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 :

1. Human subjects should not be placed at undue risk.
2. 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), Ken Hill, and Todd Little-Siebold.

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. So if you answer "Yes" to any of the following questions 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:

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:

1. Will people themselves be the subjects of study?*
2. Will the study involve interacting with living people?
3. Will you gather information that would ordinarily be private (e.g. personal beliefs)?
4. 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.

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."

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:

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

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.

Once you've prepared your documents and saved them on your computer, you should submit them electronically to the ERRB.

Make sure to save a backup copy of all documents for your records.

For Students, note: When you submit your online 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.

What Happens Next?

Applications will be processed as promptly as possible but in more complex cases , may require more detailed and in depth review by the entire Board. You will be notified by email of the conclusions of the Board including any concerns or suggestions it may have as well as formal approval or disapproval of the project.

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."

On Ethics in General

Online Guide to Ethics and Philosophy

Association for Practical and Professional Ethics

Carleton University (Canada) offers a list of useful ethics sites

Codes of Ethics Online

Very comprehensive international listing of codes around the world

How to write a code of ethics

Carleton College in Minnesota provides a very useful model for the review of the kinds of work specifically covered by the law on research on human subjects. It was drawn on heavily at a number of points for constructing this COA website.

Some websites with relevant guidelines and discussions of ethical issues in anthropology are here and here.

For consent forms see visit this site.

The University of Toronto's webiste offers some useful guidelines on participant observation.

An excellent set of cases on multiple topics at Santa Clara University can be found here.

Anthropology cases can be found here.

American Sociological Association Code of Ethics

These series of ethics case studies compiled by the American Anthropological Foundation highlight the complexity of ethical issues in research; in many cases, there are not "easy" or "obvious" answers, and these are often sources of great debate:
http://www.aaanet.org/committees/ethics/ch3.htm
http://www.aaanet.org/committees/ethics/ch4.htm

Glossary of some key terms for Ethical Research

Consent Form
A Consent Form is used by any researcher who intends to work with human subjects in order to seek legally effective "informed consent from each prospective subject or the subject's legally authorized representative." Under federal regulations, this is a mandate, not an optional matter, because informed consent is "one of the primary ethical requirements underpinning research with human subjects," reflecting the principle of respect for persons.

Missing or inadequate Consent Forms are the most common reason for delays in the processing of IRB application.

Cooperative (multi-site) Research
Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or Agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. [45 CFR 46.114]

Exculpatory language
When the language used asks to waive (or appear to waive) any legal rights, or asks to release the investigator, any funding organization, or College from liability for negligence. When used, the subject is "signing away" rights.

Formal Application
A Formal Application to the IRB is a federal requirement for faculty, students, and staff who plan do do Research on Human Subjects. It consists of an IRB application form, a Consent Form, and a list of questions if the subjects will be interviewed.

Legal Adult
In Maine, a legal adult is a person at least 18 years of age.

Minimal Risk
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." [45 CFR 46.102(i)]

Minimal risk means that the subjects' responses, if linked to identifying information, would not reasonably be expected to place the subjects "at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, or reputation, or be stigmatizing." [63 FR 60364-60367, November 9, 1998]

Research
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstrations and service programs may include research activities. [45 CFR 46.102(d)]

Research Supervisor
The Research Supervisor is a member of the faculty whose role is to sign ERRB applications in the case where students are the investigators. Please note: this faculty member is not necessarily the student's academic advisor. The supervisor needs to be the individual overseeing the student research project.

"Vulnerable Public"
Children, prisoners, pregnant women, mentally disabled person, or economically or educationally disadvantaged persons.

Some Principles from Major Ethical Theories

• The Greatest Happiness Principle (Jeremy Bentham and Utilitarians): Do whatever is most likely in the long run to cause the greatest net happiness to everyone affected by your action.

• The Categorical Imperative (Immanuel Kant): Act only according to a maxim or plan of action that you can, at the same time, will as a universal law; a. You could accept it as a policy if someone else adopted it dealing with you. b. It could be sustainable as a policy if everyone acted according to it. c. It treats people always with respect, as “ends in themselves,” and not merely as means to achieve your desires — as people with dignity rather than mere things with prices.

• Virtue or Character-based ethics (Aristotle): Let your actions be expressions of an admirable character of the kind that other people should try to develop — e. g. honest, courageous, wise, temperate, generous. And let each action find the mean or balance between doing too much and too little of any thing.

• Intuitionist: Do what you intuit as being Good (or Right or Loving).

• Theological : Do what is God's will as known by some form of revelation in holy books, prophets or direct experience.

• Relationship based ethics: Act to maintain the correct kind of loving or respectful relationships with people with whom you are in community or should be. {Feminist ethics sometimes emphasize the mother/child relationship as a key paradigm for this.}

• Traditionalist: Do what is the custom in your community.

• The television principle: Only do things you would be willing to live with if they were reported on that same evening on television. (Only do things you would be willing to do completely publicly).