1. Research Involving Human Subjects
Institutional Review Board
(IRB)
Judette Haddad, PhD, CIP

2. History and Ethical principles
Nuremberg Code 1947
Declaration of Helsinki 1964
Belmont Report 1979
Respect for person- Informed consent
Beneficence- Favorable benefit-risk ratio
Justice- Selection of subjects

3. Human Subject Protection Regulations
DHHS Regulations
45 CFR part 46- Subparts A, B, C, D, & E
FDA Regulations
21 CFR part 50, Protection of Human Subjects
21 CFR part 56, Institutional Review Boards
21 CFR part 312, Investigational New Drug Application
21 CFR part 812, Investigational Device Exemptions

4. OU Federal Wide Assurance
All research involving the participation of human subjects must be submitted for review by the IRB (Institutional Review Board for the Protection of Human Subjects)

5. DHHS Definition 45 CFR 46.102(d)
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

6. DHHS Definition (cntd)
45 CFR (f)
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

7. DHHS Definition (cntd)
Private Information:
Information about behavior that occurs in a setting in which the individual can reasonably expect that no observation or recording is taking place
information that has been provided for specific purposes, other than research, where the individual can reasonably expect that it will not be made public (e.g., a medical record.) [45 CFR (f)].
Protected Health Identifiers (PHI)

8. Institutional Review Board
IRB is a review committee established to help protect the rights and welfare of human research subjects.
Authority of the IRB:
Approve, disapprove, or modify research
Conduct continuing reviews
Observe and verify changes
Suspend or terminate approval
Observe the consent process and research procedures

9. Review Categories Exempt Expedited Review Full board Review
Depends on the Risk Level

10. What is “minimal risk”?
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.

11. Review Categories (cntd)
May be “Exempt”
Projects that present no more than “minimal risk” to the participants and do not compromise the privacy of the participants or confidentiality of the data
Fits 1 of 6 categories
Reviewed by IRB Chair or a designated member
Common in Educational Research- No identifiers

12. Review Categories (cntd)
May be “Expedited”
Projects that present no more than “minimal risk” to the participants, and for minor changes in approved research
Has to fit 1 of 7 categories
Reviewed and approved by 2 IRB Committee Members
Common in Educational Research for data collection methods that use audio/visual data collection- Retain identifiers

13. Review Categories (cntd)
Full Board Review
Projects involving more than minimal risk
Full Committee meets once per month (Applications must be received at least 10 days before the next meeting date)
Researcher are invited to present the research
Committee members ask the researcher questions regarding the research and participation of human subjects
Vote is taken (in the absence of the researcher) and recommendations are made

14. Review Categories (cntd)
Continuing Review
Annually for Expedited or Full Board approved applications.
notifications sent two month prior to approval expiration date.
Must complete the Continuing Review Form and attach a copy of the consent form.
Same type of review as the original application with some exceptions.

15. Criteria for IRB Approval of Research
1. Risks to subjects are minimized
sound research design which do not unnecessarily expose subjects to risk,
using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, and the importance of the knowledge that may result.
3. Selection of subjects is equitable.

16. Criteria for IRB Approval of Research (cntd)
4. Informed consent is sought.
5. Informed consent is appropriately documented.
6. Plans for monitoring the data collected to ensure the safety of subjects.
7. adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
8. additional safeguards to protect vulnerable population (children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).

17. Analyzing Risks and Benefits
To judge the application the IRB needs full information about:
the selection and recruitment of subjects,
research design,
scientific rationale,
conflicts of interest.

18. Informed Consent
Participants must understand the nature of the research.
Participants must be able to knowledgeably and voluntarily decide whether or not to participate.
Participants must understand the risks and benefits of participation.
The IRB must determine that informed consent will be properly obtained.

