Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
Informed Consent in Tissue Donation 
Expectations and Realities 
JANUARY 2001 
OEI-01-00-00440  OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to 
protect the integrity of the Department of Health and Human Services programs as well as the 
health and welfare of beneficiaries served by them.  This statutory mission is carried out through a 
nationwide program of audits, investigations, inspections, sanctions, and fraud alerts.  The 
Inspector General informs the Secretary of program and management problems and recommends 
legislative, regulatory, and operational approaches to correct them. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) is one of several components of the Office of

Inspector General.  It conducts short-term management and program evaluations (called

inspections) that focus on issues of concern to the Department, the Congress, and the public.  The

inspection reports provide findings and recommendations on the efficiency, vulnerability, and

effectiveness of departmental programs. 

OEI's Boston Office prepared this report under the direction of Mark R. Yessian, Ph.D., Regional

Inspector General.  Principal OEI staff included:

BOSTON  HEADQUARTERS

Russell W. Hereford, Ph.D., Project Leader  Alan Levine, Program Specialist

Maria E. Maddaloni, M.A., Program Analyst

Elizabeth A. Robboy, M.M.H.S, Program Analyst

China D. Eng, M.P.H., Program Analyst

To obtain copies of this report, please call the Boston Regional Office at 617-565-1050. 
Reports are also available on the World Wide Web at our home page address: 
http://www.hhs.gov/oig/oei  E X E C U T I V E   S U M M A R Y  
PURPOSE 
To assess expectations for and limitations of informed consent for tissue donation. 
BACKGROUND 
Human tissue is an important source of medical treatment.  The specific number of tissue 
donors in this country is unknown.  It is clear, though, that the numbers are growing.  In 
1999, more than 20,000 donors provided cadaveric tissue, up from perhaps 6,000 donors 
in 1994.  Tissue banks distributed over 750,000 allografts for transplantation in 1999. 
A first step in tissue donation is obtaining consent from a deceased individuals family. 
Even if the individual had indicated willingness to donate organs (e.g., on the drivers 
license), it is practice in this country to obtain consent from the next-of-kin. 
Tissue banking is subject to more limited regulation than is the nations organ 
procurement system, even though both organ procurement organizations (OPOs) and 
tissue banks are involved in approaching families to request consent for donation.  For 
example, the National Organ Transplant Act requires OPOs to meet certain organizational 
and staffing requirements; the Act also requires OPOs to assist hospitals in establishing 
and implementing protocols for making routine inquiries about organ donation by 
potential donors.  No similar requirements exist for tissue banks. 
This report responds to a request from the Secretary of Health and Human Services, 
asking the Office of Inspector General to examine issues related to informed consent for 
tissue donation.  We base our report on interviews with 30 organizations involved in tissue 
recovery and processing; responses from more than 50 donor families to questions posted 
on an Internet web site; interviews with officials of associations representing sectors of the 
tissue banking industry; and a review of laws, regulations, and association standards for 
tissue banking. 
In this report, we use the term tissue banks to refer to entities involved in procuring, 
processing, storing, and distributing tissue.  We use the term tissue to refer to skin, heart 
valves, and musculoskeletal tissue such as bone, cartilage, ligaments, and tendons. 
FINDINGS 
The expectations and altruistic motives of donor families are the foundation of 
tissue banking.  Donor families and tissue bank staff told us that in agreeing to donation, 
families make some basic assumptions: 
CC  Enhancing the lives of others.  Tissue will be used to meet important medical needs. 
C	 Respect for the donor and the family.  The donors body will be respected during tissue 
recovery, the gift will be recognized as coming from donated human tissue, and 
Tissue Donation: Informed Consent  i  OEI-01-00-00440  the donor familys emotional needs will be respected. 
C	 Trust in the tissue banking community.  Organizations involved in procuring and using 
the donation will act as stewards of the gift. 
However, the reality of tissue banking raises some underlying tension with 
families assumptions. 
C	 Commercialization of tissue banking.  Large scale financial operations may overshadow 
the underlying altruistic nature of tissue donation. 
C	 Tissue viewed as a commodity.  After processing, tissue and products containing tissue 
often are marketed and sold as a medical supply, rather than as a donation. 
C	 Cosmetic uses of tissue.  Some tissue, particularly skin, may be processed into products 
that are used for cosmetic purposes that may not be medically indicated. 
Fundamental factors limit the amount of information that is given to families. 
C	 Families are asked to give their consent at a point in time when they are extremely 
vulnerable. 
C  Families may not wish to receive detailed information about tissue banking. 
C	 Obtaining consent and documenting a donors medical suitability require time-consuming 
and invasive questioning about a recently deceased loved one. 
Current practices in requesting consent raise concerns about how and what 
information is provided to families. 
C  Tissue banks often request consent over the telephone, rather than in person. 
C	 Many tissue banks rely on staff from other organizations to obtain consent. There may be 
little training and accountability of external tissue requestors. 
C  Tissue banks provide donor families with little written material at the time of donation. 
