Researchers have a responsibility to protect all subjects, especially those who
are considered to be in a vulnerable population. Children, pregnant women, the
unborn, frail elderly, prisoners, and individuals with some level of mental incapac-
ity are considered to be members of vulnerable populations. In some situations,
factors such as ethnicity, gender, socioeconomic status, education, and language
may create potential vulnerability for certain subjects (Polit & Beck, 2014).
To ensure subject protection, researchers maintain anonymity and confiden-
tiality. Anonymity means keeping the names of the subjects separated from the
data so that no one, not even the researcher, knows their identities. In some
studies, it is not possible for subjects to remain anonymous. In these situations,
confidentiality must be protected. Confidentiality refers to protecting subjects’
identities. One way identities are protected is to keep a master list with the
names of subjects and the codes assigned to the data collected. The list is locked
away from other data and destroyed after all data are collected. The principal
researcher or designee should be the only person who has the list of names and
code numbers. Another way to ensure confidentiality is by reporting results as
group data, not as individual data. Actions such as these are in accordance with
the ANA code of ethics and human rights guidelines (ANA, 2001), as well as
the Health Insurance Portability and Accountability Act (HIPAA) guidelines.
Another major responsibility of researchers is maintaining subjects’ rights
to self-determination by obtaining informed consent. Prior to beginning a
research study, institutional review board (IRB) approval must be obtained.
This board consists of individuals who review research proposals to ensure
that research is conducted in an ethical manner and that the rights of subjects
are not violated. The IRB pays particular attention to the process of informed
consent and ensures that mandatory content is included in consent forms. See
Box 11-2 for a list of essential components of consent forms.
Subjects must be informed that they may choose to participate or not par-
ticipate in the study and that they may withdraw at any time without harm or
consequences. There must be a clear and concise explanation of the study and
what subjects will be asked to do in the study. There should also be a discus-
sion of the potential benefits and risks of participation in the study. If there
are monetary benefits, there must be a description of the amount of money
participants will receive and what is required to receive that monetary amount.
KEY TERMS
vulnerable
population: A
special group of
people needing
protection because
of members’ limited
ability to provide
informed consent
or because of their
risk for coercion
anonymity:
Keeping the names
of subjects separate
from data so that
no one, not even the
researcher, knows
subjects’ identities;
concealing the
identity of subjects,
even from the
researcher
confidentiality:
The protection of
subjects’ identities
from everyone
except the
researcher
informed consent:
An ethical
practice requiring
researchers to
obtain voluntary
participation by
subjects after
subjects have
been informed of
possible risks and
benefitsCheck out the Health Insurance Portability and Accountability Act (HIPAA) regulations at
http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html. How do these guidelines
provide direction to researchers about protecting confidentiality of subjects?CRITICAL THINKING EXERCISE 11-4
11.4 Keeping It Ethical 303