19. Elements of Informed Consent
Eight Basic Elements
Research, Purpose, Procedures (experimental), Expected duration
Risks and discomfort
Benefit
Alternatives procedures (Treatments)
Confidentiality of records
Medical treatment in case of research related injury
Contact Info: Research Qs, Rights Qs, Injury Qs
Participation is Voluntary

20. Elements of Informed Consent (cntd)
Additional elements, as appropriate
Unforeseeable Risk (embryo or fetus)
Participation may be terminated by researcher
Additional cost to subjects
Consequences of early withdrawal by subjects
Significant new findings that may affect wiliness to continue participation
Approximate number of participants

21. Elements of Informed Consent (cntd)
Voluntary
Consent if voluntary, free of coercive elements
Right to refuse or withdraw with no penalty
Unjustifiable pressures occur when persons in authority urge a course of action for a subject
Coercion is likely whenever possible sanctions are involved (implied or actual)
Undue influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward
Consent process may not involve the use of “exculpatory language”

22. Elements of Informed Consent (cntd)
Comprehension
Organized
Ample time for consideration
Opportunities for questions
Lay language appropriate for subject

23. Important Components of Protection
Minimizing Risk
Maintaining Confidentiality
Maintaining and Destroying Records
Maintained for at least 3 years after the completion of the study and then destroyed in a manner that will protect the identity of human subjects.
Reporting Adverse Events Related to Research

24. Approved Research Research must be conducted as approved by the IRB.
Any changes to original application must also be approved before implementation.
Report changes to IRB through message to Dr. Haddad
IRB approval is valid for a maximum of one year – a “Continuing Review Form” must be submitted to extend the research beyond one year.

25. How to Apply Submit and application at http://www.oakland.edu/research
All sections of the form must be completed
An endorsed hard copy of the signature page must be forwarded to the Research Office, 530 Wilson Hall.
All research must be conducted or sponsored by an Oakland faculty member.

26. What Happens?
For research falling within the categories of exempt or expedited review, maybe reviewed and approved within 2-3 weeks.
For research review by the full committee, you will be sent a written invitation to attend the committee meeting at which it will be discussed.
Investigator will provide explanations and rationale for all procedures, discuss the risks and benefits, and information about informed consent procedures.
If approved by the majority of IRB members attending the meeting, you will be notified in writing within a few days.

27. Faculty Responsibilities
All investigators conducting research involving human subjects need to be familiar with Oakland University IRB Guidelines
Complete CITI Training
Faculty training is available periodically throughout the year
Faculty must inform students with whom they are working to read OU Guidelines

28. Faculty Responsibilities (cntd)
Faculty must approve student application before it is submitted to the IRB
All research must be exempted or approved before it can be conducted
Research must be conducted as described in the approved or exempted application
Research applications must be submitted through the Research Application Manager (RAM 2.0)

29. Where Do I Find Information?
Most information on guidelines, procedures, and submitting research applications can be found at
Contact Dr. Judette Haddad (Compliance Officer) at or
Contact Dr. Chris Stiller (IRB Chair) at or

30. Tips: Before you Apply Get a login and password for the RAM 2.0
Be familiar with the questions that are asked on the application
Write the major components of the application (Abstract, Protocol, Consent Form(s), Instruments)
Use the “suggested language” on the checklist within the consent form
Attach other items given to subjects such as survey questionnaire or advertisements
Allow ample time for the review process to take place

31. CITI Training Collaborative Institutional Training Initiative
Register- Choose OU as Participating Institution
Student Module
Mandatory Starting January 2011

32. CITI Course in Basic Human Subject Research
Undergraduate Students
1. Oakland University
2. Research Misconduct
3. Students in Research – SBR

33. CITI Course in Basic Human Subject Research- OU Maters Final Projects or Theses, and Doctoral Dissertations
Oakland University
Belmont Report and CITI Course Introduction
Defining Research with Human Subjects – SBR
Assessing Risk in Social and Behavioral Sciences – SBR
Informed Consent – SBR
Privacy and Confidentiality – SBR
Records-Based Research
Internet Research – SBR
Research and HIPAA Privacy Protections
Research Misconduct
Data Acquisition, Management, Sharing and Ownership
Conflicts of Interest and Commitment
If Applicable:
Research with Children– SBR
Research with Prisoners – SBR
Vulnerable Subjects - Research Involving Pregnant Women and Fetuses in Utero

34. CITI Course in Basic Human Subject Research- OU Faculty Modules
Oakland University
Belmont Report and CITI Course Introduction
Defining Research with Human Subjects – SBR
Assessing Risk in Social and Behavioral Sciences – SBR
Privacy and Confidentiality – SBR
HIPAA and Human Subjects Research
Data Acquisition, Management, Sharing, and Ownership
Informed Consent – SBR
Conflicts of Interest in Research Involving Human Subjects
Records-Based Research
Internet Research – SBR
If Applicable:
Research with Children – SBR
Research with Prisoners
Vulnerable Subjects – Research Involving Pregnant Women and Fetuses in Utero

35. Questions?