Page 11 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

behavioral research. The report also describes the assessment of risk-
benefit criteria and introduced the written informed consent. CIOMS
Guideline (Annex-3).

In 1993, Council for international organization of Medical Science
(CIOMS) in collaboration with World Health Organization (WHO)
developed international ethical guidelines for biomedical research with
special attention to developing country in response to common research
e.g. HIV / AIDS. CIOMS took 20 years to develop guidelines involving
participants from developing and developed country. Any intervention or
product or knowledge generated by research will be made available for the
benefit of the population or community of the research country is the
cornerstone of the CIOMS. It also justifies the placebo control and
includes a section on compensation for research injuries not found in other
documents.

International Conference for Harmonization–Good Clinical
Practice (ICH-GCP) was promulgated in 1996 by international
conference for harmonization of technical requirements for registration of
Pharmaceuticals for human use. It depicts the standard for review
committee, investigators, and sponsors. It is specific for research on drugs
or devices seeking regulatory approval. It opposes the active control trial.
ICH-GCP is agreed by Europe, USA and Japan as well as those of
Australia, Canada, the Nordic countries and WHO. WHO has developed
GCP Guidelines, known as WHO-GCP. (Annex-4)

03. ISSUES IN ETHICAL CLEARANCE

3.1. Informed Consent of participants

Informed Consent of participants refers to having consent of participants
by informing detail particulars of the study. For all research involving
human participants, the investigator must obtain the informed consent of
the prospective participant. In case an individual is not capable of giving
informed consent, the proxy consent of a properly authorized
representative must be obtained. The form which is used to take the
consent of participants is called the Informed Consent Form (lCF). The
information should be given in language that is capable of understanding
by the participants e.g. for Bangladeshi subject the Informed Consent
Form should be written in "Bangla" along with its English version. The
Informed Consent Form be attached with Research Proposal and shall get
Ethical clearance from NREC.

Informed Consent Form shall include following information:
 Aim and method of the research
 Criteria for selection of the participant
 Duration of participation

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 7