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Frequently Asked Questions and Concerns

Does the IRB Review Completed Projects?
No. Both federal regulations and Miami University’s policy, is very clear: research projects using human subjects are to be submitted and approved by the IRB before any research activity is initiated. Consistent with this policy, the IRB never conducts a review (or approves) a completed project. However, occasionally a researcher realizes that he or she has begun or even completed a project without seeking IRB approval. Although these should never occur, in the past these have sometimes happened due to some other process (e.g. a professor would like to incorporate some previously obtained information from a class in a professional article that he/she did not get previous IRB approval to obtain) and sometimes by neglect or ignorance (e.g. a graduate student conducts a masters thesis in which he/she interviews people about their knowledge of particular Greek myths. However, no one ever told the student that he/she needed IRB approval).

In cases such as these, the researcher should submit a proposal describing the project; this proposal should describe the circumstances that led to the research in addition to description of the project. This application will be examined by the full IRB and the IRB will render a decision about whether the rights of subjects/participants had been adequately protected during the course of the project. This decision will be given to the researcher. Naturally, future projects of the researcher should be approved in the normal/required manner.

Oral Histories
A number of disciplines do not perform experiments using human subjects, but do interview a few individuals about their own lives. Frequently, a record, e.g. a video or audiotape, is made of the interview and is deposited in a public archive, either a library or museum, along with other artifacts associated with the person. Historians, folklorists, musicologists, or psychologists may conduct this research.

Such research raises a number of questions for an IRB:

The first question is whether such activity is research and therefore falls under the purview of the IRB. The glib answer to this question is that oral histories are not research unless the researcher thinks about it. What is meant by this is the following. Sometimes, a scholar will obtain the oral history of an individual or two and will deposit the history in a library and/or museum so that others can view it. However, the scholar does nothing more; he or she does not publish a paper comparing this history to others or provide a historical context in which to analyze this history. In this case, the project is not research and therefore does not have to be approved by the IRB. The ethical guidelines of the scholar’s professional organizations should still be followed in this case, however. The more common situation is the following. Several oral histories are obtained with the intention of comparing them. In addition to depositing the materials in a depository, the scholar provides the cultural context of the histories or writes a critical analysis of the histories. In this case, the scholar is a researcher who is using human subjects and therefore the project must be approved by the IRB before it can be initiated. Professional guidelines still apply.

A second question that arises from such project concerns the issue of confidentiality. The usual stance of IRBs is that a project remains ”open” and therefore requires continuing review by the IRB and active protection of the dataset by the researcher until all personal identifiers have been removed. However, in oral histories, frequently the subject/participant is proud of his or her history and wants to be identified with the history. Usually the deposited materials include explicit personal identifiers (i.e. the person’s name, age, picture, professional title, etc.). The procedures of Miami’s IRB allow the researcher in such a case to petition the IRB to ‘close’ the project with personal identifiers attached to the data file. This petition takes the form of a letter to the IRB that makes the request; this letter usually accompanies a continuing review application. A necessary condition for the IRB to grant the petition is that the consent form explicitly mentions that the subject’s/participant’s name, etc. will be included in the dataset, including deposited materials. The location, or nature, of the expected depository should also be mentioned in the consent form. A good idea, although not an absolute requirement, is that the subject/participant be asked to consent twice. The first consent is granted at the beginning of the project and is the consent to be interviewed and recorded by the researcher. The second consent is granted by the subject/participant after he/she has been given the opportunity to examine his or her materials, allowed to add or delete material and is consent to deposit the material with his/her identifiers attached. If the subject/participant is granted (or not granted) the right to alter the researcher’s analysis, this should be mentioned in the consent form.

Research Conducted at Other Institutions
Miami researchers usually conduct their research using Miami personnel (i.e. students, faculty or staff), but occasionally the research is conducted at another institution. The general policy is that approval must be obtained from all appropriate ethics boards. Researchers should be aware that different institutions have different procedures for granting approval and they are responsible for satisfying the requirements of each. The following describes the most common cases. In the following examples, the principal investigator (PI) refers to the person who is responsible for the project:

PI at Miami and the Research Conducted at Another University
It is very unusual for a university or college not to have an IRB. Given that the institution has an IRB, approval must be sought from all institutions. Frequently one IRB will not grant approval until the other sites have granted approval. In the current case, Miami’s IRB will grant approval that is contingent upon receiving approval from the other sites. Once this approval is received, the researcher may correctly say that Miami’s IRB has granted approval when submitting an application to the other IRBs. However, the research may not be initiated until copies of the other IRB approval letters have been submitted to the Miami IRB. In this case, it makes the most sense to submit an application to Miami’s IRB first.

