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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 an ERRB 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 ERRB, 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 ERRB is a federal requirement for faculty, students, and staff who plan do do Research on Human Subjects. It consists of an ERRB application 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.

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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.

Some other kinds of principles that take various forms:
    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).

You may also direct further questions to:

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

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