Q: What is an Institutional Review Board (IRB)?
A: IRBs are committees, mandated by the federal government, who review research projects that recruit or involve human participants. The primary responsibility of the IRB is to ensure that all ethical issues concerning the protection of the human subjects who volunteer to participate in research projects are fully addressed. A secondary responsibility is to protect students, faculty, and staff from taking unwarranted risks in generating new knowledge. The purpose of the IRB is to inform and protect human subjects through the information provided in the informed consent document. During its review of the informed consent and research process, the IRB has the right and responsibility to ensure that a research subject is fully informed of the procedures involved in a study as well as the risks and (when applicable) alternative treatments that are available if participation in a study is refused.
Q: What ethical principles guide the IRB in the protection of human subjects?
A: Three basic principles of ethics are particularly relevant to the protection of human subjects in research. They are:
- respect for persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;
- beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and
- justice: fairness in the distribution of research benefits and burdens.
Q: What is research?
A: Research is defined by Federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [Federal Policy 45 CFR 46.102(d)]. Human subjects are defined by the regulations as "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information". Further, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Q: What types of research does the IRB review?
A: The SJU IRB reviews research involving human subjects if one or more of the following apply:
- the research is sponsored by SJU, regardless of the location of the project
- the research is conducted by, or under the direction of, any staff, faculty, student, or other agent of SJU in connection with his or her institutional responsibilities
- the research is conducted by or under the direction of any employee or agent of SJU using any property or facility of SJU, and/or
- the research involves the use of SJU's non-public information to identify or contact human research subjects or prospective subjects.
Special consideration is required for research involving fetuses, pregnant women, human ova in vitro fertilization, prisoners, children, persons with decision-making impairments, or other potentially vulnerable groups. For additional details, refer to SJU’s Standard Operating Policy & Procedure 1 & 2.
Q: Who is required to obtain approval if humans are proposed as subjects of research?
A: All faculty, staff, and students (undergraduate or graduate) must obtain IRB approval before involving humans (or data collected about or from humans) as subjects of research. If you are not sure whether this policy applies to your proposed study, please contact the IRB office to get clarification prior to starting work which may not be sanctioned by the university. The IRB is in place to protect both human subjects and Investigators. Failure to obtain IRB approval for research activities may result in a range of legal and disciplinary consequences for the Investigator.
Q: What types of research must be submitted for possible review by the IRB?
A: All proposed research projects involving the direct or indirect contribution of human subjects to the research process (e.g., survey, interview, comparison of teaching techniques, etc.) or a human's participation as a research subject (e.g., a dexterity study, physical or mental task, biomedical procedure, audio/video recordings, etc.) must be submitted to the IRB for determination of the appropriate review procedure in accordance with federal regulations and SJU policies. These examples are not intended to be inclusive. For additional information or clarification of the review requirements, contact the Research Compliance Coordinator, Samantha Ambrico-Custer, at (610)-660-1298 or firstname.lastname@example.org, or consult SJU IRB Standard Operating Policy & Procedure 1.
Q: What are the components of IRB review?
A: When reviewing research the IRB gives proper consideration to the following:
- risks to the subjects
- anticipated benefits to the subjects and others
- importance of the knowledge that may be reasonably expected to result from the research
- consent process to be employed
Q: What is the difference between the three levels of IRB review (exempt, expedited, and full board)?
A: Research that is exempt is exempt from (or not subject to) applicable federal regulations, although a review by the IRB is still required. Exempt research involves no greater than minimal risk (i.e., no greater risk than that which a participant would face in daily life), and data must be recorded in such a manner as to not readily identify participants. The proposed research project must also fall under one of the exemption categories (link to be attached once finalized) set forth in 45 CFR 46. Exempt research is reviewed by the Research Compliance Coordinator. Once all materials are submitted to IRBNet and the package is complete, researchers can expect a determination within two business days.
Research that may be reviewed under expedited conditions also poses no more than minimal risks to participants. Such research must fall into one of the expedited review categories set forth in 45 CFR 46 and refer to Standard Operating Policy & Procedures 4. Expedited research is reviewed by two IRB Members and the IRB Chair. Once all materials are submitted to IRBNet, researchers can expect a determination within 14 business days.
Research that poses greater than minimal risk to participants or does not fit into one of the exempt/expedited categories may be reviewed by the full board during a convened meeting. Projects under full board review may take up to two months for a determination, as all materials must be submitted and the board must vote on whether or not to approve the project.