Until recently, standards governing how families are approached and what they 
are told about tissue donation have been nonexistent.  However, some advice 
and guidance have emerged. 
C	 Federal laws and regulations do not address the manner in which tissue banks obtain 
consent. 
C	 States Uniform Anatomical Gift Acts do not address what information tissue banks 
should provide in obtaining consent. 
C	 The National Donor Family Council has proposed key elements of an informed consent 
policy for tissue donation. 
C	 Organizations representing the tissue banking industry have issued a statement that 
addresses elements of informed consent.  These organizations include the American 
Association of Tissue Banks (AATB), the Association of Organ Procurement 
Organizations, and the Eye Bank Association of America.  The AATB is incorporating 
this statement into its accreditation standards for tissue banks. 
Tissue Donation: Informed Consent  ii  OEI-01-00-00440  CONCLUSION 
Tissue banking and processing practices have gradually diverged from donor families 
expectations in recent years.  The tissue banking industry has expanded and become more 
complex and costly.  New ways of using tissue for medical treatment have been 
developed.  Processed tissue often is marketed and sold like any other medical product. 
For some people, these practices call into question the non-profit basis of the tissue 
banking community.  Despite these changes, the industrys foundation remains that of 
human tissue altruistically donated by individuals and their families at an extraordinarily 
sensitive time.  The special nature of this product, and the circumstances under which it is 
made available, call for steps to be taken above and beyond those that would apply to 
most other business or philanthropic enterprises. 
RECOMMENDATIONS 
Importance of increasing donation.  The Office of Inspector General has examined 
issues related to organ, tissue, and bone marrow donation, allocation, and transplantation 
for more than a decade.  The principles underlying our work have focused consistently on 
enhancing equity for patients, improving access to transplantation, and encouraging 
donation. 
Encouraging donation was of paramount importance to us as we developed our 
recommendations.  It is our hope that these recommendations will encourage donation. 
Our recommendations encourage joint action among groups representing the tissue 
banking industry, donor families, and the government. 
RECOMMENDATIONS TO THE DEPARTMENT 
The Health Resources and Services Administration should work with groups 
representing donor families and the tissue banking industry to develop 
guidelines for conveying information to families about tissue donation. 
HRSAs Division of Transplantation supports the development of programs to increase 
donation.  In that role, HRSA has gained considerable expertise about effective practices 
in requesting consent.  The agency could act as a resource to tissue banks and families. 
HRSAs efforts could focus on such areas as: 
C	 Identifying principles and guidelines that should underpin consent requests, such as those 
outlined recently by the National Donor Family Council and by industry groups; 
C	 Making suggestions as to the type, format, and content of written information about 
donation that tissue banks could share with families. 
C	 Making recommendations on information that would be useful for training tissue bank 
staff and external requestors; and 
C	 Making recommendations on assessment tools that would be useful in evaluating the 
effectiveness of requestors. 
Tissue Donation: Informed Consent  iii  OEI-01-00-00440  The Health Care Financing Administration should address informed consent for 
tissue donation through the Medicare conditions of participation. 
HCFA requires hospitals to assure that the family of each potential donor is aware of its 
options to donate tissues, organs, and eyes.  Elsewhere in this report, we call upon donor 
family groups, the tissue banking industry, and HRSA to develop guidelines for conveying 
information to families about tissue donation.  HCFA could use these guidelines as it 
provides information about the conditions of participation for organ, tissue, and eye 
donation.  The agency could publicize these principles through the HCFA Internet site. 
In the longer term, the agency may wish to examine the Medicare conditions of coverage 
governing organ procurement organizations.  In that examination, the agency could 
consider additional requirements to strengthen working relationships between OPOs and 
tissue banks.  Such requirements might include: 
C  Holding OPOs responsible for informed consent for tissue donor families when they 
request consent on behalf of tissue banks; and 
C  Requiring OPOs to include tissue banks in the training that they conduct for designated 
requestors. 
RECOMMENDATIONS TO THE INDUSTRY 
At the time of obtaining consent, tissue banks should provide families with 
written materials that provide fuller disclosure about the uses of tissue and the 
nature of the gift. 
Tissue banks should give written material to families at the time the banks ask for consent 
to donation, or in the days immediately following the request.  The material should be 
appropriately thorough.  It would serve as one way to supplement the information that 
requestors provide to the family during their conversation about donation, while providing 
requestors with flexibility to adapt that conversation to the unique needs and responses of 
each donor family.  At a minimum, this material should include: 
C  A copy of the signed consent form;

C  Written material on how to follow up with the tissue bank if concerns arise;

C  A full description of the uses to which donated tissue may be put; and

C  A list and description of other companies and entities with which the bank has

