Guidelines for Research Involving Vulnerable Populations

What is Vulnerable Population?

Vulnerable population refers to the individual that does not have the decision-making capacity to provide voluntary Informed Consent. Vulnerable population is considered as a disadvantaged sub-segment of the community requiring utmost care, specific ancillary considerations and augmented protections in research. There are two types of vulnerable groups, namely:

  • Subjects with limited capacity to make autonomous decisions for their own interest;
  • Subjects who face coercion and pressure in making decisions because of the situation they are in.

Historically, those who are vulnerable have been subjected to one or more of these four common types of abuses in human research.

Common Types of Abuses in Human Research
Types of Abuse Explanation
Physical Control Subjects who are physically forced to participate in research. This represents a complete lack of voluntariness. When subjects have no choice about whether or not to participate in research and are under the complete physical control of the investigators.
Coercion The use of a credible threat of harm or force to control another person. This also represents a lack of voluntariness.
Undue Influence The misuse of a position of confidence or power to lead or influence others to make a decision they would not otherwise make.
Manipulation The deliberate design and management of conditions or information intended to lead subjects to make a decision they would not otherwise make. Examples include lying about information, withholding information, or exaggerating information.

 

Sources of Vulnerability: Situational Considerations

Based on the 2011 Health Research and Development Ethics Standard Guidelines (KEPPKN Guidelines), vulnerable groups are defined as human beings, either individually, in households, groups, socially, or in society who are relatively or absolutely unable to protect their own interests or their group. They may lack the freedom, intelligence, education, economy, resources, power, and other necessary things to protect their own interests.

This method of classifying vulnerability does not account for situations in which an individual might be vulnerable (such as, someone who is acutely ill). Additionally, the group-based classification of vulnerability does not adequately address when an individual has multiple sources of vulnerability (such as, pregnant minors, individuals with mental illness who are also homeless, and others).

The NBAC (2001) provided an alternative way of thinking about and analyzing vulnerability. The NBAC looked at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social.

  1. Cognitive or Communicative Vulnerability

Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a cognitive or communicative vulnerability. This vulnerability may be thought of in three broad categories. In any of these situations, subjects may not be able to provide the PSP to participate in the research.

    1. Capacity-related cognitive vulnerability – the subject lacks the ability to make choices. Examples might include a child or adult with a cognitive impairment that affects decision making.
    2. Situational cognitive vulnerability – the subjects have abilities but are in conditions that do not allow them to use their abilities effectively. Examples might include when the subject is bullied or during an emergency, such as a serious illness or injury.
    3. Communicative vulnerability – the subject has the ability, but there are limitations to communicate with the investigator so they cannot use their abilities effectively. Examples might include subjects who speak or read in a different language from the investigator, or subjects who have speech or reading difficulties.
  1. Institutional Vulnerability

Prospective subjects in research who are subject to the formal authority of others may have an institutional vulnerability. These individuals have the cognitive capacity to give Informed Consent but may not be able to make a truly voluntary choice, and may be unduly influenced (or coerced) to participate when they otherwise might not have done so. Institutional vulnerability may arise when subjects are prisoners, enlistees in the military, employees, or college students. For example, college students may be required to be research subjects for course credit or participate to earn a higher grade. In these situations, Informed Consent may be compromised because it is not truly voluntary. Further, those individuals might be exploited because of their subordinate status.

     3. Deferential Vulnerability

Deferential vulnerability is similar to institutional vulnerability, but the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. The power relationship may be based on gender, race, or class inequalities, or they can be inequalities in knowledge (such as in the doctor-patient relationship). Like institutional vulnerability, deferential vulnerability increases the risk of harm because PSP would be compromised and not fully voluntary.

     4. Medical Vulnerability

Medical vulnerability occurs when prospective subjects have a serious health condition for which there is no standard of treatment. Subjects may not be able to weigh the risks and potential benefits of the study, so PSP may be carried out with insufficient understanding. Further, these subjects are at risk of being exploited because they may overestimate the benefit. When subjects’ views of the role of physicians and research (in cases where the physician treating the patient is also an investigator) are blurred or they fail to distinguish between research and treatment, the misunderstanding exacerbates medical vulnerability.

