Outcomes of Review

An IRB review may result in the following outcomes:

1. The research project is considered exempt from further review and the IRB administrator informs the PI that research may begin immediately.
2. The research project qualifies for an expedited review and is reviewed by the IRB administrator and the IRB Chair or another member of the IRB committee who reviews the application and judges the research project: 
   
   • More Information is needed or changes are required. The IRB administrator contacts the PI.
   • Approved. The proposal is within acceptable guidelines and the IRB administrator informs the PI that research may begin immediately or
   • Not Approved. The proposal requires a full IRB review. The IRB chair assigns the review to a Board member.
3. The research project requires a full IRB review and is considered in a regularly convened IRB meeting where it may be judged:
   • Approved as written and the IRB chair informs the PI that research may begin immediately or
   • Not Approved as written. The IRB chair will inform the PI of the parts of the proposal that were not acceptable. The PI may rewrite and resubmit the proposal.
   • Disapproval. The IRB chair will inform the PI that the research project may not be done under the auspices of Kenyon College.

IRB decisions and requirements for revisions, if any, are conveyed to investigators in writing, with the provision of an opportunity for appeal by the investigator in the case of disapproval. Although research may receive IRB approval, the department chair or other administrative officials may conclude that the research project does not meet the policies and goals of the college and may disapprove, suspend, or terminate a project. However, IRB decisions to require modifications in, disapprove, suspend or terminate a project are final. No other committee or official can override these IRB decisions. Further, no committee or official can approve an investigator to conduct any human subject's research that the IRB has not approved. [See 45 CFR 46.112 .]

The IRB's approval may be suspended if the following conditions are not followed:

• No subjects may be involved in any study procedure prior to the IRB approval date or after the expiration date (not more than 1 year). (PIs are responsible for initiating Continuing Review proceedings. )
• All unanticipated or serious adverse events must be reported to the IRB within 5 days.
• All protocol modifications must be IRB approved prior to implementation . This includes any change of procedures, investigator, faculty adviser.
• All protocol deviations must be reported to the IRB within 5 working days.
• All recruitment materials and methods must be approved by the IRB prior to being used.

What could keep me from getting IRB approval for my research?

Timing

1. Length of time for review of a research protocol depends on the quality of the application and the level of the review. Full Board meetings are usually scheduled 3 times a semester. Applications for full board review must be filed 2 weeks in advance of the next scheduled meeting.

Training

1. The IRB will not begin a review until they have verified that you have successfully completed the required training.

Application – Read the Instructions!

1.  The IRB will not begin a review until all files have been received online.
2. The IRB will not start a review until it has received a hard copy of the signed assurance page.
3. You will be asked to rewrite sections of the application, or other associated documents, that are poorly or carelessly written or do not fully answer the questions.
4. Answer every part of every question. Describe each step of your protocol thoroughly.
5. When you describe your research process, think about a reviewer who does not know anything about your discipline or research methodology.  Take us through your research process step by step.  Does each step make sense? Did you leave anything out? Could the reviewer carry out your research?

Consent Process

1. Consent forms, assent forms, debriefing documents should be submitted exactly as they will be given to research participants (subjects.)  If they are not well designed, if they are too difficult for the subject population to understand, if they are riddled with typos, you will be asked to redo them.
2. If you are asking for an oral consent process, you must submit the script for the process.
3. A waiver of consent is actually a waiver for or alteration of the requirement for documentation of informed consent, not permission to bypass an informed consent process. “Too hard to get” or “will take too long to get” are generally not considered good arguments for requesting a waiver.

Anonymity vs. Confidentiality/Data Protection

1. Your data can be anonymous or be kept confidential, not usually both.
2. Anonymous means that participants do not provide any identifying information or that their identity cannot be linked to the data they give. If you are interviewing someone or audio or videotaping someone, or getting signed statements, the data is not anonymous. At the least, you know. 
3. An anonymous online survey may not be anonymous.  You need to know about and explain the protection features of the survey software you will use.  For instance, does it record the IP address?
4. Confidentiality means that the researcher will do everything necessary to prevent anyone else from connecting the data to a subject.  This involves developing a data protection plan.  This also may mean that you promise to protect information to the best of your ability.
5. Keeping your field notes or computer with you at all times is not a plausible data protection plan. We all know how many notebooks and computers are lost or stolen. Think about pass wording, encrypting, protected servers, etc.

Subject Populations and Institutions

1. If you are using a particular population for your potential subjects, all men, all women, school children, retired people, etc., you need to explain why.  Easy to get is not a good answer.  The study should be about that population not that population as representative of all people.
2. If you are using a population in a school, another college or university, hospital, retirement home, convalescent home, etc.,  you have to provide documentation from that institution’s IRB or equivalent, if they have one, or permission from the appropriate administrator.
3. If your population includes children under the age of 18, even Kenyon College Students under 18, you must get parental consent and subject assent.  In loco parentis is not acceptable. Passive consent, meaning that if the parent or guardian does nothing it implies consent, will not be reviewed favorably.

Risk Assessment

1. You need to really analyze the possible risks to participating in your study.  Do not assume your subjects live or work in an environment similar to your own. Do not assume that because they may live or work in what you think is a risky environment that being in your study might not have any meaningful risks. What is the possible affect participation in this study may have on your subject?  Is this really no more risk than those the risks encountered in everyday life?  Who’s life?

Deception

1. Though deception may occasionally be allowed in a study, there must be a very well argued case for using it.  That you will debrief the subjects afterwards is not justification for using deception.  If you are permitted the use of deception, there will be an expectation that your subjects will be debriefed.

Paying Your Subjects

1. If Kenyon students are subjects and are to be given course credit, there must be another activity for which they could receive comparable credit for a similar amount of effort.
2. If you pay your subjects with funds that come from an account that was funded by or is handled by Kenyon College, you must use the forms provided on the IRB forms page. 
3. Kenyon employees that participate in a study must do so on their own time.  Don’t expect a Kenyon employee to sit for an interview for 30 minutes during their work time.

What happens if I don’t get approval?

1. When a PI conducts unapproved research, it places the entire institution at risk of having all research shut down by OHRP. Kenyon has signed an FWA (Federal Wide Assurance) that promises that we will review all research prior to it being initiated by our community and/or on our campus.  
2. The IRB can prevent a student researcher from getting credit for projects making use of unapproved research.
3. The Kenyon IRB may prevent a researcher from publishing information acquired through unapproved research.
4. Some journals and professional associations will not publish or allow the presentation of unapproved human subject research.

The Kenyon College IRB is committed to working with our researchers to make their research possible while ensuring the highest degree of protections for human subjects participating in that research.  Please help us by submitting the best application that you can.

Be thorough.  Be accurate. Be honest.

Students should consult with their Faculty Advisor for the project.

You may call the IRB administrator for help.