circumstance of the planned subject population.

Inclusion of Prisoners When a previously enrolled research subject becomes a prisoner and the relevant research protocol was NOT reviewed and approved by the institutional review board (IRB) in accordance with the requirements of HHS regulations at 45 CFR46, subpart C, the principal investigator should promptly notify the IRB of this event. All research interactions and interventions with, and obtaining identifiable private information about, the now- incarcerated prisoner-subject must cease until the requirements of subpart C have been satisfied with respect to the relevant protocol

Informed Consent of Non-English Speakers Informed consent must be presented in a language understandable to the subject or legally authorized representative [21 CFR 50.20/45 CFR 46.116 & §46.117] & contain all the elements necessary for legally effective informed consent

Informed Consent of Non-English Speakers Local Policy A non-English translation of the English version of the IRB approved informed consent document + Translator's Declaration Person obtaining informed consent must be fluent in both English & the language of the subject or legally authorized representative (LAR) or be assisted by an interpreter, who must be physically present during the informed consent interview. Family or friends of the prospective subject or LAR may not serve as interpreters Verbal translation of the English informed consent document is not acceptable After consent is obtained, the subject or the LAR must be given a copy of the signed informed consent document Informed consent is an ongoing process, an interpreter must be available for all research-related interactions involving subjects or LARs who are non-English speaking

Informed Consent of Non-English Speakers Methodist Healthcare (MH) facilities only: A written translation of the informed consent document is required Language line service for MH is the Certified Languages International 800.237.8434 & the Patient Affairs Department Regional One Health Page an Interpreter or call via Vocera (Interpreters). Allow five (5) minutes for a response from an interpreter if paged. Medical Interpreters are available seven (7) days a week. Monday-Friday 7:45 am – 7:30 pm Saturday-Sunday 9 am – 5:30 pm Interpreters can be contacted via pager: 242-9189 Language Services 5-7264

Illiterate English Speaking Subjects A potential subject who speaks and understands English but does not read or write, can be enrolled in a research study The consent form may be read to the prospective subject The individual will “make his/her mark” on the consent document in the space for the subject’s signature Person obtaining consent should document in the research record the method(s) utilized to communicate with the subject and the method(s) utilized by the subject to communicate agreement to enter the study. A potential subject who can understand and comprehend English, but is physically unable to talk or write (e.g., paralysis) can be entered into research studies. A subject can verbally indicate that he/she consents and can designate a representative (e.g., a relative, hospital patient advocate, social worker, etc.) to sign the consent line for him/her, provided the latter party is not involved in the actual conduct of the study. This situation should be explained and documented in the consent discussion notes in the research record, including a description of the identity of the person to whom the authorization has been given.

Illiterate English Speaking Subjects Upon verbal explanation, the potential subject should be able to: describe the study procedures in lay terms and appreciate what will be involved in participation in the study, understand the risk(s) and benefit(s) of being in the study, and indicate approval or disapproval regarding participation in the study. After consent is obtained, the subject or the LAR must be given a copy of the signed informed consent document Video and audiotaping of the process may be utilized with permission of the individual and in accordance with the institution’s policies

Alteration/Waiver of Informed Consent Federal regulations permit the waiver or alteration of informed consent (45 CFR 46.116(d) if a protocol meets very specific criteria the research involves no more than minimal risk to the subjects; the waiver or alteration will not adversely affect the rights and welfare of the subjects; the research could not practicably be carried out without the waiver or alteration; and whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Waiver of Informed Consent The UTHSC IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the requirement for written documentation of consent is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Alteration of Consent/Waiver of Documentation of Consent If you are conducting a survey, the following statements should be incorporated into an introductory paragraph. Willingness of the subjects to complete the survey will serve as adequate documentation of informed consent. A brief statement that the survey is part of a “research study.” A brief statement regarding the purpose of the research and who is performing it. A statement regarding research procedures. Explain that the study involves answering a series of questions and will take a specific length of time. A statement regarding any foreseeable risks. These might include tiring from answering questions or being asked sensitive questions. If there are no risks, this should be indicated. A statement regarding anticipated benefits. Describe the potential benefits of the knowledge to be gained and any benefits for subjects. If there are no benefits to subjects, this should be indicated. A statement that participation is voluntary and failure to participate will not adversely affect the subject’s rights, medical care, grade in any course, or employment status. A statement regarding provisions to maintain the confidentiality of the data.

Telephone Consent A request to secure telephone consent must be submitted to the UTHSC IRB as an alteration of informed consent. FDA guidance states that it is acceptable when necessary to send the informed consent document to the subject or LAR by fax and to conduct the consent interview over the telephone when the subject or LAR can read the consent form as it is discussed. Study procedures may not be initiated until the signed consent form is returned by fax to the investigative site. The consent form with the original signatures must be mailed or brought to the investigative site at the earliest opportunity. The UTHSC IRB will also permit the use of alternative communication technologies in FDA-regulated study, i.e., email, mail, or videoconference. Telephone consent is generally not allowed at Methodist Healthcare facilities.

Reminders Use the UTHSC IRB consent form templates http://www.uthsc.edu/research/research_compliance/IRB/co nsent.php Document consent discussion in the research record Contact the IRB office (448-4824) if you have any questions!