     5. Economic Vulnerability

Economic vulnerability occurs when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Participation in research provides the possibility of paying, obtaining health care, or other services and encouraging individuals to participate in research when they may not want to. These inducements to participate undermine the voluntary value of the PSP and increase the risk of exploitation in research.

     6. Social Vulnerability

Prospective subjects who belong to undervalued social groups may be subject to social vulnerability. The perception of these groups as less valuable to society could lead to reduced concern (by investigators) for risks and burdens on those groups, and increase the risk of exploitation.

 

Terms of Research with Vulnerable Groups

This guideline provides a detailed procedure for KEP LPEM FEB UI and investigators in reviewing research involving vulnerable populations.

 

Research Involving Children as Subjects

Children are individuals who have not attained the legal age for consent to treatments or procedures involved in the research. According to Indonesian Law, children refer to any human being under the age of 18 (Law No. 35/2014 on Child Protection).

The involvement of children in research raises particular ethical concerns due to their lack of autonomy and inability to provide PSP. They are possibly vulnerable to control, coercion, undue influence, and manipulation by others (for example, parents or guardians, investigators, and teachers). 

 

Permitted Research Categories Involving Children as Subject

  • Research does not involve risks that exceed the minimal risk;
  • Research that involves risks that are greater than minimal risk but has the prospect of direct benefit to the children involved in the research;
  • Research involving greater than minimal risk and no prospect of direct benefit to the child involved in the study, but has the potential to yield general knowledge about the subject’s disorder or condition;
  • Research does not meet the above conditions, but potentially provide a deeper understanding of, prevent, or alleviate problems affecting children’s health or well-being.

Protocols:

Protocol 1: If the research is not involving greater than minimal risk
To approve this category of research, KEP LPEM must ensure the following conditionalities:

  • This research have a risk that does not exceed the minimal risk to children;
  • Investigators are able to provide documents to obtain consent from children and their parents or guardians.

Protocol 2: If the research involves risks that are greater than minimal risk but have the prospect of direct benefit to the children involved in the study.

This category of research will only be approved by KEP if the board finds that:

  • The risks that occur are proportional to the benefits that the subject may receive;
  • The benefits that the subject may receive from this research procedure are at least as beneficial as the benefits received if using an alternative approach.
  • Investigators are able to provide documents to obtain consent from children and their parents or guardians.

Protocol 3: If the research involves greater risk than minimal risk and no prospect of direct benefit to the child involved in the study, but has the potential to yield general knowledge about the subject’s disorder or condition.

This category of research will only be approved by KEP if the board finds that:

  • The risk represents a minor increase over minimal risk; 
  • The intervention or procedure are reasonably comparable with those inherent in subjects’ actual or expected medical, dental, psychological, social, or educational situations; 
  • The intervention or procedure provided has the potential to yield general knowledge about the subjects’ disorder or condition that is essential for understanding or improving the subject’s disorder or condition;
  • Investigators are able to provide documents to obtain consent from children and their parents or guardians.

Protocol 4: If the research does not meet the permitted conditions, but may be able to understand, prevent, or address issues affecting children’s health or well-being.

The research that falls within this category will only be proceed if the consultation with a panel of experts in pertinent disciplines has determined that:

  • The research in fact satisfies the conditions in protocol 1, 2, and 3, or: 
  • The research has the potential to better understand, prevent, or address serious problems affecting children’s health or well-being;
  • The research will be conducted in accordance with sound ethical principles; 
  • Investigators are able to provide documents to obtain consent from children and their parents or guardians.

 

Children’s Assent

Investigators must seek a child’s consent, unless the KEP decides that: 

  • The children involved (as a group or individually) are unable to give consent, given their age, maturity or mental state;
  • The research has a prospect of an important direct benefit to children and is only possible through this research procedure; or
  • The research involves circumstances that would allow waiver of consent for adults.

