CITI : vulnerable subjects research involving employees

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\ Genetic information has the potential to cause significant harm to research subjects if inappropriately disclosed, including harm to a subject's privacy, social standing, family obligations, employment/employability, or insurance/insurability.

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 The Common Rule does not classify workers as a vulnerable population. The categories of vulnerable populations provided for in the Common Rule are children, prisoners, and individuals with impaired decision-making capacity.

The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms by stigmatizing members of the group (even for individuals who do not participate in the research) is:

A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state.

Which of the following studies has the LEAST potential to create group harm?

A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer. A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer is unlikely to cause group harms. It is thus unlikely that such a study will be harmful to women with breast cancer or to women in general who do not participate in the study. The results from other hypothetical studies listed have the potential to be distressful, to stigmatize or in another way harm individual members of the Group who did not actively participate in the research.

Which of the following practices can be effective in minimizing group harms?

All of the above Community consultation is used with the community of interest to make sure that potential harms are recognized and understood, and that the study is designed to provide benefits to the community. Collaborative IRB review with tribal IRB's will also maximize the likelihood that group harms are minimized. On-going consultation ensures that group leaders are provided with accurate information about the research as it progresses. By planning disclosure of the research, the researcher informs the community about how the research results will be disclosed early on in the process to reduce the possibility of harms to the group as the research is published or presented.

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:

All of the above Researchers must recognize that the primary harm in social and behavioral research is the breach of confidentiality. This risk of harm is especially significant when the data being collected involves an employee's experiences at their place of employment (for example, a situation where the employers have ongoing efforts to reduce healthcare costs by getting rid of employees who they believe will cause their healthcare insurance premiums to rise).

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

All of the above Workers who serve as research subjects at their place of employment are vulnerable to numerous kinds of pressure from their co-workers, unions, and employers. Pressure can be applied to workers in subtle ways (such as, an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs).

An example of an institutional COI is:

An industry sponsor pays for the construction of a new research laboratory at the organization An institutional COI can arise when the financial interests of an organization or institutional official (acting within his or her authority on behalf of the organization) may affect or appear to affect the research conducted under the organization's auspices. This could include significant gifts received by the organization from the sponsor of human subjects research.

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies The FDA's regulation governing disclosure of individual COIs requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or to disclose financial interests of researchers who conducted clinical studies covered by the regulation. The regulation specifies that the FDA may refuse to file any marketing application that does not contain a disclosure of researchers' financial interests or a certification that the applicant acted with due diligence to obtain researchers' disclosures, but was unable to do so.

What is the term for management controls that are built in to a research study (for example, independent data analysis)?

Inherent controls When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher's opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial.

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success\\ A researcher's membership on an advisory board of an entity sponsoring research can create a conflict of interest because there may be a perception that the researcher has a motive to bias the research to create an outcome that is favorable for the sponsor.

A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.

No later than the time of proposal submission The NIH is a PHS agency. Therefore, this proposed research is subject to the PHS regulation regarding objectivity in research, which requires researchers to submit COI disclosures no later than the time a proposal is submitted to a PHS funding agency.