Presenting a live 90-minute webinar with interactive Q&A Complying With Final Rule Revising the Common Rule for Clinical Trials and Human Research TUESDAY, FEBRUARY 28, 2017 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Abram S. Barth, Esq., Ropes & Gray , New York Emily Marcus Levine, Senior Attorney, U.S. Department of Health and Human Services , Rockville, Md. Laura Odwazny, Senior Attorney, U.S. Department of Health and Human Services , Rockville, Md. David Peloquin, Esq., Ropes & Gray , Boston The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
Tips for Optimal Quality FOR LIVE EVENT ONLY Sound Quality If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. If the sound quality is not satisfactory, you may listen via the phone: dial 1-866-927-5568 and enter your PIN when prompted. Otherwise, please send us a chat or e-mail sound@straffordpub.com immediately so we can address the problem. If you dialed in and have any difficulties during the call, press *0 for assistance. Viewing Quality To maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key again.
Continuing Education Credits FOR LIVE EVENT ONLY In order for us to process your continuing education credit, you must confirm your participation in this webinar by completing and submitting the Attendance Affirmation/Evaluation after the webinar. A link to the Attendance Affirmation/Evaluation will be in the thank you email that you will receive immediately following the program. For additional information about continuing education, call us at 1-800-926-7926 ext. 35.
Program Materials FOR LIVE EVENT ONLY If you have not printed the conference materials for this program, please complete the following steps: Click on the ^ symbol next to “Conference Materials” in the middle of the left - • hand column on your screen. • Click on the tab labeled “Handouts” that appears, and there you will see a PDF of the slides for today's program. • Double click on the PDF and a separate page will open. Print the slides by clicking on the printer icon. •
Complying With Final Rule Revising the Common Rule for Clinical Trials and Human Research February 28, 2017 Emily Levine Laura Odwazny Senior Attorney Senior Attorney Office of General Counsel Office of General Counsel HHS HHS David Peloquin Abram Barth Ropes & Gray LLP Ropes & Gray LLP abram.barth@ropesgray.com david.peloquin@ropesgray.com 212.596.9040 617.951.7786
Disclaimer – Emily Levine and Laura Odwazny Disclaimer for Emily Marcus Levine and Laura Odwazny: This presentation does not constitute legal advice. The views expressed are the presenters’ own and do not bind the U.S. Department of Health and Human Services or its operational components. 6
Agenda I. Common Rule Background II. Effective and Compliance Dates III. Changes to Scope IV. Key Definitional Changes V. Exemptions for Secondary Research Use VI. Changes to IRB Review Process VII. Expedited Review VIII. Continuing Review IX. Single IRB Review X. Informed Consent Requirements XI. Waiver of Consent XII. Intersection with FDA Regulations 7
Background • The National Research Act (Pub. L. No. 93-348), passed in 1974, created that National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to identify basic ethical principles that underlie the conduct of biomedical and behavioral research The National Commission published the Belmont Report in 1979 • The Belmont Report identified three fundamental ethical principles for all human • subjects research ― Respect for Persons ― Beneficence ― Justice 8
Background • The National Research Act also empowered the Secretary of the U.S. Department of Health & Human Services (then the Department of Health, Education and Welfare) to promulgate regulations governing federally-funded research – The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an “ Institutional Review Board ”) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research (42 U.S.C § 289) 9
Background • In 1991, the Department of Health and Human Services (HHS) developed a set of regulations, adopted by 14 other federal departments and agencies, known as the “Common Rule” – 45 C.F.R. pt. 46, subpt. A The regulations applied the Belmont Report’s three principles • • Additional protections for pregnant women/fetuses/neonates, prisoners, and children (45 C.F.R. pt. 46, subpts. B-D) • These additional subparts are not part of the Common Rule Adopted by HHS, but not by all of the other Common Rule agencies and • departments 10
Background • Shifting landscape of clinical research over the past two decades ― Rapidly evolving technologies have accelerated mobile and computer capabilities, allowing researchers to collect and access troves of data, which may be pooled, mined, analyzed, and shared ― Breakthroughs in biomedical sciences related to genome sequencing and precision medicine ― Increase in biospecimen repositories and tissue banks, accumulating hundreds of millions of human samples • Changing Risks: ― Interventional research often presents the risk of physical harm ― Risks related to information and biospecimen research often implicate subject privacy and confidentiality 11
Background • In July 2011, HHS issued an Advance Notice of Proposed Rulemaking (ANPRM) announcing intention to revisit and modernize the Common Rule • In September 2015, HHS released the NPRM ― The rule contained many controversial provisions, including requiring consent for all research involving biospecimens ― HHS received more than 2,100 public comments Final Rule issued January 19, 2017 • 12
Final Rule’s Effective and Compliance Dates • Effective Date of Final Rule: January 19, 2018 • General Compliance Date: January 19, 2018 • Compliance Date for Cooperative Research: January 20, 2020 • Caution: like all regulations, possibility of future changes 13
Transition Provisions under the Final Rule: §__.101(l) • Ongoing Research Begun Prior to January 18, 2018 : § __.101(l)(3) • Begun = initially approved by an IRB, review waived under § __.101(i)(departmental/agency waiver), or exemption determination made • Presumption: prior rule applies • Optional flexibility: revised Common rule applies to a study if: • institution makes this determination; & • IRB documents this determination • Research Begun On or After January 19, 2018 : § __.101(l)(4) • Revised Common Rule applies 14
Effective and Compliance Dates - Commentary • Dividing line: January 19, 2018 ― Research approved or exempted before ― Research approved or exempted after Many commenters to NPRM noted significant time and resource investment necessary • to comply with the revised Common Rule May require changes to an institution’s or hospital’s clinical settings • Academic medical centers, hospitals, tissue banks, drug and device companies, and • CROs may not be implementing revised rule just yet because: ― Lag time to understand fully the revised Common Rule and determine what changes will be necessary (in-house capacity: GC, regulatory affairs, compliance; external consultants/counsel) ― Uncertainty about whether the new administration will repeal or modify the revised Common Rule 15
Effective and Compliance Dates (cont’d) - Commentary • List of minimum activities to reach compliance: ― Revise written IRB procedures ― Train IRB members, researchers, and sponsors on revised procedures ― Revise forms (e.g., consent and protocol templates) ― Update IT systems ― Implement reliable and complete research tracking system • Transition ― Research approved or exempted before Jan. 19, 2018 that continues after that date may voluntarily become subject to the revised Common Rule ― Purpose is to provide “additional flexibility to regulated entities” ― But what is required? ― Full compliance, including modifying consent forms and reconsenting; or ― Partial compliance with those provisions considered “flexible,” such as the less rigorous continuing review process 16
Recommend
More recommend
