Question

Identify an organization such as a research hospital or pharmaceutical company that involves human research subjects including all of the following at risk populations; children, women, minorities, and cognitively impaired subjects.

Describe the organizations specific guidelines/policies regarding conducting research on each of the at risk human populations; children, women, minorities, and cognitively impaired subjects

Answer 1

Institutional Review Board (IRB) is a committee that reviews proposals for research with human participants in order to ensure that the project conforms to accepted ethical standards.

The IRB consists of 5 individuals with diverse backgrounds, that includes at least 1 scientist,1 nonscientist academic and one person who is not affiliated with the college or university.

Organizations have a profound responsibility to ensure that all IRB designated under Federalwide assurance possess sufficient knowledge of the local research context to satisfy the requirement for human subjects protection regardless of the IRB's location relative to the organization and the research.

Knowledge of the local context may be provided by:

*Specialists with personal, direct knowledge of the local research context who participate in IRB discussions and provide insight on achieving protections for research participants.

*An IRB is situated within the local context.

If the IRB has determined that the use of deceptive techniques is justified by the study's significant prospective scientific, educational or applied values and that effective nondeceptive alternative procedures are not feasible.

*If the study places them under no more physical or emotional risk that would be encountered in daily life or in physical or psychological examinations or tests.

*Informed consent may not be mandatory, but most psychologists obtain consent away.

*The research and the members of the IRB must determine whether the potential benefits of the study outweigh the potential for harm.

*Debriefing is important because the subjects learn more about the benefits of the research to them and to the society in general, and the researcher has the opportunity to make less severe any discomfort the subjects may be experiencing. They can take the new information to the same thought process they had prior to the study.

*Research that involves children must follow the requirements for parental permission.

*NIH inclusion policy in the United States:

Acceptable inclusion of women and /minorities depends both upon the scientific question addressed by the study and the prevalence of disease, disorder or condition in these populations. In this case, it is scientifically appropriate to include groups that would be affected by this condition could result in gaps in scientific knowledge.

According to the ethical principle of justice is applied through the inclusion of women and minorities as participants in human subjects research. The policy should be shaped equally to all.

It is important to consider whether the intervention or therapy under scrutiny affects women or members of minority groups and their subpopulations differently.