Does my project need to be reviewed?
The IRB only needs to review research that falls into the category of “regulated research,” as defined by The United States Department of Health & Human Services. Your project needs to be reviewed if it meets ALL the following criteria:
- Your research is defined by a systematic investigation
- Your research has as its goal the generation of generalizable or universal knowledge.
- Your research involves human participants.
For example, research in mathematics would not need to be reviewed because it does not involve humans as research participants. However, research on factors that contribute to more or less successful math students would, because it involves human participants.
Alternatively, interviewing prisoners for a magazine article on prison life or students for a magazine article on college life would not need to be reviewed because its goal is not the production of generalizable or universal knowledge—the information generated is specific to the people interviewed in their current and specific situation. However, interviewing the same people for an anthropological study would require review because it would be a systematic investigation (in line with disciplinary norms) and would have as its aim to contribute to generalizable or universal knowledge. Although in this case the substance of the interviews might be quite similar, the scientific goals of the anthropological study bring it into the sphere of the IRB.
Similarly, collecting blood samples for a cell biology lab course would not need to be reviewed because its primary goal is educational (though there might be other non-IRB-related procedures and guidelines you must follows). Collecting blood samples for a study of the distribution of sickle cell anemia among migrant workers would require IRB review because it is research whose goal is the production of universal or generalizable knowledge.
Using a US census dataset does not require review because it does not contain information that can be linked back to individuals. Research using a publicly-available dataset that contains names, addresses, or other identifying information that could be readily tied back to individuals does require review (if the determination of review might result in the research being exempt). Visit the Human Subject Regulations Decision Charts webpage for further information
I'm doing a class project. Does it have to be reviewed?
Class-based or lab projects that are being carried out primarily for educational purposes (i.e., teaching students) do not need to be reviewed by the IRB. It is, however, expected that they will uphold the same standards for the ethical treatment of research participants as other research projects. We recommend that student researchers go through the on-line training in ethics required of other researchers. In some situations, it may also be educational for students to complete the application process for IRB review, even if they do not submit the proposal for review.
However, class-based or lab projects taking place in an education setting but whose primary goal is the generation of generalizable or universal knowledge should be reviewed by the IRB. For example, a pilot project that will be the basis of a publication, a grant proposal, or a senior project should be reviewed even if it is being carried out in a class setting.
Does my Senior Project have to be reviewed?
If your Senior Project or any other project at Bard falls into the category of “regulated research” as defined elsewhere on this website then it requires IRB review and approval.
What is meant by "minimal risk" and why does it matter to the IRB?
The level of risk to human participants in “regulated research” helps the IRB determine whether the application for IRB approval merits a full-board review, an expedited review, or is exempt. As specified by federal regulations, “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 exactly constitutes "deception" and why does it matter to the IRB?
You will note a question on the Online IRB Proposal Form asking whether your research involves deception or not. Deception consists of intentionally misleading research participants about the nature, goal, or methodologies of a study they are participating in. Withholding details about the specifics of your hypothesis until after the participant has completed the task does NOT constitute deception.
- An example of a study using deception: A researcher misleads participants into believing that they will be speaking in front of a crowd in order to raise and measure the participants' stress level, when in fact they never actually speak in front of a crowd.
- An example of a study NOT using deception: A researcher informs participants that they will be answering survey questions about a variety of subjects. The researcher lists those subjects. The researcher then uses the resulting survey data to draw specific conclusions about the relationship between only two of the ten variables included in the survey.
Whether or not the researcher uses deception, all studies must include a full debriefing statement, wherein the researcher explains the research question fully and allows the participant to ask any questions she, he, or they may have about the study. In a study including deception, debriefings should explain the deception, explain why the deception was necessary, and allow the participant the option of removing his or her data from the study now that they know they were deceived in that way. In a study not including deception, the researcher should more fully explain the research question (i.e., what is being studied), and answer any questions the participant may have about the study.
What is meant by "exempt review"? If research is exempt, why is it reviewed?
