Some common mistakes made in filling out IRB applications

 

• Graduate students need to be listed as co-investigators for any thesis or dissertation. It is not sufficient to be listed as data analyzers or key research personnel. Also, if the hypotheses indicate different methods or analyses than the original approval (particularly if it is a borrowed data set) then the student may have to file a separate IRB application.

·       There must be a debriefing form any time subject pool participants are being used. The debriefing form must provide a specific educational benefit to the student about the research that is being conducted. By communicating in simple terms, this educational information may include some of the following (1) explaining the methodology (deception, stimulus materials, study design, independent/dependant variables, demand characteristics, etc.), (2) discussing the hypotheses or theoretical issues, (3) specific information about why this research in this area is important, (4) screening procedures, (5) differences in techniques, or other ideas as applicable.

·       Rationale for Expedited Review: The rationale should specifically mention how the proposal meets the criteria on the previous pages. Needing it in a hurry is not an acceptable rationale. Be sure also to explain why it is minimal risk.

·       Lay Summary: Clearly and simply describe the procedures. This should include why the research is being done and how it will be conducted and analyzed (not specific statistical tests, just what IV and what DV). Please explain. It is extremely important that the summary be written in non-technical language. For example, instead of "affect", say "mood" or "emotion". Eliminate all traces of specialty area buzz words or acronyms such as "cognitive dissonance", "DSM-IV", or "priming". All five areas listed in the instructions at the top must be addressed in the summary. Good luck filling out all five sections in 300-500 words! Often the benefits and risks are omitted. It is okay not to have direct benefits to the participants as long as the risk benefit ratio is acceptable.

·       Section A1, Subject population: The number of subjects requested should be realistic. The number should include a reasonable replacement amount for dropouts but not an astronomically high number just so you can avoid filing an amendment later. If you do have a high number of subjects, please be sure to add a justification (high drop out rate, sampling returns are unknown). Since subject time is a cost of research, the IRB may balk at a large request that is not justified. Be aware, however, that if your proposed sample is too small to provide any power, there will be no benefit (no results) and so the risk/benefit ratio will be unacceptable.

·       Do not exclude minors from subject pool research without a valid scientific reason. Never indicate that the reason you are excluding non-English speakers is because you do not have the resources to include those populations. This is not a sufficient reason (except for pilot work). Acceptable reasons are scientifically justifiable only (measures not validated in other languages, English speaking is central to the study, etc) 

·       Recruitment procedures must be specific. How, when, and where should be spelled out exactly. All recruiting materials (fliers, newspaper or Internet ads, posters, etc.) must be submitted and approved by the IRB.

·       Section B, Risks and Benefits: Risks are not only actual but potential. Is it foreseeable that someone may experience discomfort? No matter how remote the possibility, if it exists then it should be listed. Be sure to list all potential risks. This should be reflected in your consent documentation as well as in the application.

·       Section C, Confidentiality of the Data: Be as specific as possible about how long the data will be kept, where the data will be kept, and who will have access to the data. Section XIII Question #5 should almost always be answered YES because the IRB has the right to review records at any time. (We call this the IRB trick question.) The exception would be anonymous responses without documentation of consent.

·       Consent Forms:

Ø     Leave a 2"x2" space at the bottom of the document for the IRB stamp

Ø     Remove witness signatures for any literate populations.

Ø     All footers must contain the title of the study, the type of document (assent, consent, parental permission), the version number, the date, and the page in "Page X of Y" format. Title is the real title, not the funny cryptic title you use for posting. If there are multiple forms (different groups, consent, permission, assent, etc) the footer of each should distinguish among them.

Ø     For subject pool participants the assent and consent form should be the same; it should be headed “Agreement to Participate”. Parental permission for minors is obtained as a blanket permission by the subject pool coordinator – minors who don’t have such permission won’t have access through PECOLSUS. Note that this means your project must be minimal risk.

Ø     We have posted an annotated consent form template to assist you. The template is unwieldy, but it can be modified intelligently to make a less discouraging document. There is some sentiment that the template was essential when UIC was first getting back from the shutdown but may now have outlived its purpose and become more of a hindrance than a help. Nevertheless, it is still encouraged.

 

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