Page 15 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

such a way that an individual remains unidentified. ** The investigator
should adopt following measures to maintain confidentiality:

✓ Code numbers for data

✓ Remove core sheets (containing names "and address of the
subject)

✓ Omitting identifications

✓ Prevent unlimited access to data

✓ Train related manpower in confidentiality. Keep research
records in locked cabinets. Provide security codes for
computerized records.

✓ The investigator must establish safeguards of the
confidentiality or research data. Subjects should be told of the
limits to the investigators' ability to safeguard confidentiality and
of the anticipated consequences of breaches of confidentiality.

Degree of importance of confidentiality depends on the nature of
research study. If the research study involves collection of data on
sensitive issues, protections of confidentiality become prominent
and essential.

✓ The investigators responsibility is to secure safeguards of the
confidentiality

✓ Limitations of the investigator related to breach of
confidentiality and anticipated consequences of breaches of
confidentiality should be told to subjects.
* Confidentiality between investigator and subject is considered
because disclosure of data may cause harm or distress.
** Foreseeable adverse social consequences must be discussed.

3.3. Inducement

Inducement means to encourage the participants to participate in the
study

 Participants may be paid for inconvenience and time spent.
 They should be reimbursed for expenses incurred, In connection
with their participation in research.

 They may also receive free medical services. However, the
payments should not be so large or the medical services so extensive
as to induce prospective subjects to consent to participate in the
research against their better judgment (undue inducement).

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 11