The most important additional safeguard that should be included in a social and behavioral study is to remove all the direct identifiers from the data promptly.
According to the Human Subject Protection Program, the additional safeguards are described under the risk to research participants including the research on vulnerable populations. Additional safeguards are important to preserve the rights and welfare of the subject who will be vulnerable to undue influence, compulsion (or using force or threat) such as children, pregnant women, prisoners, human fetuses, people with mental disorders, or educationally and economically helpless people.
As mentioned in the Research information system, the direct identifiers include name, mobile number, address, email id, social security number, and 14 other identifiers.
All the data identifiers should be removed once the research comes to an end to avoid a security breach.
About Social and Behavioral study
Two types of research can help treat the illness of people i.e Social and Behavioral therapy. Social research includes how a person communicates with people such as family, group, community, or society. And behavioral study includes people’s actions and reasons behind being involved in doing such things so we can say it includes psychological aspects such as emotions.
These two factors help in knowing, understanding, preventing, and even controlling the illness. It also helps in changing the behavior of people and understanding the treatment. By this researches, we can easily treat them and can help them to stay focused or consistent.
IRB: Institutional Review Board and its Importance
IRB (Institutional Review Board) is an administrative system that is made to protect the rights and welfare of human research subjects carried under the administration’s permission. It needs IRB approval to collect data and sensitive information from vulnerable subjects. IRB has also the right to approve, disapprove, monitor, and do modifications in research activities that lie under the authority as per the administrative policy and Federal rules.
The necessary steps to measure and ensure that each subject is protected during the research may be different as per the nature of the project and which institution is conducting the research.
Regardless of the scope of the project, institutions need to submit all the reports of the evaluation to IRB.
Points need to be considered while reviewing the research for vulnerable participants
The elements of the research plan include following points:
The Calculated issues involve inclusion and exclusion criteria of selecting participants.
All together Characteristics involve the study of social, economical, physical, and environmental conditions of vulnerable participants.
The State or Local Law Applications involve issues related to eligibility, consent of minors, research and legal representatives, and the age of the people who are involved in the study.
The Process of ensuring and evaluating participant’s efficiency, understanding, and informed permission.
The Necessity for Additional safeguards involves the safeguards to protect vulnerable participants like children, prisoners, pregnant women, etc the IRB has investigators to make the consent form signed by the participants and submit it to IRB. Once the research is done, researchers can remove all the direct identifiers from the data as soon as possible so that it will secure the confidential meetup.
The Final Words
The utmost priority while evaluating any research is that it needs extra safeguards to protect the rights and welfare of the vulnerable participants and following the procedure for taking their consent and ensuring that their data will be kept private. And when the research is done, the data identifiers will be removed to maximize confidentiality.
