Human Subjects in Research Nicole Farnese-McFarlane Sr. Compliance Coordinator Research Office nicolefm@udel.edu 302-831-1119
Humans Subjects in Research • Regulations • What is Research with Human Subjects? • Ethical and Regulatory principles • Training Requirements and Researchers Responsibilities • IRB Submission Procedures and Compliance requirements at UD • Q&A
Regulations Common Rule (19 agencies) 45 CFR 46 A,B,C, and D A- Basic Policy for Protections of Human Research Subjects B- Pregnant Women C- Prisoners D- Children Revisions the Common Rule The Office of the Federal Register announced revisions to update, modernize and strengthen the Common Rule (originally adopted in 1991) in order to better protect human subjects involved in research, while facilitating valuable research and reducing burden delay, and ambiguity for investigators. Some of the key changes include: • Broadening of the Exempt Categories Changes in the continuing review process for minimal Risk research • New requirements to the structure and content of informed consent documents • (summary of key information) • Single IRB Review requirement for research involving external collaborators Revisions originally planned to take affect January 19 th 2018 . • However………………..
There has now been a delay on the updated Common Rule effective date On January 17, 2018, The U.S. Department of Health and Human Services and 15 other federal departments and agencies announced an Interim Final Rule (IFR) that delays the effective date of revised common rule scheduled to go in affect January 19 th 2018” by six months. This delays both the effective and compliance date of the revised Common Rule to July 19, 2018. IRB Office will continue preparation for updated rule, and changes will be announced to the UD research community prior to their implementation. In the meantime, UD IRB policies and procedures remain unaffected.
Federal Wide Assurance • UD FWA00004379: In compliance with U.S. Department of Health and Human Services (DHHS) Applies to ALL human subjects research FDA Oversight • FDA (Investigational Products- Drugs and Devices ) 21 CFR 50 and 56 HIPAA (Protected Health Information) 45 CFR 160, 162, 164
What is Research? • A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge . What is a Human Subject? A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information
Protection of Human Subjects Belmont Report- Ethical Principals • Respect for persons = Informed Consent - Treat individuals as autonomous agents - Allow people to choose for themselves - Do not use people as a means to an end • Beneficence = Risk/Benefit Analysis – Do no harm / Prevent harm • Justice = Appropriate Selection of Subjects - Treat people fairly- fair sharing of burdens and benefits of research
Human Subjects In Research Protections Training Requirement • Training for the protection of human subjects in research is required for all researchers (faculty, students, staff) who will be directly interacting with research participants or who will have access to identifiable private information. • Human Subject Training Requirement: All human subjects training to be completed via www.citiprogram.org 85% overall passing score needed Training expires every 3 years. Biomedical Focus OR Social Behavioral Educational Focus ( choose 1) * RCR and/or GCP training DO NOT fulfill the Humans Subjects Protections Training required to conduct research involving human subjects.
Additional Requirements for Clinical Trials • For NIH Supported Clinical Trials Only- As per NIH policy, in addition to the required humans subjects protections training, research team members must also complete Good Clinical Practice (GCP) Training . Effective January 1, 2017. Good Clinical Practice Training Requirements : Completed via www.citiprogram.org 85% overall passing score needed Training expires every 3 years. NIH defines a clinical trial as any research study in which one or more humans subjects are prospectively assigned to one of more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health related biomedical or behavioral outcomes . Clinical Trials Registration - Awardees undertaking clinical trials funded by NIH must register the study no later than 21 days after enrollment of the first participant as well as provide a summary of results in ClinicalTrials.gov no later than 1 year after the completion of the primary study outcomes. This applies to applications and proposals to NIH on or January 18 th 2017. http://www1.udel.edu/research/clinicaltrials/
Institutional Review Board (IRB) UD Protocol Review and Approval Procedure: • ALL research involving human subjects must be reviewed and approved by the UD IRB which meets monthly • IRB ensures ethical conduct of research by reviewing, approving, and monitoring the involvement of human subjects • Members include scientists, non-scientists, prisoner-advocate, and community representatives • Review at convened meetings with the majority of members present (quorum) • Makes risk determinations http://www.udel.edu/research
http://oprs.usc.edu/review/typesofirb/
Protocol Submissions at UD • All Submission s to the IRB must be done at www.irbnet.org – PI/Advisor must sign off on the IRBNet submission – All investigators should be ‘shared’ in the project • Submissions arrive at a single queue and are pre-reviewed by our office. • Our office communicates with researchers via IRBNet to request changes, clarifications, issue approval documents, posting of IRB-stamped documents, etc. • If project can be determined exempt or review via expedited methods it may take 3 weeks to be processed. Plan accordingly. • If project requires review by the convened IRB it will be assign to the next available Full Board Meeting agenda for review: – UD IRB meets the 3 rd Wednesday of every month – http://www.udel.edu/research/researchers/calendar.html – New Projects get invited to meeting. Preliminary Comments shared with PI http://www.udel.edu/research
How to Submit Application • Training Resources: http://www.irbnetresources.org and click on the "RESOURCES" link Login name: delaware Password: irb1 • Step by Step at IRBNet at a Glance UD Forms and Templates available in IRBNet • • All submission must have at a minimum: – UD Protocol Form – Informed Consent Documents – Training Records – Other research measures – Tracked Changes (Revisions, Amendments) http://www1.udel.edu/research/preparing/irb-submission-requirement.html
Researcher Responsibilities • Comply with appropriate regulations • Obtain prior IRB approval • Implement research as approved • Obtain and document informed consent/assent • Obtain prior approval for deviations from protocol (amendment) • Submit continuing review reports as required by IRB • Promptly report unanticipated problems and adverse events • Appropriate record keeping http://www.udel.edu/research
Consent Process & Form • Describe overall experience • Emphasize voluntary participation • Selection procedures & number of participants • Risks and benefits • Alternatives for treatment if applicable • Confidentiality • Provide contact info for research and subject rights • Explain rights to refuse and withdraw • Explain why a subject might be withdrawn • Cost to participant / Explain compensation if any • Explain how will data be used and maintained
IRB Protocol Life Cycle
University of Delaware Policy and Procedures • UD research policy 6-4 http://www.udel.edu/ExecVP/polprod/6-04.html • UD human subject protocol submission procedures http://www.udel.edu/research/preparing/humansub- protocolreview.html • IRB Standard Operating Procedures http://www.udel.edu/research/preparing/irb-sop.html • UD Training- Humans Subjects Protections in Research http://www1.udel.edu/research/training/training-human-subjects- research.html http://www.udel.edu/research
Resources http://www.udel.edu/research/preparing/humansub.html http://www.hhs.gov/ohrp/ Research Office Maria Palazuelos , Ph.D. Director of Research Compliance Nicole Farnese- McFarlane, Sr. Research Compliance Coordinator email: hsrb-research@udel.edu phone: (302)-831-2137 http://www.udel.edu/research
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