relationships for processing and distributing tissue. 
Tissue processors and distributors should ensure that information accompanying 
their product clearly indicates it is derived from donated human tissue. 
Such a step would require only minor changes in packaging and marketing materials.  But 
it would go a long way towards showing ongoing respect for the donor, the family, and 
the gift of donation.  Tissue banks should: 
C	 Indicate clearly on all tissue packaging that the contents derive from donated human 
tissue; and 
Tissue Donation: Informed Consent  iv  OEI-01-00-00440  C	 Indicate clearly on all marketing and informational material that these products derive 
from donated human tissue. 
Tissue banks should foster greater accountability for the performance of those 
who request consent for donation. 
Responsibility for ensuring that requestors are providing accurate, sensitive, and 
appropriate information rests with tissue banks and the processors with which they work. 
These organizations should: 
C	 Ensure that requestors  both from their own organizations and from hospitals  are 
fully and appropriately trained; 
C  Provide continuing education for requestors; and 
C	 Conduct an ongoing assessment of requestor performance as a means of ensuring that they 
are providing full and accurate information to families approached for donation. 
The tissue banking industry should work with groups representing donor families 
to explore a process for periodic public disclosure about tissue banks financing. 
The purpose of the examination we recommend here is to respond to family and general 
public concerns about knowing the sources of funding for tissue banks and other entities 
with which the bank has financial arrangements.  The examination would consider whether 
financial information would be useful as part of a package of information provided to 
donor families.  The examination would consider: 
C	 What types and how much financial information would be useful for families and 
individuals in making decisions about donation; 
C	 The advantages and disadvantages of disclosure, including the potential impact of financial 
disclosure on donation; 
C	 Whether the information should be provided in all cases, or only if requested by a family; 
and 
C  The content, style, and format of disclosure. 
COMMENTS ON THE REPORT 
We received comments on a draft of this report from the Department of Health and 
Human Services.  They are supportive of our findings and recommendations.  The full text 
is included in Appendix C. 
Our work in tissue banking continues.  We will maintain an active watch on how the tissue 
banking community responds to the concerns we have raised. 
Tissue Donation: Informed Consent  v  OEI-01-00-00440  T A B L E  O F  C O N T E N T S  
EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  i

BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

FINDINGS

Family expectations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Tension between expectations and reality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Limits on information provided  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Concerns about requesting consent  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Limited guidance on requesting consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

CONCLUSION  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  12

RECOMMENDATIONS

Department of Health and Human Services  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Tissue banking industry  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

APPENDICES 
A:  National Kidney Foundation/Donor Family Council . . . . . . . . . . . . . . . . . . . . . . . . 17

B.	 American Association of Tissue Banks, Association of Organ Procurement

Organizations, Eye Bank Association of America  . . . . . . . . . . . . . . . . . . . . . . . . . 19

