Common Problems

Common Problems with the IRB Application
These are the ten most frequently occurring problems with applications requiring a full-board review.

Common Problems

The IRB provides solutions for the “top 10” list of problems with IRB’s submissions:

Researchers fail to state the consequences for subjects who might decide not to participate in the study. If research is providing any kind of service (for example, special class activities) be sure to specify what happens to a participant who refuses to be part of the research. Will you still provide the service to anyone who refuses to participate? Are the proposed services available elsewhere? What steps have you taken to ensure that those who decide to not participate are not made to feel uncomfortable?

Researchers are unclear as to whether the members of the research team have the expertise to conduct the proposed research. Two basic questions to be answered in the application: What are the credentials of the research personnel, and who will be taking what actions in conducting the study? This last question is frequently of concern when there are student co-investigators. In your application, be sure to clearly identify who will be doing what and specify their qualifications. For example, if a licensed psychologist will be present during observed therapy sessions clearly identify the person, and state that she or he is licensed. Also, if you use pronouns in your text make sure that the referent is clearly identified.

Reviewers have been concerned with collections of sensitive data without the appropriate precautions specified. If you are dealing with confidential data, specify how confidentiality will be maintained throughout the research process as well as where and how long the date will be kept and plans for its destruction. If employees will be handling data, specify how they will be trained. Clearly identify everyone who will handle information, and describe the process they will use and their qualifications.

Reviewers give consent forms particular attention and many problems have been encountered. Make sure that your consent form is consistent with your protocol. If possible have someone proof read the consent form, checking for consistency with your protocol and for grammatical or spelling errors. Child assent forms should be written at the reading level of the children to be used as subjects in your research. Be sure to provide institutional consent from authorities responsible for the research site (for example, hospitals, schools).

In Nebraska, children are defined as under the age of 19 which technically makes 18 year-olds a vulnerable population. If you are sampling from the general population, you may want to set your bottom age range at 19.

Reviewers have been uncertain as to what is being proposed. It helps if you clearly state your design, specify procedures, and provide a thorough discussion of the relationship between the theoretical concepts and the procedure. This is particularly helpful if your independent variable is an intervention. In describing your procedures, you should use terminology that is most common within the discipline. For example, if you are planning to conduct an experiment you should specify your procedures; such as, “randomly assign subjects to the control or experimental groups which are. . .”

Reviewers will not approve an application without seeing all the materials. This includes scripts, questionnaires, surveys, paper and pencil tests, pictures, artwork, video and audio materials, movies, web sites, and music. If a supplemental item is too bulky to submit, or available only online, provide a written detailed description.

The validity of research can be called into question. Part of the IRB's responsibility is to see to it that human subjects are not used frivolously. This not only protects the subjects but also protects serious researchers. Integrate the literature review into your Background section of the application. Organizing your discussion around the operationalization of your independent and dependent variables aids in clearly expressing your research question to reviewers.

Scales or instruments are presented with little comment. If you are using a scale or survey that has been extensively used in your discipline please tell us. If a scale contains sensitive questions, but has found to be reliable and valid, then the reviewers are less likely to be concerned.

Some researchers forget to inform their subjects that they have the right to withdraw from any study with no negative consequences (for example, loss of course credit or points or money if offered for participation). To ensure that your subjects understand that they have the right to withdraw for the research, state this explicitly in your consent form or in your instructions to subjects.