

































KEY WORDS: commercialization, confidentiality, human tissue sample, informed


Bangladesh Journal of Bioethics 2010; 1(2):11-19

ETHICAL PERCEPTION OF TISSUE BANKING IN BANGLADESH

Hasan M. Zahid*, Kanchan Chakma, Mamun Miah and Azizun Nessa

Tissue  Banking  and  Biomaterial  Research  Unit,  Atomic  Energy  Research  Establishment 
(AERE), GPO Box-3787, Dhaka-1000, Bangladesh

Bangladesh  Atomic  Energy Commission  has  initiated  the processing of  human tissue for 
utilization in reconstructive surgery as allograft in cooperation with the International Atomic 
Energy Agency (IAEA). Tissue donation and grafting has comprehensive and versatile role in 
the health  care  sector.  IAEA programmes  to  develop a  series  of  tissue banks throughout 
South  East  Asia  by  having  great  significance  for  improving  basic  health  care  in  other 
developing countries. Utilization of human tissues has been practicing in many countries and 
it has a long history. Bangladesh is somewhat new in the field of tissue banking activities to 
treat degenerative bone diseases, congenital deformities, bone fractures, gap non-union from 
traumatic accidents, dental defects, different type of burns, acid violence, leprotic ulcer, bed-
sore, traumatic open wound, diabetic wound etc. Several hospitals and clinics throughout the 
country are currently involved in tissue procurement and grafting though some of intricate 
ethical problems (ideological, cultural, psychological, and religious) and conflicts stay behind 
this field. For ethical and legal concern, the healthcare personnel have been working under 
the  law  of  “Human  Organ  /  Tissue  Donation  and Transplantation  Act”,  as  the  National 
Parliament  of  the  People’s  Republic  of  Bangladesh  has  approved the  declaration  on 13th 

April-1999 requiring consent from the donor or next of kins. Before considering the legal and 
ethical  questions  associated  with  tissue  banks,  several  functions  must  be  identified  and 
followed:  improvement  of  the  patient  care,  elimination  of  the  trauma  and  morbidity 
associated with secondary surgical procedures, reduction of the prolonged hospital stays and 
medical costs etc. Although ethics, moral principles, and legal aspects are practicing within 
some degree of people, it should disseminate enormously to the general public of the country 
as  they could be more  aware and interested  to  tissue donation thereby more  people will 
contribute to alleviate sufferings and more lives will save. 

Key  Words:  amniotic  membrane,  bone,  confidentiality,  informed  consent,  organizational 
policies, standards, and tissue banking.

* Correspondence:   Hasan M. Zahid,  Scientific  Officer,  Tissue Banking and Biomaterial 
Research  Unit,  Bangladesh  Atomic  Energy  Commission,  GPO  Box-3787,  Dhaka-1000, 
Bangladesh, E-mail: zahid_bmb@yahoo.com

INTRODUCTION 

Radiation  Sterilized  human  amniotic  membrane  and  bone  allografts  have  been  using 
successfully in different types of clinical disorders and injuries in Bangladesh. To rehabilitate 
and treat these sorts of health problems in our country, such as different type of burns, acid 
violence, leprotic ulcer, bed-sore, traumatic open wound, diabetic wound, degenerative bone 
diseases, congenital deformities, bone fractures, gap non-union from traumatic accidents, oral 
and maxillofacial defects ‘‘Tissue Banking and Biomaterial Research Unit’’ of Bangladesh 
Atomic Energy Commission regularly providing radiation sterilized amnion membrane and 

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Bangladesh Journal of Bioethics 2010; 1(2):11-19

bone allografts  to  different  hospitals  and  clinics  throughout  the  country.  At  present,  109 
hospitals and clinics and more than 300 surgeons & physicians are involved with this unit 
through utilization of radiation sterilized tissue allografts. By following scientific procedure, 
gamma radiation  (Co60) is  used for  tissue graft  sterilization.  This  unit  is  also  undertaken 
research activities on both the fundamental and applied / clinical areas of tissue banking.