PI at Another University; Research Conducted at Miami.
PIs who desire to conduct research at Miami University must identify a member of the Miami faculty who will serve as an advisor to the project and willing to sign the project application. Usually two proposals are necessary–one filed at the PI’s home university and one at Miami. Before Miami’s IRB will approve the project, the PI’s home university must approve the project. In this case, it makes sense for the PI to submit his or her home IRB proposal first.

Note that Miami’s IRB only considers the protection of human subjects; it does not grant approval for the PI to conduct the research at Miami. Therefore, permission from the appropriate university official must be sought (e.g. Dean of the school, Dean of Students, Director of Clinical Training, etc.) in addition to the IRB approval. It is a good idea to mention this approval in the IRB application.

Research performed at a hospital, or other clinical setting
Most hospitals have IRBs so that the procedure is similar to that described in the section entitled “PI at Miami; Research Conducted at Another University.” Conducting research with clinical subjects is more complicated because there are two sets of regulations that must be satisfied. There are the IRB regulations and the HIPAA regulations governing the privacy of patient records. The PI is required to be aware of both sets of regulations and satisfy both. Also, since research in this area is considered a “specialized population” according to our training standards, the PI must also complete the one-line supplemental training module on “HIPAA and Human Subjects Research” prior to submitting an IRB application for approval.

Research Conducted in Elementary and Secondary Schools
Most schools do not have IRBs. Projects conducted within a school system would have to be approved by the school IRB if the school has an IRB committee as well as Miami’s IRB. However, school principals and/or superintends frequently act like an IRB and as such need to approve projects. There is no policy that requires that a school official provide a written approval statement; however, the more a research project interferes with normal school activities the more likely that the IRB will require written approval. For example, a project in which two different types of classroom activities are compared and both types of activities have been used in other educational settings, then documenting approval is not required. However, in a project in which students are removed from a study hall in order to be interviewed by the researcher, the IRB would require a note from a school official that states that he or she is aware of the project and approves it.

The role of the IRB is to protect human subjects, in this case, students in a school system. However, the IRB is aware that researchers sometimes need to be protected. When conducting research in a school system, researchers should be sure to have the appropriate school officials on their side. Imagine the case in which a researcher is studying drug use in public schools. If a parent contacts the principal to complain about the questions being asked of his or her child, the researcher needs to have evidence that the principal is aware of the study and has approved it. If a principal has given verbal approval, it is possible that he or she will disavow the study if complaints are received. Such disapproval would be more difficult if the approval was documented. Also, since research in this area is considered a “specialized population” according to our training standards, the PI must also complete the on-line supplemental training modules on “Research with Children-SBR and/or Research in Public Elementary and Secondary Schools-SBR” prior to submitting an IRB application for approval.

Surveys Conducted by a Miami Office
People who evaluate the educational mission of the university perform some projects that use human subjects. For example, a University office may survey a number of Miami faculty and students to evaluate attitudes and opinions about their program and/or services. The results of the survey are used to improve the quality of the services provided by the office. The results of the survey will only be seen by the people conducting the project and will be used to change the operations of the office rather than being generalized to apply to other universities. Hence, this project is not research as defined by the federal regulations and therefore this project does not need IRB approval before being conducted. This type of project is referred to as a Quality Assessment Project (QAP).

If you are contemplating conducting such a project, you should be aware of a potential problem. Sometimes, a researcher intends to perform a quality assessment project, but discovers that the information that results from the survey is so interesting, they want to publish the results because they believe individuals at other universities can benefit from the study. Unfortunately, this desire changes the project from being a QAP to an Educational Research Project, requiring IRB approval. The IRB is loath to grant approval to already completed projects. If you believe there is any chance that you might want to publish or generalize the results from a QAP, you should treat the project as a regular research project and submit a proposal to the IRB. People who are contemplating conducting such a research project are encouraged to contact the chair of the IRB to discuss whether your project requires IRB approval.

Are IP Addresses Secure?
99%. However, if you are using an internet based survey, the IRB suggest adding to the consent form the following:
"Although every effort will be done to ensure confidentiality of your responses, all Internet-based communication is subject to the remote likelihood of tampering from an outside source. IP addresses will not be investigated and data will be removed from the server.”
OR
“The responses you provide today are being collected with online survey software that is designed to secure your data and provide you with confidentiality. Nevertheless, despite these safeguards, there is always a remote possibility of hacking or other security breaches that could compromise the confidentiality of the information you provide. Thus, you should remember that you are free to decline to answer any question that makes you uncomfortable for any reason.”