Vulnerable Subjects - Research Involving Workers/Employees (ID 483)

True or False: When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.

True

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. The employer may encourage or deny participation of workers. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. The research study's finding could affect an employee's pay, benefits, or promotion potential. All of the above

Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:

Who will have access to the data. If personal identifiers will be retained and used in the data analysis. If the study results, if any, will be included in the employee's personnel records. How the data will be collected and secured. All of the above

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:

Workers