         
  

Photograph 1 & 2 represent  processing and use of  human tissue (amniotic  membrane  & 
bone).    

Tissue banking research progressively more is accomplished in partnership between the for-
profit  and  not-for-profit  spheres,  lifting  up  many  ethical  considerations  (1).  In  part,  this 
change  can  be  attributed  to  the  growing  sophistication  of  genomic  technology  and,  in 
particular, the new interest it has fueled in human tissue (2). In addition, tissue banks in the 
non-profit sector are often supported by the pharmaceutical and biotech industries that help 
fund academic research and rely on human biological samples recovered and banked by these 
institutions (3). Some contend that the current system of safeguards (at least in the US) will 
become increasingly obsolete in protecting tissue donors; others point to a variety of cultural, 
organizational, and professional issues that question the ethical appropriateness of for-profit 
tissue banks and academic-industry relationships (4). In these regards, various governments, 
non-governmental organizations, and other institutions have been planning and promulgating 
policies to regulate tissue banks and their relationships with industry. These policies represent 
the consensus of private associations (such as the American Association of Tissue Banks), 
reflect the national policies of certain governments (such as Spain), and are the products of 
various international bodies (such as the European Union). Thus, these policies are broad in 
scope; we have not surveyed the institutional policies of individual banks, academic medical 
centers, or other institutions. Moreover, the enforcement mechanisms will similarly reflect 
the authority of the bodies that produce such policies. For instance, a private association will 
have relatively little authority to sanction individual banks for violations of certain policies; 
on the other hand, governments  will  have appropriate  enforcement  mechanisms to ensure 
compliance  (although  resources  to  achieve  such  compliance  will  vary  from  country  to 
country).

Wherever  tissues  are  removed  from human  beings,  and  possibly  transplanted  into  other 
human beings, the activities involved in the collection and use of such tissues are subject to 
ethical requirements intended to safeguard respect for human beings, their dignity and 

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         1- Amnion membrane       2 - Human femoral head 



Bangladesh Journal of Bioethics 2010; 1(2):11-19

autonomy,  and for the common good. As the issue of safety is vital,  the protection must 
extend to tissue donors and recipients,  and to all  health  care professionals  - whose work 
involves collecting, manipulating and using human tissues.

LAWS AND REGULATIONS: BANGLADESH

1.   A bill  on “Human Organ/Tissue Donation and Transplantation Act” has been passed by 
the National Parliament of the people’s Republic of Bangladesh on 13th April 1999 (5/1999) 
requiring consent from the donor or next of kin. (5/1999)

2. A bill  on “Safe Blood Transfusion Act, 2002” (12/2002) has been passed by the national 
parliament of the people’s Republic of Bangladesh making serological screening mandatory 
for tissue/ organ donation. (12/2002)  

VIABILITY OF HUMAN TISSUES    

A  number  of  potential  benefits  stem from the  commercialization  of  human  tissues.  For 
industry, the likelihood of profit based on medical products derived from human tissues is an 
effective incentive to invest in related academic research. With the judicious use of patents 
and other forms of intellectual property rights, industry has added reason to support cutting-
edge and sometimes financially risky academic research involving human tissues. From the 
perspective  of  academic  centers,  the  infusion  of  capital  by  industry  can  help  to  fund 
innovative  research  and  support  the  training  of  researchers.  Perhaps  the  most  important 
benefit  associated with the commercialization of human tissue comes from the successful 
interchange between the two spheres,  toward a more efficient  transmission of knowledge 
from academic based tissue banks to industry, facilitating the development and delivery of 
medical  products  to  the  public.  There  is,  however,  a  potential  downside  to  the 
commercialization of human tissues. Specifically, the growth of for-profit tissue banks and 
augmented academic-industry partnerships increase the likelihood of conflicts of interests. 
For example, financial incentives to academic researchers (e.g., stock options and royalties) 
could undermine scientific standards of integrity by promoting secrecy, data hoarding, and 
even the manipulation of research outcomes. If this occurs, the commercialization of human 
tissues could have the unintended consequence of compromising human tissue research and 
subordinating the health of the public to profit  maximization.  Beyond concerns regarding 
conflicts of interests, the commercialization of human tissues also raises a host of broader 
social, cultural, religious, and psychological issues on the meanings we assign to the human 
body and, in particular, on how we treat it during life and after death (5). Table 1 and  2 
represent non-profitable collection, processing and supply of amniotic membrane and bone 
allografts those were being prepared by the Tissue Banking and Biomaterial Research Unit of 
Bangladesh Atomic Energy Commission in 2008. These grafts were used to treat different 
types of diseases throughout Bangladesh.     

