Research Involving Human Subjects

Defining “Research”

Research is “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

In the social and behavioral sciences, much research fits within the traditional understanding of scientific methodology. However, the application of the term “systematic” depends largely upon discipline-specific methodology. A systematic inquiry in psychology might involve observing the interactions between dependent and independent variables. On the other hand, when ethnographers study communities, they may not have a priori hypotheses, but their observations and interviews are informed by constructs, such as the function of communities, and are thus systematic in terms of their discipline.

Defining “Human Subject”

A human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual or (2) Identifiable private information.”

Interactions include communication or interpersonal contact between the subject and the investigator. Communication does not have to be face to face, and may even exist entirely on paper or in electronic realms. Participant observation, such as occurs in some ethnography, is a variant of interaction, often including both formal and informal interviews in addition to observation

Defining Research with Human Subjects

To meet the definition of research with human subjects, one or both of the following must be true:

1. You are conducting a pilot study, a preliminary study, or other preliminary research.
2. You have designed a study to collect information in a systematic way with the intention of contributing to a field of knowledge.  (This does not mean that your study needs to be replicable, but rather that you intend to develop or contribute to a field of knowledge in a manner consistent with your discipline.)

And you must be:

1. Interacting with living human beings in order to gather data about them, using methods such as interviews, focus groups, questionnaires, and participant observation, or
2. Conducting interventions with living human beings such as experiments and manipulations of subjects or subjects' environments, or
3. Observing or recording private behavior (behavior that individuals have a reasonable expectation will not be observed and recorded), or
4. Obtaining private identifiable information that has been collected about or provided by individuals, such as a school record or identifiable information collected by another researcher or organization.

Why Ethics are Necessary

We are concerned with normative ethics, asking questions such as: What ought morality be? How should researchers behave? How should researchers not behave? What character traits should researchers cultivate as virtues? And, what character traits should researchers try to avoid?

The advantages of understanding research ethics include:

1. Research ethics provides us with a structure for analysis and decision-making.
2. Research ethics support and remind researchers to protect human subjects.
3. Research ethics provide workable definitions of benefits and risks, along with guidelines for evaluating and balancing the benefits and risks of our studies

 The Belmont Report

 The Belmont Report (published in 1979) identifies three basic ethical principles that underlie all human subject research. These principles are commonly called the Belmont Principles and include Respect for Persons, Beneficence, and Justice.

 The Belmont Principles

 A.  Respect for Persons

It requires us to treat individuals as autonomous human beings and not to use people as a means to an end. We must allow people to choose for themselves and provide extra protection to those with limited autonomy.

Elements of autonomy include:

1. Mental capacity, the ability to understand and process information.
2. Voluntariness, freedom from the control or influence of others.
   

Therefore, subjects have full autonomy when they have the capacity to understand and process information, and the freedom to volunteer for research without coercion or undue influence from others.

Rules derived from the principle of respect for persons include:

1. The requirement to obtain informed consent.
2. The requirement to respect the privacy of research subjects.

 B.  Beneficence

This principle reminds us to minimize harms and maximize benefits. Derived rules include:

1. The requirement to use the best possible research design to maximize benefits and minimize harms.
2. The requirements to make sure the researchers are able to perform the procedures and handle the risks.
3. The prohibition of research that is without a favorable risk-benefit ratio.

 C.  Justice

The principle of justice requires us to treat people fairly and to design research so that its burdens and benefits are shared equitably. Derived rules include:

1. The requirement to select subjects equitably.
2. The requirement to avoid exploitation of vulnerable populations or populations of convenience.

 Applying the Belmont Principles

The need for protecting human subjects through research ethics and regulations is as prevalent now as ever. Applying the Belmont principles to our studies is an important start:

1. From the principle of respect for persons we need to conduct initial and continuing informed consent. We need to evaluate whether the research allows subjects to withdraw from the research and maintains the welfare of each subject.
2. From the principle of beneficence we need to evaluate the social and scientific value of the research, the scientific validity of the research, and determine whether the research has a favorable risk benefit ratio.
3. From the principle of justice we need to evaluate whether there is fair subject selection. We also need to evaluate the inclusion and exclusion criteria and the methods of recruitment.