human subjects research Introductory remarks

On the next page, you'll be introduced to a smattering of resources relevant to the topic of Human Subjects Research. But first, here are some initial remarks to help you to get situated.

The Belmont Report (1979) is the cornerstone of Human Subjects Research (HSR) policy in the United States. That report identifies three principles necessary for conducting—in an ethical manner—human subjects research. The three principles are:

Respect for persons
- Where this means that the human individuals (aka the persons) upon whom research is being conducted, or being proposed to be conducted, must be treated as autonomous agents—meaning that their participation must be both voluntary and adequately informed; unless
- In cases where the human individuals (aka the persons) upon whom research is being conducted, or being proposed to be conducted, have diminished autonomy—then they may still be able to ethically participate in research, but in the course of doing so must be granted special and extensive protections.
Beneficence
- The first rule of beneficence in the context of HSR is not to cause harm to research participants in order to secure benefits for others (those who are not participating in the research); and
- The second rule of beneficence in the context of HSR is to maximize possible benefits and minimize possible harms both within the context of the study—for participants—and outside it—for non-participants, for knowledge, for future tech, for society at large, etc.
Justice
- Where this is understood to concern issues of equality, equity, and fairness, along with the philosophical concept of desert (pronounced like "dessert"); all with respect to
- The distribution of the efforts, burdens, and fruits of the (proposed) research.

Members of Institutional Review Boards (IRBs) across the country assess investigators' proposals to engage in HSR, and they approve or deny those proposals on the basis of how well the proposals show consideration of these ethical commitments (among other procedural and institutional factors).

For each of the three ethical principles, there is a paradigmatic and distinct "test" which is often applied in review—in other words, there is, in each case, a typical way of assessing that principle's sufficient consideration:

Consideration of respect for persons is typically assessed in terms of whether or not the practice of obtaining informed consent from participants for the (proposed) research has been followed; or, in special cases for which direct consent cannot be obtained, whether special protections have been put into place.
Consideration of beneficence is typically assessed along two dimensions:
- In terms of whether research participants are themselves receiving any benefits from the (proposed) research and, if not, whether they are being put at risk for the sake of others (who are not themselves participating); and
- In terms of the overall balance of risks and benefits expected to be conferred by the study (not just to participants but also more widely), and in a manner which should arrive at an acceptable ratio of benefits to be obtained relative to risks taken.
Consideration of justice is typically assessed in terms of whether or not the practice of equitably selecting research participants has been followed.

One way to understand at least a significant portion of the most difficult cases of HSR to assess and / or approve is in terms of conflict among these commitments. If a proposed bit of HSR offers a lot of promise in terms of beneficence but scores low in terms of justice, then this can create a bit of a dilemma or a quandary for both the proposing investigators and the IRB members evaluating the proposal.