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Bangladesh Journal of Bioethics 2010; 1(2):11-19

Table- 1

Type  of 
tissue
collected

Number 
Number  of  grafts 
prepared

Number  of 
grafts supplied

Patients treated

Human 
amniotic 
membrane

389
(Foetal  sacs./ 
placenta) 

       1901 pieces

   

    1751 pieces

Heat burn              146

Acid burn 05

Diabetic wound/
 diabetic foot ulcer

01

Leprotic ulcer 03

Abdominal  wall 
reconstruction

04

                               Total :159

154 pieces
(Eye graft)

136 pieces
(Eye graft)

Chemical (acid) burn
(corneal surface Rt.)

01

Chemical (lime) burn 01
Pterigium removal site 05
Peripheral corneal ulcer 01
Orbit reconstruction 01
                                Total : 09

 
Preparation and uses of Human amniotic membrane (in 2008)

Table- 2

Type  of 
tissue
collected

Number 
Number  of  grafts 
processed

Number  of  grafts 
supplied

Patients treated

Human
femoral 
head

423
3810 
(chips/segments)

        3172 
(chips/segments)

Giant cell tumor (GCT) 76
Aneuroysmal  bone  cyst 
(ABC)

18

Simple bone cyst (SBC) 13

Fibrous dysplasia (FD) 19

Gap non-union 27

Bone fracture 66

Spinal fusion/scoliosis 02

Osteomyelitis  &  other 
bone defects.

03

                                 Total: 229

Preparation and uses of Human femoral head (in 2008)

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Bangladesh Journal of Bioethics 2010; 1(2):11-19

Many people conceptualize the transfer of human organs and tissues during life or after death 
as a gift motivated by altruistic feelings, not economic incentives. U.S. federal law prohibits 
the buying and selling of human organs, it does allow fees for the recovering, processing and 
transporting of human tissue (6). The exportation of blood from the U.S. alone is a multi-
billion dollar industry (7); other human tissues such as hair and corneas play an important 
role in commerce. The American Association of Tissue Banks (AATB) (8) provides even less 
guidance, as it has no explicit statement, general or specific, about the commercial aspects of 
tissue banking. Unlike the BATB and the AATB, two reports from the Health and Human 
Services/Food  and  Drug  Administration/Office  of  Inspector  General  (HHS/FDA/OIG) 
provide guidelines that address some of the commercial aspects of tissue banking (9).

CONFIDENTIALITY

Confidentiality, which refers to the promise not to disclose information that the donor does 
not want disclosed, is treated by all the organizations and countries that were surveyed as an 
important value to be protected. Different levels exist among methods to curtail breaches of 
confidentiality. Commentators have outlined a useful taxonomy of:
• Identified: The tissue source is known and the individual’s identity is tied to the sample.
• Identifiable: The tissue source is tied to the specimen through the use of a link (e.g., a code 
number), but the identity of the source is not directly known without tracing the link.
• Anonymized: The tissue source’s identity is irrevocably unlinked from the specimen, so that 
the individual’s identity cannot be discerned (i.e., the tissue is not identifiable).
• Anonymous: The tissue source’s identity is never known, since the specimen is collected 
with no identifiers at all (i.e., the sample is unidentified) (10).

