Protected Population
- protected species means any of the following animals:
- Protected Activity means filing a charge, complaint, or report with, or otherwise communicating, cooperating, or participating in any investigation or proceeding that may be conducted by, any federal, state or local government agency or commission, including the Securities and Exchange Commission (“Government Agencies”). ...
What populations need additional protection from research?
Vulnerable and Other Populations Requiring Additional Protections 1 Pregnant women, human fetuses, and neonates. Because research may pose additional and/or unknown risks to pregnant women, human fetuses and neonates, the regulations require additional safeguards in research. 2 Children. ... 3 Prisoners. ...
Which groups are termed as protected populations?
Groups like women, children and prisoners are termed as protected populations… If the null is rejected, there is the alternative which is called the alternative hypothesis and it takes the part of the null if it is not true.
What does vulnerable populations mean?
Vulnerable Populations. The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Though there are no federal regulations...
What are unacceptable human subjects protections?
Unacceptable risks and/or inadequate protections for participants who are prisoners must be identified as Unacceptable Human Subjects Protections in the Summary Statement. The need for documented approval from OHRP prior to the initiation of any research involving prisoners
Who are the vulnerable populations in research?
There are some groups who have been identified by the federal regulations as “vulnerable populations”: pregnant women and fetuses, minors, prisoners, persons with diminished mental capacity, and those who are educationally or economically disadvantaged.
What are examples of vulnerable populations?
Vulnerable populations include the economically disadvantaged, racial and ethnic minorities, the uninsured, low-income children, the elderly, the homeless, those with human immunodeficiency virus (HIV), and those with other chronic health conditions, including severe mental illness.
Why is it important to protect vulnerable populations in research?
The concept of vulnerability is a cornerstone of the theoretical basis and practical application of ethics in human subjects research. Risks to humans participating in research must be minimized; that is, subjects must be offered protection from risks. Vulnerable subjects require additional protections.
How can we protect vulnerable populations?
Protect vulnerable populations and promote health equity.Prepare health systems and hospitals for future surges.Establish protocols to tighten controls rapidly in response to new outbreaks.Promote alignment and coordination with government authorities and employers.
Who is considered a vulnerable person?
In general, a vulnerable person is either a minor or someone who, for physical or mental reasons, is unable to look after themselves or their finances.
How do you define vulnerable populations?
Vulnerable populations include patients who are racial or ethnic minorities, children, elderly, socioeconomically disadvantaged, underinsured or those with certain medical conditions. Members of vulnerable populations often have health conditions that are exacerbated by unnecessarily inadequate healthcare.
Why are vulnerable populations considered vulnerable?
Vulnerable populations are groups and communities at a higher risk for poor health as a result of the barriers they experience to social, economic, political and environmental resources, as well as limitations due to illness or disability.
Why are students considered vulnerable populations?
Students in subordinate relationships (like that between student and instructor, or employee and supervisor) are considered vulnerable subjects because of the risk of real or perceived coercion. The voluntary nature of their participation could be skewed by their relationship with the investigator.
How do you protect vulnerable groups in research?
providing appropriate information to elicit freely-given informed consent for participation as well as information regarding data deposit and data re-use (where deposit is possible) limits to confidentiality and occasions where this may occur.
What are social problems of vulnerable populations?
The most common health-related social challenges include lack of employment, food and housing insecurity, poor social support, and illiteracy.
Why are elderly a vulnerable population?
Older adults are often economically vulnerable because their cost of care can exceed their income. In particular, chronic illness increases an older adult's dependency and cost of living.
Are prisoners a vulnerable population?
Prisoners, individuals involuntarily confined or detained in a penal institution, as a population are considered vulnerable because the constraints of incarceration may affect an individual's ability to give voluntary, informed consent.
What is a vulnerable community?
Vulnerable populations are groups and communities at a higher risk for poor health as a result of the barriers they experience to social, economic, political and environmental resources, as well as limitations due to illness or disability.
Who are the most vulnerable to disaster?
One measure of the strength of a community's response and recovery system is its attentiveness to its most vulnerable citizens–children, the frail elderly, the disabled, and the impoverished and disenfranchised. It is a cruel fact: disasters discriminate.
Which of the following is a characteristic of a vulnerable population?
Which of the following is a characteristic of a vulnerable population? Vulnerable population groups are more sensitive to risk factors and have worse health outcomes.
What is the Code of Federal Regulations?
The Code of Federal Regulations outlines specific requirements to enhance protections for three groups. Click on the links below to learn more about what is required for each of the populations. It is important for researchers to keep in mind that risks may vary for particular groups, depending on the nature of the research being conducted.
Can children be involved in research?
Research involving greater than minimal risk is permitted with children only under specific conditions, and requirements depend on the prospect or absence of direct benefit to the individual participants.
Can NIH exclude women?
NIH policies state that studies should not be designed to exclude women, minorities, and individuals based on age unless there is a scientific or ethical reason not to include them. Please visit the Inclusion of Women and Minorities in Clinical Research website and the Inclusion Across the Lifespan website for more information about these policies.
Can reviewers comment on the additional protections for prisoners in their critiques?
Reviewers may choose to comment on the additional protections for prisoners in their critiques. Unacceptable risks and/or inadequate protections for participants who are prisoners must be identified as Unacceptable Human Subjects Protections in the Summary Statement.
What are vulnerable populations?
The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
Why are individuals in these groups considered potentially vulnerable?
Individuals in these groups may be considered potentially vulnerable because they may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.
Why do investigators need to provide protocol specific justification to the IRB?
Investigators must provide protocol specific justification to the IRB so that the IRB may make a determination that the enrollment of children in the research is justified.
Is there a federal law that protects students and employees?
Though there are no federal regulations that provide explicit protections for Students and Employees, the involvement of students and employees may present special concerns.
