It is incumbent on the individual submitting the protocol to provide a persuasive case for the protocol's approval. The time and resources the committee has at its disposal are limited. Delays will inevitably result when IRB members have questions that are not addressed in the protocol. It is in the author's best interest to provide the IRB with a protocol that is as complete and detailed as possible, especially with reference to the experimental methodology and procedures to be followed, yet confined to a reasonable number of pages
The IRB is in the business of evaluating risk to participants and counseling authors to avoid or minimize risk. Under circumstances where risk is involved, the IRB must make a judgment of risk versus benefit. When there is risk, it is in the best interest of the author(s) to comment on the degree of risk versus the potential benefit(s) to be derived from the proposed activity.
The online proposal is required for submission to the committee.
Part 1. Expedited Review Request:
The Baylor University Committee for Protection of Human Subjects in Research (Institutional Review Board or (IRB) has agreed to perform expedited reviews of certain research proposals that involve only survey research that poses minimal risk to research subjects. Proposals handled through the expedited review process are held to the same standard as those that go through the normal review process. If you feel the proposal meets the criteria listed on the form for expedited review, check the box.
Part 2. Introduction and Rationale:
The proposal to the committee should begin with a description of the research background and rationale (or pedagogical aims) for the project. A compelling case should be made for the use of human subjects. Relevant research (include references in a bibliography), including the author's, should be cited. The question(s) being addressed should be clearly outlined. Any special expertise of the author in this area of research or teaching should be mentioned.
Part 3. Methodology:
The methodology to carry out the project/teaching exercise should be described completely and compulsively. Discussion with regards to how many subjects will be used, how they will be recruited, possible risks to subjects (both physical and psychological), method(s) to limit risks, and proposed safeguards to protect subjects' right to privacy should be especially comprehensive. Additionally, research proposals should include a section outlining the method(s) to be used to analyze the data and what avenue will be pursued to disseminate the results of the research project.
Part 4. Informed Consent Form and Checklist:
An Informed Consent Form (ICF) that fully informs potential subjects of the nature of the activity should be constructed. Refer to the Checklist for the Informed Consent, which enumerates issues that should be addressed in the ICF. The form should include a signature blank for the subject. Subjects should be given a copy of the ICF to keep for their records. Investigators who are conducting a mail or telephone survey are not necessarily required to use an ICF. However, a cover letter or an introductory telephone statement explaining the rights of the human subject is usually required and a copy should be submitted.
All protocols using students in classes at Baylor University as subjects must obtain a signed informed consent from the participants. In addition, protocols using minors as subjects must acquire parental consent since the parent bears the responsibility of consenting to their child's participation in a study. IRB approval does not include university approval for protocols involving faculty, staff, and/or students outside of class.
The use of electronic mail as a surveying technology brings out important questions about data security and the confidentiality of participant information. A disclaimer for use of the Internet should be included in the ICF for such purposes (an example is available with the checklist).
The informed consent form should be submitted exactly as it will be used (e.g., correct formatting, on letterhead, etc.) as it will be stamped with an IRB approval date after final approval has been given and returned to the investigator to use in the data collection.
The Checklist outlines all the required information for the ICF. It should be submitted to the committee with those items marked that are applicable to the project and are included in the ICF. An Example Consent Form with explanations is available with the checklist for convenience.
Part 5. Research Instrument(s) to be used (such as surveys, interview questions, etc.):
If the research study involves the use of an interview protocol or a survey questionnaire instrument, submit a copy as part of the application.
If applicable, attach other information pertinent to the proposal, such as consent letters already received from participating agencies, etc.
Informed Consent Form Example
Current IRB Chair contact information for use in the Informed Consent Form:
Dr. David W. Schlueter, Ph.D., Chair Baylor IRB, Baylor University, One Bear Place #97368 Waco, TX 76798-7368. Dr. Schlueter may also be reached at (254) 710-6920 or (254) 710-3708.
Parental Consent Example