PROTECTION OF THE DONOR AND RECIPIENT

With regard to the removal of tissues, the main ethical principles from the donor’s point of 
views are the respect for the human body, even after the person’s death; for the autonomy of 
the  donor;  thus,  tissue  may  not  be  removed  whenever  the  person  refuses.  For  deceased 
persons, this implies that tissues may not be removed if the person refused consent during 
her/his  lifetime.  It is required to protect  vulnerable people,  namely people unable to give 
consent; respect for private life and medical confidentiality, which is a fundamental right; the 
right to prior information on the conditions of removal and the expected use of the tissues; the 
right not to be subjected to unfair discrimination, which could result from the revelation of 
data collected from the donor, or the family, to third parties (e.g. employers and insurance 
companies).

The main principles affecting recipients of allografts are the respect for the autonomy of the 
person  concerned,  which  requires  clear  information  on  the  risks  and  advantages  of  the 
proposed transplant; respect for private life and medical confidentiality, which applies to all 
medical treatment;  the right to safety,  which requires prior verification of the quality and 
safety of the tissue to be transplanted with regard to the risk of transmission of infectious 
diseases, neoplasms and immunological diseases; the right of patients to have fair access to 
the therapeutic possibilities offered by the transplantation of human tissues; the effectiveness 
of this right depends partly on the greater or lesser availability of tissues.

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Bangladesh Journal of Bioethics 2010; 1(2):11-19

INFORMED CONSENT

Informed consent serves as a safeguard for individuals’ rights and welfare, by providing them 
the opportunity to understand an intervention,  its  scope,  and its  implications,  before they 
decide  whether  to  agree  to  it.  In  the  context  of  this  discussion,  the  intervention  is  the 
collection of tissue samples by a tissue storage facility for the purpose of research.

What should the informed consent process for the collection of tissue samples include? This 
question pertains to tissue samples that have yet to be collected. It needs to be distinguished 
from a related but separate matter: What should be done with collected tissue samples that 
were  obtained  with  informed  consent  that  would  not  meet  current  standards?  The  latter 
question is not directly addressed in this paper, which concerns itself with the collection of 
tissue, except to say that the more rigorous alternative of going back to donors or donors’ 
families to obtain consent for unanticipated uses is the gold standard: it provides assurance 
that the donor’s wishes will be respected. Unless donors (or their families) understand the 
specific nature of a research protocol in which they are enrolling, they neither can assess 
adequately whether participation in the overall investigation is consistent with their values, 
nor freely and deliberately refuse participation in certain aspects of a study.

ROLE AND RESPONSIBILITIES OF TISSUE BANK 

Activities of procurement,  which are non-commercial,  as well as activities carried out by 
tissue banks require an authorisation. This authorisation must be subject to compliance with 
basic ethical  principles and with health safety standards,  which themselves are an ethical 
imperative.  Safety  rules  must  be  uniform throughout  the  country.  Tissue  banks  have  an 
eminent responsibility to monitor implementation of these rules and principles. They should 
refuse to  accept  tissues the procurement  of  which does  not  satisfy ethical  principles  and 
safety  rules.  Tissue  banks  also  have  specific  responsibilities  as  regards  protecting  the 
confidentiality of the personal data they keep on donors and their families. In view of their 
responsibility for the quality and safety of the tissues they provide to third parties, banks 
should be obliged to keep a register of the tissues stored and distributed. This register should 
be available for presentation to the national inspectorates at all times.

