BELAJAR MANDIRI

Mata Kuliah : Etika Penelitian Epidemiologi / EKM705

Kelas : Semester 7 Peminatan Epidemiologi
Materi : Privacy and Confidentiality in Research Ethics

Instruksi:

1. Bacalah dengan seksama case study berikut!

2. Jawab pertanyaan berdasarkan konteks case study. Saudara boleh menggunakan
sumber bacaan lain sebagai pedoman menjawab pertanyaan. Jawaban yang Saudara
berikan ditulis dalam Bahasa Indonesia.
3. Waktu pengerjaan adalah 3 hari (7/8/9 Oktober 2019). Tugas dikumpulkan pada hari
KAMIS 10 OKTOBER 2019 pukul 10.00 WIB di atas meja.
4. Tugas diketik dengan format:
a. Kertas A4
b. Times New Roman 12
c. Spasi 1.5
d. Margin 3cm x 3cm x 3cm x 3cm
e. Halaman di pojok kanan bawah
f. Nama di tulis dipojok kanan atas
g. Tidak memakai cover dan tidak dijilid, cukup disteker saja

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Case Study: Social Sciences and Behavioural Case

Dr. Alberto Ruiz, a sociology researcher in the Newton University HIV Center, is conducting
a complex international high-risk study of HIV and illicit drug use — in this case, the use of
crystal methamphetamine. The purpose of the study is to compare crystal meth use among
those who are HIV-positive living in the U.S., France, and Turkey. Specifically, the researcher
intends to study users who are making the drug in their homes. The researcher has colleagues
doing research in HIV clinics in those countries that will make sample accrual relatively easy.

Dr. Ruiz will recruit interviewers who are gay and have access to these drug-using populations.
Interviewers will be carefully trained to maintain confidentiality as that is the only means for
the interviewers to gain the trust of the sample of participants. Dr. Ruiz has had a hard time
getting the proposal through the IRB that is concerned about how the data, particularly
identifiers, will be protected. Dr. Ruiz describes a complex password-protection plan, which
the IRB accepts. In addition, a Certificate of Confidentiality will be obtained.

Dr. Ruiz has decided to collect the study sample using the Internet. He proposes to send
recruitment flyers to gay Web sites and Listservs. When potential study participants reply,
volunteering for the study, he will promise not to collect their names or addresses. What these
men do not realize, however, is that he will be collecting their IP (Internet Protocol) addresses.

The IRB was very particular about the informed consent process, requiring that Dr. Ruiz take
special measures to protect the participants‘ Protected Health Information (PHI), invoking the
HIPAA protections. Dr. Ruiz claims that this is not necessary as the University is not a health-
related institution. The IRB claims that this is beside the point; they are concerned with more
than just compliance. Their aim is to protect the rights and welfare of all research participants.

One of the members of the IRB is a domestic violence investigator, Doris Grant. She informs
Dr. Ruiz that domestic violence is often a problem for crystal meth users and their partners as
this drug is associated with episodes of violent behavior, paranoia, anxiety, confusion, and
insomnia that can persist for long periods. As Dr. Ruiz is especially interested in those who are
making crystal meth in their homes, the likelihood of domestic violence is high. Ms. Grant asks
him how he intends to instruct the interviewers to respond if they learn that one of the partners
frequently beats up the other partner, especially if the interviewer notices signs of abuse (e.g.,
visible bruises or a secret plea for help).

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Ms. Grant asks Dr. Ruiz if he knows whether the Certificate of Confidentiality is absolute or if
the interviewer can breach confidentiality if there is danger of imminent harm.

After the study has been running for two years, Dr. Ruiz is surprised one day when two CIA
agents enter his university office with a subpoena for his data. They are trying to break up a
Turkish crystal meth smuggling ring. Dr. Ruiz feels confident that he does not have to give
them access to data from the U.S. meth users. He never expected, however, that there would
be an interest in the data he collected from Turkey. He strongly believes, though he has no
direct knowledge, that the CIA does not have jurisdiction over data he collected from Turkey.
He realizes now that the risks of the study are far higher than he had ever imagined, and that
he needs a lawyer badly as he now may risk being jailed for obstructing justice.

Source: Joyce Plaza, Ruth L. Fischbach, The Columbia Center for New Media Teaching &
Learning (CCNMTL), Columbia University's College of Physicians and Surgeons and the
Mailman School of Public Health, Current Issues in Research Ethics (CIRE), from the National
Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Department of
Health and Human Services (DHHS)

Questions:

1. What constitutes an adequate data protection plan? Is password protection enough?

2. In this case, what else could the PI do to protect the data?
3. How do you obtain a Certificate of Confidentiality (CoC)?
4. Is a CoC valid in Turkey or France or other countries outside the U.S.?
5. Since he is not collecting the names of the participants, can this study be considered
anonymous?
6. Who is correct?
7. Is the interviewer a mandated reporter in this situation?
8. Can the interviewer breach confidentiality?
9. Does the CoC protect Dr. Ruiz from having to reveal the identity of participants living
in Turkey?

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