Presenting a live 90-minute webinar with interactive Q&A Clinical Trials and Human Research: Complying With New Regulatory Obligations Navigating New Requirements for Informed Consent, Disclosures, Data-Sharing, and More WEDNESDAY, JANUARY 18, 2017 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: David Peloquin, Esq., Ropes & Gray , Boston Thomas D. Shrack, Esq., Hall Render Killian Heath & Lyman , Indianapolis 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 .
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Clinical Trials & Human Subjects Research New Regulations and Guidance David Peloquin 617.951.7786 david.peloquin@ropesgray.com ROPES & GRAY LLP
Agenda • Changes for Clinical Research in the 21 st Century Cures Act (the “Act”) • FDA/OHRP Final Guidance on Electronic Informed Consent 6 ROPES & GRAY
21 st Century Cures Act • Signed into law by President Barack Obama on December 13, 2016 – Contains several important changes for the healthcare, pharmaceutical and medical device industries • Promoting Drug Development • Medical Device Innovation • Digital Health • Reimbursement/Fraud & Abuse • Regulation of Clinical Research 7 ROPES & GRAY
21 st Century Cures Act • Harmonizing FDA Human Subject Regulations and the Common Rule (Section 3023) – HHS Secretary required to make modifications to both sets of regulations to: • Reduce regulatory duplication/unnecessary delays • Modernize for multisite and cooperative research • Protect vulnerable populations , incorporate local considerations and support community engagement – Timeline: Completion by December 2019 8 ROPES & GRAY
21 st Century Cures Act • Waiver or Alteration of Informed Consent for Minimal Risk FDA-Regulated Studies (Section 3024) – Food, Drug & Cosmetic Act (FDCA) historically limits IRB ability to waive informed consent • Drugs: Consent not feasible or contrary to best interests of human beings • Devices: Life threatening situation necessitating use of the device and not feasible to obtain consent from subject or representative 9 ROPES & GRAY
21 st Century Cures Act – The Act amends the FDCA to permit IRBs to waive or alter informed consent requirements for both drug and device clinical investigations if the clinical testing: • Poses no more than “ minimal risk ” to the human subject; and • Includes appropriate safeguards to protect the rights, safety, and welfare of the human subjects – Requires regulation for implementation • Permits flexibility to mirror Common Rule waiver criteria 10 ROPES & GRAY
21 st Century Cures Act • Central IRBs for Medical Device Studies (Section 3056) – The Act removes FDCA requirement that medical device investigations be overseen by a “local” IRB • Does not mandate use of a central IRB, but rather provides flexibility for use of central IRBs in device studies • Local IRBs may still provide central IRB with input regarding local considerations • Does not require regulations for implementation 11 ROPES & GRAY
21 st Century Cures Act • Reducing Administrative Burdens for Researchers (Section 2034) – Requires HHS Secretary to review policies of all research funding agencies on disclosure of financial conflicts of interest (“FCOI”) and consider: • Modifying timelines for reporting to “just -in- time” • Ensuring requirements are appropriate for awards directly funding research • Updating NIH training modules related to FCOI disclosures 12 ROPES & GRAY
21 st Century Cures Act – Requires NIH Director to implement measures to reduce monitoring obligations of “prime” grant awardees by considering: • Alternative grant structures that remove need for subrecipients • Exemption from subrecipient monitoring if: – Subrecipient subject to federal audit requirements in the Uniform Guidance; – Primary awardee conducts a pre-award evaluation of each subrecipient’s risk of noncompliance; and – Primary awardee remains liable for subrecipient misconduct 13 ROPES & GRAY
21 st Century Cures Act – Requires FDA Commissioner, HHS Secretary and Secretary of Agriculture to review and revise regulations and policies governing the care and use of laboratory animals to reduce administrative burden, by taking steps to: • Identify ways to ensure policies are not inconsistent, overlapping or duplicative and eliminate any such characteristics • Improve coordination of regulations and policies 14 ROPES & GRAY
21 st Century Cures Act • Changes to Privacy Regulations (Sections 2063, 2012) – HIPAA’s “ preparatory to research ” provision prohibits researchers from removing protected health information (“PHI”) from covered entity when performing review preparatory to research – The Act requires HHS to issue guidance clarifying that the HIPAA Privacy Rule does not prohibit remote access if: • Security/privacy safeguards of rule are respected • PHI not copied or retained by researcher 15 ROPES & GRAY
21 st Century Cures Act – The Act requires HHS to issue HIPAA authorization guidance • Clarifying circumstances under which authorization for use/disclosure of PHI for future research contains sufficient description of use/disclosure • Clarifying when it may be appropriate to provide annual notice to individual reminding of right to revoke authorization • Clarifying appropriate mechanisms for revocation of authorization for future research – Requires HHS to convene working group to review uses/disclosure of PHI for research 16 ROPES & GRAY
21 st Century Cures Act • Changes to Certificates of Confidentiality (“CoC”) (Section 2012) – At present, HHS has discretionary authority to issue CoCs for research – The Act requires HHS to issue a CoC in connection with federally funded research that collects “indentifiable sensitive information” (“ISI”) • ISI includes information on mental health and alcohol and psychoactive drug use • Secretary retains discretion to issue CoC for non- federally funded research involving ISI 17 ROPES & GRAY
21 st Century Cures Act – The Act further clarifies that the CoC will prevent release of any information for which there is even “a very small risk, as determined by current scientific practices or statistical methods” of identification – ISI may still be disclosed, if: • Required by law; • Necessary for medical treatment of individual; • Individual consents to disclosure; or • Disclosure made for purposes of other scientific research in compliance with applicable federal regulations on human subjects protection 18 ROPES & GRAY
21 st Century Cures Act • Protections from Freedom of Information Act (FOIA) Disclosures (Section 2013) – Permits HHS to exempt from FOIA disclosures certain biomedical information collected in research if (i) individual is identified, or (ii) there is at least a “very small risk, as determined by current scientific practices or statistical methods” of identification – Determination must be made in writing, include a statement of the basis for the determination, and be provided to the public upon request 19 ROPES & GRAY
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