Page 23 - Exhibit No. 3 Copies of Instructional Materials Actually Used

b. Risk/Benefit Assessment

One of the strategies that researchers use to protect study participants-
and that you as a reviewer can use to assess the ethical aspects of a study-is
to conduct a risk/benefit assessment. Such an assessment is designed to
determine whether the benefits of participating in a study are in line with the
costs, be they financial, physical, emotional, or social- i.e., whether the
risk/benefit ratio is acceptable.

The risk/benefit ratio should also be considered in terms of whether the
risks to research participants are commensurate with the benefit to society
and the nursing profession. The degree of risk to be taken by those participating
in the research should never exceed the potential humanitarian benefits of the
knowledge to be gained. Thus, an important question in assessing the overall
risk/benefit ratio is whether the study focuses on a significant topic that has the
potential to improve patient care.

Minimal risk – is a risks anticipated to be no greater than those ordinarily
encountered in daily life or during routine physical or
psychological tests or procedures. When the risks are
not minimal, researches must proceed with caution,
taking every step possible to reduce risks and maximize
benefits.

c. Confidentiality Procedures

Participants right to privacy is protected either through anonymity or
through other confidentiality procedures. Anonymity occurs when even the
researcher cannot link a participant with his or her data. For example, if a
researcher distributed questionnaires to a group of nursing home residents and
asked that they be returned without any identifying information, the responses
would be anonymous. As another example, if a researcher reviewed hospital
records from which all identifying information (e.g., name, address, Social
Security number, and so forth) had been expunged, anonymity would again
protect people's right to privacy.

d. Debriefings and Referrals

Researchers can often show their respect for study participants and
proactively minimize emotional risks-by carefully attending to the nature of the
interactions they have with them. For example, researchers should always be
gracious and polite, should phrase questions tactfully, and should be sensitive
to cultural and linguistic diversity.

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Nursing Research I