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 ORSP.

• Who needs IRB approval?
• What qualifies as research?
• What qualifies as "human subject" research?
  
• Do I need to obtain consent from human participants involved in my research project?
• When should I apply for IRB approval?
• Who are the members of the IRB?
• How do I apply for IRB approval?
• What is the approval process?
• What research projects qualify as Exempt?
• What research projects qualify for Expedited review?
• What research projects qualify for Full review?
• What if my approved research project needs to be extended beyond one year?
• How do I make changes to an approved research project?
• What do I do if I need to end my project earlier than anticipated or when it is officially completed?

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 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 designed to 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
In general, classroom activities are for instructional purposes and are not expected to contribute to generalizable knowledge. Even though they may be called "research projects" for pedagogical reasons, the results are usually not disseminated beyond the classroom. Although there are certainly exceptional cases, classroom activities are usually not considered "regulatory research."

If there is any serious possibility of a student publishing or presenting, then IRB approval may be required before the project begins. If, for instance, completed student projects are to be subsequently evaluated by faculty for publication or presentation, then such projects must be approved by the IRB before they commence in order to be considered. The federal regulations prohibit approval after the fact.

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.

Undergraduate Poster Presentations
For undergraduate projects with poster presentations, the policy of the Frostburg State University IRB is to consider a presentation to a campus audience as an instructional exercise, not "regulatory" research. Campus presentations must have a local scope, that is, participation by family and friends is acceptable, but, for example, a presentation at a regional conference hosted by FSU would no longer qualify as an instructional exercise.

If there is any serious possibility of a student publishing or presenting, then IRB approval may be required before the project begins. If, for instance, completed student projects are to be subsequently evaluated by faculty for publication or presentation, then such projects must be approved by the IRB before they commence in order to be considered. The federal regulations prohibit approval after the fact.

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) 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?
• 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 ORSP 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. The IRB generally does not meet or review protocols during official school holidays or vacations, winter session (January), or during the summer. Therefore, if you need IRB approval you must plan in advance and submit your application to the Committee during the active part of the school year.

Who are the members of the IRB?

The IRB is a committee, appointed by President Gira, 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 Research and Sponsored Programs (ORSP) provides policy oversight and guidance to the IRB as well as administrative support. The Director of Research and 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 forms may be submitted electronically to the ORSP, 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 ORSP.

What is the approval process?

There are 3 types of review categories: (1) Exempt (2) Expedited and (3) Full.

Projects that qualify as Exempt are exempt from further review and approval beyond the IRB Chairperson. "Exempt" does not mean that the proposed research is exempt from being reviewed. Exempt reviews typically take from 1 - 2 weeks to complete.

Projects that qualify for Expedited review are sent to the Chairperson and two members of the IRB Committee and take on average 2 - 4 weeks to complete. Questions and/or concerns may arise during Expedited reviews. The Director of Research and Sponsored Programs communicates comments received from the IRB to the applicant and additional information or further clarification may be requested from the applicant prior to further review.

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. Questions and/or concerns may arise during Full reviews. The Director of Research and Sponsored Programs communicates comments received from the IRB to the applicant and additional information or further clarification may be requested from the applicant prior to further review.

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. 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 research projects qualify as Exempt?

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) if: (a) the human participants are elected or appointed public officials or candidates for public office; or (b) the research is conducted for the Department of Justice under Federal statute 42 U.S.C. 3789g, or for the National Center for Education Statistics under Federal statute 20 U.S.C. 12213-1, which provide certain legal protections and requirements for confidentiality.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimen, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, if (a) wholesome foods without additives are consumed or (b) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the US Department of Agriculture.

NOTE: Exemption category # 2 for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, except for research involving observations of public behavior when the investigator(s) does not participate in the activities being observed.

What research projects qualify for Expedited review?

Expedited review may occur when the research involves no more than "minimal risk" to participants. "Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Some examples include:

1. Collection of hair and nail clippings in a non-disfiguring manner.

2. Collection of saliva.

3. Moderate exercise by healthy volunteers.

4. The study of existing data, documents, records, pathological specimens or diagnostic specimens.

What research projects qualify for Full review?

Full review is required when the research involves more than "minimal risk". It is also required when the research involves children, pregnant women, fetuses in utero, or prisoners.

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 ORSP at least 30 days prior to the expiration of your approved protocol. Completed forms may be submitted electronically to the ORSP, 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 ORSP.

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 submitting memo. 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.

If you require modification approval, please forward a memorandum describing the changes requested to the ORSP. Describe the exact nature of the changes requested and a justification for the changes. Be sure to include any associated information normally requested on the application form. For example, if you are requesting an increase in number of human participants, please provide a justification for the increase requested. If you are adding personnel to a project, please describe their training and experience with the procedures they will perform. Significant changes in procedures or experimental objectives will result in the need for you to complete a new application form. Send the modification memo to the Director of Research and Sponsored Programs.

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 ORSP within 30 days. If you have questions about the form please contact the ORSP.