Frequently Asked Questions
What kinds of projects require IRB approval?
Many different types of research projects involving human subjects that are carried out under the auspices of Vassar College must be approved by the IRB before the project begins. This may include survey/questionnaire research, structured and semi-structured interviews, and experiments. Some forms of observational research require IRB approval. One year after approval, ongoing research that underwent full review must be resubmitted for review. Also note that if your research is being conducted off campus, it must also be reviewed by the Vassar IRB, and may require review by another institution’s IRB as well depending on where it is being done.
There are categories of research with human subjects that may be exempt from review. For example, some projects based on oral histories of one or two interviewees may not constitute research as defined by the HHS regulations, which is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (for additional information see part (l) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102).
Such projects are not ordinarily subject to IRB review. In addition, observational studies of public behavior typically do not involve human subjects as defined by the regulations because there is no intervention or interaction and the behavior is not private. If, however, there is an assumption of privacy or the observation includes interactions or interventions with subjects or identification of subjects, IRB approval may be necessary. However, it is very important to determine whether your research project does require IRB review before proceeding to collect data. If you have any questions about the status of your project in this regard, please contact the IRB administrative assistant, Gail Garrison, at 845.437.7368.
Please note that even if your project does not constitute research, or is otherwise exempt from IRB review, it likely still requires the use of a release form signed by participants or their parents if it involves audio or video recording (see the Forms section of this website).
How long does the review take?
IRB review can take up to 30 days, depending on the type of project and demands on the panel.
Do I need to get informed consent?
Under most circumstances, informed consent is a necessary aspect of all human subjects research that requires IRB review, including surveys and interviews, but there are possible exemptions for obtaining written informed consent. The IRB may waive the requirement to obtain a signed consent form for some or all subjects if there are potential confidentiality problems due to informed consent and both of these conditions are met: (a) the only record linking the subject and the research would be the consent document and the principal risk would be harm resulting from breach of confidentiality, and (b) the research presents no more than minimal risk and involves no procedure for which written consent is normally required.
In cases where documentation of consent is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
How is informed consent obtained?
There are many elements to informed consent. “Informed consent” means knowing consent. The person giving consent must be able to choose, freely and knowingly, to participate.
Here are some of the elements required to obtain informed consent.
What is minimal risk?
According to the federal guidelines, “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
What is harm?
According to the federal guidelines, harm refers to an injury to the rights, welfare, or safety of the participant.
What is expedited review?
According to federal guidelines not all kinds of research require full review. Click here for a description of the kinds of research that fall under expedited review policies.
Note, the standard requirements for informed consent apply regardless of the type of review utilized by the IRB
How do I find the appropriate consent forms?
The various consent form documents are included with the application.
Do I need training?
Training in human subjects research is strongly recommended. A suitable training course is available here. Key personnel on NIH-funded human subjects research are required to obtain such training, even if the research is exempt from IRB review.