Vulnerability in Health Research

Ghaiath M. A. HusseinMBBS, MHSc. (Bioethics)

• What is vulnerability?• Who is considered vulnerable?• Ethical considerations (Risk/Vulnerability Matrix)• Practical points

• Vulnerable: “Vulnerable persons are those who are relatively (or absolutely) incapable of

• protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources strength, or other needed attributes to protect their own interests.” (CIOMS, 2002)

Making use of this definition… let’s brainstorm!

www.amanet-trust.org

1. WOMEN• Women in the reproductory age group are usually

excluded in drug/vaccine studies where the possible effects on foetus are not known.

• As justice to women, their health conditions should be addressed through involving them in research.

• Types of research that benefit women directly include, obstetrics and gynaecology, sexually transmitted infections, vitamin studies etc.

2. PREGNANT WOMEN• Should be awarded special protection because of

additional health concerns during pregnancy and the risk of damage to the foetus.

• pregnant women must be excluded from research unless the purpose is to meet the health needs of the mother, and

• the foetus will be placed at risk only to the minimum extent necessary to meet such needs or

• the risk to the foetus is minimal

3. CHILDREN• particularly vulnerable group. The major ethical

issue for involving children is that parents are the primary decisions makers for their minor children.

• there must be no undue inducement to participate for parent, guardian or child, although reimbursement of expenses is allowed.

• A “small gift” to the child after completion of the research is however acceptable.

• the purpose of the research is to obtain knowledge relevant to the health needs of children

• a parent or legal representative of each child should give permission;

• the agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and

• a child`s refusal to participate or continue in the research should be respected.

• Minimal risk• Greater than minimal risk and with the prospect of

direct benefit• Greater than minimal risk without the prospect of

direct benefit to individual subjects, but likely to yield generalisable knowledge about the subjects disorder or condition.

• Significant risk and special opportunity

• Minimal Risk- risk in relation to normal experience of average, healthy normal children – daily life/routine physical psychological exams

• Minimal Risk varies with age but not social status, illness or circumstances

• Consultation with experts – paediatricians , social workers etc

• Written Parental/Guardian consent only required for those below the “legal age”

• Assumption : best interests of the child should be regarded

• Both parents of the child should sign or just one?• Institutionalised children?• Children without any recognisable legal guardian?

• After the age of 7 and below legal consenting age (which is different for different countries depending on regulations) those who are competent to understand the opinion of the child should be respected

• “A child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent” Silence Assent

• Waiver of parental consent may be granted in adolescent research in certain circumstances i.e. drug abuse, sexual behaviour etc.

• Assent documents may include – age appropriate information sheets and forms where applicable

4. MENTALLY ILL / MENTALLY HANDICAPPED PERSONS• Is s/he capable of self-determination?• Respect for the immature and the incapacitated may

require protecting them as they mature or while they are incapacitated (Belmont Report)

• it is usually that informed consent will be provided by a surrogate/ legal representative of that person.

• The golden rule for involving mentally ill or handicapped people is that ; The objections of these subjects to involvement should be honoured, unless the research entails pro-providing them a therapy unavailable elsewhere.

5. THE ELDERLY• Old age alone does not render a person incapable

of consenting to health research. • In the absence of any indication to the contrary,

elderly patients are generally assumed to be competent to consent to research.

• However, consideration should be given to the possibility of mental deterioration, the ability to comprehend, and the dependence and vulnerability of the elderly

6. PRISONERS• Prisons are organisational structures exacerbate

vulnerability of the incarcerated individuals.• They have limited economic power, inadequate

protection of human rights, limited availability of health care and treatment options.

• The prison structure makes the incarcerated prisoners confined, stressed, crowded, psychologically devastated with symptoms such as psychosis, severe depression, and complete social withdrawal.

7. CAPTIVE/D ISPLACED/RETURNING POPULATIONS• Have constrained movements and choices• refugees, those in police custody, and displaced

population, • hospitalised patients, students, institutionalised persons

and military personnel. • readily available for research activities for extended

periods, enhancing their attractiveness to research enterprise.

• Researchers should always have to be sure if participant’s decision making capacity is not compromised.

• nature and degree of risk,• the condition of the particular population involved,

and • the nature and level of the anticipated benefits. • Relevant risks and benefits must be thoroughly

arrayed in documents and procedures used in the informed consent process

• Vulnerability is considered to offer better protection, not to stop research on the vulnerable

• Vulnerable groups should not be denied their right to participate in relevant research

• The risk assessment varies with the degree of vulnerability

Discussion… Q & A