What is the IRB (Institutional Review Board)?The Bay Path University Institutional Review Board (BPU IRB) is a group of people designated to review and
monitor research involving human subjects. The purpose of the IRB is to protect the rights and welfare of humans participating as subjects in the research, before and throughout the study. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. In addition, the IRB must review and approve or disapprove the investigator for the research
If I don't have funding for my research, do I need IRB review? Yes. All research studies that involve human subjects are subject to IRB review, whether or not they are funded.
Who reviews my application?The BPU IRB consists of at least five members from a variety of backgrounds, in compliance with U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) requirements. For example, the IRB includes: one member who has no other affiliation with the University; members who are scientists; and members who are non-scientists.
In accordance with the regulations, the non-scientists may include attorneys or clergy and the scientists may include physicians and PhD level scientists.
What criteria will the IRB use for reviewing my application?The IRB may approve research only after it has determined that the following requirements, as described by federal regulations, have been satisfied.(45 CFR 46.102(d)).
Define "human subject"? A "human subject" is a living individual about whom an investigator obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (45 CFR 46.102(f)).
I'm only interviewing a few people. Do I need to submit a protocol?
Yes. Research on human subjects must include a prior review by the IRB, including those studies involving only a few subjects.
Define "informed consent"?
"Informed consent" is an ongoing process. It starts before any consent forms are signed and continues until the subject's participation is complete. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed. For consent to be informed, the subjects must understand the study. The investigator is responsible for determining whether the subject is capable of giving consent, and discussing the purpose, risks, and benefits of participation. The informed consent process is different from the consent form. The consent form formalizes the agreement to participate and should be designed to document the process.
How can I manage consent forms if the survey is conducted on a web page?
A survey on a web page should include the elements of informed consent. A study subject’s reply is considered to be implied consent, as with a survey that is not on a web page. If confidentiality is necessary, the survey could be printed and mailed back to the investigator. Where subjects are to reply via e-mail, they should be told in the cover letter that the confidentiality of their response cannot be guaranteed.
What's the difference between an Assent Form and a Consent Form?
Study subjects who cannot give consent, but who are able to participate in the process to some degree can do so through the assent process. For older children, for example, the assent process can be similar to the consent process used with a competent adult. For a younger child, the process may be less detailed.
Do I always have to get consent of everyone participating in the study?
The regulations generally require that the investigator obtain informed consent from subjects or, where warranted, from a legally authorized representative of the subject. (see 45 CFR 46.116).
How do I obtain consent from children?
45 CFR 46.408(a) requires that "adequate provisions are made for soliciting the assent of children."
I'm doing research with a group of children, is it possible not to have parental consent?
Under 45 CFR 46.404-407, researchers are required to obtain parental consent in order to do research on children.
Anonymous data can never be linked to the subject (directly or indirectly) either because the name/identity of the subject is never obtained by the investigator, or because there is no code linking the data to the subject's name/identity. Confidential data is recorded so that the information is not immediately identified, but could potentially be linked with the subject who supplied it. Confidential data is usually "coded". That is, the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data, and the subject's identity is kept separate from the code and data. Coded data is not anonymous.
Define "minimal risk"?
"Minimal risk" means that the probability of harm or discomfort anticipated in the research are not greater than ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
My study doesn't involve any risk of any kind. Do I still need to submit an application? Yes. Research on human subjects must include a prior review by the IRB, including those studies that do not involve any risk.
Define "exempt" review?
If the IRB decides that your study involves little or no risk to the subject, the research is exempt from further IRB review. Exemption waives the need for further IRB review; however, you must still provide documentation showing that you have the consent of subjects where applicable.
Does exempt mean I don't have to apply to the IRB?
No. Every investigator proposing to work with human subjects must apply for IRB approval.
I've already started a research project and didn't realize that I needed to receive IRB approval first. What should I do?
If the research is not exempt, the research would have required IRB approval in advance and, therefore, the research is not in compliance with federal regulations. There is no retrospective IRB review.
If I am using data compiled by someone else such as a governmental agency or another researcher, do I need IRB approval?
The research may be exempt from IRB approval if the research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by an investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. If the data is not publicly available, you must submit documentation that the original researcher has provided permission.
My research will be done in another country. Do I have to obtain IRB review and approval? Research conducted by University investigators in foreign countries remains under University purview and guidelines. While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different research protocols may be required, particularly in informed consent, recruitment practices, and documentation. Research projects must have been approved by the local equivalent of an IRB before they are presented to the IRB. The IRB requires documentation of this "local approval" before it will give approval. Researchers should describe what if any, knowledge or experience they possess regarding the language and culture of the country in question. Researchers proposing international research should allow additional time for this review process.
Do I need IRB approval if my work will be conducted off campus?
Yes. For a University researcher to conduct a research project anywhere, the project needs to be reviewed by the IRB.
Does everyone listed on my protocol have to have training?
Yes. Everyone that will have contact with participants involved in the study is required to complete Human Subjects Training. Human Subjects Training is available on the http://phrp.nihtraining.com/users/login.php
Does the training requirement apply to students conducting interviews?
Yes, anyone contacting human subjects in any way is required to complete training.
How long will it take for the IRB to review my application?
Depending on the nature of the study, IRB review may take one day or as long as one month. The IRB may request additional information from the investigator which could lengthen the process.
Can I begin my research as soon as I file my application with the IRB?
No - research can only begin once you have written approval from the IRB.
Can I reward my research subjects with items such as discount coupons, movie tickets, or free food items? This is not recommended because it implies to the subjects a certainty of favorable outcome of the study. (see also ww.fda.gov/oc/ohrt/irbs/faqs.html)
***These frequently asked questions were modeled after the Columbia University IRB FAQ’s, with their permission, and our thanks.***