Guidelines for IRB Application
Please read this information carefully and refer to it as you are preparing your application. It will identify your responsibilities in the application process and provide information about the different categories of review, how the review is conducted, and the typical timeline of review.
If you are a student, there is additional information you need to provide as part of your application, and this is clearly identified below.
Step 1: Training Required for Research Involving Human Subjects
All investigators (faculty, staff, and students) conducting research that involves human subjects must complete the necessary training prior to submitting their IRB proposals. Ideally this should occur prior to preparing your application as it will provide useful information that can inform the design of your research study. CITI Program's Human Subjects Research (HSR) series covers the historical development of human subject protections, as well as current information on regulatory and ethical issues. It consists of a series of modules.
All IRB applications require proof of completion of CITI training by all investigators, e.g. faculty researchers, student researchers, and faculty mentoring both undergraduate and graduate student research projects (including all dissertation committee members).
Visit the CITI Program website and click on "Register" on the right of the homepage. If you encounter any difficulties in the registration process, refer to the "Getting Started Guide" section and follow step-by-step instructions on how to register for CITI training. Choose St. John Fisher College as your organization affiliation.
When you register, you will be asked to identify your learner group which determines the training modules you will have to complete. This is based on the nature of your research activity. The options are: 1) Biomedical Research Investigators, 2) Social & Behavioral Research Investigators, 3) Research with Data or Laboratory Specimens Only (i.e., no direct contact with human subjects), 4) IRB Members, or 5) Students in UG Research Classes. You must earn a cumulative score of 80% after completing all of the modules for your particular learner group. Please note, the online training can take up to several hours to complete. You are able to save your work, exit, and return to the training at a different time.
If you need more information about the different learner groups, please see the descriptions provided below:
Biomedical Research Investigator
Biomedical researchers study human physiology and the treatment or understanding of disease. Studies that are designed to evaluate the safety, effectiveness, or usefulness of an intervention including research on therapies, diagnostic procedures, and preventive measures are classified under biomedical research. Such studies can additionally include research on normal human functioning and development of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Further, studies may also compare the functioning of a particular physiological system at different stages of development. Also, studies can be directed at defining normal childhood development so that deviations from normal can be identified.
Social/ Behavioral/ Educational Research Investigator
Social/behavioral science is the study of human society and of individual relationships in, and to, society. This type of research is typically associated with the fields of education, psychology, sociology, anthropology, economics, political science, history, business, and more. Examples of studies would include (but are not limited to) research conducted in educational settings, psychological testing, research involving the use of educational tests, survey procedures, and/or interview procedures.
Research with Data or Laboratory Specimens Only
This learner group is specific to research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. The research has no direct contact with human subjects.
Students in Undergraduate Research Courses
The IRB strongly encourages instructors to require students who are conducting research involving human subjects as part of a course project to take this abbreviated 4-module training course. In such courses, class activities are designed so that students learn about the research process of a particular disciplinary field. See the "Course Projects Guidelines" document for more information about this category of research.
In addition to CITI training, you should also familiarize yourself with: 1) any published guidelines for the ethical treatment of subjects associated with your particular field of inquiry (e.g., as published by the American Psychological Association, American Sociological Association, etc.); 2) the policies and procedures of St. John Fisher College regarding human subjects; and, 3) any official policies in your department and/or school concerning research with human subjects.
Step 2: Preparing and Submitting Your Application for IRB Review
All Fisher investigators requesting IRB review of their project/research activity must submit a complete application form with all necessary supporting documents. The application form is available as a fillable Word template that you can complete and save as a Word document. Specific prompts are provided for you to record the essential information needed for the IRB review. Any student conducting research must collaborate with their research supervisor to complete the entire application.
The St. John Fisher College IRB conducts different levels of review depending on the type of research being proposed. Revised federal guidelines have established new exempt categories of research studies based on their risk profile. See descriptions of each level of review below.
Your application is considered complete when you include all required supporting documents. Common examples of required supporting documents include:
- Consent form(s) (review the Consent Form Guidelines [pdf] first and then create any required consent forms using the appropriate templates available on the Documents and Forms page)
- Copies of data collection tools (surveys, questionnaires, etc.)
