Ethics committee composition.

WHAT IS THE DEFINITION OF BASIC MEDICAL SCIENTIST?

Basic sciences include anatomy, physiology, biochemistry, molecular biology, pharmacology, microbiology, pathology.

As per the Central Drugs Standard Control Organization (CDSCO) draft guidelines for registration of Ethics Committee (EC), a basic medical scientist should have post-graduate qualifications and adequate experience in his/her respective field.

A basic medical scientist should be an MD in one of the basic sciences.

An MD in Medicine is not a basic qualification for a medical scientist.

An MBBS qualified person cannot serve as a basic medical scientist

A non-medical person cannot serve as a basic medical scientist

WHO CAN BE CONSIDERED A LAY PERSON?

A person who does not have specialized or professional knowledge of the subject

A person who is a non-expert in a given field of knowledge

A lay person is one who does not have qualifications of an expert e.g., lawyer, doctor, scientist, chartered accountant etc.

CAN AN EC MEMBER FULFILL TWO REPRESENTATIONS IN THE QUORUM, E.G. SOCIAL WORKER AND LAY PERSON?

No. A person cannot represent two categories listed in the quorum. The representation has to be decided when the EC is formed, and should be documented in the composition and Standard Operating Procedures with clear representation. An EC member cannot change the representation during the EC meeting.

IF A LAY PERSON IS ABSENT FOR PROTOCOL REVIEW MEETINGS, CAN THE MEMBER SECRETARY OF THE IEC OR ANY IEC MEMBER ACT AS A LAY PERSON?

No. This is not acceptable. A person designated as “Lay person” in EC composition must be present to fulfill the quorum requirements. Nobody else can act as a lay person, unless he/she is serving as a lay person in the EC and has been mentioned in the composition. If a lay person is absent, the quorum is not filled, and the EC approval is invalid.

WHAT IS QUORUM?

The quorum is the count of the number of members present in the EC meeting.

The quorum means: The minimal number of officers and members of a committee or organization, usually a majority, who must be present for valid transaction of business.

If the number present falls below the required number, the quorum fails.

If any member category defined in Schedule Y Appendix VIII is absent, the requirement of quorum will not be met.

If an investigator is part of the quorum of five members, and if he is unable to vote for his own study, the quorum will fail.