- Is my project considered research?
- What if I'm only doing a pilot study to determine whether to engage in a full project?
- When does the IRB meet?
- How long does a full IRB review take?
- What training do researchers need?
- Why do I need approval from the IRB for my research involving human subjects? I am an experienced researcher and I have never had to do this before.
- May I recruit participants for my study before IRB approval? May I advertise to recruit participants for my study?
- Is there a time limit on IRB approval?
- I am working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to submit the protocol with the Seattle University IRB?
- What is informed consent and when is it needed?
- What are "assent" and "parental permission"?
- I think I'm on the right track, but I'd like more guidance with my protocol. What should I do?
According to the Federal definition, two criteria must be met for an activity to be defined as research. First, the project must be a systematic investigation involving data collection with discipline-related research methodologies. Second, the ultimate aim of the project is to contribute generalizable knowledge (whether quantitative or qualitative) to the field. "Contribute" may mean publication but can also mean dissemination in another venue, such as a conference, poster session, etc.
Even pilot studies must have IRB approval if they involve human subject participants. Here, you should ask: "Would I be doing this pilot study unless I thought it might lead to a future research project?" If the answer is "no," then IRB approval must be obtained because the pilot is in anticipation of a larger research study.
The IRB meets on a monthly basis during the academic year. A meeting may be cancelled at the discretion of the IRB chair if no full protocols are to be reviewed. Deadlines are posted on the IRB web site.
Researchers should submit protocols to the IRB 2-3 weeks before the scheduled meeting date. (Protocols missing the deadline will not be discussed until the subsequent scheduled meeting.) After a full-board review, the IRB Administrator will contact researchers within 3-5 business days with feedback from the board. If minor revisions are required, most protocols will receive approval within the next 1-2 weeks. If major revisions are necessary, the protocol may need to be discussed at the following full board meeting. (But we try to work closely with researchers to avoid such delays.)
Before submitting a protocol, all researchers must have current (within the past three years) CITI certification, available at: www.citiprogram.org. Faculty and staff researchers should complete the entire human subjects training modules. Student researchers should complete the "student researcher" modules. Faculty advisers must complete the "faculty adviser" module in order to sign off on a student protocol. Printed copies or PDFs of certification for all PIs must be included with protocol submissions -- the IRB cannot issue a determination without appropriate proof of human subjects training. [Note: in some cases, NIH or other human subjects training may be appropriate for individuals assisting in data collection. PIs must clearly explain any request for alternate training in the protocol submission.]
6. Why do I need approval from the IRB for my research involving human subjects? I am an experienced researcher and I have never had to do this before.
Since the mid-1970s, the Federal government has mandated the ethical protection for human subjects in research, as articulated in the Belmont Report. Adherence to the principles of respect, beneficence, and justice must be documented in each study conducted under the auspices of any agency receiving federal funds. The federal Office of Human Subjects Protections (OHRP) provides oversight for Institutional Review Boards (IRBs) located in universities, hospitals, and other agencies where research is conducted. Although individual IRBs maintain much discretion in overseeing human subjects research, Federal rules and regulations stipulate that certain protections must be verified by an IRB before data can be collected. Non-compliance places institutions at risk for loss of federal funding and at risk for lawsuits by research subjects based upon ethical violations. As a result, Seattle University maintains policies and procedures designed to ensure compliance with the Federal regulations. The IRB policies and procedures apply to all research conducted by faculty, staff or students at Seattle University, regardless of experience and even if no federal funding is sought for the study.
7. May I recruit participants for my study before IRB approval? May I advertise to recruit participants for my study?
Researchers should not approach prospective participants prior to IRB approval. However, some preliminary tasks can be initiated. For example, although advertisements and consent forms must be approved by the IRB, the researcher may begin identifying prospective participants and making plans to obtain informed consent. Under no circumstances may data be collected without IRB approval, nor can the IRB provide retroactive approval.
Federally funded studies typically receive one-year approval. Some minimal risk, non-funded studies may received "flexed approval" of two years. However, if the IRB determines that higher risks are involved, a monitoring process may be initiated in order to audit an on-going research protocol. At the end of the designated approval period, researchers must submit a Continuing Review/Downgrade to Exempt Application or a 11b.SU IRB Closeout Report FORM.11.12.
9. I am working on a project with faculty from another university. If my co-investigators receive IRB approval from their university, do I still need to submit the protocol with the Seattle University IRB?
Yes. Because the SU IRB would not know if another institution’s policy is compatible with ours, the SU IRB conducts its own review of research projects. If available, the researcher should submit the other institution’s IRB approval to the SU IRB. Please contact the IRB for questions regarding these cases.
The informed consent process consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to the subject's questions, and ensuring that the subject or the legal representative understands the information. In addition, the process includes obtaining the subject’s voluntary agreement to participate in the research, indicated by the subject’s signature on the written consent document (or alternative, as approved by the IRB). Even after a subject provides initial consent, the process of consent continues all the way through the research study because the PI must continue to update participants with information, and answer their questions.
Out of respect for developing persons, Federal regulations require that children/minors (those under 18 in the state of Washington) be included in the decision-making process whenever possible. Though they may not be able to give legal consent, they have the ability to give their assent to participate in research (or to dissent if they do not wish to participate). A child’s failure to object to participation should never automatically be construed as assent! However, age, maturity, and psychological state also need to be taken into account in matters of assent.
For minors/children not of legal age, parents or legal guardians are asked to give permission for a child to participate in research.
Contact the IRB to schedule a pre-submission consultation! Whether you're in the idea stage, have a partial draft, or are nearly ready to submit, we're here to help you. At any stage of the process, we can help answer your questions, make suggestions on your protocol, and offer feedback. (However, please note that the IRB staff cannot issue approval, nor can we guarantee that the IRB reviewers will not have other comments or revision requirements.)