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?