Page 78 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

13.10 BIO-BANK

A biobank is a form of biorepository devoted for storing human biological
samples include embryonic stem cells, neonatal tissues (Wharton’s Jelly ),
iPS cell lines, adult stem cell lines, sperm, ova etc. from large number of
individuals intended for future use by multiple researchers for multiple
purposes. Multiple biobank exist in the developed countries and some
developing countries. As future research on genomics, personalized
medicine, cancer etc. will heavily depend on biorepository, it has invoked
research and medical ethical questions as well as national issues.

Types of biobank:

1. Tissue banks harvest and store human tissue from living,
cadaver and biomedical (pathological) samples.

2. A virtual biobank is a virtual repository which provides data
extracted from and characterizing samples stored at an
existing biobank.

3. Population banks store biomaterial as well as associated
characteristics such as lifestyle, clinical, and environmental
data.

The biorepository activities involve three components:

1. Collection of tissue samples;

2. The repository storage and data management; and
3. The recipient investigators, type of research and its outcome.
(ICMR, 2006, India)

13.10.1 Repository Collections

The steps involve the initial process of collecting, processing,
freezing, “anonymizing”, and storing tissue with its corresponding
clinical information in a database. As tissue banking concerns
research at a later time, the ethical issues pertain to consent
requirements for the banking and further uses of tissue and DNA
samples, their control and ownership, and the benefit sharing to the
individual or community. Permission must be obtained for shipping
samples abroad.

The sample collector must obtain informed consent of the donor for
DNA banking or for cell-line transformation and banking. The
process of seeking informed consent for purposes of banking must
clearly be stated in addition to possible risks and benefits, the
conditions under which samples from the Repository shall be
provided to other researchers, how long and in what condition the

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 74