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Humans as Participants in Research

E-mailed submissions are encouraged; however, the IRB requires either an original or facsimile (FAX or scanned PDF) of the application signature page in order to issue an approval. If you have any questions, email the IRB at IRB@frostburg.edu.

Elements of the Informed Consent Document

Federal and USM policies for the protection of human subjects require that FSU and its employees protect the rights and welfare of human participants in research. To comply with these regulations, all faculty, staff and students who plan to use human participants in research must have prior approval from the FSU Institutional Review Board (IRB).

Questions and answers regarding how to obtain approval are detailed below. If you have any questions regarding use of human participants in research at FSU that are not answered below, please contact the OSP.

Who needs IRB approval?

All research (see below) involving human participants conducted by FSU faculty, staff, or students requires the approval of the IRB. All projects must be fully approved before any use of human participants occurs.

 

What is the jurisdiction of the FSU IRB?

A proposed activity will be considered under the jurisdiction of the IRB if any of the following are true:

  1. The research is sponsored by this institution.
  2. The research is conducted by or under the direction of any employee or agent of this institution
    1. in connection with his or her institutional responsibilities or
    2. using any property or facilities of this institution.
  3. The research involves the use of this institution’s non-public information to identify or contact human research subjects or potential subjects.

What qualifies as research?

Please note that if the project does not need to be approved by the IRB, then the instructor is responsible and liable for the appropriateness of the activities.

A project need not be reviewed by the IRB if it does not meet the regulatory definition of research which is, in brief, "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." The policy of the Frostburg State University IRB is to consider a project as qualifying as "regulatory research" if the project director ever intends to publish or present any findings. There may be exceptions to this general rule, but the IRB should review the project and make that determination.

There are gray areas, but in general if you can answer "no" to the following questions, then your project does not need to be reviewed by the IRB:

  • Is this project more than an instructional exercise?
  • Will the results ever be published or presented?

Classroom Activities
Research that is conducted exclusively as part of a course assignment or classroom activity (i.e., where the results will only ever be presented to the instructor and/or students within the course), or a presentation to a campus audience consisting of only FSU students, faculty and staff, is considered an instructional exercise and not "regulatory" research. Although there are certainly exceptional cases, typically IRB review is not necessary for such activities.

However, in order for a student to be able to publish their data or present them publicly, including at the Undergraduate or Graduate Research Symposia, IRB review should take place before the data collection begins. The federal regulations prohibit approval after the fact. And so, if there is a possibility that the activity or assignment may lead to a public presentation of the data, then an IRB application should be submitted before the project begins.

Surveys
In general, marketing and opinion surveys, even if they are not anonymous, are focused on specific issues or organizations and, therefore, do not produce "generalizable" knowledge. In general, they are not considered "regulatory research." An obvious exception would be if the results were to be analyzed, generalized, and published as research.

On Campus Student Presentations
Undergraduate and graduate student research that will be presented at an on campus event attended by members of the public, including friends and family, is required to have undergone IRB review. This includes presentations of research at the Undergraduate Research Symposium and Graduate Research Symposium, as well as presentations at regional conferences hosted by FSU.

 

What qualifies as "human subject" research?

Even it if qualifies as "regulatory research," a project need not be reviewed by the IRB if it does not involve human subjects. The regulatory definition of a human subject is "a living individual about whom an investigator obtains (a) data through intervention or interaction or (b) obtains, uses, studies, analyzes or generates identifiable private information." "Identifiable private information" includes any information that is not public that could be used to deduce the identity of an individual. Depending on the sample size and the type of information collected, it may be relatively easy to identify individuals even without such data as name, address, or telephone number.

If a project qualifies as "regulatory research" (see above), then, if the answer to at least two of the following questions is "yes," the project must be reviewed by the IRB:

  • Will you collect data about living individuals?
  • Will you interact directly with the participants in any way? (On-line information gathering is considered interaction. Simply observation is not.)
  • Will you use private information that could identify individuals?

A research project involving human subjects may still qualify as exempt from review under specific regulatory categories, but the IRB should make that determination.

 

Do I need to obtain consent from human participants involved in my research project?

Yes. The informed consent of any potential human participant must be obtained before involving that person in research. Unless the IRB waives the requirements to obtain informed consent, you must provide the participants with informed consent documents written in simple, lay language. Please see Elements of the Informed Consent Document for more detailed information.

 

When should I apply for IRB approval?