C.  Comments from the Department of Health and Human Services . . . . . . . . . . . . . . .  22

D.  Endnotes  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Tissue Donation: Informed Consent  OEI-01-00-00440  I N T R O D U C T I O N  
PURPOSE 
To assess expectations for and limitations of informed consent for tissue donation. 
BACKGROUND 
Transplantation of Human Tissue 
Human tissue is an important resource used in medical treatment.  Physicians and dentists 
use cadaveric human tissue for a variety of medical purposes.  Donated skin can meet 
critical needs in healing burn victims and in reconstructive surgery.  Donated bone can be 
implanted to replace cancerous bone, for knee and hip replacements, and for spinal 
surgery; it can be processed into powder for use in dental surgery.  Donated heart valves 
can replace defective valves in young children, saving their lives. 
The exact number of tissue donors in this country is unknown.  It is clear, though, that the 
numbers are increasing.  In 1999, more than 20,000 donors provided cadaveric tissue, up 
from perhaps 6,000 donors in 1994.  Tissue banks distributed over 750,000 allografts for 
transplantation in 1999. 
Consent for Donation 
A first step in tissue donation is obtaining the consent of a deceased individuals family. 
Even if the individual had indicated willingness to donate organs and tissues (e.g., on the 
drivers license), it is practice in this country to obtain consent from the next-of-kin.  A 
family may refuse to give consent, or it may give consent for donation of all or only some 
tissues. 
Tissue banking is subject to more limited regulation than the nations organ procurement 
system, even though both organ procurement organizations (OPOs) and tissue banks are 
involved in approaching families for consent.  For example, the National Organ Transplant 
Act requires OPOs to meet certain organizational and staffing requirements; the Act also 
requires OPOs to assist hospitals in establishing and implementing protocols for making 
routine inquiries about organ donation by potential donors.  No similar requirements exist 
for tissue banks.1 
Concerns about Tissue Banking 
Several press reports in the Spring of 2000, appearing in the Orange County Register and 
the Chicago Tribune, raised a number of concerns about tissue banking.  A particular 
focus of these articles related to financial aspects of the tissue banking industry.  Several 
members of Congress asked the Secretary of Health and Human Services to examine the 
Tissue Donation: Informed Consent  1  OEI-01-00-00440  tissue banking industry, including the extent to which families were informed about 
financial arrangements or uses to which tissue might be put. 
This Inquiry 
The Secretary asked the Office of Inspector General to review two aspects of tissue 
banking: consent for donation and the overall regulatory structure governing the industry. 
This report responds to the first of those requests, focusing on informed consent.  Our 
companion report, Tissue Banking Oversight (OEI-01-00-00441), provides a profile of 
the oversight system for tissue banking and addresses limitations in that system. 
We use the term tissue to refer to skin, heart valves, and musculoskeletal tissue such as 
bone, cartilage, ligaments, and tendons.  Our report does not address eyes and 
reproductive tissue. 
METHODOLOGY 
We conducted interviews with senior staff from 30 organizations involved in obtaining, 
processing, and distributing human tissue; 25 of these organizations were involved in 
obtaining consent and recovering human tissue.2  Our interviews focused on their policies, 
practices, and experiences relative to consent. 
With assistance from the National Kidney Foundation, we posted a series of questions on 
the web site of the National Donor Family Council.  These questions sought to provide us 
with a donor family perspective of experiences with the donation process.  We received 50 
responses from donor families through this web site.  We recognize that the findings from 
this posting do not constitute a random sample from which projections can be made. 
Nevertheless, we believe that the responses provide important information and a valuable 
perspective on the process of obtaining consent. 
We interviewed officials and staff, and reviewed documents, from associations involved 
with tissue banking, including the American Association of Tissue Banks (AATB), 
National Donor Family Council, Eye Bank Association of America, Association of Organ 
Procurement Organizations, and North American Transplant Coordinators Organization. 
We reviewed State and Federal laws and regulations related to tissue banking, and 
standards from the AATB. 
We conducted this inspection in accordance with the Quality Standards for Inspections 
issued by the Presidents Council on Integrity and Efficiency. 
Tissue Donation: Informed Consent  2  OEI-01-00-00440  F I N D I N G S  
The expectations and altruistic motives of donor families are the 
foundation of tissue donation.  Donor families and tissue bank staff 
told us that in agreeing to donation, families carry some basic 
assumptions: 
Expectation that the donation will enhance the lives of others. 
Families expect that their loved ones tissue will be used in meeting important medical 
needs.  The primary expectation is that the tissue will be used for transplantation, as a way 
of improving the lives of people with medical needs.  Many families also provide consent 
to use tissue for medical research and medical education. 
Families may view donation as a way of creating something positive from the death of 
their loved one.  The mother of one tissue donor captured this view when she told us, If 
my son helped just one person live a better life, then his donation was worth it.  This 
expectation is reflected in the comments we received from a number of donor families. 
These families hoped for some type of follow-up with people who had benefitted from 
their loved ones gift of tissues, as a way of confirming the usefulness of and appreciation 
for the gift. 
Respect for the donor and the family. 
Respect has two broad components.  First, families anticipate that the donor will be 
respected.  This respect should last through the entire donation process.  It includes, for 
example, respect for the donors body during tissue recovery.  Tissue recovery requires 
invasive surgery.  For families, respect entails that no more harm is done to the body than 
absolutely necessary. 
During processing, distribution, and transplantation, respect entails that the gift be 
recognized as coming from a donation of human tissue.  Musculoskeletal tissue often is 
processed into many forms.  These forms include bone screws, dowels, and bone chips, 
which have many different medical uses.  These final products often bear little resemblance 
to human tissue; in fact, they look more like tools, hardware, supplies, and devices than 
what most people would call human tissue.  The mother of a donor exemplified the 
concern that respect be maintained for the donor when she told us, That screw is not a 
screw to me  it came from somebodys loved one or child. 
Second, donor families expect that their own needs will be respected by the tissue banks. 
Respect for the family includes discussing the option of donation in a sensitive manner, 
answering all questions, and ensuring that the timing of and plans for funeral arrangements 