 

Parent or Guardian’s Permission

  • Research involving children must obtain permission from each parent or guardian.
  • If the study was conducted using Protocol (1) or Protocol (2), the investigator only required the consent of one parent.
  • If the study was conducted using Protocol (3) or Protocol (4), both parents must give their permission. 
  • If the KEP decides that parental or guardian permission is not a relevant requirement to protect the subjects (e.g., neglected or abused children), it may waive the consent requirements so long as there is an appropriate mechanism for protecting the children involved.

 

Guidelines for the 13th KEPPKN 2011 regarding the Inclusion of Children Subjects:

Before starting research involving children, investigators should ensure that:

  • The study could not be carried out with the same results in adults.
  • The purpose of the study was to acquire knowledge according to the needs of children’s health and welfare.
  • Parents or legal representatives have given consent for each child.
  • The consent of each child has been obtained if the child is considered capable of making his own decisions.

 

Research Involving Prisoners as Subjects 

Prisoner means any individual involuntarily confined or detained in a penal institution. According to Indonesian Law, a prisoner is suspect or defendant who is detained by investigator (Law No. 8/1981 on Criminal Procedure Code). Prisoners may be subject to coercion because they are under the control of regulators. They may also experience state abuse because they may wish to participate in research to improve their existence or receive parole.

Prisoners are considered under constraints because of their imprisonment which could affect their ability to make a truly voluntary and uncoerced decision regarding their participation as the subject of a research.

 

Permitted Research Involving Prisoners as Subject:

The KEP can approve research involving prisoners, only if all of the following conditions are met:

  • Study of the possible causes, effects, and processes of incarceration, and of criminal behavior; 
  • Study of prisons as institutional structures or of prisoners as incarcerated persons;
  • Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults); 
  • Research on practices which have the intent and prospect of improving the health or well- being of the subject. 

Protocols:

The KEP should only approve such research only if it finds that:

  • The benefits of prisoners participation in research should not exceed limits that could affect the prisoners’ ability to assess potential risks;
  • The risks involved in the research are comparable with risks that would be accepted by non-prisoner volunteers if the research were conducted outside of prison;
  • Subject selection procedures in prisons are fair to all prisoners and are free from interference by prison authorities or prisoners.
  • The information is presented in understandable language to the subject population; 
  • The investigator should provide assurance and clearly inform that the prisoners participation in research will have no effect on decisions regarding parole;
  • If the study requires a follow-up procedure after the study, the investigator must inform the subject of this and prepare adequate documents to carry out the procedure, taking into account the variation in each subject’s detention period.

 

Pregnant Women, Human Fetuses and Neonates Involved in Research

Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. Fetus means the product of conception from implantation until delivery. 

Some types of studies may include procedures that could potentially harm an unborn child or pregnant woman. For this reason, pregnant women should be included as a group that guarantee special protection.

Protocols:

Pregnant women or fetuses may be involved in research if all of the following conditions are met: 

  • Scientifically appropriate preclinical studies have been conducted and data for assessing potential risks to pregnant women and fetuses are available. 
  • The risk to the fetus is caused solely by the interventions or procedure administered during the study;
  • If there is no prospect of direct benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important knowledge which cannot be obtained by any other means.
  • Any risk that may occur is the smallest risk to achieve the research objectives;
  • No incentive, monetary or otherwise, will be offered to terminate a pregnancy; 
  • The individuals involved in the study will have no role in the decision-making regarding the time, method, or procedure used to terminate a pregnancy;
  • The individuals involved in the study did not play a role in determining the survival of the new born.

 

Informed Consent of Research Involves Pregnant Women, Fetuses, and Infants as Subjects

  • Any research that has or does not have a direct benefit to pregnant women and/or fetuses requires the consent of the mother.
  • If the study has the prospect of direct benefit only to the fetus, the consent of the mother and father of the fetus is required. However, this does not apply if the father is unable to give consent due to his absence (in the life of the pregnant woman and fetus), incompetence or inability to provide PSP, or the pregnancy was the result of rape or incest.
  • Each individual who gives consent is fully informed about the possible risks to the fetus or neonate.

