Additional safeguards that may be included in a social and behavioral study may include:
A) Remove all direct identifiers from the data as soon as possible.
B) Requiring a legally authorized representative to provide signed consent for an incapacitated subject.
C) Frequent monitoring of the subject’s heart through ECG after administration of the study drug.
D) Requiring pregnancy tests before administration of the study drug.
The correct Answer for the given question is A) Remove all direct identifiers from the data as soon as possible.
In situations where the disclosure of a subject’s responses is the primary cause of harm, collecting data anonymously is the best protection, and removing direct identifiers is an additional safeguard. These responses are additional safeguards, but they are related to studies that may involve investigational drugs or are biomedical, not social behavioral in nature.A social and behavioral study cannot be conducted effectively without protecting the subjects involved. It is important to consider additional safeguards since the survey involves human beings.
It is important to remove the identifiers from the data because in a social and behavioral study, the identifying information of the participants does not matter; what matters is the collection of data. Participants may be identified by their names, telephone numbers, addresses, email addresses, social security numbers, and medical records.