Guidelines for IRB Proposal

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.

Please note, 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.

Beginning 9/1/16, all new IRB applications will require CITI training of all investigators conducting research that involves human subjects. This includes faculty researchers, student researchers, and faculty mentoring both undergraduate and graduate student research projects.

Anyone that has an NIH Certificate of Completion for the Protecting Human Research Participants Training Module issued prior to 9/1/16 can continue to use this as proof of training through 8/31/17. After this time, all investigators must complete CITI training.

Visit the CITI Program website and click on the "Register" button located in the blue log in box to the right of the homepage. If you encounter any difficulties in the registration process, refer to the following step-by-step instructions on how to register for CITI training.

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 Investigator, 2) Social & Behavioral Research Investigator, 3) Research with Data or Laboratory Specimens Only (i.e., no direct contact with human subjects), or 4) IRB Member. 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 (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis, chorionic villi testing, and fetoscopy), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste) 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 (e.g., infancy, childhood, adolescence, adulthood, or old age). Also, studies can be directed at defining normal childhood development so that deviations from normal can be identified. Studies may even include record research used to develop and refine hypotheses. Research on specific disease processes (e.g., research on the biochemical changes associated with AIDS or schizophrenia, or the neurological changes associated with senile dementia of the Alzheimer type) and on the human genome and genetic markers is also considered under this category.

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

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.

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 Your Research Proposal for IRB Review

All Fisher investigators requesting IRB review of their project/research activity must prepare a detailed description of their project/research which provides the committee with information about: the purpose, method of data collection, and measures taken by the project author to protect human subjects. This must be included with the appropriate forms (see information below). Proposals typically run 2-5 pages plus appendices. Please include page numbers on the proposal document. The main body of the proposal should include:

  • Introduction
  • Purpose
  • Methodology
  • Sample
  • Dissemination
  • Disposition of Data

As appendices, please include:

  • Consent form(s) (Please use templates provided on the documents and forms page.)
  • Copies of data collection tools. (surveys, questionnaires, etc.)
  • Letter of introduction to the participants (Includes status as Fisher student/faculty and that IRB has reviewed the project/research.)
  • Cover Letter if Applicable. (e.g. if participants are minors or if there is no face to face interaction with the researcher)

Below we provide guiding questions to help you prepare each section of your proposal. We recommend that you address the following questions (if relevant to your research activity), so that you provide sufficient detail to facilitate the IRB review process.

Introduction

  • Have you provided a statement describing what the project/research is about?
  • Is there adequate background information provided to justify the research?

Purpose

  • Is the purpose of the research clearly specified?

Methodology

  • Is the scientific design/research procedures described in sufficient detail and adequately justified?
  • Is the study designed so that the risks to subjects are minimized?
  • Is the study designed so that the potential benefits of the research justify the potential risks?
  • Is the scientific design adequate to answer the research question?
  • Are the objectives likely to be achievable within the identified time period?
  • Are the individuals performing the research procedures appropriately educated?
  • Is the location of where the research will be performed acceptable?
  • Are there adequate plans to inform subjects about specific research results if necessary?
  • If appropriate, is there a clear differentiation between research procedures and standard care?
  • Are the plans for data and/or statistical analysis defined and justified?

Sample

  • Is the rationale for the proposed number of subjects reasonable?
  • Is the choice of subjects appropriate for the question being asked?
  • Are inclusion and exclusion criteria clearly specified and appropriate?
  • If women, minorities, or children are included or excluded, is this justified?
  • Are the methods for recruiting potential subjects well defined?
  • Are there acceptable methods for screening subjects before recruitment?
  • Are the location and timing of the recruitment process acceptable?
  • Is the individual performing the recruitment appropriate for the process?
  • Are all recruitment materials submitted and appropriate?
  • If compensation is being provided to research subjects, is the amount reasonable?
  • Are there adequate provisions to avoid out-of-pocket expenses by the research subjects?

Dissemination and Disposition of Data

  • Are there adequate provisions to protect the privacy and ensure the confidentiality of the research subjects?
  • Are there adequate plans to store and code the data?
  • Is the use of identifiers or links to identifiers necessary and how is this information protected?
  • What are the plans for disseminating the research findings (e.g., dissertation, conference presentation, etc.)?
  • What will happen to research material/data after conclusion of research?

Informed Consent/Assent

  • Are all the elements of informed consent contained in the consent document?
  • Is the process of obtaining consent adequately described?
  • Is assent required?
  • Is waiver or modification of consent possible?