 

Guidelines for the 15th KEPPKN 2011 regarding the Participation of Pregnant Women Subjects

Before starting the research by including pregnant women as research subjects:

  • Investigators must ensure that the research cannot be carried out with the same results in women who are not pregnant or in men.
  • The aim of the research is to gain knowledge according to the health and welfare needs of pregnant women and their fetuses.
  • Investigators also need to convince the KEP that the research does not harm the woman and her fetus by providing reliable evidence.
  • Investigators or sponsors also need to understand the culture, beliefs, and habits of the community regarding women’s health in the place where the research is carried out.
  • Consent was obtained from pregnant women after the investigator gave sufficient explanation about the risks and benefits that might occur for themselves and their fetuses as well as the benefits for the development of science related to the health and welfare of pregnant women and their fetuses.
  • Investigators and sponsors must ensure the maintenance of the health and well-being of pregnant women and their fetuses by providing appropriate health care and other support facilities during the study and until safe delivery.

 

Subject with Limited Ability to Read, See, and Hear

Individuals in this group may be unable to read consent forms or instructional materials or hear answers to questions.

Protocols:

  • When individuals in this group are subjects in research, all information and communication must be provided in a way that is understandable to the subjects. 
  • People who cannot read or see should be provided with verbal descriptions of all procedures, requirements, potential risks, etc. 
  • For people who cannot hear, all communications should be provided in writing or via sign language, or in some other way that is clearly understandable to the subject.
  • Consent After Explanation (PSP) must be made clear and understandable to the subject.
  • If consent is obtained orally, the investigator must apply for a PSP documentation requirement waiver by filling out the following form: Informed Consent Documentation Requirement Waiver Form.

 

Subjects with Cognitive Disorders

Subjects with cognitive disorder requires special protection because of their limitations in making decisions. This group includes infants and young children, as well as individuals who are mentally impaired, have Alzheimer’s disease, are comatose, etc.

Protocols:

  • Subject must be represented by an authorized third-party (parent, guardian, next of kin, etc.) that can represent the subject’s interests.
  • The third parties should be those who are most likely to understand the incompetent subject’s situation and to act in that person’s best interest.
  • Investigators should inform and communicate with the subject, as well as the third party, as much as possible.
    • If possible, communications should occur immediately before undertaking the investigation, to increase the likelihood that the subject will understand and remember what he/she has agreed to.
    • If possible, the PSP documents should be signed by both the subject and the authorized third party.
    • Third parties who represent the subject can follow the research development.

 

Vulnerability Due to Critical Illness

Vulnerability for the group of critically ill individuals and in the situation of emergency research may be due to intrinsic factors (such as reduced decision-making capacity of subjects and reduced capacity of subjects to provide Informed Consent) and situational factors (such as coercive conditions or abuse of circumstances).

Even if potential subjects can understand and communicate well, their voluntary decision can be influenced by situational factors, as in emergency research. If the treating physician also has a research role, this may result in an abuse of circumstances in the individual’s willingness to participate in a study.

 

Vulnerability Due to Terminal Illness (Research at the End-of-Life)

Individuals with terminal illness are vulnerable because of cognitive and physical impairment, which may worsen as death approaches.

Threats to voluntariness may occur as a result of an often a desperate desire for relief from pain and suffering, presenting the risk of exploitation. Desire to please caregivers may be particularly prominent. In addition, the risks and benefits that are important to patients near the end-of-life may be much more difficult to define. In other words, an individual’s goals and perceptions of burden and risk may change substantially as he or she nears death.

 

Vulnerability Due to Decisional Impairment

It is important to recognize that decisional impairment can result from a variety of intrinsic and situational factors and is not limited to individuals with a psychiatric diagnosis. Decisional impairment exists along a spectrum and therefore must be assessed in the context of the information that must be understood and the nature of the decisions to be made.

Decisional impairment can result from many causes including stroke and other central nervous system disorders, trauma, medical treatment, and drug abuse. In some cases, decisional impairment can arise through disability. 