- Letter of introduction to the participants (you need to include your status as a Fisher student/faculty and that the St. John Fisher College IRB has reviewed the project/research)
- Letter of institutional support (if another agency, institution, etc. is involved in your study)
- Proof of successful completion of CITI training by all investigators
- Research Supervisor Form (required of all students)
- Current CV (required of all doctoral students only)
When your application is complete with all necessary supporting documents, please submit it via email to email@example.com. The body of the email must include your full name (students should also include the name of their research supervisor), the title of your application, and a numbered list of all attachments (the application and all supporting documents). The title of each attachment must include your last name and a clear description of the document, e.g., Smith Consent Form.
Additional Information About Categories of IRB Review
Recent changes to the federal guidelines have increased the categories of research that now fit under exempt review. A full description of these categories can be found in the Electronic Code of Federal Regulations (Part 46 Protection of Human Subjects, Subpart A, 46.104): The categories include:
- Research in established or commonly accepted educational settings
- Educational tests, surveys, interviews, observations of public behavior
- Benign behavioral interventions in conjunction with the collection of information from adult subjects
- Secondary research for which consent is not required
- Research and demonstration projects that are conducted or supported by a federal department or agency
- Taste and food quality evaluation and consumer acceptance studies
- Storage or maintenance for secondary use for which broad consent is required
- Secondary research for which broad consent is required
Proposals will be reviewed by the IRB chair or vice chairs. The chair/vice chair may request revisions to the application and the applicant will need to resubmit a revised application. Once the chair/vice chair is satisfied with the proposal, it will be recorded as approved and the researcher will then receive formal, written notification. Please allow at least two weeks for approval. Time may vary depending on revisions.
Research categorized as exempt review that is being conducted as part of a class activity can follow the modified application process for Course Projects. See information about Course Project Review below.
If the proposed research study does not fit in any of the eight categories for exempt review, and involves minimal risk to human subjects, then it will require an expedited review. The proposal will be reviewed first by the IRB chair or an experienced IRB member. The initial reviewer may request missing information or clarification about elements of the proposal and this may necessitate that the applicant resubmits a revised application. Once the initial reviewer is satisfied, the proposal will then be forwarded to two members of the IRB Committee for review. The IRB members may request revisions to the application. If this is the case, the IRB chair will provide the applicant with a memo detailing all requested revisions. The applicant will need to resubmit a revised application. Once the reviewers have approved the proposal, the researcher will receive formal, written notification. Please allow at least one month for approval. Time will vary depending on the extent of revisions required.
If the proposed research study involves more than minimal risk to human subjects, then it should be submitted for review by the entire IRB. The proposal will be reviewed first by the IRB chair. The chair may request missing information or clarification about elements of the proposal and this may necessitate that the applicant resubmits a revised application. Once the chair is satisfied, the application will be accepted for full review. This will be scheduled to take place at the following month's IRB meeting. Application materials will be forwarded to all IRB members. The IRB members may request revisions to the application. If this is the case, the IRB chair will provide the applicant with a memo detailing all requested revisions. The applicant will need to resubmit a revised application. When the IRB has approved the proposal, the researcher will receive formal, written notification. Please allow at least one month for approval. Time will vary depending on the extent of revisions required.
Course Project Review
Many courses require students to engage in research activities. Examples include laboratory courses in psychology and capstone projects in education. Undergraduate students enrolled in these courses typically conduct their projects for the sole purpose of meeting course requirements. Research conducted solely for pedagogical purposes may not need IRB review. Use the Guidelines for Course Projects [pdf] document to determine if your intended course activity does not require IRB review. In such cases, the IRB strongly encourages that instructors require their undergraduate students to complete the abbreviated CITI training as a course assignment. It is important to note that students will not be able to make data or results of this project publicly available beyond St. John Fisher College.
Project Modification or Continuation Review
All research is initially approved for one year. Any change to an approved research protocol requires the submission of the Project Continuation or Modification Form [dotx]. A modification is defined as any change to a protocol from what was previously approved (e.g., changes in research procedures, the informed consent process, the consent/assent document, etc.). Substantive changes may require submission of an entirely new IRB application at the discretion of the IRB. A modification approval within the original timeline of the project does not change the approval termination date.
Any approved research that goes beyond one year also requires the submission of the Project Continuation or Modification Form [dotx]. Renewed research applications are approved for one year.