Q: Do all research activities involving human subjects require a full IRB review?
A: Not all research activities involving human subjects require a full board review. There are certain categories of research that may be granted an exemption from full Board review, or expedited review by two IRB members and the IRB Chair. Such determinations will decide turnaround times. See 45 CFR 46.101(b) for general guidelines for exemption, and see SJU IRB Standard Operating Policy & Procedure 1 & 2 for additional details.
Q: If I believe that my project meets the requirements for an "exemption" does that mean I don't have to do anything else?
A: SJU policy states that exempt determinations will be made by the Research Compliance Coordinator. Therefore, researchers should not make self-determination but rather submit all materials for review via IRBNet. If a research project is determined to be exempt, it is still required to be reviewed by the IRB. An initial application and any amendments/modifications must be reviewed and determined by the Research Compliance Coordinator.
Q: How can I secure IRB approval/exemption?
A: To secure an exempt determination or approval, researchers must submit all materials (see SJU IRB New Project Submission Checklist) to the IRB via SJU’s electronic submission system for human subjects research proposals: IRBNet. Once all materials, including an initial application, supporting documents (study instruments, recruitment materials, consent documents, etc.), CITI certificates, CVs (for faculty and graduate students, only), and electronic signatures have been received, the project will be reviewed and a determination letter will be provided via IRBNet.
Q: How do I know when I may begin my research?
A: Research activities involving human subjects may not commence until an exempt or approval letter has been received by the researcher via IRBNet.
Q: Who needs human subjects training and how can I meet the training requirements?
A: All persons involved in Human Subjects Research must receive human subjects training. This includes Student and Faculty Investigators, Faculty Advisors, and Research Assistants. Saint Joseph's University subscribes to the CITI Human Subjects training courses to meet the human subjects training requirements. All persons involved with a research project must complete this training before final approval can be given. For information regarding training requirements, see the CITI Training Requirements Guide.
Q: How long does approval of an exemption or expedited review take?
A: This depends on the information provided (or additional information needed) that clearly explains your proposed research. If the protocol is deemed to be "exempt", clear, complete, and all attachments are in order, it is possible to receive approval from the Compliance Coordinator to proceed with the study within 48 hours from the day the completed protocol is submitted. To ensure an expedient review, you may want to contact the Research Compliance Coordinator at email@example.com to arrange an appointment to review your protocol and attachments before formal submission for IRB review. It is recommended that you initiate the review process no less than a month before you intend to begin work on the project, as initial reviews may take up to two weeks.
Q: How long does it take to receive approval for a protocol which must be reviewed by the full IRB?
A: If the protocol is reviewed by the full IRB, the review cycle could take anywhere from four (4) to eight (8) weeks. The length of the review process depends on many factors, among them: how well the protocol is prepared; the extent of revisions/clarifications requested by the Board; reconciliation of subject numbers, recruitment practices, acceptable consent procedures, etc. On rare occasions, a proposed project may require significant revisions and consideration of a rewritten protocol (and/or attachments) by the Board before final approval is granted. More often, minor revisions may be requested by the IRB and approval may be granted by the Administrator upon receipt of an acceptable response to the IRB's questions/concerns. In any case, for any type of research requiring an IRB authorization, it is advisable to begin the IRB review process as soon as possible.
Q: When and how often does the IRB meet?
A: The Board typically meets once per month.
Q: What is the submission deadline?
A: If a research project requires full board review, all materials must be submitted for review by the first business day of the month to be reviewed during that month’s meeting.
Q: How do I submit my research project for review by the IRB?
A: SJU’s IRB uses an electronic submission system called IRBNet. You may refer to the SJU IRB New Project Submission Guide and SJU IRB New Project Submission Checklist for details on how to submit your materials for review.
Q: The site where I intend to conduct my research has its own IRB. Does my protocol have to be reviewed by the site IRB and the Saint Joseph's University IRB? If so, how do I do this?
A: The answer to this question is not straightforward and will depend on several factors. Researchers in this position should contact the Research Compliance Coordinator to determine a path for such projects.
Q: What if I need to amend or modify my research project?
A: All amendments and modifications should be submitted for review to the IRB via IRBNet. See the Amendment/Modification Submission Guide and Amendment/Modification Checklist for details.
Q: How do I find the necessary forms and templates to support my submission?
A: All forms and templates are available on IRBNet. You must have an IRBNet account to access such documents.