are not disrupted by tissue recovery. 
Tissue Donation: Informed Consent  3  OEI-01-00-00440  The AATBs Statement of Principles reflects the importance that the association and its 
members accord to the importance of respect.  Member banks pledge to honor and treat 
with respect the gifts that have been donated and to reflect this in all activities related to 
cell and tissue procurement.3 
Trust in the organizations involved in procuring and using the donation. 
At the time of their loss, families are asked to place enormous trust in tissue banks.  Prior 
to requesting donation, it is unlikely that any relationship existed between the donor family 
and the tissue bank.  Quite possibly, the family may never have heard of tissue donation. 
Tissue banks request a donation of their loved ones body at the time the family is 
grieving.  As a member of one donor family noted, It is an extremely emotional display of 
trust, to allow someone to take parts of a loved one. 
Tissue banks we spoke with echoed the sentiments of donor families.  One tissue bank 
director viewed tissue procurement as a public service and said that the bank has the 
responsibility for ensuring that tissue is used for the right purposes.  Another tissue bank 
director shared her view of this responsibility: We are stewards of the gift the family is 
giving, and it is up to us to handle it in an appropriate manner. 
However, the reality of tissue banking raises some underlying tension 
with families assumptions. 
Commercialization of tissue banking 
Families view tissue donation as an altruistic act.  This perspective is buttressed by the 
National Organ Transplant Act, which states that it is unlawful to acquire, receive or 
otherwise transfer any human organ [including several defined types of tissue] for valuable 
consideration for use in human transplantation.4  Although the act permits  recovery of 
reasonable costs associated with activities such as retrieval and processing, concerns have 
been raised about whether individuals and firms may be receiving unreasonable financial 
enrichment from procuring, processing, or distributing the altruistic donation.5 
No one denies that there are costs associated with processing tissue, conducting research, 
developing new products and uses, and advancing science.  However, the large-scale 
financial aspects of tissue banking create tensions with an altruistic act. 
These tensions have particular relevance to the operation of for-profit firms in what is, at 
least nominally, an altruistic enterprise based on donation.  Publicly-traded companies 
have raised capital and brought entrepreneurial energy to tissue processing, leading to the 
development of new processes and products.  Yet, it is precisely at this point that tension 
arises.  The concern may be best characterized as unease about a focus on the bottom 
line, as portrayed in the following question:  If a companys primary interest is financial 
benefit to its stockholders, is it making choices to put tissue to more lucrative uses over 
Tissue Donation: Informed Consent  4  OEI-01-00-00440  medical needs?6 
A second facet of tension with commercialization relates to the level of salaries and costs 
incurred by both non-profit and for-profit firms.  Although reasonable costs are permitted, 
there is no definition of, and undoubtedly no consensus about, what constitutes 
unreasonable costs.  In fact, no guidelines are in place regarding disclosure of costs, and 
no comparative data are available publicly on the range of costs that would permit such a 
determination. 
Finally, the industry is intensely competitive, with firms establishing proprietary patents on 
a number of products and processes.  Some observers view this as primarily an effort to 
gain competitive advantage and market share in the distribution of tissues. 
In a vacuum, these issues do not raise concerns.  Yet in an industry that is premised on 
donation of parts of a loved ones body, it should not be surprising that donor families 
could feel misled as they question why everyone is making money off of this altruistic gift 
except the donor and the donors family. 
The importance of concerns about commercialization for informed consent relates to 
whether families may wish to know about commercial relationships that exist between the 
agency to which it makes an altruistic donation, and an entity  be it non-profit or for-
profit  that realizes revenue from the gift.  If they are not made aware of these 
relationships, it may be difficult to say that their consent truly is informed. 
Tissue viewed as a commodity 
Maintaining respect for the donor and the donors family is an underpinning of the tissue 
system.  As we discuss above, tissue is processed extensively for many different uses.  The 
marketing of human tissue as a commodity bears particular relevance to donor families 
assumption that their loved ones tissue will be treated with respect and honor, and that it 
will be respected by the users and the recipients of tissue. 
The packages in which human tissue is supplied  bottles, vials, containers shrink-
wrapped in plastic  resemble many other medical supplies.  The labeling does state that 
the contents are human tissue, but this is related to concerns about safety and disease 
transmission rather than respect for the donor.  The packaging does not indicate that the 
enclosed materials derive from donated human tissue. 
We reviewed marketing materials from both for-profit and non-profit companies.  These 
product brochures look like typical medical supply catalogues, contributing to a 
perception that tissue is no different from other supplies.  As with the packaging, the 
marketing materials rarely indicate that the materials derive from donated human tissue. 
Cosmetic uses of tissue 
A number of products used in reconstructive surgery utilize donated tissue, particularly 
Tissue Donation: Informed Consent  5  OEI-01-00-00440  skin.  These products are used in procedures that most people would, no doubt, consider 
medically appropriate and necessary.  Examples of such procedures include alleviating 
serious scarring or constructing a bladder sling for treatment of urinary incontinence. 
On the other hand, there clearly are some uses of these products that many people would 
consider to be non-essential cosmetic uses.7  It is not clear how much tissue goes for such 
cosmetic uses; because the actual use of these products is determined by physicians and 
patients, tissue banks that manufacture them do not have that information.  However, a 
family may be reluctant to give its consent for donation if it is aware that the gift would be 
used for purposes that are not medically indicated. 
The American Medical Associations policy provides a useful framework for considering 
the differences between cosmetic and reconstructive surgery.  That policy states that 
cosmetic surgery is performed to reshape normal structures of the body in order to 
improve the patient's appearance and self-esteem.  Reconstructive surgery is performed on 
abnormal structures of the body, caused by congenital defects, developmental 
abnormalities, trauma, infection, tumors or disease.  It is generally performed to improve 
function, but may also be done to approximate a normal appearance.8 
Fundamental factors limit the amount of information that is given to 
families. 
Families are asked to give their consent at a point in time when they are 
extremely vulnerable. 
