Additional Safeguards Included In A Social And Behavioral Study May Include The Following?
As a social and behavioral study involves human beings, it is essential to consider additional safeguards that include the protection of research participants. These include removing all direct identifiers from the data immediately and retaining the subject participants from any risk.
Vulnerable individuals such as children, pregnant women, and people with mental illness or economic disadvantage need additional safeguards to protect their rights and welfare.
Confidentiality Of Direct Identifiers
When conducting a social and behavioral study, additional safeguards must be used to protect research participants’ personal information. This is especially true for people with HIV/AIDS, psychiatric disorders, genetic abnormalities, and substance abuse.
These individuals are more likely to be sensitive about sharing their identifying information. They may risk losing their reputation, employment, or civil or criminal penalties if their privacy is compromised. Therefore, explaining to participants that their personal information will be kept confidential is important; they need to agree to this.
The identifiability of the data collected should be restricted to what is needed for the research objectives. For example, individually identifiable information, such as name and address, may be necessary to answer research questions and data management purposes (e.g., to check for duplicate records).
Researchers must also remember that other potentially identifying elements could be included in the data. For example, indirect identifiers, such as gender, age, race/ethnicity, town size, community character, and family structure, could be revealed even when direct identifiers are absent. This information could be used to re-identify an individual, particularly when small samples are involved.
The IRB will consider the degree to which these indirect identifiers are associated with a participant’s name and the sample size to determine whether the dataset is truly de-identified. The IRB will also consider the degree to which the dataset consists of elements that are not directly identifiable and coded so that they are not linked to the direct identifiers. This criterion is often more difficult to assess than the direct identifiers because several indirect identifiers may be combined to identify an individual.
Protection Of Vulnerable Individuals
Protecting vulnerable individuals when conducting a social and behavioral study is an important consideration often overlooked or underappreciated. This is especially true in a society that values individuality and freedom. The vulnerability may arise from many factors, including cultural, economic, and structural disadvantages, such as discrimination, or a lack of access to necessary health care, such as for people with disabilities.
Several research ethics guidelines and policies (CIOMS, UNESCO Declaration, ICH GCP, Australian National Statement, and TCPS2) explicitly state vulnerability’s importance in conducting ethically responsible research. They also describe the risks associated with research involving vulnerable subjects and suggest that they should be protected as much as possible.
However, this approach is limited in its rigor. For example, the CIOMS and TCPS2 guidelines define vulnerability as existing on a spectrum rather than as a unique feature that varies between situations. In contrast, the ICH GCP definition emphasizes an element of consent as a source of vulnerability.
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Similarly, the Common Rule highlights that certain subjects are particularly vulnerable to coercion or undue influence. This includes pregnant women, prisoners, and children. It also identifies groups with disabilities that are less likely to consent to participate, such as handicapped persons.
While these guidelines and policies do specify that these groups should be protected, they do not provide any additional explanations for the basis of their designation. This is a significant weakness, given that research participants with disabilities are often at an increased risk of harm.
For example, patients in emergency settings, prisoners, and ethnocultural and racial minorities are frequently designated vulnerable groups, but their vulnerabilities are not clearly explained. This omission is particularly concerning for patients with physical disabilities, who are often subjected to disproportionate medical surveillance and whose health status may be insufficiently safeguarded by research.
As a result, it is unclear whether the guidelines and policies we examined in this sample effectively and appropriately protect their subjects when conducting research. There is a need for further research to determine whether these protections are effective and how they can best be used.
Requirement Of Authorized Representative Consent For Incapacitated Subjects
When a study involves the participation of an incapacitated individual, additional safeguards are required. This includes the use of a legally authorized representative (LAR).
Legally authorized representatives include the parent or legal guardian if the research participant is a child, an agent under a durable power of attorney for health care, a court-appointed guardian, and an attorney. They may also be a friend or family member.
When a legally authorized representative can represent an incapacitated subject, the investigator should ensure that the LAR and the subject receive the same information about the research. This will help the LAR to understand the risks, benefits, and alternatives to participation.
Generally, the LAR should be asked for consent after receiving all relevant information. The PI should ensure the LAR has adequate time to read and understand the consent document before providing the signed consent form.
If the LAR does not wish to consent, then the study should be terminated. This does not require the IRB to review the matter, but it is helpful for the PI and the research team to make every effort to ensure that the LAR’s wishes are respected.
Several factors, including dementia or other cognitive disorders, serious mental illness, or intoxication, can impair a LAR’s decision-making capacity. Therefore, when a person’s consent capacity is affected by these factors, it is important to consider whether transitioning to a LAR’s decision-making process would be in the best interest of the study.
Using a step-wise consent process can be beneficial in these situations. The PI can first discuss the study with the prospective subject, followed by a discussion with the LAR. This can increase the LAR’s understanding of the risks, benefits, and alternatives to participation in the study.
The PI must also ensure that the subject has sufficient time to read and understand the consent form and is provided with an opportunity for questions and answers. The PI should also be sure that the consent document is not signed until both the PI and the LAR are satisfied that the subject has no further questions.
