1. Institutional Review Board
Rhonda C. Holliday, PhD
Chair
Social and Behavioral Sciences IRB

2. To protect the rights and welfare of research participants
The IRB Mission
To protect the rights and welfare of research participants

3. The IRB Mission
Approve, require modifications in or disapprove research activities
Annual review of research progress
Suspend or terminate approval of research

4. The IRB Mission The IRB ensures: Equitable subject selection
Adequate informed consent
Minimization of risks
Privacy and confidentiality is maintained

5. IRB Members Academicians/scholars of various backgrounds and expertise
Community/lay people
IRB training

6. What does the IRB do? Review all applications
Consult federal regulations to ensure that each project protocol is in compliance with the regulations.
Determine the level of review required
Assign study to a reviewer
Ensure that investigator has appropriate ethical training (CITI course completed)

7. Federal Regulations
Established to ensure protections for human subjects in research.
Derived from the ethical principles recognized in the Belmont Report
1991- Numerous federal departments and agencies adopted a common set of regulations called the “Common Rule”- these govern human subjects research sponsored by the federal government.

8. Federal Regulations & MSM Policy
MSM has provided a formal guarantee to the DHHS that it will follow procedures (Code of Federal Regulations) that will assure the protection of all human subjects involved in research projects (FWA # )
Guarantee applies to all human subjects research conducted:
by anyone on the premises of MSM and
to research conducted elsewhere by faculty, students, staff or other representatives of MSM in connection with their institutional responsibilities.

9. Belmont Report Respect for persons Beneficence Justice
Individuals treated as autonomous agents
Individuals with diminished autonomy entitled to protection
Beneficence
Do not harm
Maximize possible benefits, minimize possible harms
Justice
Fairness in distribution (research costs & benefits)
Inclusion of diverse populations

10. Is it Research?

11. IRB Reviews
Type of review is determined by the amount of risk associated with the study.
Minimal risk means that 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 examinations or tests
Greater than minimal risk
No more than minimal risk

12. Type of Review
Determined by the IRB
Full
Expedited
Exempt

13. Types of IRB Reviews Full Board Review
Studies are reviewed by a fully-convened IRB committee. The committee discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects.

14. Types of IRB Reviews Expedited Review
Studies are reviewed by a qualified member of the IRB committee. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research.

15. Expedited Review
Clinical studies of drugs or devices only when it is not a new drug or device and not being used in a way that increases risk
Collection of small volumes of blood
Collections of biological specimens by non-invasive means
Collection of data through non-invasive procedures
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
Collection of data from voice, video, digital, or image recordings made for research purposes
Research on individual or group characteristics or behavior
Continuing review of research previously approved by the convened IRB
Continuing review of research where IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified

16. Types of IRB Reviews Exempt review
The IRB Office screens studies for exemptions. If a study fits into an exempt category of research and is low risk to subjects, it will not need to go through expedited or full-committee review. If the study is not found exempt, it will need to go through expedited or full-committee review.

17. Exempt Review Research involving educational practices
Research involving the use of educational tests that are anonymous
Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior of public officials or candidates for public office or personally identifiable information will be maintained throughout the research and thereafter.
Research and demonstration projects for public benefit or changes to public programs or services.
Taste and food quality evaluation and consumer acceptance studies
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

18. Type of Review Full board review More than minimal risk
Vulnerable populations
Primary and secondary reviewer; other members can review prior to meeting
Voted on by members of the board (quorum must be present for voting to occur)

19. Type of Review Expedited review The research is minimal risk; and
The research falls into one or more of the expedited categories;
The research will not place participants at risk for civil liability or damage to their financial standing, employability, reputation, etc.;
Assigned to one reviewer

20. Type of Review Exempt review Minimal risk Assigned to one reviewer
Must fall into one of six categories
Does not apply to research involving vulnerable populations

21. Documents for Review Research Protocol IRB Application Consent Forms
Survey Instruments
Recruitment Materials
Human Subjects Certification (CITI certification)
Other Pertinent Materials

22. Key Review Criteria Risk Validity Consent Is the risk minimized?
Will the study yield results that matter
Consent
Is the consent form clear and easy to understand?
Is the consent form appropriate for the population being studied

23. Criteria for Approval Risks are minimized
Risk-benefit ratio is reasonable
Selection of participants is equitable
Informed consent is obtained as needed
Consent documented as required
Data is monitored to ensure safety
Participant privacy/confidentiality is protected
Vulnerable populations are protected

24. Minimize Risk Risks to subjects must be minimized
Procedures with sound research design
Procedures do not expose participants to unnecessary risk
Use standard of care procedures whenever possible

25. Risk: Benefit Ratio Risk: Benefit ratio must be appropriate
Evaluate risks specifically from the research
Evaluate reasonable benefits, not long-range effects
Consider appropriate risk for children

26. Equitable Selection of Subjects
Consider the purpose and setting of the research
Are vulnerable populations included? Should they be included?
Provisions to include non-English speaking participants

27. Informed Consent
Must be sought from a participant or a legal authorized representative
Consent documented appropriately
Consent process
Required elements of Informed Consent Form

28. Data Monitoring
Provisions for monitoring the data to ensure the safety of participants (when appropriate)
Can vary depending on the level of risk
All studies are required to report:
Unanticipated problems involving risks to participants or others
Adverse Events
Non-compliance

29. Privacy and Confidentiality
Privacy refers to people
Persons and their interest in controlling access of others to themselves
Controlling the access, extent, timing and circumstances of sharing oneself
Confidentiality refers to data about people
Participants understanding of ways that their identifiable information will be stored and shared
Control circumstances of sharing information

30. Vulnerable Populations
More vulnerable to coercion or undue influence
Additional safeguards should be included

31. Vulnerable Populations
Three categories
Pregnant women, human fetuses and neonates
Prisoners
Children
Other categories
Employees
Students
Economic status
Educational level
Physical or medical disability
Mental capacity

32. Common Rule Changes New requirements for informed consent
Information that must be given to potential participants
Allows for broad consent
Storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimans
New exempt categories
Research may be required to undergo limited IRB review

33. Common Rule Changes Single IRB requirement
U.S. Institutions engaged in cooperative research within the U.S.
Continuing review for expedited studies is no longer required
Data analysis only
Observational follow-up in conjunction with standard clinical care
Effective January 2018

34. IRB Tips Know and complete all of the required forms and paperwork
Know the deadline for submitting IRB application
Review an approved application
Details, details, details
Consent forms
Reading level
Including all required elements of the form
Communicate with IRB to resolve any issues

35. What happens if I don’t get IRB approval from my research study?
Dissertation or thesis work will not be accepted: Graduate students must present evidence of IRB approval for their studies involving human subjects. Thesis or dissertation work will not be accepted without it. Degrees will not be awarded for work based on non-IRB reviewed studies.
Articles may not be published: most professional journals require evidence of IRB approval when considering articles for publication.
MSM will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the researcher. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted to them by MSM.

36. Resources Office of Human Research Protection (OHRP):
Food and Drug Administration (FDA):
Final Rule Changes
MSM IRB:
Collaborative Institutional Training Initiative (CITI):