1. COCE Institutional Review Board Academic Spotlight
July 13, 2017
Presenters: Drs. Michelle Hill, Sonique Sailsman, & Alycia Harris

2. Agenda Who We Are Key Definitions When Do You Need an IRB Review?
Preparing for IRB Submission
During IRB Review
After IRB Review

3. Who We Are
The COCE IRB shall protect the rights and welfare of human subjects recruited to participate in research activities conducted on or by College of Online and Continuing Education (COCE) stakeholders.

4. Who We Are
The COCE IRB shall have the primary responsibility to review and monitor all human subject research in compliance with all local, state, and federal laws; SNHU policies and procedures; and the highest standards of ethical conduct and practice. 
The COCE IRB follows SNHU’s Institutional Research Review Board Policies and Procedures Manual.

5. Who We Are Voting Members: Non-Voting Members: • Chair • Vice-Chair
• Academic Dean
• Graduate Faculty Representative
• Undergraduate Faculty Representative
• Student Representative
• Outside Community Member not affiliated with SNHU
Non-Voting Members:
• Legal/Regulatory/Compliance Representative
• Secretary (Project Analyst/IRB Administrator)

6. Who We Are The members are charged to:
Review all proposals involving human subject research conducted at SNHU and/or in collaboration with other institutions. This includes all human subject research conducted under the direction of any employee or agent in connection with his or her institutional responsibilities or use of SNHU’s name or academic or nonacademic titles.
Approve, require modifications to, or disapprove the aspects of research activities that involve human subjects.
Notify applicants of decisions made by the board concerning their proposed research.
Conduct periodic reviews of ongoing research projects that involve human subjects and maintain records of review proceedings, decisions, and activities, in accordance with federal and SNHU guidelines, for at least three (3) years following completion of the projects.
Develop policies, procedures, and instruments needed to align SNHU policies with the scope and purpose of the COCE IRB and disseminate those policies, procedures, and instruments to the COCE community.

7. Key Definition: Research
Research is defined by federal regulations at 45 CFR as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

8. Human Subjects Research Checklist

9. When Do You Need an IRB Review?
If your research study includes:
Human participants
Generalizable knowledge

10. Key Definition: Human Subject
A human subject is defined by federal regulations at 45 CFR  as “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."

11. Key Definition: Generalizable Knowledge
Generalizable knowledge is the knowledge learned from research that may be shared with or applied to populations not involved in the research project.
YES NO
Sharing survey results with the general public
Sharing survey results with survey participants
Presenting information at a conference
Presenting information from a course assignment in that course
Published research

12. Preparing for IRB Submission

13. Note Regarding Adjuncts
SNHU adjuncts must have taught at least 15 sections at SNHU in order to serve as a faculty sponsor for students or be a Primary Investigator (PI) on a protocol application.
Adjuncts are encouraged to speak with their Associate Dean of Faculty (ADF) regarding any planned studies prior to COCE IRB submission.

14. COCE IRB Application Checklist

15. Request for COCE IRB Review Form

16. Key Definition: Vulnerable Populations
Individuals may be considered vulnerable because they do not have the decision-making capacity to provide voluntary informed consent or because of their situation. The following are examples of groups that are often considered vulnerable populations (Block & Gordon, 2014):
Pregnant women
Human fetuses
Neonates
Prisoners
Children
Individuals with physical disabilities
Individuals with mental disabilities or cognitive impairments
Economically disadvantaged
Socially disadvantaged
Terminally ill or very sick
Racial or ethnic minorities
Institutionalized persons (for example, persons in correctional facilities, nursing homes or mental health facilities)
Block, J. N., & Gordon, B. (2014, August). Populations in research requiring additional consideration and/or protections. Retrieved from 

17. Key Definitions: Confidentiality vs. Anonymity
Participants’ identities are known only by the researcher(s)
Participants’ identities are unknown even to the researcher(s)

18. Completed Protocol
Review COCE IRB Application Checklist to ensure that you have all necessary forms
Attach all forms in an and send to

19. During IRB Review
You will receive an acknowledgment of receipt from as soon as possible
Protocol submission will then be reviewed for completeness
You will receive another either verifying completeness or requesting additional documents
When protocol submission is determined complete, review type and reviewers are assigned
You may be requested to revise your protocol multiple times
Revisions must be submitted within 10 business days of receipt

20. During IRB Review Types of review:
Exempt: review by Chair (or designee)
Expedited: review by Chair (or designee) and at least one other committee member
Full: involves the full IRB committee

21. After IRB Review
You will receive an from indicating approval or disapproval of your protocol
Some protocols may be “Approved with Recommendations”
Comments must be addressed before beginning research study
will include signed Research Review Notification Form and additional documents from protocol (if necessary)

22. After IRB Review Approval expiration date: one year from approval date
When your protocol approval expires, all research activities must stop. Please ensure that COCE IRB receives a Request for IRB Extension form no later than 30 days before the approval expiration date, if the study is expected to extend beyond one year.
COCE IRB must be notified if there is any change made in the protocol

23. Important Note
DO NOT interact with any participants until you receive a signed Research Review Notification Form indicating approval of your research study.
If it is found that you have interacted with participants prior to receiving approval, your research will not be sponsored by Southern New Hampshire University.

24. Website: https://my.snhu.edu/Offices/COCE/IRB/pages/default.aspx
Questions?
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