To protect subjects from harm, the goal is to maximize
the benefits while minimizing the risks. For example,
suppose a researcher is testing radiation doses in
women with breast cancer. Ideally, the researcher
should select the dose of radiation that obtains the
desired effect with the least amount of side effects. It
would be unethical to irradiate women with unusu-
ally large doses of radiation, even though it could be
hypothesized that larger doses are more effective, because there are known
complications associated with high doses. Consideration must be given to
potential psychological harm as well. For example, suppose a researcher
plans to interview women shortly after their miscarriages. Because mis-
carriage is an emotional incident for most women, the researcher must
use sensitive language in consent forms and during interviews. Referring
to the product of conception as a baby may cause undue emotional stress
for some subjects.
In some studies, the risk of harm remains high regardless of strategies incor-
porated by researchers. For example, a researcher is testing a new medication
for a serious condition. Regardless of whether subjects are assigned to the
control or experimental groups, they are at risk for harm. When it is identified
that one treatment is better than another, all subjects should be offered the
best intervention. At times, unanticipated adverse reactions to interventions
occur. When researchers discover that subjects are having adverse reactions,
they should report the reactions immediately. Careful consideration should be
given to discontinuing a study if this occurs.
Researchers have an obligation to minimize subject burden—that is, to place
as few demands as possible on subjects. For example, a researcher is studying
the effects of diet on cholesterol. Careful consideration should be given to the
length of the study and the number of times subjects need to have blood samples
drawn. If subjects perceive their participation in a study to be too burdensome,
there is greater likelihood that they will not complete the study.
Although it is important to exert control to reduce threats to validity,
researchers must ensure that strategies used are sensitive to the rights of
subjects. When recruiting subjects, care must be taken to follow selection
criteria to reduce selection bias. Sometimes subjects express a desire to be
placed in a particular treatment group. Researchers cannot be swayed by
these requests, and they must adhere to protocols about assigning subjects
to groups. When subjects are enrolled in studies, it can be tempting to co-
erce subjects to remain in a study to limit threats related to mortality, but
this is unethical. Subjects must feel free to withdraw at any time without
consequences.
FYI
When designing quantitative studies, re-
searchers must assess the associated benefits
and risks of any intervention or test that they
plan to use. To protect subjects from harm,
the goal is to maximize the benefits while
minimizing the risks.7.5 Keeping It Ethical 189