Institutional Review Board

1
Institutional Review Board

• Orientation of New Members

2
IRB Who are we?

• The Institutional Review Board
• Reviews all Research that involves humans in any
  fashion on behalf of GSU
• Mandated by the Department of Health and Human
  Services
• Federal Wide Assurance number FWA00008095
• Compliant with
• 45CFR46 the Common Rule and other guidelines
  and regulations

3
Service

• IRB members
• serve for 3 year terms.
• Appointed by the Provost on recommendation of
  Deans, Department Chairs and ORSSP
• Members can be reappointed
• Representatives from each content area involved
  in research at GSU

4
Service

• IRB Chair
• Elected by the committee
• Conducts meetings
• Liaison with University Faculty and
  Administration

5
Right to Recuse

• Members may not vote or review where
• Supervise or advise investigator or
  co-investigator
• Serve as co-investigator
• Benefit from conduct of study
• Subject of study
• Self identify conflict of interest
• Reply to ORSSP to alert Oversight

6
Regular Members

• Attend regular IRB meetings
• Prepare by previewing protocols scheduled for
  full board review and drafts for committee
  business discussion
• Participate in all IRB discussions and committee
  business
• Review expedited protocols within 5 days of
  receipt. (Notify ORSSP if planning to be out of
  town for more than a couple of days)
• Notify your alternate if you will miss a meeting
  and update them on committee business

7
Alternate Members

• Attend meetings in the absence of the regular
  member to whom they are matched.
• Retain voting rights for the regular member when
  serving as proxy
• Votes their own conscience not how the regular
  member would have voted.
• Review expedited protocols within 5 days of
  receipt.

8
Committee Review

• Protect Human Subjects
• Unnecessary Stress
• Harmful consequence
• Participation without fully informed consent
• Guidelines for Review
• Respect for persons (Autonomy)
• Beneficence Ethical, Maximize benefit/ minimize
  risk
• Justice Fair distribution of risk and benefit

9
Common Rule

• 45 CFR Part 46
• (One rule for all Federally Funded research)

10
Research

• Systematic Investigation
• Development
• Testing
• Evaluation
• Generalizable knowledge

11
Human Subjects

• Living Individuals
• Data gathered
• Interaction with individual
• Data from individual
• Samples from individual

12
High Risk Populations

• Children
• Prisoners
• Pregnant women/fetus
• Terminally ill
• Comatose Patient
• Students/Employees

• Mentally ill
• Language barrier
• Illegal Immigrants
• Illegal activity
• Activity beyond Social Morays

Others who may be vulnerable to deception,
coercion or unrecognized injury through inquiry
13
Third Parties as Human Subjects

• Information gained from participants about a
  friend, spouse, relative or other.
• YES data from or about an identifiable
  person
• No general data not traceable to specific
  individual

14
IRB Training - Online

• Meets the National Institutes of Health training
  for use of Human Subjects in research
• http//cme.cancer.gov/clinicaltrials/learning/huma
  nparticipant-protections.asp
• Housed on the National Cancer Institute training
  web site.
• Registration required but Free
• Training is good for 3 years

15
IRB Training - Online

• Required for all applicants to the IRB
• Faculty/Staff
• Principal investigators
• Co- investigators
• Graduate students
• Undergraduate students
• External researchers
• Required for all IRB members prior to service

16
Review Types

• Full Board
• Expedited
• Exempt from Full Board Review
• Exempt as Research

17
Full Board

• Greater than minimal risk
• Upon recommendation of 1 board member or ORSSP
• High risk population
• Sensitive or potentially harmful research method,
  strategy or content
• Potential harm to institution

18
Expedited Review

• No risk greater than minimal
• 2 board members review
• Comments emailed to ORSSP with in 5 business days
  of receipt
• ORSSP relays comments to applicants as board
  comments
• Response reviewed by ORSSP
• ORSSP may consult the reviewer for confirmation
  of acceptable response

19
Review Options

• Request Additional information to clarify
• Suggest modifications for enhanced protection of
  human subjects
• Suggest modifications to enhance validity of
  research where flaws may impact fair use of human
  subjects
• Approve conditionally Minor changes
• Approve as read

20
Board Review Complete Submission

• Cover Page
• Proposal Narrative
• Informed Consent
• Individual, parent, minor
• Certificate of Investigator Responsibility
• Investigator and Co-Investigator

• Human Subjects Training Certificate
• For each individual handling data
• Survey or data collection instrument
• If using..
• permission from institutional authority to
  access institution subjects.
• - Copy of recruitment flyer or email

21
Exempt from Full Board Review

• Review by ORSSP or IRB Chair
• Specific criteria for exemption in regulation
• Exemptions do not apply to any high risk
  population except school children in normal
  educational settings under normal educational
  practice
• Exemption status not to be determined by
  researcher

22
Exemption Category

• Exemption Categories are
• Normal educational practice conducted in normal
  educational setting
• Research involving the use of educational test
  (standardized), survey procedures, interview or
  observation of public behavior UNLESS
• Recorded in a manner that subjects can be
  identified directly or indirectly and
• Disclosure of responses could place participant
  at risk of criminal or civil liability or damage
  financial standing, employability or reputation

23
Exemption Category Cont.

• Research involving the use of educational test
  (standardized), survey procedures, interview or
  observation of public behavior IF
• Subject are elected or appointed public official
  or candidates for public office or
• Federal statute requires without exception that
  the confidentiality of the personally
  identifiable information be maintained throughout
  the research and thereafter. (e.g., minor
  offense records)
• Research involving the collection or study of
  publicly available data
• Research designed to evaluate public health
  benefit or service programs and approved by
  Federal department or agency head
• Taste and food- quality evaluation and consumer
  acceptance studies

24
Exempt Not Defined Research

• Oral History
• Story teller is aware of recording
• No conclusion drawn
• Market Survey
• No use but for Program Evaluation
• Not applied to a broader concept
• Archeological dig
• No living subjects or third parties
• No risk to current living individuals

25
Exempt Complete Submission

• Cover Page
• Exempt Questionnaire
• NIH Training Certificate
• Survey or Data Collection Instrument

26
Review Summary

• Informed consent
• Participant is aware and able to agree
• Human subject protection from unnecessary risk
• Realized and unrealized
• Ethical research
• Balance of risk/benefit
• Valid research
• Potential value balances risk to subject
• Institution unharmed

27
Administration

• ORSSP
• Compliance Officer
• Eleanor Haynes
• Graduate Assistant
• Brian Butler
• IRB_at_georgiasouthern.edu
• 681-5465 - front desk
• 681-0843 - compliance office
• http//academics.georgiasouthern.edu/research/comp
  liance.htm