1. Paula Peyrani, MD Division of Infectious Diseases University of Louisville p0peyr01@louisville.edu The Informed Consent Process

2. THE INFORMED CONSENT PROCESS It is not just signing the document It is an on-going process that starts with the presentation of the study to a potential research subject and continues until the subject ends participation or the study closes The greatest potential for misunderstanding exists in the initial consent process Potential study subjects should have enough time to understand what the study is about and what he/she is committing to No study-related procedure can be done before IC is signed

3. WHO CAN SIGN THE INFORMED CONSENT? Only the individual or his/her Legally Authorized Representative Any one of the following responsible parties, in the following order of priority if no individual in a prior class is reasonably available, willing, and competent to act, shall be authorized to make decisions on behalf of the person: a) The judicially-appointed guardian of the person if the guardian has been appointed and if medical decisions are within the scope of the guardianship

4. WHO CAN SIGN THE INFORMED CONSENT? b) The attorney-in-fact named in a durable power of attorney, if the durable power of attorney specifically includes authority for health care decision c) The parent or spouse of the person d) If the person is incompetent, an adult child of the person, or if the person has more than one child, the majority of the adult children who are reasonably available for consultation e) The nearest living relative of the person, or if more than one relative of the same relation is reasonably available for consultation, a majority of the nearest living relatives

5. WHO CAN SIGN THE INFORMED CONSENT? Under UofL IRB, a LAR is not required to provide consent for subjects who are cognitively capable of consenting, but physically unable (e.g paralysis) IC can be obtained from the subject with the assistance of a witness

6. SOME OTHER TECHNICALITIES If the individual decides to participate, subject is asked to sign and date the consent form The person obtaining the subject’s IC must also sign and date the form The subject must be given a copy of the form the subject signed If the investigator is not the person who obtains the IC then, an investigator on the study must sign and date the consent document within two weeks of the subject’s giving written IC

7. NON-ENGLISH SPEAKING SUBJECTS Information in the IC should be written in the language that the subject can understand Development of non-English language consent forms involves the translation of the original consent from English to the second language and then back to English Back translation is necessary to ensure that the information is correctly conveyed A certificate of accuracy from the qualified translator should be submitted.

8. ENGLISH SPEAKING SUBJECTS UNABLE TO SIGN THE IC A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means The consent form should document the method used for communication and the specific means by which the subject communicated agreement to participate in the study

9. ENGLISH SPEAKING SUBJECTS UNABLE TO SIGN THE IC A person unrelated to the study should witness the entire consent process and sign the consent document A video tape or audio tape recording of the consent interview is recommended.

10. RE-CONSENTING SUBJECTS A subject who regains the cognitive ability to consent as determined by the PI, must be reconsented IF consented by a LAR, and a LAR of higher priority subsequently notifies the investigator of that relationship to the subject, the investigator must defer to the higher priority LAR’s decision regarding whether the subject will continue to participate or to withdraw from the study.

11. RE-CONSENTING SUBJECTS A subject who regains the cognitive ability to consent as determined by the PI, must be reconsented IF consented by a LAR, and a LAR of higher priority subsequently notifies the investigator of that relationship to the subject, the investigator must defer to the higher priority LAR’s decision regarding whether the subject will continue to participate or to withdraw from the study.

12. References 1. Woodin K. The CRC’s Guide to Coordinating Clinical Research. Thompson Centerwatch. 2004 2. University of Louisville. Investigator’s Guide for Human Research. Version November 29, 2010.