Ethical Research Review Board

What is the ERRB?

The Ethical Research Review Board (ERRB) is a committee at College of the Atlantic (COA) serves to promote ethical research in all kinds of work in Human Ecology at COA as well as to insure, specifically, that research on human subjects at COA conforms with federal law by upholding the following two standards:

Human subjects should not be placed at undue risk.

Subjects should give uncoerced, informed consent to their participation in the research.

The Board's mandate is provided by a policy passed by the COA All College Meeting in March of 2007. Its current members include: Nancy Andrews, Mary Cline, Gray Cox, Heath Cabot (chair), and Ken Hill.
To contact the committee send an email to Heath Cabot (chair) at hcabot@coa.edu.

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 well-being 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" involved. 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.

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.


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:

1. Will the results of your study be made public through a publication, a senior project (which will be publicly 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.

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 B, 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.”

Part C: Is my study still research but is it exempt from review?
(Note, this will not apply to most of you):
Some forms of research have been designated, again by federal law, to be “exempt” from institutional review. This includes much research and service learning done in educational environments, which at COA, is administered through the Education Studies Program.
Does your project fall into any of the following categories?
1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness or the comparison among instructional techniques, curricula, or classroom management methods.

2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
This exemption category for research involving survey or interview procedures or observation of public behavior does not apply to research with children, except for research involving observations of public behavior when the investigator(s) does not participate in the activities being observed.

3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) the research is conducted for the Department of Justice under Federal statute 42 U.S.C. 3789g, or for the National Center for Education Statistics under Federal statute 20 U.S.C. 12213-1, which provide certain legal protections and requirements for confidentiality.

4) Research involving the collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; ( c ) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

6) Taste and food quality evaluation and consumer acceptance studies, if (a) wholesome foods without additives are consumed or (b) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
(Research that Qualifies for Exemption from Federal Regulations for the Protection of Human Subjects - Code of Federal Regulations, Title 45 CFR 46.101)

Checklist Results:

1) Did you answer YES to BOTH questions in Part A AND YES to ANY of the questions in B? If so, then your project most probably does count as "research on human subjects" and you are required by law to submit an application form. Submit a full application for review using the “conventional application” (process outlined below).

2) Did you answer “no” to all of the questions? Please submit an explanation to the committee outlining, in one to two pages, your answers to these questions and clarifying why you do not think you are required to undergo a review. Please also include a description of your project as well (a project proposal will suffice). 

3) Did you answer yes to BOTH questions in A, and any questions in B? If so, it is probably research with human subjects. UNLESS you think your research falls into an exempt category in section C? If so, please submit an application to the committee asking for exemption. Outline why your research falls under one of the exempt categories, and include a project description as well.

4) Did you answer “no” to all questions but still have ethical concerns that fall outside the purview of law? If so, we invite you to submit an application for review to the committee using the “general application” (process outlined below).


**Note: all those working with potentially more “vulnerable” or marginalized populations (including children, pregnant women, and prisoners, as well as undocumented migrants or refugees), or in situations that the committee deems to be particularly ethically charged (such as in medical or legal offices) will likely be invited to meet with the committee, regardless of your exemption status, in order to discuss strategies for addressing and managing these issues.

Deadlines

All of the above categories of applications are due to the committee by Friday of 6th week the term before the project will be conducted. This is to ensure that the committee can examine applications in a timely manner, meet with applicants directly, and that applicants can integrate comments and make changes well before beginning research.
Follow up meetings among the whole committee, the student, and if possible, the project adviser will take place 8th week.

All efforts should be made to meet this deadline. In circumstances where this is not possible, owing to timing of projects, submit the application to the ERRB. Please leave 3 weeks of processing time for the committee to give comments and for investigators to revise the proposal. Some applications may be expedited or processed more quickly, but we cannot guarantee it. *Factor this in when making travel and curricular plans. By law, you may not begin research until you have heard from the committee.

The Application Form

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 Application 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."

Submission Process
Once you've prepared your documents and saved them on your computer, you should submit them electronically to the ERRB by sending them to Heath Cabot, hcabot@coa.edu,
Make sure to save a backup copy of all documents for your records.
When you submit your application, you need to also send an email to your research advisor requesting that he or she review the application. Be sure to communicate with your advisor to be sure he or she reviews it promptly and provides the ERRB with a recommendation to approve.

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 should be in contact with your project adviser throughout the process, who is the primary faculty member responsible for advising you about your project.

You may also direct further questions to:

Heath Cabot, chair of the ERRB, at hcabot@coa.edu, or other members of the Board including: Nancy Andrews, Mary Cline, and Ken Hill.

Federal Law requires that all Research on Human Subjects done at College of the Atlantic by faculty, students, and staff be approved in advance by the ERRB. This is done by submitting a formal application before research begins.

What Happens Next?

If you have submitted your application (for exemption or for review) by Friday of 6th week, you will meet with the committee in person to discuss the application and ethical questions surrounding the project. In some cases, those who applied for exemption will be asked to undergo a review. Applicants will be asked to address the issues that came up in the discussion and resubmit their application for final approval. For those who do not make the deadline, a review will take place within three weeks, with written comments from committee members.

Ethical Research Resource List

What are some useful resources for learning about ethics in general and ethical research in human ecology in particular?

Web based resources for understanding traditional ethical concerns and approaches from within individual disciplines and professional societies are listed below. It is important to note however, that Compared with traditional theoretical research in a specific discipline, the ethical challenges for doing research in Human Ecology, are compounded. Why? Because the work involves multiple disciplines, various forms of connection between theory and practice or real world problems, and multiple stakeholders. It typically calls not only for the judicious application of the ethical standards formulated by a single discipline but for the creative resolution of conflicts between different ethical standards and concerns related to different disciplines, problems, and communities.

Useful texts for practicing conflict resolution in general include the classic GETTING TO YES by Roger Fisher et. al. and the materials provided on line at http://www.beyondintractability.org. A short essay suggesting how to apply such principles to ethics in the context of work on ecological and socially responsible business is provided in "The New Entrepreneurial Ethics."