webinar: research involving subjects with limited capacity: irb expectations for recruitment and...
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DESCRIPTIONQuorum Review presents a special webinar with J. Claire Carbary, JD, CIP to discuss IRB expectations when research involves minors or adults with limited capacity to consent. The presenter will outline guidance in recruiting these populations and clarify who might serve as the appropriate legal representatives based on federal regulations and state law.
- 1.fully accredited since 2006 September 10 & 12, 2013 Research Involving Subjects with Limited Capacity: IRB Expectations for Recruitment and Consent
2. 2 3. 3 4. Questions & Answers Feel free to submit questions at any point during the webinar using the chat box on your webinar dashboard 4 WEBINAR HOUSEKEEPING We will address a select number of questions at the end of the presentation today. Responses will be sent by the presenters following the presentation for the remainder. 5. Recording & Slide Deck The webinar recording and slide deck will be posted on our website within 5 business days We will email you a link to view the recording as soon as it is available Feel free to share the link with your staff and/or colleagues 5 WEBINAR HOUSEKEEPING 6. 6 ABOUT QUORUM REVIEW IRB Accredited Fully accredited by AAHRPP through 2014 Fully compliant with FDA and OHRP requirements Regulatory Leadership 6 in-house licensed attorneys providing guidance and thought-leadership International Boards available for the review of U.S. and Canadian studies Strong Framework One of the largest IRBs in the U.S. with ~180 employees Certified IRB Professionals (CIP) 60% of Affiliated IRB members, 40% of Regulatory staff and 20% of study management & study support positions 7. 14 Board meetings each week 24-hour site turnaround, 36-hour amendment review, and same day site changes One time CV and audit documentation submission Support available 8am-8pm ET Dedicated Study Manager 7 THE QUORUM ADVANTAGE 8. Secure portal with SmartForms, status reports, and approval documents Customized Phase I and Post-Marketing processes Flexible, customized process for AMCs 100% Quality Control on all documents 8 THE QUORUM ADVANTAGE 9. Quorum Review Regulatory Attorney J. Claire Carbary, JD, CIP IRB Experience Joined Quorum Review IRB in September 2009 WIRB prior to Quorum CIP certification since 2010 Member of the Northwest Association for Biomedical Research (NWABR) and Public Responsibility in Medicine and Research (PRIM&R) Legal Background Juris Doctor from Seattle University Member of the Washington State Bar Association (WSBA) Member of the Health and Corporate Law Sections of the WSBA 9 ABOUT THE PRESENTER 10. Research Involving Subjects with Limited Capacity: IRB Expectations for Recruitment and Consent Research Involving Children 11 Allowable Research with Children 12 Defining Child 16 Recruitment for Research Involving Children 20 Assent 21 Permission 27 Wards 32 Neonates 35 Research Involving Adults Requiring a Legally Authorized Representative (LAR) 37 Allowable Research with Adults Requiring an LAR 38 Determining whether an LAR is Needed 40 Identifying an Appropriate LAR 43 Recruitment for Research with Adults Requiring an LAR 46 Assent 47 10 WEBINAR OVERVIEW 11. 11 Research Involving Children The inclusion of children in research advances the commitment to justice in research by improving our knowledge of, and ability to respond to, the unique needs of children throughout their development - Canadian Tri-Council Policy Statement (TCPS 2), Ethical Conduct for Research Involving Humans 12. Category 1: Research not involving greater than minimal risk Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical examinations or tests. Must have adequate provision for soliciting assent of children and permission of parent/guardian Citation: 21 CFR 50.51, 50.53; 45 CFR 46.404, 46.102(i) Allowable Research with Children 12 13. Category 2: Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects Risks must be justified by anticipated benefits Risk-benefit ratio must be at least as favorable as that presented by alternative approaches Must have adequate provision for soliciting assent of children and permission of parent/guardian Citation: 21 CFR 50.52; 45 CFR 46.405 Allowable Research with Children 13 14. Category 3: Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects disorder or condition Risk must represent a minor increase over minimal risk The intervention or procedures must present experiences on par with those inherent in their actual or expected situations Must have adequate provision for soliciting assent of children