WHY DOES THE BLACKBURN COLLEGE INSTITUTIONAL REVIEW BOARD (IRB) EXIST?
The IRB exists as a safeguard to promote ethical and responsible treatment of human subjects/participants in research. Blackburn College and federal policies require projects involving studies with human subjects to be reviewed for the following considerations:
- The rights and welfare of the subjects involved
- The appropriateness of methods used to secure informed consent
- The balance of risks and potential benefits of the investigation
The ultimate responsibility for treatment of human research subjects rests with the researcher and with Blackburn College. The researcher’s informed and enthusiastic participation in this process helps to ensure a positive, ethical, and responsible climate for scholarly research at Blackburn College.
WHO MUST FILL OUT AN APPLICATION WITH THE BLACKBURN COLLEGE IRB?
All faculty, staff, or students conducting research involving human subjects and under the auspices of Blackburn College is subject to IRB review. In conformity with Federal Regulations, there are three separate avenues for review of research involving human subjects:
- Full IRB Review
- Expedited Review
- Exempt Review
All three of these review protocols use the same IRB Application Form (PDF). Applications are accepted on a continuous basis. Allow at least four weeks for a decision. Some types of activities are specifically exempt from IRB review. These include:
- Non-intrusive observation of subjects in public places
- Data-gathering from class members for classroom purposes (e.g., class exercises, course evaluations)
- Needs assessment or evaluation data intended to remain within the Blackburn community
Any questions regarding whether a particular study requires IRB approval should be directed to the current IRB Chair: email James Bray, Blackburn College Biology Department or phone (217) 854-5669. The IRB Chair will make final determination.
NOTE: Class related projects conducted within the Blackburn College community that are not distributed for publication, or used off-campus; which do not exceed a one-semester time period, and do not involve protected population subjects—as identified in 45 CFR part 46—are exempt from IRB review. Approval from the students’ professor(s) is sufficient for undertaking such research. All other research undertaken requires an IRB application—even when classified as exempt under 45 CFR Part 4.
WHERE DO I FILE THE BLACKBURN COLLEGE IRB APPLICATION?
File your completed IRB application form with the Office of Institutional Research located in Ludlum, Rooms 214 and 217.
WHERE CAN I FIND A BLACKBURN COLLEGE IRB APPLICATION?
Photocopies of the general IRB Application Form are available at the Office of Institutional Research. Or you can download and print an IRB application from this website.
WHO DO I CONTACT IF I NEED HELP FILLING OUT THE IRB APPLICATION?
Questions regarding the IRB application should be directed to the Office of Institutional Research at (217) 854-5594.
HISTORY AND NEED
Institutional Review Boards are a response to the scientific community’s realization that general ethical principles were not sufficient to fully guide the conduct of modern scientific research. International efforts
to develop ethical research principles began after World War II and were formally codified in various treaties, resolutions, policies, and laws during the 1960s through the 1990s. The Belmont Report (1979) helped to frame the ethical and philosophical foundation for the modern IRB.
The composition, tasks, and responsibilities of the Blackburn IRB are outlined in U.S. Federal Policy (Federal Policy for the Protection of Human Subjects – Federal Register, June 18, 1991–Sections 46.101-124) and Blackburn College procedures (Blackburn College Handbook). A copy of the Blackburn College Faculty and Staff Handbook is on reserve in the Blackburn College Library.
The official task of the Institutional Review Board at Blackburn College is to assist and inform researchers in the development of appropriate practice in four areas relevant to human subject protection:
- Risk/benefit analysis,
- Subject selection,
- Informed procedures
- Subject debriefing
The IRB assists researchers in anticipating and developing remedies for circumstances, which may put participants at risk. The Blackburn IRB commenced operation during the 2004-2005 school year. The chair and members are appointed by the President, and report to the Provost.
The Blackburn College Institutional Review Board has registered with the United States Department of Health and Human Services (HHS). In addition, the Blackburn IRB has been approved by the Office of Human Research Protections of HHS. Blackburn has received Federal-wide Assurance indicating our compliance with terms of the Office for Human Research Protections terms and guidelines.
NOTE: It is expected that all research investigators will read all material on the IRB website and fully complete the application for IRB approval. The IRB will provide IRB members and research investigators with more information regarding the protection of human subjects upon request.
Due to Federal Regulations, the IRB is requiring that students, faculty, and researchers obtain a certificate from a tutorial regarding research with human subjects. This may be obtained from the following online site:
- New to PHRP Course
- Registration – set up a free account, indicate College/university as institutional affiliation
- Click to being the Protecting Human Research Participants course
- Complete the seven sections, pass four quizzes, and print your certification. Include a copy of that certificate with this application.
At the recommendation of OHRP, the board is requiring that students, faculty, and researchers read The Belmont Report. This is kept on file at the Office of Institutional Research. The final recommendation for the IRB is a requirement that all students, faculty, and researchers read the ethical principles for research with human subjects from their respective disciplines.
All research involving human subjects and which is conducted under the auspices of Blackburn College by its faculty, staff, or students is subject to IRB review.
In conformity with Federal Regulations, there are three separate avenues for review of research involving human subjects:
- Full IRB Review. Research involving more than minimal risk to the subject requires review by the full IRB using current scientific and ethical standards. All research using children or vulnerable populations requires review by the full IRB.
- Expedited Review. Research involving no more than minimal risk and in which the only involvement of subjects will be in one or more of the categories defined by Federal Policy 46.110 requires review by the Chair and selected members of the IRB. Follow this link for eligibility.
- Exempt Review. Research of minimal or no risk as defined by Federal Policy 46.101b requires review by the IRB Chair only. Follow this link for eligibility.
All three of these review protocols use the same IRB Application Form (PDF). Care should be given to early planning and rigorous scholarship when preparing an IRB Application. All portions of the application must be complete.
OTHER IRB FORMS:
Application for Extension of IRB Approval (PDF)
This form is to be completed by the researcher (and his/her advisor, if appropriate) in order to receive an extension if the project is delayed beyond the dates specified in the original proposal approved by the IRB.
Brief Application for Continuation of Classroom Research Projects (PDF)
A form for Blackburn faculty and staff—for expedited or exempt reviews only.
Sample Consent Form (PDF)
Use this form as a template to prepare your consent form.
Sample Assent Form (PDF)
Use this form as a template to prepare your consent form.
If you have difficulty using these files, feel free to contact the Office of Institutional Research here, or ext 5594 for assistance.
Elements of Informed Consent (PDF)
This page reviews the elements of informed consent, consent requirements, and guidelines for developing consent forms.
Checklist for Investigators (PDF)
Use this list to verify your application is complete. Applications will be returned if not complete.
Expedited and Exempt Review Categories (PDF)
Use this list to determine for which review category you qualify. Contact the IRB Chair with questions if unsure. The IRB Chair will make final determination.