Human Subjects in Research Nicole Farnese-McFarlane Sr. Compliance - - PowerPoint PPT Presentation

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Human Subjects in Research Nicole Farnese-McFarlane Sr. Compliance - - PowerPoint PPT Presentation

Jan 04, 2023 143 likes •335 views

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

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Nicole Farnese-McFarlane

  • Sr. Compliance Coordinator

Research Office nicolefm@udel.edu 302-831-1119

Human Subjects in Research

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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
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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 19th 2018 .

However………………..

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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 19th 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.

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Federal Wide Assurance

  • UD FWA00004379: In compliance with U.S. Department
  • f Health and Human Services (DHHS)
  • Applies to ALL human subjects research
  • FDA (Investigational Products-Drugs and Devices)
  • 21 CFR 50 and 56

FDA Oversight

HIPAA (Protected Health Information)

45 CFR 160, 162, 164

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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

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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
  • f research
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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.

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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

  • ther control) to evaluate the effects of those interventions on health related biomedical
  • r 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

  • f the primary study outcomes. This applies to applications and proposals to NIH on or

January 18th 2017. http://www1.udel.edu/research/clinicaltrials/

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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

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http://oprs.usc.edu/review/typesofirb/

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Protocol Submissions at UD

  • All Submissions 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 3rd 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

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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

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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

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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
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IRB Protocol Life Cycle

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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

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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