and permission of both parents/guardian Citation: 21 CFR 50.53; 45 CFR 46.406 Allowable Research with Children 14 15. Allowable Research with Children Category 4: Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children Must be disapproved by the IRB and sent to the Commissioner of Food and Drugs or Secretary of HHS IRB must find that research presents a reasonable opportunity to further understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children The Commissioner or Secretary (as applicable) must determine the research actually meets one of the previous categories OR must agree with IRB determination about the research and find: o that the research will be conducted in an ethically sound manner, and o Must have adequate provision for soliciting assent of children and permission of parent/guardian Citation: 21 CFR 50.54; 45 CFR 46.407 15 16. 16 Quote involving children in research Defining Child A persons a person, no matter how small. - Dr. Suess, Horton Hears A Who! 17. Defining Child Children means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. Citation: 21 CFR 50.3; 45 CFR 46.402 17 18. Most states set the age of majority at 18 or over, with some exceptions: o Alabama- Age 19 (Ala. Code 26-1-1) o Nebraska- Age 19 (Nebraska Revised Statues 43-2101) o Puerto Rico- Age 21 (21 P.R. Laws Ann. Tit. 31 971) State Law & Age of Majority Nebraska Alabama Puerto Rico 18 If the protocol inclusion criterion regarding age indicates 18 and older, and the research will be in these jurisdictions, then, the research involves children. 19. Generally- minors aged 14-15 can consent to medical treatment There may be notification requirements: o Connecticut: Minors 14 and older may consent to mental health treatment, provided that the parents are notified within five days. See Connecticut Gen. Stat. 21a-110. Citation: Boonstra, Heather and Elizabeth Nash; Minors and the Right to Consent to Health Care, Guttmacher Institute, Guttmacher Report on Public Policy, August 2000, Volume 3, Number 4 Available at: http://www.guttmacher.org/pubs/tgr/03/4/gr030404.html, accessed 08.26.2013. State Law & Consent to Medical Care vs. Research 19 If the research involves procedures or interventions that are not treatment, it is likely parental permission is needed. Connecticut 20. Payments o Who is paid? o Type of payment? Advertisements o Where are you advertising? o Directed to children or parents? Recruitment for Research Involving Children 20 Understandability o Is advertisement or recruitment aimed at children written at an appropriate grade level? Therapeutic misconception ENROLL YOUR CHILD TODAY! 21. 21 Obtaining Assent Childrenfrom 22. Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent. Citation: 21 CFR 50.3; 45 CFR 46.402 22 What is Assent? 23. The IRB must determine whether adequate provisions are made for soliciting the assent of children WHENthe children are capable of providing assent If the IRB determines the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out the prospect of direct benefit that is important to the health or well- being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Citation: (21 CFR 50.55(a); 45 CFR 46.408(a) 23 When is Assent of Children Required? 24. 24 State Laws Regarding Assent for Research Illinois: Minors must consent when considered capable. (405 ILCS 5/2-110 774 Ad. Code 260.1900 (2010)). Maine: Subjects between the age of 12-18 must provide consent unless they are unable to do so in addition to parent/guardian consent. (CMR 14-472001 (XI)(H)(3)(c)(2010)). Massachusetts: Informed consent cannot be given on behalf of a minor who has refused consent. (105 CMR 700.009(E)(4)). California: If subject is older than 7 years or older - must provide consent themselves. (California Health and Saf. Code 111530 (2012). California Illinois Maine Massachusetts 25. The IRB should take into account: Ages of the participants Maturity level Psychological state Citation: 21 CFR 50.55(a); 45 CFR 46.408(a) 25 Factors to Consider when determining whether Assent is required 26. Written assent forms for ages that would typically be reading Reading level should match age- range of participants (might need multiple assent forms) Consider including images to explain concepts Consider an electronic-based approach to assent Signature or not? Obtaining Assent 27. 27 Parental Permission 28. The IRB must determine that the permission of each childs parents or guardian is granted For categories 1 and 2 of research involving children - the IRB may determine that the permission of one parent is sufficient, otherwise permission of both parents is required The signature of the second parent is not r