The Office of Sponsored Programs and Research is the first point of contact regarding human subjects research at (or involving) Towson University faculty, staff or students.
The use of human subjects in Towson University faculty, staff or student research requires approval by the appropriate university review committee, the Institutional Review Board (IRB). The IRB is appointed by the Provost, and is comprised of volunteers from TU’s faculty and staff, and at least one member of the community. The IRB is responsible for reviewing research involving human subjects to ensure compliance with all governmental regulations with the use of human subjects. Approval of the IRB must be obtained prior to the involvement of human subjects in research, and for any modifications to the project after IRB approval which would impact the human participants.
Applicable federal regulations are detailed in Title 45 of the Code of Federal Regulations, Part 46.
Have questions that may be related to your academic major or discipline? Contact your IRB college representative.
One of the keys to successfully navigating the IRB review process is to understand what reviewers are looking for in an application. Read further for essential information that will help to reduce the number of revisions that may be required and speed up the review process.
The primary responsibility of the IRB is to ensure that the risks of research are either outweighed or justified by the anticipated benefits. When approaching your IRB application, be sure to clearly state the potential benefits of the research. Moreover, anticipate, and list, any risks to participants and clearly describe how they will be mitigated.
The IRB requests one to two paragraphs, with citations, that support the importance of the research and its anticipated benefits. At the end of the rationale, clearly describe the aims of the research. The IRB examines your study design to see if it is sufficient to meet those aims. One of the mottos that reviewers keep in mind during the review process is that “a study that is not sufficiently well-designed to meet its aims has only risks and no benefits”. This is because a study that cannot meet its aims will waste participants’ time which, while arguably minor, is in fact a research risk. Because the risk/benefit ratio would not be favorable, the study would not be approvable.
Provide a detailed description of your study methodology from the first to the last contact with participants. Remember that informed consent begins when the participant is first introduced to the study, whether this is through an email, flier, social media post, or other means, and ends after the last study procedure has concluded. As such, you need to describe your recruitment methods; how, and by whom, informed consent will be obtained; where the study will take place; what the participant will be expected to do as part of their participation; and how/where the data will be stored. At each step, be clear about any risks (such as the potential for loss of confidentiality) and how those risks will be managed or mitigated. If you are requesting a waiver or alteration to the process of informed consent, a justification must be provided.
The IRB requires final copies of all recruitment materials, stimuli, and measures. Moreover, the IRB requests that you submit the Consent Forms, Surveys, and/or Interview Questions, in the format in which they will be presented to participants. If data collection is occurring online, submit both a pdf copy of the survey and a link. For studies involving qualitative interviews or focus groups, submit the script you will use to introduce the interview followed by the questions you plan to ask (it is not necessary to include all follow-up prompts, however). Finally, if the interview is to be recorded you must make that clear to participants as soon as recording starts. Inform participants that you plan to document their acknowledgement to agree to be recorded, and that they have read the consent form, understand what is expected, and have had their questions answered. Finally, if the study involves more than minimal risk, the specific risks to participants should be reiterated on tape before the interview begins.
Make sure your Informed Consent Document/Information Sheet includes all required information. This part of the application gets the most attention and often requires the most revisions. To ensure that you are including all required information, please refer to the Consent Form Template that can be found under Resources and Guidance on the IRB website. Be sure that the information in the consent document is consistent with the information presented in the application.
If you are asked to revise your application, it is helpful to provide a written response that summarizes what changes have been made. You MUST respond to every comment, regardless of whether you agree or not. If you disagree with, or can’t make, a requested revision, justify why you are not making the change. If your justification is sound, and the procedure does not result in an unfavorable risk/benefit ratio for participants, the reviewer may accept the justification. However, please note that the IRB reviewer may not find the justification compelling or may require other revisions to ensure that all potential risks are mitigated to the extent possible.
Please make your revisions apparent to the reviewer. The Kuali system will make the revisions in the on-line forms visible to the reviewer, but it is important for you to make the changes in the attachments apparent. This can be done by highlighting the changes, using track changes, or using a different colored font. Submitting attachments without doing this will elongate the review process.
Please note that this is not an exhaustive list but does cover the main concerns that prolong the review process. If you have questions, please feel to reach out to me or any other member of the IRB.