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What is the definition of “Human Subjects Research”?
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
- Data through intervention or interaction with the individual, or
- Identifiable private information.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
What is the definition of “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.
Are there forms of data collection that do not require IRB review?
Routine and anonymous institutional surveys that are conducted to gather faculty, staff, or student opinions will not generally require IRB approval (e.g., Freshmen and Senior Surveys, Add-drop or reading day surveys). (An exception might be found where the survey asks personal or sensitive questions, or where there is not a reasonable expectation of privacy.)
What about blanket approvals for class-wide projects?
Faculty in some classes encourage or require students to conduct small scale studies, interview members of the campus or local community, etc. If the procedure is standardized, a blanket approval may be obtained from the IRB. All the information described above should be included (see under, "how do I submit a proposal for IRB review?"). In addition, a sample letter of instructions to the student, from you (the faculty member) outlining to the student what they will need to do (obtaining consent from subject, obtain consent from program directors where applicable, etc.).
What does the IRB look for in a proposal?
The IRB seeks:
- Research design that's sound, given the proposed use of human subjects in the project
- Equitable selection of subjects
- Balanced risks and benefits
- A thoughtful and comprehensive informed consent process
How do I know the IRB will understand my proposed research?
The IRB is a standing committee of at least five individuals, including faculty, researchers and members of the community at large. Individual experiences and interests cross diverse areas.
When the IRB receives protocols that require expertise beyond that available on the Board, it seeks assistance from qualified persons outside its membership. While outside experts may inform the IRB's decisions, they do not vote on KSC research protocols presented for review.
How do I know when my protocol's been approved?
You will receive written notification of the status of your protocol following IRB review. The IRB will also identify any required revisions at that time.
What if IRB approval is denied?
You may contact the IRB chairperson and ask to discuss your proposal with the full IRB committee at the next scheduled meeting. It may also be possible to revise your proposal and thereby get approval.
I'm conducting my research at a non-KSC site with its own IRB. Should I apply for project approval through that site's IRB and the KSC IRB?
Yes. Many hospitals, universities and other institutions have their own IRBs. If the site of your research has an IRB, the site IRB and the KSC IRB must approve your project before you begin your project.
You may submit your protocol for review to KSC at the same time you submit your protocol to the other institution's IRB for review, or you may submit the protocol after the other institution's review is completed.
Remember that review and approval requirements may vary among institutions, so you should familiarize yourself with each IRB's policies. You should also plan your research timeline accordingly.
I'm conducting my research at a non-KSC site that doesn't have an IRB. I know I need KSC IRB approval, but how do I document approval from the non-KSC site?
Elementary schools and high schools, and community centers often serve as non-KSC research sites, and rarely have IRBs.
You should ask appropriate personnel (e.g., school principal, director of nursing home, community center director) at the research site to provide a letter indicating that you, the investigator, have permission to conduct your research at their facilities. Alternatively, appropriate personnel may co-sign, with you, an invitation-to-participate letter to indicate institutional permission for you to conduct your research on-site.
The KSC requires evidence of site permission for its review and approval of your project.
My protocol was approved, but now I want to modify it. How do I do that?
Changes to a research protocol must be reviewed and approved by the IRB prior to their implementation. To submit proposed changes for IRB review, send a cover letter (be sure to include the IRB protocol number from your approval letter) with a summary of modifications you wish to make. Attach new or revised instruments, measures, consent documents, etc., as appropriate.
Will I be asked to attend an IRB meeting?
You may be asked to attend an IRB meeting to clarify questions that are raised by your proposal.
What's the worst that can happen if I don't get IRB approval?
Aside from potential ethical implications for the subject and for the investigator, bypassing IRB review brings other risks:
Funding may be withheld: IRB approval is required for research projects funded through the undergraduate research grant program. Funds will not be released without IRB approval.
Credit may be withheld: The University may, at its discretion, refuse to grant students course credit for research conducted without IRB approval.
Honors or M.A. projects will not be accepted: Honors and graduate students must present to their departments evidence of IRB approval for their projects involving human subjects. Honors or graduate projects will not be accepted without it. Degrees will not be awarded for work based on non-IRB-reviewed projects.
Articles may not be published: Most professional journals require evidence of IRB approval when considering articles for publication.
Faculty and Staff
Funding may be withheld: Federal sponsors, and virtually all private sponsors, require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which review is not complete/pending at the time of proposal submission. Some sponsors will not release funds to the College for the investigator's use without IRB approval.
Articles may not be published: Many professional journals require evidence of IRB approval when considering articles for publication.
The College will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the College. The College will not, therefore, provide an investigator of an unapproved project the resources to answer a liability complaint.