                                                             

           
  Photograph 3 & 4 represent the processing of amniotic membrane and bone allografts  

16

 3- Gamma radiation sterilized 
amnion membrane

 4 - Human femoral head cancellous      
                bone segments 



Bangladesh Journal of Bioethics 2010; 1(2):11-17

FINDINGS FROM RESEARCH ON TISSUE SAMPLES

It seems best to discuss at the time consent is sought what will later become of information 
derived from tissue samples. Two major questions arise with regard to findings. Should they 
be communicated to the donor (or donor’s family)?  It  may be feasible  for the facility to 
contact the donor (or donor’s family) with findings that pertain to them, where the samples 
were  identified.  So,  it  is  important  for  potential  donors  to  contemplate  whether  this  is 
information they would welcome – and in what detail. Knowledge regarding the risks and 
benefits  associated  with  learning  this  sort  of  information  –  and what  it  means  that  it  is 
familial  in nature – can help inform this decision. Where tissue samples are anonymized, 
general findings are the only kind of information the donor (or donor’s family) can consent to 
receive. The other question that arises from the findings is whether the donor (or donor’s 
family)  can  share  in  any profits  from products,  tests,  or  discoveries  that  result  from the 
research. While it seems easiest to preclude this sort of sharing, some organizations allow it.
Details of how the donor (or donor’s family) will benefit are worked out during the consent 
process. In these latter cases, it is helpful to determine conditions as part of the informed 
consent process. Several of the European policies rely on notions of presumed consent for 
organ  and  tissue  retrieval  from  deceased  individuals  (Belgium,  European  Commission, 
France,  and  Spain),  while  British  and  American  policies  stress  informed  consent  with 
different levels of specificity.

COLLECTED TISSUE SAMPLES: ANTICIPATED USES

Tissue storage facilities receive donations and make samples available to investigators for 
research purposes. The donor (or donor’s family) may want to know whether the facility has 
ties  with  commercial,  as  well  as  non-commercial,  companies.  Does  it  stand  to  benefit 
financially?  What  criteria  does  the  facility  use  to  determine  to  whom  to  provide  tissue 
samples? The party making the donation may be able to limit  or suggest to what sort  of 
company the samples should be provided. Along similar lines, the donor (or donor’s family) 
might have the opportunity to specify or recommend toward what type of research the tissue 
may be used. The risk is that people with insufficient scientific grounding will participate in 
complex research decisions and that they may request limits that are difficult, unfeasible, or 
impossible to implement.

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    5- Dressing of burn wound with 
            amnion membrane

 
6- Transplantation of massive bone 
allograft in resected bone gap.



Bangladesh Journal of Bioethics 2010; 1(2):11-19

Photograph 5 & 6 represent the use of amniotic membrane and bone allografts to rehabilitate 
burn and bone injured patient  
DISCUSSION

In Bangladesh,  we believe  that  tissue banks systematically should consider  the following 
requirements: First, each tissue bank should have a mission statement, against which it can 
assess the merits of proposed uses of donated tissue. Developing such a document will serve 
to provide a definition of what constitutes high quality research in the eyes of the particular 
bank. Second, financial conflicts of interest can be addressed, in part, by ensuring that those 
making tissue allocation decisions do not have personal financial stakes in potential recipient 
organizations, or by sharply circumscribing such relationships. 

Third, tissue banks should be explicit about their standards of ‘‘confidentiality:’’ Are tissues 
identified, identifiable, anonymized, or anonymous? They should develop adequate methods 
to limit breaches of confidentiality, which are made known. Tissue banking guidelines and 
policies need be specific about the conditions under which donated tissues will be deemed 
confidential.  By doing so, tissue banking guidelines will be more effective in minimizing 
potential harms to donors, donor families, as well as to future tissue research and product 
development. Fourth, tissue banking guidelines and policies should specify what information 
to address as part of the informed consent process. To do this, tissue banks will already need 
to  be  clear  about  their  mission,  financial  arrangements,  and  level  of  confidentiality 
protections  they intend to use.  It  is only after  receiving the required information that  the 
donor (or donor’s family) can arrive at an informed decision about whether to provide tissue 
samples to the facility. Toward this goal, the information to be addressed should be presented 
in  clear  and  understandable  language.  These  four  main  requirements  are  meant  to  offer 
general  guidance  regarding  ethical  considerations  that  deserve  to  be  examined.  They are 
neither exhaustive, nor absolute. Rather, they relate to the four factors (commercialization, 
confidentiality,  informed consent, and quality of research) that emerged from the authors’ 
review. Institutional  Review Boards, or corresponding bodies, the purview of which is to 
ensure  the  protection  of  research  participants,  must  be  involved  to  aid  tissue  banks  by 
providing appropriate oversight and monitoring of their activities that relate to research, as 
well as assistance with specific ethical issues as they arise.

