Which study titles would alert the members of an institutional review board (IRB) that the study sample may include vulnerable subjects? Note: Credit will be given only if all correct choices and no incorrect choices are selected

Question

Select all that apply. 1. Identification of Coping Patterns Among Pregnant Wives of Soldiers Involved in Combat
2. Development of Cancer in Persons Exposed to Passive Tobacco Smoke
3. Interventions to Delay Development of Alzheimer Disease in Persons with Down Syndrome
4. Weight Gain in Students during the First Two Semesters of Nursing School
5. Interventions to Decrease Feelings of Breathlessness in Terminally Ill Subjects

Answer 1

1,3,4,5
Rationale 1: The vulnerable population identified in this title is pregnant women. Pregnant women are vulnerable because of potential risks to the fetus.
Rationale 2: This title does not specifically identify a vulnerable population.
Rationale 3: Cognitively impaired persons, in this case persons with Down syndrome, are considered a vulnerable population because they cannot legally or ethically provide informed consent.
Rationale 4: Students are considered a vulnerable population as they may believe participation in a study is linked to grades.
Rationale 5: Terminally ill subjects are considered vulnerable. The risk/benefit ratio and comfort must be considered.