Page 79 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

samples shall be preserved in the Repository and what will be the
costs to individual researchers in obtaining samples from the
Repository. The sample collector must also clearly inform every
donor that he reserves the right to order destruction of his sample
from the Repository at any time.

To prevent any exploitation and protect the rights of participants,
the three main requirements at collection level are:

1. Individual informed consent,
2. Approval of the ‘Institutional Review Board’ and

3. the ‘Repository Ethics Committee’ (which may be
formed by the BMRC)

Human biological samples: These include whole or part of an
organs, tissues, cells (somatic and gonadal), body fluids or samples
like serum, buffy coat, DNA, hair, nails, excreta, sweat, buccal
scrapings etc.

Unidentified Specimens: Identifiable personal information was
not collected or, if collected, was not maintained and cannot be
retrieved by the repository.

Identified Specimens: These specimens are linked to personal
information in such a way that the person from whom the material
was obtained could be identified by name, patient number, or clear
pedigree location ( i.e., his or her relationship to a family member
whose identity is known).

13.10.2 The use of research samples

General Principles

An Ethics Committee exclusive to the Repository formed by the
BMRC should play an important role in looking at the issues
related to informed consent, privacy and confidentiality, risk-
benefit analysis, benefit sharing, maintain linkages with other
biobank and repositories while adhering to the basic principles of
bioethics viz. Autonomy, Justice, Beneficence and Non-maleficence.

The samples supplied to the investigators are:

Unidentified Samples: Sometimes termed “anonymous,” these
samples are supplied by repositories to investigators from a
collection of unidentified human biological specimens.

Unlinked Samples: Sometimes termed “anonymized,” these
samples lack identifiers or codes that can link a particular sample
to an identified specimen or a particular human being.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 75