Decisional impairment is often compounded by situational factors that limit freedom of choice and the ability to understand the nature and consequences of research participation. Some examples include:

  • Stigma
  • Lack of or insufficient healthcare insurance coverage
  • Under-education
  • Discrimination
  • Institutionalization
  • Homelessness
  • Inadequate access to housing

 

Vulnerability Due to Physical Disabilities or Impairments

Physical disabilities and impairments can result in diminished participation in society because the disability limits a major life activity (Equal Opportunity for Individuals with Disabilities 2009). The diminished participation in society can lead to vulnerability both because of an intrinsic factor (such as, a physical limitation the individual experiences) or a situational factor (such as, a lack of an adequate accommodation for the disability allowing for full participation).

Intrinsic factors such as a limitation in one of the senses (like sight) can lead to a very strong desire to participate in research that may have the prospect of direct benefit to the subject. This may potentially lead to undue influence. Additionally, situational factors in the study design can lead to vulnerability. For example, not providing a large-print or Braille consent form to an individual who has a visual impairment or blind can interfere with the voluntariness of consent.

 

Vulnerability Due to Economic Disadvantage or Social Marginalization

Economically disadvantaged individuals are those who are under-resourced to provide for themselves or their families, and experience particular hardships due to disparities and inequalities in the society in which they live. These situational factors can affect or limit the subject’s voluntariness to participate in research.

Socially marginalized individuals are those who lack influence in society or standing for a socially constructed reason (such as, race, religion, or disease state). Individuals who are socially marginalized often lack adequate access to social organizations such as the legal system.

The potential for undue influence or manipulation is higher for these subjects. For example, the prospect of getting monetary compensation for participation in research could significantly affect the willingness to participate, influencing the subject to accept greater risks of harm than they would otherwise accept. Economically disadvantaged individuals may also enroll in health research because it could mean access to healthcare where they may not otherwise have access.

 

Vulnerability Due to Social Hierarchy

Hierarchical social structures are found in situations throughout society. Examples include hospitalized individuals, nursing home residents, students, employees, prisoners, soldiers, other military personnel, or in some cases ethnic groups (such as, indigenous populations).

Hierarchical structures have the potential to create issues centered on power/control, coercion, undue influence, and manipulation. The “higher” hierarchical individual has the ability to exercise power or control over others (subordinates) in some way that is either real or perceived. Examples include:

  • Program directors seeking enrollment in research from residents they directly supervise.
  • Faculty members recruiting students they currently teach.
  • Commanding officers seeking enrollment in research from soldiers or military personnel that report to them through the chain of command.

 

Vulnerability Due to Minority Sexual Orientation Status

“Sexual and gender minority” is an umbrella phrase that encompasses lesbian, gay, bisexual, and transgender populations as well as those whose sexual orientation, gender identity and expressions, or reproductive development varies from traditional, societal, cultural, or physiological norms (NIH 2017). Members of the community may be vulnerable to discrimination, bullying, violence, and prejudice. Gender differences in societal structures, usually directed towards women, may render one gender vulnerable to these forces as well.

Individuals with minority sexual orientations face social and cultural vulnerability because many have experienced some forms of prejudice and discrimination at home, school, work, and/or other social contexts or organizations due to their sexual orientation. Gender differences may also make some individuals vulnerable, especially in areas of the world where women do not have the basic rights of citizenship (for example, access to an education, the right to divorce, and the right to vote). These vulnerabilities can lead to increased risks of harm to the individuals in their participation in research, and the prospect of undue influence or manipulation.

The principle of beneficence, or “do no harm,” is particularly important in research involving minority sexual orientations. Social and behavioral investigators should be aware of the potential harm to research participants and use safeguards to minimize the potential risk of harm when conducting research involving such groups.

 

Vulnerability Due to Uncertain Immigration Status and Individuals Involved in Illegal Activities

Individuals or groups of people who are regarded as being involved in illegal activities or are undocumented immigrants may be vulnerable because of the potential consequences that exposure may have to them. This can include risks of retaliation against them by others and legal consequences.

The risks of harm are higher for such individuals and often include group-based harm risks such as violating public trust which may have negative impacts on public health and well-being. For example, if undocumented individuals or those involved in illegal activities fear that they will be exposed when seeking medical care, they may not seek medical care when they need it. This can result in an increased negative health impact on this group of individuals.