Requirement Of IRB Review
Research involving human subjects requires review and approval by an Institutional Review Board (IRB). The IRB is responsible for reviewing research protocols, informed consent documents, investigator brochures, and other materials to ensure that the rights and welfare of research participants are protected. The Board also maintains records of its activities, including copies of research protocols reviewed, meeting minutes, and correspondence.
The IRB’s primary responsibility is to protect the rights of research participants against exploitation. However, the IRB also recognizes the need for continued scientific and human progress. As such, the IRB seeks to promote scientific stewardship and foster a culture of ethical behavior in all research. This means that it is important for researchers to examine their projects in light of the basic principles of respect for persons, beneficence, and justice.
In determining what level of IRB review is needed, the IRB considers the level of risk to the subject of the study, as well as the complexity and scope of the project. Applications requiring review by the full IRB (full Board) are accepted by the submission deadlines and presented at the next scheduled full board meeting for a vote by all members.
Applicants are encouraged to submit their applications before the anticipated study start date so that issues can be addressed before a full board meeting. Additionally, investigators should plan to attend the full board meeting to answer questions from the IRB and provide a brief update on the study.
As part of the IRB review process, the Lead Researcher and faculty advisor/supervisor must receive required human subjects protection training. This includes the Collaborative Institutional Training Initiative (CITI) online courses. CITI also offers additional research ethics training specific to social and behavioral research.
The IRB also reviews studies of vulnerable populations, such as minors, the cognitively impaired, and prisoners. These studies may include intrusive contact methods with the subject, so researchers need to describe the purpose of these contact attempts and explain why they are necessary.
The IRB must approve all new and continuing projects that involve human subjects, regardless of the source of support for the study. Generally, the IRB reviews new and continuing projects every year. However, in some cases, the IRB may decide to review more often, especially if the project has changed or added to its procedures.
The Best Guide Of Additional Safeguards That May Be Included In A Social And Behavioral Study May Include?
Social and behavioral research involves studying human behavior, thoughts, and attitudes. As with any research involving human subjects, social and behavioral research requires additional safeguards to protect the rights and welfare of participants. In addition to the basic ethical principles outlined in the Belmont Report, several other safeguards may be included in a social and behavioral study.
- Informed consent: Informed consent is fundamental to social and behavioral research. Participants must be provided with information about the study and the risks and benefits of participation. Informed consent also requires that participants be allowed to ask questions and that they understand that their participation is voluntary.
- Confidentiality: Researchers must protect participants’ privacy by keeping their personal information confidential. This includes any identifying information such as names or addresses. Researchers should take steps to ensure that data is stored and transmitted securely.
- Debriefing: Debriefing is an important aspect of social and behavioral research. After the study, participants should be allowed to ask questions and receive feedback.
- Data monitoring: Data monitoring is necessary to ensure the study is conducted according to the protocol. This may include reviewing data as it is collected, checking for errors or inconsistencies, and monitoring participant safety.
- Institutional review: Institutional review boards (IRBs) are responsible for reviewing social and behavioral research studies to ensure they comply with ethical standards. IRBs are typically composed of experts in the field of research, as well as community members who are not affiliated with the institution.
- Data sharing: In some cases, social and behavioral research studies may involve sharing data with other researchers. Researchers must ensure that data is shared responsibly and ethically and that participants’ confidentiality is protected.
- Adverse event reporting: Adverse events are unexpected or harmful events that may occur during a research study. Researchers must report adverse events to the IRB and take appropriate action to protect participants.
- Community engagement: Community engagement involves working with community members to ensure the research is relevant and acceptable. This may include involving community members in the design and implementation of the study and communicating the study results to the community.
In summary, social and behavioral research requires additional safeguards to protect the rights and welfare of participants. These safeguards include informed consent, confidentiality, debriefing, data monitoring, institutional review, data sharing, adverse event reporting, and community engagement. In addition, researchers must be committed to upholding ethical standards and protecting the well-being of their participants.
FAQ’s
What are the primary risk to participants in social behavioral and educational research?
There are four possible dangers for study participants to consider: exploitation, misrepresentation, identification of the participant in published papers, whether done by the participant themselves or by others, worry and discomfort, and exploitation.
What is social behavioral research?
The behavioural and social sciences are used in social behavioural research to examine how people and animals react to various internal and external stimuli. The academic fields of economics, political science, sociology, psychology, anthropology, and history all do this type of research.
What are additional safeguards that may be included in a social and behavioral study?
A social and behavioural study may also incorporate the following additional safeguards: As soon as you can, eliminate all direct identifiers from the data. Which of the following is truest concerning hazards in social and behavioural sciences research: Hazards vary depending on the period, circumstance, and society.
What are Behavioural research methods?
By measurement and interpretation, behavioural research can be used to analyse and comprehend both individual and social behaviour. This course explores the theoretical underpinnings of behavioural research and the use of modern research methodologies.
What is one of the most important uses of behavioral research?
Research in the behavioural and social sciences aids in the prediction, prevention, and management of disease in both individuals and entire groups. Additionally, this research aids in behaviour modification and teaches patients how to adhere to therapies.
What are behavioral research methods?
Individual cognitive testing, focus groups, debriefings, expert evaluation, behaviour coding, and split ballot field trials are typical research techniques.