CONCLUSION

In  different  hospitals  and  clinics  throughout  the  country,  the  legal  and  ethical  questions 
associated with tissue banks and their  function must  be identified :  these are  to provide 
improved patient  care through tissue transplantation;  to abolish the trauma and morbidity 
associated  with  secondary  surgical  procedures   used  to  harvest  autografts;  to  reduce 
prolonged hospitals stays  and reduce medical costs; to avoid the sacrifice of the patient’s 
normal structures; to provide unlimited quantities of grafts in suitable sizes and shapes.  

Some organizational policies do not address commercialization, while others fail to consider 
confidentiality and quality of research. However, even in those instances where one of the 
four  factors  is  recognized  by  all  policies  (commercialization,  confidentiality,  informed 
consent, and quality of research); there is often a lack of uniformity in its meaning, scope, 

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Bangladesh Journal of Bioethics 2010; 1(2):11-19

and ethical significance. Until uniform ethical guidelines regulating the storage, distribution, 
and use of human tissues for research are established,  the international transfer of human 
tissues and multinational research involving industry will not only remain cumbersome but, 
in many instances, ethically problematic. We propose that in Bangladesh, governments, non-
governmental organizations, and other institutions further collaborate and harmonize policies 
regarding human tissue. 

REFERENCES

1. Deborah Josefson, ‘‘Human Tissue for Sale: What Are the Costs?’’ Western Journal of 
Medicine 5 (2000): 302–303.
2. Ted T. Ashburn, Sharon K. Wilson, Barry I. Eisenstein, ‘‘Human Tissue Research in the 
Genomic Era of Medicine: Balancing Individual and Societal Interests,’’ Archives of Internal 
Medicine 160 (2000): 3377–3384. 
3. Joseph B. Martin, Dennis L. Kasper, ‘‘In Whose Best Interest? Breaching the Academic-
Industrial Wall,’’ New England Journal of Medicine 343 (2000): 1646– 1649.
4. Deborah Josefson, ‘‘US Hospitals to Ask Patients for Right to Sell their Tissue,’’ British 
Medical Journal 321 (2000): 653.
5. Dorothy Nelkin, Lori Andrews, ‘‘Homo Economicus: Commercialization of Body Tissue 
in the Age of Biotechnology,’’ Hastings Center Report 28 (1998): 30–39.
6.  National Organ Transplant Act, 1984. Pub L. No. 98–507, 3 USC 301.
7.  Danielle M. Wagner, ‘‘Property Rights in the Human Body: The Commercialization of 
Organ Transplantation and Biotechnology,’’ Duquesne Law Review, 33 (1995): 931–958.
8. American Association of Tissue Banks, ‘‘Ethical  Guidelines for Commercial  Activities 
and Advertising,’’ (Sept. 11, 1996). 
9.  Department  of Health  and Human Services,  ‘‘Human Cells,  Tissues,  and Cellular  and 
Tissue-Based Products; Establishment Registration and Listing,’’ Federal Register 66 (Jan. 
19, 2001).
10. Curtis  Naser and Sheri  Alpert,  ‘‘Genetic  Information,  Ethics,  Ethical  Issues in Tissue 
Banking  and  Human  Subject  Research  in  Stored  Tissues,’’  in:  Encyclopedia  of  Ethical; 
Legal; and Policy Issues in Biotechnology, eds. T.H. Murray and M.J. Mehlman (New York: 
John Wiley & Sons, 2000), p. 365.

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