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Frequently Asked Questions

-Does my project need to be reviewed?

-Why aren't all scholarly activities that involve human participants covered by the IRB?

-What is meant by "minimal risk?"

-What exactly constitutes "deception?"

-What is meant by "exempt review?"  If research is exempt, why must it be reviewed?

-I'm doing a class project.  Does it have to be reviewed?

-Does my Senior Project have to be reviewed?

-Where do I get training in ethical treatment of human participants?

-Why do you talk about "human research participants?"  Is this the same as "human subjects?"

-Who do I talk to if I'm not sure my project needs to be reviewed?

-What do I do with my completed proposal?

-What do I do if my adviser has not yet approved my proposal?

-What do I do during the summer?

-Where can I learn more?

Does my project need to be reviewed?

The IRB only needs to review research that involves people as participants. Your project needs to be reviewed if it meets ALL the following criteria:

• Your research has as its goal the generation of generalizable or universal knowledge.

• There are many types of research. The IRB reviews research which is a "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge" (45 CFR 46.102d).

 

• Most scientific activities have the goal of providing insight into universal or generalizable principles or knowledge and are thus subject to IRB review.

 

• Although biographers, historians, and other scholars may do a great deal of research in the course of their work, the knowledge they are developing is particular to the individual or individuals they are studying. Thus biography, most journalism, artistic endeavors, and other similar activities are outside the purview of the IRB and do not require review. Many projects fall in gray areas. If you are not sure about your own project, please contact us.

 

• Most oral histories have recently been EXCLUDED from oversight by IRBs.  However, please consider the following information when preparing your oral history: 

  • Are the purposes clearly set forth?  How realistic are they? 
  • What factors demonstrate a significant need for the project? 
  • What is the research design?  How clear and realistic is it? 
  • Are the terms, conditions, and objectives of funding clearly made known to judge the potential effect of such funding on the scholarly integrity of the project?  Is the allocation of funds adequate to allow the project goals to be accomplished? 
  • How do institutional relationships affect the purpose and objectives?
  For more information about ethics and oral histories, please visit Dickinson College's page for the Principles and Standards of the Oral History Association. 

• Your research involves human participants.

• Human participants include those who are actively involved in the research process (being interviewed, filling out surveys, etc.).

 

• They also include those who may not be in front of us: those who provided medical samples, left records of their activities through applying for marriage licenses, etc.

• The IRB reviews research that involves living individuals (1) about whom "an investigator conducting research obtains data through intervention or interaction with the individual" or (2) which contains "identifiable private information"(Title 45 CFR, Part 46.102.f). Secondary analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB.

 

• A decision tree on what constitutes a 'human subject' is available in Chart 1 here. If you are doing research involving the secondary analysis of biological specimens or which contains private information, more detailed guidance is available here.

Most research conducted primarily for the purpose of evaluating learning or teaching students to do research is not required to be reviewed. For example:

• Research in mathematics would not need to be reviewed because it does not involve humans as research participants. Research on factors that differentiate more or less successful math students would, because it does.

• Interviewing prisoners for a magazine article on prison 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 situation. Doing very similar interviews for an anthropological study would require review. 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.

• Collecting blood samples for a cell biology lab would not need to be reviewed because its primary goal is educational, rather than scientific. 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 the goal is the production of univeral 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 (see chart 2).

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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.

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What is meant by "minimal risk"?

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." (This definition comes into play in determining which IRB review procedure applies to research proposals.)

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What exactly consitutes "deception?"

Deception consists of intentionally misleading participants about the nature, research question, or methodologies of a study.  Witholding 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. 

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 two of the many variables included in the survey. 

Please note:  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 or he may have about the study.  In a study including deception, debriefing 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.  In a study not including deception, the researcher should more fully explain the hypothesis or research question, and answer any questions the participant may have about the study.

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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 with 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, click on the Is My Project Exempt? link to the left.

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I'm doing a class project. Does it have to be reviewed?

Class-based or lab projects that are being carried out primarily for teaching purposes don't 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.

Class-based or lab projects 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.

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Does my senior project have to be reviewed?

If it meets the other criteria for IRB review, YES.

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Where do I get training in the ethical treatment of human research participants?

Click on the Training and Certification link to the left.

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.

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Who do I talk to if I'm not sure if my project needs to be reviewed?

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. If you still have questions, please contact any of the members of the IRB. Their names and e-mail addresses are listed on the Contact Us page to your left.

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What do I do with my completed proposal?

To submit a completed proposal that has already been approved by your faculty adviser, please click on the Submit Online link to your left. 

If you have questions about your proposal, please consult your faculty adviser.  You may also contact the IRB Chair, Barbara Luka. Her IRB office hours are Mondays 4:00 pm to 5:00 pm and 11:30 am to 12:30 pm on Thursdays (Preston 108).

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What do I do if 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 he or she recommends, your advisor must send and email to IRB@bardresearch.com.  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 and I will oversee this research in its entirety."  When the website receives this email, confirmation will be added to your proposal application, and the complete application will forwarded to members of the IRB committee. 

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What do I do during the summer?

Although we usually meet about ALL projects, exempt and expedited reviews can be done by a pair of committee members if it is necessary to do so. If you need your proposal reviewed during the summer, please call or e-mail Barbara Luka or another member of the committee and we will try our best to accommodate you. If you need a full review, we will try to see whether we can constitute a quorum and meet about your proposal.

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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.

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