A “vulnerable participant” is any individual who lacks the ability to fully consent to participate in a study. 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 is a vulnerable participant in research?
Vulnerable Participants. A “vulnerable participant” is any individual who lacks the ability to fully consent to participate in a study . 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, ...
What is a vulnerable population in psychology?
A vulnerable population is a group of people that requires greater protection than normal against the potential risks of participating in research. Individuals in vulnerable populations may have a higher risk of negative outcomes as a result of participating in a research study, they may have a reduced capacity...
What are the vulnerable populations sections used for?
These sections can be used to address participation and protections for vulnerable populations, such as children and prisoners, and groups that may be at increased risk and/or require additional protections, such as pregnant women.
How do you select a vulnerable population for a study?
There are many different factors that may guide the selection of your study population, such as your research aims and the anticipated availability of participants. One important factor that you need to consider in your selection is whether the population is considered a vulnerable population. So, what exactly is a vulnerable population?
Who is considered vulnerable population IRB?
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.
Who are vulnerable populations in clinical trials?
Vulnerable participants or populations are individuals or groups of individuals who are unable to give informed consent to take part in a clinical trial, such as children or people affected by mental health conditions, or who may come under pressure from others to take part.
Who are the groups of people that the IRB considers vulnerable for research participation in the 45 CFR 46?
Vulnerable populations include those defined 45 CFR 46 Subparts B (Pregnant Women), Subpart C (Prisoners), andSubpart D (Children), and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons.
Who are the vulnerable subjects in research and clinical trials?
The federal government has established guidelines and regulations for the protection of vulnerable research subjects, especially children, pregnant women, cognitively impaired persons, and prisoners. In addition, students, residents, and employees are recognized as special research populations.
What is a vulnerable population 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.
Who is considered a vulnerable population?
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 prisoners considered to be a vulnerable population in research?
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.
Are children considered a vulnerable population in research?
Who are considered "vulnerable subjects"? People who may be especially susceptible to coercion or undue influence are considered vulnerable subject populations. These include: Children/minors.
Which of the following is not an example of a vulnerable population of research participants?
Fair selection of research participants does not apply to vulnerable populations such as children, prisoners, pregnant women, mentally disabled, or economically or educationally disadvantaged persons.
Which group would be considered vulnerable for research purposes quizlet?
Identify which population are considered vulnerable populations from a research context. person with diminished autonomy sometimes are regarded as vulnerable. Such groups may include children, individuals with cognitive disorders, prisoners, and pregnant women.
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 they considered vulnerable?
Definition. Vulnerable populations are individuals who are at greater risk of poor physical and social health status. They are considered vulnerable because of disparities in physical, economic, and social health status when compared with the dominant population.
What are vulnerable populations in healthcare?
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.
What are special populations in research?
For this summary paper, we define "special populations" by age (minors younger than eighteen years of age or elderly adults older than sixty-five), historically under-represented ethnic or racial groups, and people who live in rural areas.
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 is the IRB's role in mental health?
The IRB evaluates and approves the proposed plan for the assent of participants. If mental capacity is over 7 years of age, an assent is needed with a guardian consent.
What should a PI include in a study?
The justification must include a description of how mental capacity will be assessed.
What is an independent monitor?
The independent monitor is a qualified individual not involved in the research study who will determine the subject’s capacity to provide voluntary informed consent.
Which population is not usually requiring independent monitoring?
Populations not usually requiring independent monitoring would include those with substance use disorders.
Who does recruitment work for?
Recruitment is done by a person who is not teaching the class or is not the supervisor. The faculty or employer can recruit, however it must be clear that the class status, grades or employee status will not be affected by non-participation or draw.
What is a vulnerable population?
In accordance with federal regulations, The University of Tennessee, Knoxville ensures that additional safeguards are included in the research design to protect participants that are likely to be vulnerable to coercion or undue influence or have diminished decision-making capacity.
Children
For further information on how these populations are defined please refer to our Standard Operating Procedures and the federal regulations.
What age can you be in NIH research?
There are also specific requirements that apply to research involving children in 45 CFR 46 Subpart D .#N#NIH defines a child as an individual under the age of 18. Note that children is defined in 45 CFR 46 as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”#N#Important points from 45 CFR 46 regarding research with children:
What is 45 CFR 46?
Note that children is defined in 45 CFR 46 as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. ”. Important points from 45 CFR 46 regarding research with children:
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 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.
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.
When is an advocate required?
When children are wards of the State or other agency/institution/entity, an advocate may be required in addition to an individual acting on behalf of the child as a guardian or in loco parentis.
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.
Why is special justification required for inviting vulnerable individuals to serve as research subjects?
The CIOMS Guidelines also state that Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied. Investigators need to explain why they have chosen to conduct the research in children or other vulnerable group instead of in a group that is more able to protect themselves. The desire to protect must be balanced with the need to conduct research in order to advance medical science in order to benefit those same vulnerable populations.
What is CIOMS in medical terms?
The Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects. provides a succinct and useful defintion; Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests.
What does "prisoner" mean?
Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
When did the FDA start allowing special protections for children?
Special Protections in the FDA Regulations. The FDA did not any equivalent protections for these population until 2001, when a draft rule created Subpart D protections for children similar but not identical to the Subpart D protections in the Common Rule.
Which commission issued three reports related to groups deserving of additional protections in the research context?
The National Commission issued three reports related to groups deserving of additional protections in the research context provide the basis for the additional protections incorporated into the Common Rule.
