additional safeguards that may be included in a social and behavioral study may include:

Research involving vulnerable populations must receive approval by the Institutional Review Board before starting. These types of studies typically involve surveys, interviews, and focus groups.

Vulnerable population participants include individuals with mental illness and substance use disorders, members of disenfranchised racial or ethnic communities, etc.

This article will discuss additional safeguards that may be included in a social and behavioral study. Read more about : additional safeguards that may be included in a social and behavioral study may include:

Protection of Vulnerable Individuals

All of the policies in our sample articulate practical implications of vulnerability, ranging from considerations that are important to the design of research to actions that must be taken when working with vulnerable participants.

These practical implications all tend towards careful inclusion rather than exclusion of vulnerable individuals from research. There is some variation in how these implications are formulated, but they all convey that special considerations must be made to ensure that the participation of vulnerable persons is voluntary and free, that ordinary inducements can be perceived as undue influences,

That researchers should respect the wishes of vulnerable individuals, and that researchers must take steps to ensure that vulnerable individuals do not feel coerced or pressured into participating in research.

The most common approach to vulnerability is one in which it is conceived of as the inability to provide freely informed consent, and most policies focus on this feature of vulnerability. However, this focus can blind researchers and REBs to other relevant features of vulnerability, including a greater likelihood of exploitation, lessened capacity for decision-making, or the possibility of being coerced or unduly influenced.

These concerns are most often addressed in the context of specific groups of individuals: children and minors, young people, prisoners, patients in emergency settings, and members of ethnocultural or racial minority communities.

Some of these groups are categorized as a result of their inherent characteristics, such as limited cognitive and deferential capabilities or their reliance on others for health care and social services.

Other groups are characterized as a result of their situational circumstances, such as being in a dependent relationship with another person or having a lack of power in their personal or professional roles.

Several policies also address economic vulnerability, which encompasses those who are disadvantaged regarding access to social goods and services. In this case, monetary incentives may be considered as an inducement and it is necessary to evaluate whether they are appropriate and sufficient in terms of the individual’s financial needs.

Moreover, these individuals must be consulted to determine whether they wish to participate in research and if so, how much risk they are willing to accept.

Confidentiality of Direct Identifiers

Most people agree to participate in research under the assumption that their responses will remain confidential. However, many studies contain information that may identify participants or link them back to the data set. The degree to which a person can be identified by the information in a dataset is called the disclosure risk, and this must be assessed for every study that uses human subjects.

Direct identifiers are characteristics or data values that directly link an individual to a specific variable in the dataset. They include names, social security numbers and other personal identifying information. Indirect identifiers can also be used to identify a participant, including unusual races and ethnicities, extreme ages or occupations, and other details known to the public. These are sometimes called quasi-identifiers.

A dataset can only be considered “anonymous” if no one can connect the responses to any individual, even the researcher. However, it is important to remember that face-to-face interviews, surveys or audio and video recordings cannot be considered anonymous if any identifiers are collected.

This issue is particularly challenging in longitudinal panels, where the same participants are interviewed more than once. In these cases, the investigator may need to retain some identifying information to contact the respondents for subsequent interviews, or to match up interview transcripts with their original recordings.

For these reasons, social and behavioral researchers often use indirect identifiers in their data sets. For example, they may record subject numbers instead of a person’s name or use codes that are not linked to identifiers (e.g., birth date). However, these coded variables are not truly anonymous, as a participant’s identity can be discerned from a combination of these variables or other linked data.

For these reasons, it is essential that a researcher carefully consider the risks to privacy and confidentiality of their data set before deciding to share it with others. This is especially critical when using a large dataset that has the potential to be linked to other data sets or to individuals through a variety of methods, including social media and digital aggregators.

When submitting a study to an IRB, the researcher should describe how they intend to protect the confidentiality of their data and why the IRB should approve their application.

Exclusion of Direct Identifiers after Completion

The information gathered in social and behavioral research may have implications for the participants’ reputation, employment, insurability, or personal safety. The IRB evaluates how well such risks are managed in proposed studies.

In addition, participants in social and behavioral research often are not aware that their behavior is being observed or recorded. This type of research can be embarrassing for participants or may cause them to behave in ways that are not natural.

For example, the study of homosexuals using public restrooms by a social scientist who disguised himself in order to observe the behavior of unwitting participants (the Tea Room Trade) may have been uncomfortable for these individuals.

For this reason, it is important that direct identifiers be excluded from the data when possible. These include a participant’s name, address, telephone number, email, medical records, and any other information that could be used to identify a person.

Whether or not this information is included in the final data set will depend on the specific study and its goals, but it is critical that such identifiers be removed from the initial data as soon as practicable. This protects participants’ rights to privacy and their right to self-determination.

It also helps to prevent the risk of unauthorized use or disclosure of their information after the study has been completed. Read more about : additional safeguards that may be included in a social and behavioral study may include:

Approval by the Institutional Review Board

IRBs are federally mandated, locally administered groups charged with evaluating risks and benefits of human research at their institutions. To some degree, risks and potential harms exist in virtually all research with human participants, including studies in the behavioral/social sciences.

In the United States, and in most of the world, IRBs are the core of a system for protecting the rights and welfare of people who participate in biomedical and behavioral research. These independent evaluations assure that a study is ethically acceptable and compliant with regulations designed to protect research subjects.

IRB members and administrators face many challenges, some of which can result in conflict. If these groups fail to recognize and deal with conflict, the safety of research subjects may be jeopardized.

Researchers must file an IRB before beginning any research project involving human participants. Some types of studies qualify for exempt status, but all social and behavioral research must be reviewed by an IRB.

This process ensures that the proposed study is minimally risky, that any risks are justified in relation to the knowledge gained from the study, that the selection of subjects is fair (including delineated inclusion and exclusion criteria), and that an appropriate consent procedure will be followed.

For studies of vulnerable populations, the IRB may require additional safeguards. In some cases, these extra measures are designed to prevent physical or psychological harm. In other cases, they are intended to minimize risk by ensuring that participants can withdraw from the study without fear of consequences.

For example, an IRB may require a study of an emotional disorder to include a statement that “The researcher will stop the research if you become emotionally distressed.”

Because social and behavioral studies often involve sensitive issues, it is important for all parties involved in the review process to remain aware of current thinking among IRBs and federal regulators regarding these topics. This can be achieved by attending regional or national conferences geared specifically to human research participant protection.

Researchers should be prepared to explain the purpose of a study in terms that are accessible to the prospective participants, even those with limited reading comprehension skills. They should also be ready to address any concerns that a prospective participant may have about participating in the study.

By admin

Welcome to the intersection of technology and knowledge! I'm Rahul Shakya, a passionate tech enthusiast and the mind behind the bytes at With a knack for unraveling the intricacies of the digital realm, I embark on a journey to demystify the ever-evolving world of tech. Email: [email protected]