Page 24 - Exhibit No. 3 Copies of Instructional Materials Actually Used

e. Treatment of Vulnerable Groups

Adherence to ethical standards is often straightforward. The nghts of
special vulnerable groups however, may need to be protected through
additional procedures and heightened sensitivity. You should pay particular
attention to the ethical dimensions of a study when people who are vulnerable
are involved. Vulnerable groups include the following:

1. Children

Legally and ethically, children do not have the competence to give
their informed consent, therefore, the informed consent of children's
parents or legal guardians should be obtained. However, it is
advisable-especially if the child is at least 7 years old-to obtain the
child’s assent as well.

2. Mentally or emotionally disabled people

People whose disability makes it impossible for them to weigh the
risks and benefits of participation and make an informed decision
(e.g., people affected by cognitive impairment, mental illness, coma,
and so on) also cannot legally or ethically provide informed consent.
In such cases, researchers obtain written consent from the
person's legal guardian.

3. Physically disabled people

For certain physical disabilities, special procedures for obtaining
consent may be required, For example, with deaf people, the entire
consent process may need to be in writing. For people who cannot
read or write or who have a physical impairment preventing them
from writing, alternative procedures for documenting informed
consent (e.g., videotaping the consent proceedings) can be used.

4. The terminally ill

Terminally ill people who participate in a study can seldom expect to
benefit personally from the research, and thus the risk/benefit ratio
needs to be carefully assessed. Researchers must also take steps
to ensure that if the terminally ill participate in the study, their health
care and comfort are not compromised.

5. Institutionalized people

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Nursing Research I