Academics
 
Optional or Required?

Is an ERRB application optional or required for the work I am planning?

Federal Law requires an application and ERRB approval for any work that is, in a specific and technical sense, "research" on "human subjects".

Note: Even if your work is exempt the law governing "research" on "human subjects", you are still welcome to submit an application to the ERRB to help you consider ethical concerns that may arise in your work. It is in the nature of work in Human Ecology that it involves many ethical concerns that go well beyond the sort that are dealt with in the Federal Law on research on human subjects.

This law grew initially out of concerns about research in medicine and psychology in which people being experimented on might suffer risks to their health and wellbeing or might have their privacy violated in some inappropriate way. Those are the concerns the law focuses on.

However, there are a wide variety of other ethical concerns that can arise in research in human ecology and a wide variety of challenges in dealing with them in an inter-disciplinary way that takes into account the points of view of all the relevant stakeholders. You may find yourself working at the crossroads between sociological research, legal advocacy, investigative journalism and performance art -- and find tensions or direct conflicts between the accepted ethical guidelines in those fields for dealing with questions of confidentiality. Or you may find that besides questions of risk and confidentiality that concern individuals there are questions of justice, peace or environmental stewardship that concern local groups or international communities and that balancing these concerns in your work is a challenging task. Or you may be working on research that involves manipulating individuals or communities of organisms other than humans and wonder about the ethics of causing them harm or transforming their character even though there are no "human subjects" invovled. The ERRB aims to not only insure that research at COA complies with federal law on "research on human subjects" but, more broadly, to help people at COA to address the full range of ethical concern that can arise in doing research in human ecology. For that reason, applications are welcome even when they are not required.


Look at the simple checklist here to see if your work requires an application:


Checklist to see if an ERRB review is optional or required

NOTE: Federal Law defines "research" that is "on human subjects" somewhat narrowly and applies only to work that is clearly both. At COA, in order to take a more Human Ecological approach to research ethics, we invite anyone who is concerned about any ethical issues in any project they are working on to consider submitting an application and we ask everyone who has any doubt about whether their work might count either as research or as work with human subjects to submit an application. So if you answer "Yes" to any of the following quesitons on the checklist, please submit an application.

Part A: Does my study constitute Research?
According to the Code of Federal Regulations, Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)].

Answer YES or NO to the following two questions:
A.) 1. Will the results of your study be made public through a publication, a senior project (which will be publically available on file in the library), public performance, public website, presentation at a public conference or other means?

If your answer is NO to this question, your study is probably not considered "research" in the technical sense because it is not designed to "develop or contribute to generalizable knowledge" that would be available to the public.

A.) 2. Does your study involve a systematic investigation that includes research development, testing or evaluation of the kind that employs methods of study drawing on principles of natural science or psychology, sociology or one of the disciplines aiming to be a social science or study producing similar, generalizable knowledge?

If your answer is NO, then your study is probably not considered "research" in the technical sense. For example, it may be an expressive activity like a dance performance, a personal reflective essay in philosophy or an advocacy activity like the filing of a legal brief, none of which is considered "research" in the technical sense at issue here.

If your answer to both of these questions in Part A is YES, then your study would almost certainly count as "research" in the technical sense. If, after looking at Part By you determine that it is "on human subjects", then you are required by law to fill out an application.


Part B: Is my study considered research On Human Subjects?

Answer YES or NO to the following questions:
. Will people themselves be the subjects of study?*
. Will the study involve interacting with living people?
. Will you gather information that would ordinarily be private (e.g. personal beliefs)?
. Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g. their homes)?
*(Interviewing your physics professor to learn about black holes does not count, since then the subject of your research is black holes; interviewing the same professor to learn about his/her values, experiences or behavior, however, IS research on human subjects.)

If your answer was NO to ALL the questions in Part B, your study probably does not count as work on "human subjects". If you answered YES to any of the questions on Part B, then your study probably does count as work "on human subjects".


Checklist Results:

If your answers to all the questions in Parts A and B are NO, then your study is not "research on human subjects", formal application is not required and you are free to begin your study. (Note, however, that if there are any other sorts of ethical issues your work raises which you would like help in dealing with, we invite you to submit an application even though it is not required.)

If your answer was YES for BOTH questions in Part A AND YES for ANY of the questions in B, then it most probably does count as "research on human subjects" and you are required by law to submit an application form. If you are not required by law to submit an application, you are still welcome to.

Note: There are two versions of the COA application form.

The first is the Conventional Application Form. It is similar to that used by institutional research boards at schools aiming simply to insure compliance with Federal Law regulating "research" that is done "on human subjects" in the technical senses of those terms. If you answered Yes to both questions on Part A and at least one of the questions on Part B on the Optional or Required Checklist then you must either fill out this form or include the information it asks for in an application that uses the second General Application Form.

The second version is a General Appplication Form intended for anyone interested in looking at ethical issues of any kind which might arise in their work and who wants some help considering them -- even if they are not required by law to seek approval for their project because it does not involve, in the technical sense, "research" that is done "on human subjects."

If you're still not certain...

If you are still not sure whether or not your study is considered Research or On Human Subjects, one useful source is the Carleton College Guidelines page where you can see detailed explanations of what does and what doesn't constitute Research on Human Subjects under the federal regulations.

You may also direct further questions to:

errb@coa.edu or Gray Cox, chair of the ERRB


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