Research Involving Vulnerable

Subject
dr. Ni Luh Putu Ariastuti, MPH
 Kasus 1
• Sebuah penelitian
randomised control
trial : uji coba vaksin
rencana dilakukan
dengan subyek anak
usia 3-7 tahun.
• Bagaimana
pertimbangan etik
untuk studi diatas?
 Kasus 2
• Sebuah studi rencana
dilakukan pada ibu
hamil trimester
pertama. Studi ini akan
mengujicobakan obat
anti emetic.
• Bagaimana
pertimbangan etik
untuk studi diatas?
 Kasus 3
• Sebuah penelitian ingin
mengeksplor perilaku
seksual para
narapidana. Rencananya
narapidana akan
diwawancara oleh
peneliti
• Bagaimana
pertimbangan etik
untuk studi diatas?
 Kasus 4
• Sebuah studi ingin
mengeksplor dampak
kesehatan mental korban
kekerasan dalam rumah
tangga. Subjek
penelitiannya adalah korban
KDRT yang melakukan visum
di rumah sakit.
• Bagaimana pertimbangan
etik untuk studi ini?
 Kasus 5
• Seorang dosen ingin
melakukan penelitian
evaluasi metode
pembelajaran yang
diterapkan di perguruan
tinggi. Subyek penelitian
adalah mahasiswa
semester 2 tempat dosen
ini bekerja.
• Bagaimana pertimbangan
etik untuk studi diatas?
Research Involving Vulnerable
Subject
 Research Involving Vulnerable
Subject
• WHO-CIOMS

• When vulnerable individuals and groups are

considered for recruitment in research,
researchers and research ethics committees
must ensure that specific protections are in
place to safeguard the rights and welfare of
these individuals and groups in the conduct of
the research.
 Vulnerable Subject
• Limited capacity to consent
– have distinctive physiologies and health needs
– may not be able to protect their own interests
– children and adolescents

• Individuals in hierarchical relationships: in a

subordinate relationship
– medical and nursing students
– subordinate hospital and laboratory personnel
– workers in settings where research studies are conducted
– members of the armed forces or police
 Vulnerable Subject
• Institutionalized persons
– Residents of nursing homes, mental institutions, and prisons
– have few options and are denied certain freedoms
– may be in a dependent relationship with caregivers or guardians

• Women: pregnant and/or other conditions

– risks to the fetus
– female or transsexual sex workers
– refugees and asylum seekers
– intimate partner violence
– trafficked women
– studies of abortion in jurisdictions where abortion is illegal
– women who live in a cultural context where they are not permitted to consent
on their own behalf for participation in research, but require permission from
a spouse or male relative
 Vulnerable Subject
• Other potentially vulnerable individuals
– people receiving welfare benefits or social assistance
– other poor people and the unemployed
– people who perceive participation as the only means of
accessing medical care
– some ethnic and racial minorities
– homeless persons, nomads, refugees, or displaced persons
– people living with disabilities
– people with incurable or stigmatized conditions or diseases
– people faced with physical frailty
– individuals who are politically powerless
– members of communities unfamiliar with modern medical
concepts
 Ethical Consideration
• the need for special protection of their rights
and welfare
• avoid stereotyping by consultation with
relevant stakeholders, where feasible, before,
during and after the conduct of the research
• Giving special protections
 Special protection
• allowing no more than minimal risks for procedures
that offer no potential individual benefits for
participants
• supplementing the participant’s agreement by the
permission of family members, legal guardians, or
other appropriate representatives
• the research be carried out only when it is targeted at
conditions that affect these groups
• Safeguards can be designed to promote voluntary
decision-making, limit the potential for confidentiality
breaches, and otherwise work to protect the interests
of those at increased risk of harm
QUESTION??
THANK YOU