Page 12 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

 Expected benefits from the research
 Risks/discomfort involved during participation
 Measures to be taken to minimize risks
 Confidentiality of records
 Medical Services to be provided by the investigators
 Provision for compensation for injury, disability or death of
subjects
 Statements mentioning that the individual is free to refuse to
participate and will be free to withdraw from the research at any
time without penalty or loss of benefits to which he or she would
otherwise be entitled. Address of contact person in case of queries
be provided.

Obligations of Investigators Regarding Informed Consent

To obtain consent from the participants in implementation of a research
study in Bangladesh the investigator shall:

❖ Communicate all relevant information to the participants

❖ Provide complete and comprehensive information

❖ Provide opportunity and encouragement to ask question

❖ Participate needs to provide sufficient time and opportunity in the
research.

❖ Exclude possibility of unjustified deception

❖ Exclude possibility of intimidation and undue influence

❖ Consideration of financial inducement should be based on poverty
level of Bangladeshi population

❖ Inform consent form must have sign by participant/legal guardian.

❖ In case of a clinical trial / experiment informed consent is to be
signed by the participant in presence of witness.

❖ For a study without any intervention (Non-intervention type of
study) involving large community it is necessary to have the
consent of the community.

❖ In case of illiterate participants the investigator shall verbally
discuss the content of the Informed Consent Form in presence of a
witness who is literate and capable of understanding.

❖ Ensure that an individual or group or community is enough
competent to understand and assess information about the
research.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 8