human subjects research and the irb
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Human Subjects Research and the IRB
Course Objectives
Review the basic ethical principles of research involving human subjects
Review the basic regulatory framework for human subjects research
Understand the differences in exempt, expedited and full board review
Belmont Principles
Respect for Persons
Beneficence
Justice
Respect for Persons
Treat individuals as autonomous agents
Do not use people as a means to an end
Allow people to choose for themselves
Give extra protection to those with limited autonomy
Beneficence
Acts of kindness or charity that go beyond duty
Obligations derived from beneficence Do no harm Prevent harm Prevent evil Promote good
Justice
Treat people fairly
Fair sharing of burdens and benefits of research
Distinguish procedural justice from distributive justice
Responsibilities of IRB
Safeguard rights & welfare of human subjects
Ensure subjects are adequately informed
Ensure voluntary participation
Ensure risk/benefit ratio is acceptable
Suspend & report studies that violate regulations
Responsibilities of Investigator
Obtain prospective IRB approval
Adverse events & protocol violations must be reported to IRB
Investigator can be held liable if willfully violates scope of research or does not obtain prospective IRB approval
Obtain Mentor
If the PI is a student/trainee, a Mentor is required.
Mentor must be full time Faculty.
This person is listed on the IRB Application as a Mentor.
Educational Mandate
CITI / Univ. of Miami Tutorial – Required
To register: http://www.musc.edu/citi
Definition of Research
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
45 CFR 46.102(d)
Definition of Human Subject
Living individual
About whom an investigator obtains Data through intervention or interaction with the
individual
OR Identifiable private information
45 CFR 46.102(f)
Types of IRB Review
Exempt, Expedited and Full Board
Type of review depends on level of risks to subjects and federal regulations. Risk due to breach of confidentiality is always considered.
Minimal Risk
A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the research is no greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests
Exempt Research Activities
Less than minimal risk to subjects
Does not mean exempt from IRB review Requires determination from IRB Chair or his/her
designee
Examples Retrospective chart review—data collection with no
identifiers Surveys, questionnaires if the information is recorded
without identifiers
Expedited
Minimal risk to subjects
Does not mean “review light” or “Fast Approval” Review by Chair or designee
Examples Studies involving venipuncture only- volume of collection
is limited. Prospective non-invasive collection of data/specimens
(i.e., hair, nail clippings, saliva, etc.) Retrospective chart review in which identifiers must be
documented
Full Board
Greater than minimal risk to subjects Investigational drugs/devices Sensitive issues (i.e., substance abuse, domestic
violence) Protected Populations (i.e. children, cognitively
impaired, pregnant women, fetuses, neonates, etc.)
Reviewed by Full Board at a convened meeting
IRB PROCESS(New Study)
PLAN AHEAD TO AVOID DELAYS
Determine which IRB to submit to Will depend on Dept and Sponsor Off Site Research Consider ancillary committees (i.e. VA R&D, PRC, GCRC)
Review meeting dates & deadlines on IRB web site IRB I & IRB II meet once a month IRB III meets twice a month
Decide the type of study Exempt (review categories) Expedited (review categories) Full Board
IRB PROCESS (Cont)
Electronic application Current System- ERMA http://erma.musc.edu/ New System- eIRB http://hssc.scra.org/HSSCSTAGING
Determine items to submit with application. For example: Protocol (Use template on IRB website)
http://research.musc.edu/ori/index.html Informed Consent (use guide on IRB website) or Consent
Waiver HIPAA Authorization / HIPAA Waiver Advertisements (include the word “research;” cannot be
coercive, need contact information, etc.) Drug / Device Information Sheet if applicable Surveys and questionnaires Budget / IIT
IRB FORMS PAGEhttp://research.musc.edu/ori/irb/forms.html
PI Statement of Assurance
Signatures may only be obtained after submission of electronic application to the IRB
Signatures needed: PI Mentor (If PI is a Student/Trainee) Department Chair Associate Provost for Research (If research is
Non-Sponsored or internally sponsored)
INFORMED CONSENT
3 Key Elements: Informed Understood Voluntary
MUSC Standard Consent Guide: http://research.musc.edu/ori/irb/Guidecon.html
HIPAA
Protected Health information is defined as individually identifiable health information transmitted or maintained in any form (electronic, paper, or oral communication) that relates to the past, present or future physical or mental health or conditions of an individual.