A request for IRB approval should be submitted to the OSP at least 30 days before use of human participants occurs. More time is preferable in the event there are questions or concerns raised by the IRB that need to be addressed by the applicant. IRB review is more limited during official school holidays or vacations, winter session (January), or during the summer. Therefore, if you need an IRB review we recommend you submit your application to the Committee during the active part of the school year.

 

Are there any training requirements?

Anyone who is listed as a PI or Co-PI on the IRB application, those who will interact with participants (including online), or have access to identifiable data, must submit a certificate of completion from the Collaborative Institutional Training Initiative (CITI) before an approval will be issued. The IRB may accept human subjects training certificates from other organizations. (Investigators who have submitted an approved protocol before 5 October 2007 are exempt from this requirement.)

 

Who are the members of the IRB?

The IRB is a committee, appointed by the President, to oversee the use of human participants in research conducted by FSU faculty, staff and students in accord with University System of Maryland Policy and Federal Policy for the Protection of Human Subjects. This Committee consists of faculty from various colleges and departments at FSU, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. They are appointed to the Committee because of their expertise in one or more areas. Federal regulations require that the Committee be comprised of at least five individuals total with at least one nonscientist and at least one nonaffiliated member. The Office of Sponsored Programs (OSP) provides policy oversight and guidance to the IRB as well as administrative support. The Director of Sponsored Programs is not a Committee member and does not review research protocols.

 

How do I apply for IRB approval?

An "Application for Initial Review of Research Using Human Participants" form must be submitted to obtain approval for research involving human participants. One protocol form must be submitted for each individual (different) project.

Completed applications should be submitted electronically to irb@frostburg.edu, and the signed signature page can be scanned and emailed or delivered as a hard copy. No parts of the form should be deleted. If there are one or more questions on the form not applicable to your work please indicate so with "N/A" in the space provided. (Please feel free to add more lines under any of the questions if you need additional space.) If you have questions about the form please contact the IRB at irb@frostburg.edu.

 

What is the approval process?

There are 3 types of review categories: (1) Exempt (2) Expedited and (3) Full. The IRB determines which type of review is appropriate.

Projects that qualify as Exempt are exempt from extensive review. "Exempt" does not mean that the proposed research is exempt from being reviewed, just that the review procedure is typically less arduous. Exempt reviews typically take 2 - 3 weeks to complete.

Projects that qualify for Expedited review are sent to at least two members of the IRB Committee and take on average about 4 weeks to complete. After the IRB’s review either a Notice of Approval or a request for revisions will be sent to the investigator.

Projects that qualify for Full review are sent to all the Committee members of the IRB and require a convened meeting of the majority of the Committee. Full reviews generally take from 4 - 6 weeks to complete, depending on when the application is submitted. Applications requiring Full review will be reviewed at the next Committee meeting after they are received, but must be submitted at least 3 weeks ahead of time. After the IRB’s review either a Notice of Approval or a request for revisions will be sent to the investigator.

During the Fall semester, the IRB is scheduled to meet on:

  • 15 September
  • 20 October
  • 17 November
  • 15 December

The IRB will notify investigators in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity. If revisions are required, the timetable for the review of the modified application will follow the guidelines described above for Exempt, Expedited and Full reviews (i.e., the time until the review will be completed ‘starts over’ at the point when revisions are received). IRB approvals are good for one year unless otherwise stated on the approval form. If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.



What if my approved research project needs to be extended beyond one year?

You must complete an "Application for Renewal of Research Using Human Participants" and submit this form to the OSP at least 30 days prior to the expiration of your approved protocol. Completed forms may be submitted electronically to the OSP, however a signed paper copy must also be submitted. No parts of the form should be deleted. If there are one or more questions on the form not applicable to your work please indicate so with "N/A" in the space provided. (Please feel free to add more lines under any of the questions if you need additional space.) If you have questions about the form please contact the OSP.



How do I make changes to an approved research project?

Once a project is approved it can be modified with the IRB's approval. This is achieved by completing the IRB Renewal Application (located at the top of the page) and submitting it to IRB@frostburg.edu. Minor modifications may be made without IRB approval, but must be reported at the next review. Modifications that affect participant selection, risks & benefits, or confidentiality are considered substantial and require IRB review.



What do I do when my project is officially completed?

When a project is completed you should submit a "Notice of Project Termination Form" to the OSP within 30 days. If you have questions about the form please contact the OSP.