 

Research Ethics Implications

The three pillars often described in research ethics (respect for persons, beneficence, and justice) are important to examine in the context of vulnerable individuals or groups participating in research. A combination of intrinsic factors and situational conditions that lead to vulnerability also open up the individual or group to potential problems that interfere with one of the pillars, requiring attention by the KEP and potentially additional safeguards being put in place in the research.

Autonomous Decision Making (Respect for Persons)

There is the possibility that due to intrinsic factors or situational conditions individuals or groups can be open to coercion or undue influence. The National Commission (1977) asserts that coercion occurs when one person intentionally presents an overt threat of harm in order to obtain compliance. An example is a professor telling students, “participate in my research or you will fail the class”.  Physicians who threaten patients who refuse to participate in research are also coercive measures. However, the National Commission’s definition may be too narrow, as coercion is not always explicit. For example, a patient who participates in a study run by her primary care physician, because the patient fears her care is contingent on participation, is reacting to fear of retribution (coercion), whether the physician intends this or not.

Inducements, in contrast, are offers that influence people to make decisions, or do things they would not otherwise do. Inducements and the influence they cause may be acceptable or they may be “undue.” The difference is not always clear or generally accepted. Offering IDR 50,000 may be acceptable for research of one hour duration; offering IDR 500,000, or more, may not be appropriate for the same length of time and research load.  In general, inducements constitute an undue influence if they alter a potential subjects decision-making processes such that they do not appropriately consider the research’s risk-benefit relationship.

Misunderstanding of the research is also a problem that can interfere with autonomous decision-making. For individuals or groups who are vulnerable, the prospect of direct benefit, whether real or perceived, can dramatically affect the individual’s voluntariness. This can lead to a person accepting a much higher level of risk of harm than they otherwise would accept or subscribing to the false belief that the research may hold out the prospect for direct benefit to them.

Beneficence

The concept of beneficence in research includes weighing the research’s risks of harm against the benefits. When conducting research involving vulnerable individuals or groups, two issues arise related to risks of harm.

  • There may be changes in the magnitude of an already identified risk of harm due to the vulnerability experienced by the individual or group.
  • There may be previously unrecognized risks of harm that arise because of the vulnerability experienced by the individual or group.

Justice

There are three considerations that may arise when assessing justice in research involving vulnerable individuals or groups.

  • In some types of research, a vulnerable group may be the primary group on which the research is conducted because the investigation is focused on the source of vulnerability. This means that the heaviest research burden lies with vulnerable groups. It should be noted whether this also means that those who experience vulnerability are the main beneficiaries of the research results. Based on the concept of justice in the Belmont Report, only under these conditions can research with vulnerable groups be accepted. 
  • Some individuals or groups who are vulnerable may become the study focus merely for ease or convenience of access, or because risks of harm or burdens to them are trivialized, as the group is undervalued. This is a significant issue and should be monitored carefully. There are historical cases of prisoners or wards of the state being studied because of convenience when there were more appropriate study groups to enroll. This was the case for both the Jewish Chronic Disease case and the Willowbrook case. In this case, the investigator includes a population that is considered low by the community and easy to study.
  • Designing studies to exclude individuals or vulnerable groups from the research because of the complications and additional requirements for studying them is problematic In this case, the lack of inclusion of vulnerable individuals interferes with the ability of research to advance understanding and knowledge, while denying the potential benefits of research.

 

Guidance for KEP and Reviewers

The breadth of the expanded view of vulnerability described here and the complications involved with adhering to the regulations, combined with a common-sense approach to try to protect subjects, result in increased difficulty in the KEP’s review of research. Therefore, a stepwise approach to consideration of the research proposal may be helpful.

 

Are subjects vulnerable?

