Page 18 - Journal of Special Operations Medicine - Spring 2017

perspective, poor black men in the South, especially in day. This stresses the importance of the IRB. More than
the 1930s, were likely to be undereducated and possi- 30 years ago, the US Department of Health and Human
bly illiterate. The lack of informed consent in language Services established the federal standards for human
understandable to the participants is a prime example subjects research. 12
of deception and misinformation. In fact, the director
of the Tuskegee experiment, Dr Sidney Olansky, stated At the local level—university or hospital—these stan-
that the participants’ illiteracy was a boon to the ex- dards are enforced by the IRB.
periment’s length, as the participants could not read
newspapers and determine that they were susceptible to The first step in ethical research, other than an overall
diseases written about publicly. 9 responsible research design, is the statement of informed
consent. This “common rule” applies to all research
In the Willowbrook study, the participants were vulner- involving human subjects, even if it is a case study or
able in their mental capacities and could not self-govern. survey research. Under the Common Rule, participants
Their powers of attorney, or the family members mak- must receive thorough information about the potential
ing decisions for them, were denied information and risks and benefits of participating in the research, must
were deceived by the investigators as to the conditions be allowed to refuse to participate without penalty, and
to which the children would be exposed. More so than must give informed consent to the researcher. Indi-
12
even the Tuskegee experiment, the children at Willow- vidual IRBs will have statements of informed consent
brook were coerced into participation as their parents that differ slightly, but all statements incorporate the el-
were promised coveted admission to the hospital or ements of autonomy, beneficence, and justice.
threatened with expulsion for participation or nonpar-
ticipation in the study, respectively. 8
Do You Need an IRB to Approve Your Study?
Although considered monstrous acts of unethical re- The short answer is yes, and always yes. At the mini-
search now, at the time, no actionable standards existed mum, you need the IRB to tell you that you do not need
for protecting autonomy, beneficence, and justice in the IRB: only the IRB can tell you that you are exempt
human subjects research. Within the contexts of those from their oversight. This is where it gets confusing.
studies, the participants were considered at that time to Like research itself, the IRB process can be a bit tedious
be noncontributing members of society and somehow to deal with—statements, forms, and permissions are
subhuman. African Americans could not vote then in time-consuming and can delay starting research—and
rural Alabama, and persons with intellectual disabilities some might seek to avoid needing IRB approval, as
were termed “mentally defective.” The Americans with they assume their study is an “internal quality improve-
Disabilities Act did not yet exist. Marginalization that ment” (QI) project, which previously was assumed to
occurred then can still occur now: with enemy combat- be exempt from the IRB’s supervision. That is still some-
ants, illiterate villagers, and less-developed coalition what true, but only if your QI project is literally going
forces deemed backward or somehow less-than by first- to stay within your department or institution and never
world Westerners. Even in some military publications be shared externally. If your study involves humans or
and presentations, photographs of wounded local na- human data (including chart reviews, registry data, or
tionals or combatants are often not blurred out, nor are aggregated patient data), send the proposal to the IRB.
their physical identities fully protected. If there is a possibility to publish or present your study,
send the proposal to the IRB. If you are unsure if your
Simply put, vulnerable populations are those who are project is QI or research, send the proposal to the IRB.
relatively or absolutely incapable of protecting their It is better to seek approval and be told you do not need
own interests. That description likely encapsulates a it than to have a study or publication embarrassingly
10
majority of oppressed peoples with whom SOF work in retracted, or rejected by a journal’s peer-review panel,
differing theaters and contexts. because you did not seek IRB approval first.

Informed Consent Conclusion
History has a tendency to gloss over the brutalities expe- This is the first of several articles intended to educate
rienced by human participants in early medical research. SOF medics and clinicians about generating valid re-
During his time as a bacteriologist in Cuba, Walter search from their own experience and practice. By no
Reed infected (believed now through purposeful expo- means is it an exhaustive interpretation of the storied
sure) dozens of immigrant workers with yellow fever. history of research ethics and/or misconduct. Gratitude
11
Examples of humans’ forced participation in research is due to the medics and providers pushing the envelope
without knowledge of the risks haunt scientists to this every day in practice.

xiv Journal of Special Operations Medicine Volume 17, Edition 1/Spring 2017