Research Community Forum

Transcription

1 Research Community Forum Joseph B. Martin Conference Center, Harvard Medical School May 1-2, 2018 Sponsored by OHRP and Harvard Catalyst

2 Legally Authorized Representatives- Ethical, Legal and Practical Issues for Researchers and IRBs May 2, 2018, Patricia Seymour, MA, CIP, CCRC

3 Conflict of Interest Statement Director of IRB Operations, New England IRB Human Subject Protection Administrator at Hummingbird IRB The opinions expressed in this presentation do not represent those of WCG, NEIRB or Hummingbird IRB

4 Agenda When are LARs required? Suggestions for IRBs in considering LAR inclusion in a study Suggestions for Sites in planning to include LAR Ethical Issues

5 Definition FDA and OHRP An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject s participation in the procedure(s) involved in research

6 Who may act as a LAR In the absence of applicable law in order of priority: A person designated by the individual to take action with regards to research participation A person, designated by individual to make health care decisions A legal guardian who may make health decisions Spouse, or a recognized civil union partner or domestic partner Adult son or daughter Parent Adult brother or sister

7 Who may require a LAR? Minors Persons with impaired decision making capacity or impaired consent capacity Acutely ill or injured individuals (may be temporarily incapacitated) Patients with multiple disorders or conditions (may be temporarily incapacitated or regain capacity)

8 Suggestion for IRBs After the LAR signature line: Select the category that best describes the Study Subject s Legally Authorized Representative who signed above: Court-appointed guardian Durable power of attorney Health care proxy Family member / next of kin (describe relationship below): Relationship to Study Subject:

9 Suggestions for IRBs Provide specific determinations to the PI regarding which populations have been approved for inclusion in the study: In the approval correspondence specify: Employee/Family members involved with the study are not allowed. Employee/Family Members not involved with the study are not allowed. Legally Authorized Representatives are or not allowed. Non-English Speakers are not allowed. Non-Readers are not allowed. Pregnancy is incidental. Minors are allowed under Subpart D with one parent/guardian signature. Approval Period of 12 months

10 Study Site Anticipate the circumstances of recruitment and enrollment Begin and sustain a dialogue with the Sponsor/CRO about their requirements for a LAR Who may serve as a LAR and documentation requirements, if any Know how and who should be contacted in case of a question about the suitability of an individual to consent as a LAR

11 Study Sites Anticipate the circumstances of recruitment and enrollment In addition to the consent, will a brief, simple explanation of the study be helpful in working with the LAR/family? This document could be used in circumstances where participant consent capacity may be regained to introduce the study prior to reviewing the much longer and more complex consent LAR debrief letter - After the study is concluded or during if practical, a letter which describes to the LAR any new information, or update on the intervention or treatment arm the participant was enrolled. Thanks the LAR for involvement. Often used in Emergency research.

12 Study Site Ask the IRB specifically to address who may act as a LAR If in doubt, call the IRB to ask about their policy either in general or for a specific study. Don t guess, don t assume Provide the proposed LAR roles to the IRB to be sure that there is consistency between what you are planning and what the IRB deems acceptable

13 Study Sites Definition and Role of LAR Include in the IRB review materials, in addition to consent and information sheets, guidance that allows someone to understand the LAR s role in this particular study. Describe what it means when LAR signs a consent on behalf of a family member What kind of information the LAR can expect to receive during the course of the study A description of voluntariness and withdrawal of consent If applicable, the circumstances in which the participant will be eligible to consent for themselves

14 Wards of the State & Emancipated Minors IRB and Sponsor/CRO communication Request approval from the IRB and Sponsor for inclusion of these individuals in a study-special considerations and steps are required State statutes for emancipated minors OHRP process for Wards

15 Children Who can serve as a LAR? Know in advance your institution s or site s policy regarding the documentation required (or not) to establish parenthood When in doubt, don t. If a parent claims that he or she is a single parent or that another individual is not involved in parental decision-making, do your best to question the family and child to verify If a family member appears to be acting in place of a parent because of abandonment or incapacity, follow the same path of questioning and verification

16 Ethical Issues for sites and IRBs For certain types of research or research risk, is it better to consider close family as suitable candidates? Are advanced directives in place? Who will assess the capacity and cognitive ability of the person asked to serve as LAR? Should the IRB and investigator work together to establish, for each study, an upper and lower limit of risk which will apply to when a LAR will be sought? e.g., no cognitive impaired participants, no one with an advanced directive or no participants who don t have an immediate family member available

17 Ethical Issues Should IRBs and investigators establish a threshold for each study that defines broadly what constitutes regaining capacity to consent? Does it mean being able to verbally communicate? Ability to listen and understand? When in the spectrum of recovery should the issue of consent be broached with the participant now that he or she is able to comprehend? How does the PI explain the concepts of research and voluntariness in the context of the type of research study the participant is enrolled given the individual s condition?

18 Thank you for your attention! Thanks to Harvard Catalyst and OHRP for this educational event