Page 16 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

 All payments, reimbursements and medical services to be provided
to research subjects should be mentioned in the research proposal
and approved by an ethical review committee.

3.4. Compensation

It is the right of the participants included in a research study to have
compensation from the investigator in case of injury, disability, caused by
the participation in the study.

 Research participants who suffer physical injury as a result of
their participation are entitled to such financial or other assistance
as would compensate them equitably for any temporary or
permanent impairment or disability.

 In the case of death, their dependants are entitled to
compensation.

Compensation is necessary for the following conditions:

I. Accidental Injury:
✓ Death

✓ Permanent or Temporary disability
✓ Investigation, therapeutic intervention, directly related to the
research study.

II. Equitable compensation:

✓ Significant physical injury from procedures performed solely for
Research. Compensations not applicable if it is due to procedures
for diagnosis or treatment of disease.

✓ Procedures & provision for compensation should be mentioned in
the proposal and be reviewed by Ethical Review Committee.
✓ Ethical Review Committee should give guidelines, directions for
compensation.

✓ Informed Consent Form should include details about compensation
procedure / provision.

III. Obligation of the sponsor to pay:

Sponsors are advised to obtain adequate insurance against risk to
cover compensation.

04. SCIENTIFIC MISCONDUCT

Beyond honest errors and errors caused through negligence are a third
category of errors: those that involve deception: making up data or results
(fabrication), changing or misreporting data or results (falsification), and
using the ideas or words of another person without giving appropriate

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 12