Reference no: EM133532032

Questions

1. Additional safeguards that may be included in a social and behavioral study may include:

Requiring a legally authorized representative to provide signed consent for an incapacitated subject.

Frequent monitoring of the subject's heart through ECG after administration of the study drug.

Remove all direct identifiers from the data as soon as possible.

Requiring pregnancy tests before administration of the study drug.

2. A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

Lose their legal status.

Lose their employment.

Feel that their privacy has been invaded.

Experience emotional or psychological distress.

3. Identify the example of when situation and time are key to assessing risk of harm in a research study:

A study asking women if they have completed an advanced degree and what city they were born in

A survey with educators on their experience about implementation of a novel preschool program

Research on the prevalence of retired individuals who have been harassed in different academic disciplines

A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers (who are underage to purchase tobacco) in the United States

4. Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

Study procedures, breach of confidentiality, and loss of employment

Invasion of privacy, adverse reaction to study drug, and discrimination

Breach of confidentiality, loss of autonomy, and study procedures

5. If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:

Have the subject sign the consent form under an assumed name.

Obtain a Certificate of Confidentiality.

Obtain a waiver of documentation of informed consent.

Code the subjects' responses.