The Bard College IRB is governed by the federal regulation 45 CFR 46. This regulation stipulates some categories of research toward generalizable knowledge that involves human participants that are exempt from regulation (46.101b). When research is exempt under 45 CFR 46, the IRB can use less stringent application and review requirements than it must apply to federally regulated research. Nonetheless, the IRB does review all research involving human participants (applying the definition above, "Does my project need to be reviewed?"). The IRB must determine whether research submitted for exempt review actually is exempt from federal regulation. If you are not sure which category of review your research falls into, go to the Project Guidelines page.
Why do you talk about "human research participants"? Is this the same as "human subjects"?
The phrases "human subjects" and "human research participants" can be used interchangeably. The disadvantage of using the term "human subjects" is that it objectifies the people who have volunteered to take part in the research.
Why aren't all scholarly activities that involve human participants covered by the IRB?
In the interview and blood sample examples above, what is actually being done in projects that need to be reviewed or don't need to be reviewed seems very similar.
The purpose of IRBs is quite specific to protecting the rights of people who have volunteered to participate in scientific studies. The ethics and practices that have evolved in fields such as journalism or artistic endeavors are somewhat different and simply outside the scope of this committee.
Where do I get training in the ethical treatment of human research participants?
Visit the Training and Certification section of the Bard IRB website.
Who do I talk to if I'm not sure if my project needs to be reviewed?
As a student, it is important to work closely with your faculty advisor to develop your study fully and accurately before submitting your first proposal. Your faculty advisor will most likely be able to field questions you may have about the IRB review process and such strategies for your discipline, program, or project that best address that process. If you still have questions, please contact the IRB at [email protected].
As a faculty or staff member, you can always discuss this matter with your program or division chair (in case of faculty) or supervisor (in case of staff). If you still have questions, or find yourself in a situation where that is not particularly helpful, please contact the IRB at [email protected].
What do I do with my completed proposal?
To submit a completed proposal, please visit the Submitting a Project page and click on SUBMIT your Proposal. Submitting a successful proposal involves submitting both the Online IRB Proposal Form and emailing all required supplemental materials.
If you are a student, you must have the approval of your faculty adviser before submitting the proposal and they must notify the IRB directly of the fact that they have reviewed your proposal, approved it for submission, and will supervise your project.
If you still have questions, please contact the IRB at [email protected].
What do I do if I am a student and my adviser has not yet approved my proposal?
Your faculty adviser must approve your project proposal (the final copy that is identical to the one you will submit) before the IRB can review your proposal.
When your adviser has read your final copy carefully and you have made all the changes they recommend, your advisor must send an email to [email protected]. The email must have your last name as the only item in the header. The email should contain the following statement, "I have reviewed [your name]'s proposal, approved it for submission, and I will oversee this research in its entirety." The confirmation will be added to your proposal application, and the complete application will forwarded to members of the IRB committee.
Please note that your IRB proposal will not be reviewed with receipt of this email from your adviser. So please plan ahead in sharing drafts with them and communicating your intended submission deadline.
What do I do during the summer?
The Bard IRB does not conduct full reviews during the summer months. During the academic year, the Bard IRB usually convenes and discusses ALL projects. However, during the summer months the Bard IRB can review proposals meeting the criteria for exempt and expedited reviews if it is necessary to do so. However such review is subject to the schedule of the IRB members that will be assigned this task. If you need your proposal reviewed during the summer, please e-mail [email protected] indicating your plan to do so and explain why you were not able to submit during the regular semester and what it is important to conduct the research before the next regular full IRB review meeting. If you need a full review, we will try to see whether we can constitute a quorum and meet about your proposal. But we cannot promise that. This is why it is critical you review the IRB submission deadlines and plan accordingly. If you still have questions, please contact the IRB at [email protected].
Where can I learn more?
There is an excellent book on ethics written by the Committee on National Statistics (CNSTAT) and the Board on Behavioral, Cognitive, and Sensory Sciences and Education (BCSSE) called Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003). It is available in its entirety ONLINE or you can order a copy of the book. It has good practical suggestions on how to enhance your research and protect your subjects and is a great thing to read while you are in the process of designing your research.
We also recommend reaching to your program/division chair of institutional supervisor for suggestions specific to your discipline, field, topic, research site, or community of research participants.