The recent, often sudden and unexpected, death of a loved one means that families are 
likely to be distraught when they are asked for consent to donate.  In the face of sudden 
tragedy, they may simply be unable to understand detailed information about tissue 
donation. 
Tissue donation is a complex topic.  Tissue banks must obtain consent for donation within 
hours following the death of a loved one.  Because the family may be in shock, discussing 
multiple aspects of tissue donation and tissue banking  recovery, processing, 
distribution, commercial relationships  may go well beyond the capacity of families to 
comprehend what they are hearing.  The father of a tissue donor echoed this sentiment 
when he commented to us, I doubt donor families can process much information; they 
hear very little at a time when they are immersed in profound shock and grief. 
At the same time, families may not wish to receive detailed information about 
tissue banking. 
Often, families know they want to consent to donation, but do not want to hear specific 
details about the process.  As one tissue donor mother told us, I really didnt need any 
more information than what was provided; frankly, I wouldnt have been able to deal with 
much more at that point.  Her thoughts were echoed by a tissue bank director who told 
Tissue Donation: Informed Consent  6  OEI-01-00-00440  us that it is crucial to be able to give families as much or as little information as they want, 
depending on where they are in the grief process. 
Tissue bank staff with whom we spoke cited the balance they must strike when speaking 
with families.  Much information needs to be communicated to the family at the time of 
consent; at a minimum, authorization for removal of specific tissues is required.  Families 
also must agree to whether the tissue may be used only for transplantation, or for other 
uses such as research and education. 
Tissue bank staff told us that families generally have two primary concerns: whether the 
family will incur any costs for donating tissue and whether the body will be suitable for an 
open-casket viewing.  They noted that it is rare for families to ask about other concerns. 
On the other hand, some families may wish to have more information to help them reach a 
decision, or they may wish to receive more information that they could reflect upon at a 
later date.  The challenge for those seeking consent is to gauge how much detail a 
particular family wishes to receive. 
Obtaining consent and documenting a donors medical suitability require time-
consuming and invasive questioning about a recently deceased loved one. 
Because tissue can transmit disease, FDA requires tissue banks to screen donors for 
evidence of behaviors that place them at high risk for HIV and hepatitis.9  This  screening 
requires completion of a lengthy medical and social history questionnaire as part of 
determining donor suitability.  Tissue bank personnel who administer the medical and 
social history questionnaire to families note that the process may take as long as an hour 
or more to complete.  The tissue bank staff must administer this questionnaire shortly after 
the family consents to donation. 
Donor families must answer questions about the deceaseds medical history and personal 
behaviors, including uncomfortable questions about drug and alcohol use, and about 
sexual behavior.  Under any circumstances, questions such as these are intrusive.  After 
the death of a loved one, this effect undoubtedly is amplified. 
Current practices in requesting consent raise concerns about how and 
what information is provided to families. 
Many tissue banks rely on staff from other organizations to obtain consent. 
We interviewed staff from 25 banks that recover tissue; 14 of these banks rely primarily on 
their own staff to request consent from families, and 11 banks rely on others to make the 
requests.  The American Association of Tissue Banks conducted an informal survey of its 
members.  AATB found that 42 percent of accredited tissue banks use their own staff to 
request consent for tissue donation, while the other 58 percent of banks use individuals 
not employed by the bank for requesting. 
About half of the external requestors are staff from organ procurement organizations 
Tissue Donation: Informed Consent  7  OEI-01-00-00440  (OPOs).  OPOs play an important role in tissue donation, even if they do not operate a 
tissue bank.  Recent changes to the Medicare conditions of participation for hospitals gave 
OPOs an important gatekeeping function by requiring a hospital to notify its OPO of all 
deaths.  Thus, even for persons who do not meet the stringent criteria for organ donation, 
OPOs play a role in referring the call to the appropriate tissue bank and, in some cases, 
seek consent from the family for tissue donation.10 
External requestors include staff from telephone triage agencies with which the tissue bank 
contracts for the specific purposes of requesting consent.  Tissue banks also rely on 
hospital staff, primarily nurses, chaplains, and social workers, to obtain consent from 
families.  Tissue banks may wish to keep hospital staff involved in and committed to 
donation.  These staff may well have been in close contact with the family, and families 
may be more trusting and receptive to donation when it is discussed by these caregivers. 
Other tissue banks prefer to handle the consent process themselves.  The director of one 
OPO that also operates a tissue bank told us she simply feels more comfortable knowing 
that trained coordinators are doing the requesting.  This approach also benefits hospitals; 
it is a way of relieving a hospital of liability for its own staff should problems arise. 
Tissue banks often request consent over the telephone, rather than in person. 
Consent requests for tissues contrast sharply with requests for organ donation.  In 
requesting organ donation, OPO staff seek consent from the family while they are still at 
the hospital.  OPO staff often have spent long hours with the family prior to disconnecting 
the ventilator, and they likely have established a rapport with that family. 
In our interviews, 16 of 25 tissue banks that recover tissue said that they primarily  request 
consent over the telephone, rather than in person.  In most cases, tissue banks make these 
requests after the family has left the hospital.  Tissue bank staff told us that it is more 
productive to give the family time to return to the familiar surroundings of home, rather 
than the coldness of a hospital.  At a practical level, it also would be quite difficult for the 
tissue bank staff to travel to every hospital when someone has died in order to request 
donation. 
There may be little training and accountability of external requestors. 
Tissue banks train and monitor their own staff who request consent.  Training programs 
typically include classroom lectures, written materials, presentations, observing other 
requestors, role playing, and mentoring by seasoned requestors.  Many banks send 
requestors to training courses offered by organizations with longstanding expertise in the 
field.  Most tissue banks we spoke with also provide their staff with continuing education. 
Training programs for tissue requestors not employed by the bank tend to be briefer. 
Training programs for external requestors at tissue banks we spoke with ran about 4 hours 
on average.  Training generally comprises presentations by tissue bank staff and covers 