Step 3: Completing Appropriate Form (Exempt, Expedited, Full, etc.)

First, determine the category of review and complete the appropriate form.

Exempt Review Application [pdf]
An exempt proposal is one that does not require full IRB committee review, as it poses no risk to human subjects. The chair of the IRB reviews exempt proposals. Please allow at least two weeks for approval.

Expedited Review Application [pdf]
Proposals for projects, which involve minimal risk to human subjects, should be submitted as an expedited review, which involves a review by a few members of the committee. Please allow at least one month for approval.

Full Review Application [pdf]
Proposals for projects which involve more than minimal risk to human subjects should be submitted for review by the entire committee for a full review. Normally, full reviews require a presentation to the full committee by the researcher to answer any questions the committee may have.

Faculty/Staff Sponsor Checklist and Signature Form [pdf] (**required of all students**)
Any student conducting research must collaborate with their Fisher mentor to complete this form.

Some additional forms available depending on the nature of the request:

Application for Course Projects Involving Human Subjects [pdf]
For course instructors only. This form should only be completed when class projects will fall within the "exempt" category of research.

Change in Protocol Form [pdf]
Any change to an approved research protocol requires the submission of this form. A modification is defined as any change to a protocol from what was previously approved including changes in research procedures, the informed consent process, and/or the consent/assent document.

Renewal Application [pdf]
All research is initially approved for one year. Any approved research that goes beyond one year must have an approved renewal application form (or Continuing Review Report of Human Subjects Research) on file. Renewed research applications are approved for one year.

Step 4: Compiling, Scanning, and Submitting Required Information

The order of your submitted materials must be:

  • Completed form(s) **Students also must include Faculty/Staff Sponsor Checklist and Signature Form [pdf].**
  • Research proposal (main body and all appendices)
  • Any required CVs **CVs are required of all dissertation students and any investigator submitting an application for full review.**

Scan into one document and submit electronically to IRB@sjfc.edu.

Additional Information About Categories of IRB Review

Exempt Review

The proposal 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.

Expedited Review

The proposal will be reviewed first by the IRB chair or vice chairs. The chair/vice 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/vice chair 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. When the IRB reviewers are satisfied with the proposal, it will then be sent back to the IRB chair for final review. If the chair is satisfied, the proposal will be recorded as approved and the researcher will then receive formal, written notification. Please allow at least a month for approval. Time may vary depending on revisions.

Full Review

The proposal will be reviewed first by the IRB chair or vice chairs. The chair/vice 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/vice 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 board 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 reviewers are satisfied with the proposal, it will then be sent back to the IRB chair for final review. If the chair is satisfied, the proposal will be recorded as approved and the researcher will then receive formal, written notification. Please allow at least a month for approval. Time may vary depending on revisions.

Course Project Review

Many courses require students to engage in research activities. Examples include laboratory courses in psychology and capstone projects in education. Students enrolled in these courses typically conduct their projects for the sole purpose of meeting course requirements. There are times when it is appropriate for course instructors to request IRB approval for the course projects which would cover all students enrolled in that course during a given semester. The following guidelines have been developed to assist you in determining whether it is appropriate for you to seek course project approval.

  • The primary purpose of the students' research is to meet course requirements.
  • Results of students' projects will be disseminated only within the class and/or department the course is being offered through and/or shared with the School where students may have collected their data.
  • The types of projects students will engage in fall within the exempt status category of research (typically anonymous and innocuous surveys and research conducted in established or commonly accepted educational settings, involving normal educational practices).
  • Projects do not require that participants divulge information that deals with sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, violence, etc.
  • There is minimal or no risk of harm to participants.
  • Participants' rights to privacy/confidentiality are protected.
  • Participation is entirely voluntary.
  • If project is to be conducted in cooperating institution (e.g., local school), the appropriate party (e.g., principal, classroom teacher) is informed of the project and its potential impact on participants.
  • You are willing to accept responsibility for ensuring that your students' projects fall within these guidelines.

It is important to note that by identifying research as "course project" students will not be able to make data or results of this project publicly available (outside of class, department, or site where research was conducted). If, after data has been collected, a student decides they would like to disseminate their results to a wider audience they can submit the Change in Protocol Form [pdf].

Change in Protocol Review

Any change to an approved research protocol requires the submission of a Change in Protocol Form [pdf]. 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.).