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Human Subjects Research >> References >>
 

Frequently Asked Questions


  Does the IRB review completed projects?
  Is my project an oral history and what do I do if it is?
  What do I do if I am conducting research at institutions other than Miami?
  How do I conduct research at a hospital, or other clinical setting?
  How do I conduct research in elementary and secondary Schools?
  I am conducting an on-campus survey about services at MU, do I need to submit a protocol?
  Are online survey tools secure?
  How do I go about compensating subjects for their time and travel expenses?
  Do paper copies of applications need to be submitted to the Compliance Office?

 

Does the IRB Review Completed Projects?

No. Both federal regulations and Miami University’s policy, are 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. 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.

Is my project an oral history and what do I do if it is?

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 these studies.

These studies raise a number of questions for an IRB:

The first question is whether the 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 about this type of 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.

What do I do if I am conducting research at institutions other than Miami?

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:

The PI is at Miami and the research is conducted at another university:

It is very unusual for a university or college not to have an IRB and policies related to human subjects research oversight. Complying with the policies of any institution is the responsibility of the researcher. Miami researchers who are the PI on a project and are representing Miami or who are a co-PI receiving federal funding to conduct research must seek Miami IRB approval. If Miami personnel are not the PI on a project and are not receiving external funds in support of the research, but are collaborating, the Miami Compliance Office may accept the review of the external collaborator's (PI's) IRB . The Miami IRB may or may not accept the external review. The externally approved protocol will be examined to determine if the review process meets Miami standards. The Miami compliance office will attempt to minimize the number of IRB's involved with the review of a project.

The PI is from another university and the research is conducted at Miami:

PIs who desire to conduct human subjects research at Miami University must have IRB approval from their home institution (or in the absence of such an IRB, a request can be made for the Miami IRB to conduct a review). To document adequate IRB oversight to Miami, external researchers must submit a copy of their protocol and a copy of the approval letter to the compliance office at sullivnh@miamioh.edu.

Note that Miami’s IRB and Compliance Office only considers the protection of human subjects; it does not grant authority for the PI to conduct the research at Miami. Therefore, the authority to conduct research must be obtained from the appropriate university official relative to the research to be conducted (e.g. Dean of the College, Dean of Students, Director of Clinical Training, Department Chair etc.) in addition to the compliance office clearance regarding HS protections. It is a good idea to reference this authorization when submitting your IRB approval materials to your home institution.
How do I conduct research 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 on-line supplemental training module on “HIPAA and Human Subjects Research” prior to submitting an IRB application for approval.

How do I conduct research 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 “vulnerable 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.

I am conducting an on-campus survey about services/pedagogy at MU, do I need to submit a protocol?

People who evaluate the educational mission of the university often conduct studies that includes interacting with 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 study 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 study, 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 that they want to publish the results since individuals at other universities might 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 study are encouraged to contact the chair of the IRB to discuss whether your project requires IRB approval.

Are online survey tools secure?

Usually. Many survey tools exist offering confidential treatment of data, Miami also has software to conduct online surveys using a secure server. See IT Help from the MyMiami page and search "Prezza". However, whenever you are using an internet based survey, the IRB suggests that you include something like either of the following statements on the consent form (and adhering to the statements):
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.

The responses you provide today are being collected with 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.

How do I go about compensating subjects for their time and travel?

There are limits to the amount of compensation that a subject may recieve. It cannot be an amount that would unduly entice a person to volunteer, if it is a study that requires repeated interactions with a subject, it should be clear to the subject that payments will be pro-rated so that withdrawing from a project does not forfeit compensation for prior time invested by the subject.

Miami has a procedure and a policy to help ensure confidentiality of subjects can be maintained during the compensation process. These procedures can be found at: Payments Policy (pdf).

Do paper copies of applications need to be submitted to the Compliance Office?

As of July 2009, signed paper copied of applications no longer need to be submitted to the compliance office.

Researchers have experienced difficulties when operating from a distance or when coordinating submissions with student researchers. Therefore, applications will be accepted by email attachment alone. However, undergraduate and graduate students still need a faculty advisors involvement.

To ensure that faculty advisors have the opportunity to review and approve of applications, all applications have to be submitted by the faculty advisor or an authorized staff member (e.g. the project manager for a research center). The application must be sent from the faculty/staff members Miami email account to the IRB before any review will be conducted (the use of your official email account is used in place of your signature as the means of establishing accountability).

The suggested method of submission by graduate and undergraduate students is:

A. The student researcher emails the application to their faculty advisors as two files (1. the cover pager template and 2. the research description including all supplementary materials, e.g. questionnaires and consent forms). The student researcher should do so using their MU email account (this serves in place of their signature).

B. The faculty/faculty advisor reviews the application and provides the student with feedback. Once both are satisfied with the application, the faculty member forwards it to the compliance office for processing (humansubjects@muohio.edu) .

C. The compliance office will manage the distribution to the IRB chair and IRB members.

D. The IRB members will submit their comments to the IRB chair who will organize the comments and send them to the researcher or the faculty advisor or both depending on the nature of the comments. In that message, the IRB chair will specify the requirements for submitting the responses to the reviewer comments (e.g. very simple suggestions/required changes may not require faculty advisor input and approval).

 

 

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