Investigators need to fully describe the population to be studied and the situation that will be felt by potential research subjects. This should answer both the question about the intrinsic factors or attributes, as well as the situational forces that may give rise to different types of vulnerability. It will also help the KEP and investigators quickly identify if there are any regulations that must be applied. Investigators generally have a much clearer understanding of the circumstances and potential challenges their research subject’s face. They are in a unique position to share their insight. When KEPs request this information, it facilitates the review of research and in the best circumstances leads to better designed research studies, improved review of research, and better protection of human subjects. Investigators and KEPs should consider:

  • Is there a power differential between investigators and subjects?
  • Is there potential excessive motivating factors for subjects?
  • Are there a potential communication issues for subjects?
  • Are there a potential decisional issues for subjects?
  • Is the recruitment process fair?
  • Does the promotion of research not create situations of manipulation or abuse of circumstances?
  • Are there economic issues that affect the fairness of the subject’s compensation or benefits?

 

Is inclusion of vulnerable subjects appropriate?

As discussed above, if some potential subjects are vulnerable, the IRB must then decide if inclusion of this population is indeed appropriate. The IRB must consider the competing ethical imperatives of respect for persons (especially protection of persons who lack self-determination and require protection), beneficence, and justice (offering a fair opportunity to benefit from participation).

According to the 2011 KEPPKN Guidelines in Point 12, the involvement of vulnerable groups in research can be appropriate if:

  • The research cannot be carried out equally well on non-susceptible subjects
  • Generate knowledge that improves the quality of diagnostics, prevention and treatment for specific or unique health and/or well-being problems in these vulnerable population groups
  • Vulnerable subjects will later get proper access to the results and benefits of research
  • The risk to the research subject does not outweigh the risk of a routine medical or psychological examination; unless KEP allows a slightly higher risk than routine examinations (if the prospective research subject is unable or unable to provide PSP, consent to participate as research subjects is obtained from his legal guardian)

 

Is Protection of Vulnerable Subjects Sufficient?

If the inclusion of vulnerable subjects is appropriate, does the research plan (including subject identification, recruitment, and PSP) minimize the possibility of coercion, undue influence, manipulation, and exploitation? Meanwhile, does the research plan maximize the likelihood of valid PSP? At a very minimum, is the process of PSP valid? That is, is information presented in an understandable manner, do subjects comprehend the details of the research and their rights as research subjects, and is the process of PSP conducive to volunteering?

In addition, investigators and KEP should consider:

  • Are there reasonable accommodations provided for subjects who may be disabled?
  • Is information presented to subjects in an understandable and accessible manner?
  • Do subjects comprehend the research details and their rights as research subjects?
  • Is the consent process conducive to true voluntariness?
  • Who is involved in the consent process?
  • Can the subjects consent for themselves?
  • Do the vulnerabilities of the subjects require the additional protections of a research subject advocate?

 

It is important to remember that the review process described here is an iterative process. Adequate protections may now allow inclusion of a population previously considered too vulnerable, or indeed may make a population not vulnerable at all.

Download this guide: A Guide to Reviewing Research Involving Vulnerable Groups

 

Reference:

  • 46 Code of Federal Regulations Part 45 – Office for Human Research Protection, US Department of Health and Human Service
  • Guidelines for Selected Procedures and Populations – Committee on the Use of Humans as Experimental Subjects (COUHES), Massachusetts Institute of Technology
  • Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan Nasional – Komite Etik Penelitian dan Pengembangan Kesehatan Nasional,  Kementerian Kesehatan RI
  • UU No. 35 tahun 2014 tentang Perlindungan Anak
  • UU No. 8 tahun 1981 tentang Kitab Umum Hukum Acara Pidana
  • WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects-59th WMA General Assembly, Seoul, Korea, October 2008
  • CITI Training: Population in Research Requiring Additional Considerations and/or Protection
  • Guidelines for Selected Procedures and Populations – Committee on the Use of Humans as Experimental Subjects (COUHES), Massachusetts Institute of Technology
  • Vulnerability in Research: Basic Ethical Concepts and General Approach to Review (2020)
  • National Bioethics Advisory Commission (NBAC). 2001. “Ethical and Policy Issues in Research Involving Human Participants: Volume 1 – Report and Recommendations of the National Bioethics Advisory Commission.
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