Institutional Review Board Overview

1
Institutional Review Board Overview Process

• The Office of Research Services and Sponsored
  Programs
• P.O. Box 8005
• Phone [phone]
• Fax [phone]

2
Office for Human Research Protections

• 45 CFR 46 The Common Rule
• DHHS Policy for Protection of Human Research
  Subjects
• Subparts A, B, C, D
• http//www.hhs.gov/ohrp/

3
What is an Institutional Review Board?

• Commonly known as an IRB, it is a committee who
  is responsible for reviewing research that
  involves human subjects.
• makes a recommendation to approve the research or
  to revise the research to ensure protection of
  the participants.
• An IRB must apply federal regulations for the
  protection of humans in research.

4
IRB Gate Keeper????

• Investigators should not have sole
  responsibility for determining whether research
  involving human subjects fulfills ethical
  standards. Others who are independent of the
  research must share this responsibility.
• National Commission Report on
• Institutional Review Boards, 1978

5
Does all research have to follow PL 45CFR46?

• To require IRB review, the project must be
  considered
• Research and
• Involve human subjects
• according to the definitions in the federal
  guidelines.

6
Research

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

7
Human Subjects

• Living Individuals
• Unless medical data gathered (HIPPA applies to
  nonliving subjects)
• Data gathered
• Interaction with individual
• Data from individual
• Samples from individual

8
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

9
Minimal Risk 45 CFR 46.102(i)

• the probability and magnitude of harm or
  discomfort anticipated in the research are not
  greater in and of themselves than those
  ordinarily encountered in daily life or during
  the performance of routine physical or
  psychological examination or tests.

10
Types of Risk

• Risk may include
• Risk of criminal/civil liability,
• Financial risk,
• Employment risk,
• Stigmatization,
• Insurability,
• Embarrassment
• Look at all aspects when deciding if risk is
  minimal

11
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
12
IRB Training - Online

• Meets the National Institutes of Health training
  for use of Human Subjects in research
• http//phrp.nihtraining.com/users/login.php
• Housed on the National Institute of Health Office
  of Extramural Research training web site.
• Registration required but Free
• Training is good for 3 years
• Training was updated March, 2008

13
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

14
Types of Review as Defined by 45 CFR 46

• Three categories of review
• Exempt
• Expedited
• Full Board
• Categories based on level of potential risk
  versus benefits

15
Review Continuum

• Exempt Expedited Full Board
• Low Risk High

16
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
• Decision returned one week after review

17
Full Board Process
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
Expedited Process
21
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

22
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
• Decision returned in one week

23
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

24
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

25
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

26
Exempt Complete Submission

• Cover Page
• Exempt Questionnaire
• Survey or Data collection instrument
• NIH training certificate

27
Exempt Process
28
Informed Consent (?)

• A process, not just a document
• If participants are under 18 years of age,
  informed consent must be obtained from
• The childs parent(s) asking permission to ask
  child to participate
• The child ask child to participate
• Must be written at no higher than an 8th grade
  reading level, or the reading level of the
  participants

29
Informed Consent (?)

• Must be written to the participant not the IRB.
  
• Write as though you were explaining your project
  to a friend
• How will this project impact the participant
• How much time will this take?
• What to I have to do?
• Why should I spend my time?
• What if I change my mind?
• How can I be sure I am safe?

30
Informed Consent (?)

• Must be written to the participant not the IRB.
  
• Write as though you were explaining your project
  to a friend
• How will this project impact the participant
• How much time will this take?
• What to I have to do?
• Why should I spend my time?
• What if I change my mind?
• How can I be sure I am safe?

31
Essential Elements for Consent45 CFR 46.116

• Invitation to participate
• Purpose, duration, procedures
• Foreseeable risks/benefits
• Confidentiality conditions
• Contact persons for questions
• Voluntary nature of participation
• Alternatives, if any
• Compensation, if applicable
• Provide copy

32
Informed Consent at GSU (?)

• Must be on GSU letterhead (provided online)
• Include PIs name and contact info and faculty
  advisors name and contact info, if a student
• Include all sections included on optional
  template, unless not applicable to your project.
• Process of obtaining informed consent from
  participants must be explained in methodology
  section of Proposal Narrative

33
Special Activities and Processes

• Passive Consent anonymous survey can use
  passive consent rather than informed consent
  form.
• Oral Consent may have to obtain from very young
  children. In this case, provide a copy of
  exactly what will be said in obtaining oral
  consent.
• Classroom Projects research project required
  for completion of a course, but cannot involve
  minors, deception, videotaping, or
  presentation/publication.

34
Special Activities and Processes

• Survey Research can be exempt only if anonymous
  no identifiers are used.
• Deception if deception is involved, include a
  debriefing form to be given to participants upon
  conclusion of research.
• Oral History if no conclusions are being made
  about oral histories, this does not fall under
  the purview of the IRB

35
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

36
In Conclusion

• If you ever have questions or concerns, please
  feel free to contact
• Eleanor Haynes at 478-0843
• ehaynes_at_georgiasouthern.edu
• Or visit
• http//academics.georgiasouthern.edu/research/comp
  liance_irb.htm