Frequently Asked Questions
Below are several frequently asked questions about the Institutional Review Board.
The Institutional Review Board (IRB) is a committee that reviews all research that involves human subjects. Its primary purpose is to ensure that human research subjects are protected. This includes protecting the privacy of subjects, respecting the autonomy of subjects, preserving the dignity of subjects, minimizing risks while maximizing benefits to subjects, and providing adequate information for subjects to make informed decisions. The IRB also ensures that the benefits and risks of research are equally distributed and that vulnerable populations are given extensive protection. In addition to promoting quality research, protecting human subjects also protects the researcher, the advisor, and the Hospital. Through IRB review, the IRB assists researchers in developing the best possible methodologies to ensure the best possible research outcomes. Human Subjects Protection is a shared responsibility and the IRB is happy to assist in this process.
Prepare and submit your application. Prepare and submit the required IRB form or application. Be sure to follow all instructions and make sure you have all the materials you need including an informed consent form, recruiting materials, survey questions, etc. Await notification. The IRB will make every effort to review your application in a timely manner. It usually takes between two to three weeks to review and respond to a proposal, depending on the IRB meeting schedule. Until you have received written notice that your research has been approved, you should not begin to collect data or interact with human subjects.
The IRB considers many complex issues, but the majority of these issues fit the following categories. Risk/Benefits: A primary issue of any IRB is the ratio of risk to benefit. A study may be very simple and have minimal risks, but if it is poorly designed and the knowledge gained is of minimal use, IRB approval may be withheld. Conversely, a study may have great risks to subjects (e.g., a study of a very toxic new cancer drug brought before a hospital IRB) but if the potential benefits are high, IRB approval may be given. Consent: A major issue of any IRB is consent: whether or not the subjects have the knowledge to fully agree to participate in the study. There is an Informed Consent Checklist on this web-page that you can use as a guide. Using this checklist will allow you to cover the major issues of consent. The subjects need to know: how they were selected for participation, what will happen to them as participants, what are the risks and benefits of this research, where to get more information, how their privacy will be protected, and that their participation is entirely voluntary. This form needs to be written in grammatically correct style, in simple, jargon-free language, and in an easily readable font (especially important for elderly subjects). When putting this document together, consider how you would react upon first seeing this document if you were a research subject. Before you put it in your IRB application, have someone who knows nothing about your research read it for clarity. Note that IRB committee members spend much of their time making sure this form is done well. You should also. Recruitment: A third major issue of any IRB is how subjects are recruited for a research study. Some common problems with recruitment include compromising subjects' privacy and recruiting subjects who cannot easily decline. An example of compromising subjects' privacy is getting a list of subjects from a medical clinic and then calling to recruit them (the clinic should call them first to see if they agree to be contacted). An example of recruiting subjects who cannot easily decline is having nursing home staff recruit their own nursing home clients (better to request co-workers to ask their clients if they would be willing to be contacted about the research). Think of how you would want any of your vulnerabilities protected. Privacy: A fourth major IRB issue is privacy. Subject privacy impacts on recruiting subjects, keeping individual data private when doing the research, and destroying data that is tied to individual subjects when the study is over. Think how you would like your privacy protected if you were a research subject.
Special considerations apply to protecting the welfare of particularly vulnerable populations such as fetuses, children, prisoners, pregnant women, mentally disabled or cognitively impaired persons, terminally ill patients, the elderly, students and employees, survey research that involves AIDS information either with the general public or with vulnerable populations, or economically or educationally disadvantaged persons. Research involving a protected class is typically never exempt from review. Visit the Office of Human Research Protection (OHRP) Guidebook: Special Classes of Subjects for specific and detailed information if your research involves a protected class of human subjects.
Anyone engaged in human subjects research, whether student, faculty or staff, needs IRB approval. The question is not whether research involving human subjects needs IRB approval --it does -- but whether the activity is truly research. If a student and his/her faculty mentor determine that a project is research, then the project must be reviewed by the IRB. It is important to keep in mind that a student who shepherds a proposal through the IRB process gains a deeper understanding of not only the process itself, but also the rationale for human subject protection, and the strengths and weaknesses of their research designs. The IRB is happy to work with faculty and students to make the IRB approval process one that enriches student learning and enhances the research experiences.