topics including how to interact with families, the use of tissues, and how tissues are 
recovered.  A few tissue banks offer longer programs that include role-playing exercises. 
Tissue Donation: Informed Consent  8  OEI-01-00-00440  After the initial training, only a small number of tissue banks we spoke with offer 
continuing education or follow-up training to external tissue requestors. 
Training for tissue donation also may take place through an OPOs designated requestor 
training program.  Yet, as we have shown elsewhere, few OPOs conduct this training.11 
Tissue bank staff we interviewed also indicated that OPOs give only limited attention to 
training about requesting tissue donation, because organ donation is often seen as a higher 
priority than tissue donation. This difference in emphasis is likely to be more pronounced 
in areas where there is competition between the tissue bank and the OPO. 
Providing in-depth training of external requestors faces some major constraints.  Tissue 
bank directors we interviewed noted that it is difficult for hospital staff to take time from 
their duties for intensive training as a tissue requestor.  Additionally, tissue banks that rely 
on hospital staff to request consent may be unable to select the hospital staff to be trained. 
Thus, staff who may not want to be tissue requestors may be trained for the process and, 
subsequently, may do a poor job of it. 
Even among those tissue banks that train external requestors, we found that few actively 
assess their performance.  The primary vehicle we found for assuring accountability was 
that some tissue banks use their own staff to contact the donor family at home to complete 
the medical-social history questionnaire.  These banks told us that having their own staff 
speak with the donor family provides a checkpoint for the consent process, because staff 
can answer questions, provide more information, and reaffirm the consent. 
Tissue banks provide donor families with little written material at the time of 
donation. 
Few tissue banks routinely give families a copy of the signed consent form.  The consent 
form, however, is the legal authorization governing the removal of tissue and specifying 
purposes for which the tissue may be used.  One tissue bank told us that it asks family 
members if they want to receive more information.  Other tissue banks indicated that they 
would give the family the form if someone requested it.  However, requiring a family to 
make such a request places it in a deferential position, when the bank could proactively 
make the consent form available. 
Following donation, it is general practice for tissue banks to send families a letter thanking 
them for the gift and expressing condolences.  We reviewed copies of these letters from 11 
tissue banks; about half gave a general description of which tissues were recovered, and 
the other half conveyed information in broad, generic terms about how tissue can be used 
to improve peoples lives.  Many of the tissue banks we spoke with provide additional 
materials about grieving and about support groups. 
Aside from this letter, tissue banks provide little additional written information to families 
about tissue use, processing, or other entities with which they have financial arrangements. 
Tissue bank staff we spoke with told us they are hesitant to provide more information to 
families, either at the time of consent or afterwards, because the family is 
Tissue Donation: Informed Consent  9  OEI-01-00-00440  grieving and may not want to think about the donation. 
Many donor families told us that consenting to donation was a positive outcome that came 
from their loved ones death.  Because families may not comprehend everything that is 
told to them at the time of donation, more information may be beneficial at a later date. 
One donor mother captured this sentiment when she told us, I know there are many 
families who would like to have some reading material to refer to when or if they are 
ready, since there is so much information that is not heard within this horrific moment. 
Until recently, standards governing how families are approached and 
what they are told about tissue donation have been nonexistent. 
However, some advice and guidance have emerged. 
Federal laws and regulations do not address the manner in which tissue banks 
obtain consent. 
The Health Care Financing Administration has no statutory or regulatory authority over 
tissue banks.  However, the 1998 Medicare conditions of participation for hospitals 
relating to organ, tissue, and eye donation require hospitals and tissue banks to work 
together to establish donor suitability criteria.  The regulations also require hospitals to 
ensure that all families of potential donors are informed of their options to donate organs, 
tissues, and eyes, and that programs for training hospital-based requestors are designed in 
conjunction with the local tissue banking community.12  However, the regulation does not 
provide specific guidelines on the content, circumstances, or manner of approaching donor 
families. 
The Health Resources and Services Administration (HRSA) provides resources and 
support to the transplantation community.  HRSA recently published a resource guide that 
provides information and approaches on training hospital staff and procurement agencies 
in working and communicating with grieving families as part of the donation process.13 
The Food and Drug Administrations (FDA) authority over tissue banks derives from 
Public Health Service Act provisions authorizing regulations to prevent the spread of 
communicable diseases.  The agency requires that donor screening and testing for HIV-1 
and -2  and for Hepatitis B and C.  FDA regulations do not address the issue of obtaining 
consent for donation; however, the regulations do require tissue banks to interview 
someone such as a close relative about the donors medical history and social behavior.14 
States Uniform Anatomical Gift Acts do not address what information tissue 
banks should provide in obtaining consent. 
All States and the District of Columbia have enacted versions of the Uniform Anatomical 
Gift Act.15  These laws establish procedures for competent adults to make anatomical gifts 
by completing and signing a legal document.  These gifts are irrevocable at the donors 
death.  The laws also include some stipulations on obtaining consent, such as the 
Tissue Donation: Informed Consent  10  OEI-01-00-00440  order in which next-of-kin may make decisions, documentation required, or the number of 
persons who must provide legal witness.  However, these laws do not address the content 
of informed consent. 
The gift acts in some States specify the informed consent document that must be signed. 
The consent form itself, however, is a legal document, not a mechanism for sharing 
pertinent information about donation with the family. 
The National Donor Family Council has proposed key elements of an informed 
consent policy for tissue donation. 
The National Donor Family Council (NDFC) represents about 8,000 donor families.  The 
NDFC recently approved a position statement on tissue donation that addresses important 
considerations for discussing donation with donor families.  The full position statement 
appears in Appendix A.  Key elements include: 
C  Explanations on how tissue is recovered, processed, stored and distributed;