HIPAA contains 18 identifiers (name, SSN, MRN, etc)
HIPAA cont.
HIPAA Authorization Form The subject has signed a written Authorization
containing all the elements specified in the Privacy Rule that will be used in the study.
HIPAA Waiver of Authorization Form Used when it is impracticable to obtain written
authorization from research participants.
IRB PROCESS (Cont)
IRB checks for completenessExempt applications are reviewed by
IRB Chair or his/her designeeExpedited and Full Board applications
are reviewed by IRB Administrator and Primary Reviewers
Comments/questions sent to PI (via electronic database)
PI provides response (via electronic database – upload revised documents)
IRB PROCESS (Cont)
Once the IRB is satisfied, approval is granted
Exempt & Expedited - IRB Chair (or the Chair’s designee) gives approval
Full Board – the board can approve, table or disapprove
Sponsored research requires release from ORSP verifying successful contract completion.
Amendments
Change in Personnel
Protocol Change
Consent Change
Change in Recruitment Process
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Full Board Amendments
Changes to approved studies that are greater than minimal risk will be reviewed by the Full Board at a convened meeting and must be submitted in accordance with deadlines. Increased risk Increased dose range or increased number of subjects Adding minors or other protected populations Changes to an IND/IDE study other than administrative in
nature.
If changes are not tracked on informed consents and/or protocols, they will be returned to the PI without review.
Continuing Reviews
Regulations require review no less than once a year or at intervals appropriate to the level of risk as determined by the Board.
Allow IRB to continue to assess the risk/benefit ratio of the study
Due one month prior to expiration; reminder sent two months prior to expiration
If a study is not renewed by the IRB, it will expire and be out of compliance. Enrollment will be suspended and/or research will be stopped. Once expired, re-instatement will require full board review and approval.
Status of study, enrollment numbers, problems or complications
AUDITS
Self Audit Checklist: http://academicdepartments.musc.edu/uco/documents/Audit%20Checklist%20MUSC%20and%20VA.doc
The University Compliance Office will initiate audits based on the following criteria: Priority 1: For-Cause-Audit: HR Study where allegations
of human subjects’ violations have been lodged against a Principal Investigator.
Priority 2: Administrative Audit: HR study where the IRB chair has identified a potential administrative problem with study documentation.
Priority 3: Random Audit: HR study selected by chance using a random number generator. Each study has an equal likelihood of selection. This is the most common type of audit.
Where to Find Assistance
The IRB
Research Support Services http://research.musc.edu/researchresourses.html
SUCCESS Center Provides assistance with research
navigation and development
IRB KEY CONTACTS
IRB Main Number- 792-4148 IRB Program Manager
Stacey Goretzka, CIP – 792-6527 (goretzka@musc.edu)
IRB I Linda Bunch, CIP- IRB I-Administrator 792-2525 (cooperld@musc.edu) Katherine Duncan- IRB I- Coordinator 792-4843 (duncank@musc.edu)
IRB II Lisa Johnson, MBA-IRB II- Administrator 792-4144 (johnsli@musc.edu) Alanna Herman-IRB II-Coordinator 792-6710 (hermana@musc.edu)
IRB III Jackie Shedrow, CIP-IRB III Administrator 792-3071 (shedrow@musc.edu) Yashmin Karten, PhD, MBA-IRB III Administrator 792-6521 (karteny@musc.edu) Kenneth Thomas-IRB III Coordinator 792-9128 (thomaskn@musc.edu) Cheryl Green-IRB III Coordinator 792-3093 (greench@musc.edu)
EXPEDITED and EXEMPT STUDIES Summer Young, JD, MPH Administrator 792-6534 (youngsn@musc.edu)
Questions?
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