Can an adult be a LAR in Pennsylvania?
When an adult does not have the capacity to consent to the procedures involved in the research, then they cannot participate without the consent of their legally authorized representative (LAR). In Pennsylvania, a competent adult may designate an individual of their choice to serve as their LAR. If that individual loses the ability to consent due to a temporary situation (surgery, trauma), their LAR may act on their behalf. Someone with a progressive condition such as Alzheimer's can also designate an LAR before they lose the competence to consent.
Can children be involved in research?
Most of the research protocols active at CHOP involve children as research subjects. Understanding the regulations governing participation of children in research is vital. Children are neither legally nor developmentally capable of consenting to their own treatment or participation in research. No one can consent for an individual other than that person. As a result, a proxy, such as a parent, must provide permission in lieu of consent and children who are deemed capable, must provide their assent.
What is a vulnerable population?
A vulnerable population is a group of people that requires greater protection than normal against the potential risks of participating in research. Individuals in vulnerable populations may have a higher risk of negative outcomes as a result of participating in a research study, they may have a reduced capacity or ability to give consent, ...
What is the purpose of section 7 of the IRB proposal?
The purpose of the IRB proposal is to answer four key questions of why your research is important, how you intend to conduct the research, who will take part in your study, and how you will manage experimental data once you have collected it.
What is a debilitating mental health condition?
Individuals with a debilitating mental health condition or cognitive impairment. Pregnant women. Victims of traumatic events (e.g., abuse, natural disasters) Individuals involved in a crisis (e.g., war, natural disaster) Individuals who are economically disadvantaged.
What is non-English speaker?
Individuals who are not fluent in the language the study is being conducted in (e.g., non-English speakers in studies conducted in the United States)
What is a child in prison?
Understand your needs and timeframe. Children (i.e., minors or individuals under the legal age of consent) Individuals who are incarcerated (i.e., prisoners ) Residents of a facility (such as a mental health facility, nursing home, treatment center, etc.)
How to get a dissertation approved?
Get Your Dissertation Approved 1 Address committee feedback 2 Roadmap to completion 3 Understand your needs and timeframe
Can IRB research be done?
However, even if you demonstrate all of those things in your IRB application, there is no guarantee that the IRB will allow you to conduct the research. In some rare cases, the IRB may not allow you to study a particular population, regardless of the ethical rigor and merit of your proposed research. This is why it is a good idea to have a discussion with your IRB in the early stages of your research if you have any plans to recruit from a vulnerable population. Having this discussion early on may save you from spending months on a proposal that could inevitably be rejected by the IRB.
What is the purpose of vulnerability in research?
It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines.
What is research ethics?
Research on human subjects is thought to be fundamentally ethically challenging, requiring ethics standards to guide researchers as well as approval and oversight of research proposals from independent committees . Society allows researchers to invite individuals to participate in research once certain conditions are met, including a research ethics board’s (REB, also known as Institutional Review Boards, or IRBs, or Research Ethics Committees, or RECs) determination that risks and benefits are appropriately balanced, that the proposed strategy for subject recruitment is fair, and that voluntary, informed consent will be sought from each potential subject [1]. The concept of vulnerability, which finds it origins in the United States Belmont Report of 1979 [2], plays a central role in research ethics thinking, drawing attention to situations where these conditions may not be met [1]. Since 1979, the number of legal and non-legal research ethics policies and guidelines has increased tremendously and, with them, the use and scope of the concept of vulnerability or vulnerable populations [2, 3]. However, there is much scholarly disagreement over the appropriate meaning and application of this concept in research ethics, and policymakers are charged with the challenge of navigating this contentious landscape in the development and refinement of research guidelines and policies [4]. A growing body of literature critiques and aims to advance the way vulnerability is conceptualised and employed in research ethics, with major debates regarding foundational elements of this important ethical concept [5–10].
What are the four guiding values?
Describes four guiding values and principles: research merit and integrity, justice, beneficence, and respect
What is a quality standard?
An ethical and scientific quality standard for designing, conducting, recording, and reporting human subject research trials; serves as a unified standard for CA, the EU, JPN, and US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions
What is a clinical trial act?
A legislative act that establishes specific provisions for good clinical practice in clinical trials; EU Member States must meet these provisions though the Directive does not legislate how
What is universal framework?
A universal framework of principles to guide States in formulating legislation and policies, as well as to guide the actions of individuals, groups, communities, institutions and corporations, public and private
How many ethics policies are there in research?
We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability.
Vulnerable Populations in Research
- T o be considered a vulnerable population, the targeted group must be the focus of the research. If the target is the general population, and one of these groups (except prisoners) will participate, they are not considered a "target" population. Note:If prisoners are the targeted study population, the study must be reviewed via full board and a prisoner representative must be consulted by th…
Diminished Capacity
- The PI should identify the intent to enroll vulnerable subjects in the proposed research in the initial submission and provide justification for their inclusion in the study. The justification must include a description of how mental capacity will be assessed. 1. If the research involves adults unable to consent, the IRB evaluates the proposed plan for consent of legally authorized representatives. …
WVU Students and Employees
- WVU students and employees are considered a vulnerable population if the student is actively being taught by the a member of the research team or the employee reports to a member of the research team. The primary concern is perceived coercion. 1. If students are targeted as participants, be sure to include the language provided in the standard IRB ...
Research Involving Prisoners
- For detailed information regarding prisoners in research, please see the SOP 047: Research Involving Prisoners.
- For National Institute of Justice-funded research (including Department of Justice):