Additional safeguards that may be included in a social and behavioral study may include:
- Remove all direct identifiers from the data as soon as possible.
- 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.
- Requiring pregnancy tests before administration of the study drug.
Additional safeguards that may be included in a social and behavioral study may consist of:
A. Remove all direct identifiers from the data as soon as possible.
B. Requiring a legally authorized representative to provide written consent for an incapacitated subject.
Let’s understand why option A and B are correct. To properly conduct a social and behavioral study, the protection of the subjects implicated in the study is essential. Since the survey is conducted on human beings therefore, taking account of additional safeguards is necessary. The identifiers from the data should be erased because, in a social and behavioral study, the personal information of the participants does not matter; what matters is the data collection. The possible identifiers of the participants include name, Phone numbers, address, email address, social security, medical record number etc.
Another safeguard is the protection of the vulnerable subjects if they are under study. Therefore, incapacitated subjects or kids must have “authorized representative consent”. As a part of the “Human Subjects Protection Program”, the additional safeguards are explained under the Risks to Research Participants involving the research on the vulnerable populations. It is worth mentioning that the other safeguards are the need to protect the rights of the participants who will likely be susceptible to the influences, such as human fetuses, children, prisoners, and mentally ill people or economically or educationally disadvantaged persons.
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