C  Explanations that the tissue may be used or modified for transplantation;

C  Explanation that the family may limit or restrict the use of tissue; and 

C  Requirements that the consent form be reviewed with families and that a copy be offered

to the family. 
Organizations representing the tissue banking industry have issued a statement 
that addresses elements of informed consent to be included in discussions with 
families. 
The American Association of Tissue Banks (AATB), the Association of Organ 
Procurement Organizations, and the Eye Bank Association of America, issued a joint 
statement in December, 2000.  The full position statement appears in Appendix B. 
AATB, which accredits 58 cadaveric tissue banks, is incorporating the elements contained 
in this statement into its accreditation standards.  The updated standards are scheduled for 
publication in January, 2001. 
The statement addresses basic elements of informed consent which should be provided to 
all families.  These basic elements include: 
C  Identification of specific tissues that are being requested for donation; 
C  Explanation that retrieved tissues may be used for transplantation, therapy, research, or 
education; and 
C  A general description of the recovery process. 
The statement also recognizes that families may seek additional information about 
donation.  If so, additional explanations should be provided to address such issues as: 
C  The possibility that the gift may take a different form than originally recovered;

C  Transplantation may include reconstructive and aesthetic surgery; and

C  Multiple organizations (non profit and/or for profit) may be involved in facilitating the gift.

Tissue Donation: Informed Consent  11  OEI-01-00-00440  C O N C L U S I O N  
Tissue banking and processing practices have gradually diverged from donor families 
expectations in recent years.  For donor families, the altruistic donation of tissue from a 
loved one is a charitable act.  Donation is made with few expectations other than that it 
will be used to enhance the lives of others, that the donor will be treated with respect, and 
that the organizations with whom tissue banks work will take special care to ensure that 
the gift is used for these purposes. 
Todays tissue banking industry and the beneficial uses of human tissues and related 
products have become more complex and costly.  New ways of using tissue for medical 
treatment have been developed.  Tissue banking has been infused with capital and 
entrepreneurial practices.  Processed tissue often is marketed and sold like any other 
medical product.  For some, these practices call into question the non-profit basis of the 
tissue banking community. 
Despite these changes, the foundation of the industry remains that of human tissue freely 
donated by individuals and their families at a most difficult and extraordinarily sensitive 
time. 
The special nature of human tissue, and the circumstances under which it is made 
available, call for certain steps to be taken above and beyond those that would apply to 
most other business or philanthropic enterprises.  In the following section, we share our 
recommendations that take these into account. 
Tissue Donation: Informed Consent  12  OEI-01-00-00440  R E C O M M E N D A T I O N S  
Importance of Increasing Donation 
The Office of Inspector General has examined issues related to organ, tissue, and bone 
marrow donation, allocation, and transplantation for more than a decade.  The principles 
underlying our work have consistently focused on enhancing equity for patients, 
improving access to transplantation, and encouraging donation. 
Encouraging donation was of paramount importance to us as we developed these 
recommendations.  It is our hope that these recommendations will encourage donation. 
Our recommendations encourage joint action among groups representing the tissue 
banking industry, donor families, and the government. 
The Department of Health and Human Services 
The Health Resources and Services Administration should work with groups 
representing donor families and the tissue banking industry to develop 
guidelines for conveying information to families about tissue donation. 
HRSAs Division of Transplantation supports the development of programs to increase 
donation.  In that role, HRSA has gained considerable expertise about effective practices 
in requesting consent.  The agency could act as a resource to convey information about 
donation to tissue banks and families. 
HRSAs efforts could focus on such areas as: 
C	 Identifying principles and guidelines that should underpin consent requests, such as those 
outlined recently by the National Donor Family Council and jointly by the American 
Association of Tissue Banks, Association of Organ Procurement Organizations, and the 
Eye Bank Association of America; 
C	 Making suggestions as to the type, format, and content of written information about 
donation that tissue banks could share with families; 
C	 Making recommendations on information that would be useful for training tissue bank 
staff and external requestors; and 
C	 Making recommendations on assessment tools that would be useful in evaluating the 
effectiveness of requestors. 
The Health Care Financing Administration should address informed consent for 
tissue donation through the conditions of participation for hospitals and for 
organ procurement organizations. 
As we note above, HCFA requires hospitals to assure that the family of each potential 
donor is aware of its options to donate.  This requirement applies to tissue donation, as 
Tissue Donation: Informed Consent  13  OEI-01-00-00440  well as to donation of organs and eyes. 
Elsewhere in this report, we recommend that HRSA work with donor family groups and 
the tissue banking industry to develop guidelines for conveying information to families 
about tissue donation.  HCFA could use these guidelines as it provides information about 
the hospital conditions of participation for organ, tissue, and eye donation.  The agency 
could publicize these principles through the Questions and Answers document posted on 
the HCFA Internet site.  For example, the agency may wish to encourage hospitals to 
include a protocol for informed consent in their agreements with tissue banks, using the 
recommended guidelines in those protocols. 
In the longer term, the agency may wish to examine the Medicare conditions of coverage 
governing organ procurement organizations.  In that examination, the agency could 
consider whether it would be beneficial to include additional requirements to strengthen 
working relationships between OPOs and tissue banks.  Such requirements might include: 
C	 Holding OPOs responsible for informed consent for tissue donor families when requesting 
consent on behalf of tissue banks; and 
C	 Requiring OPOs to include tissue banks in the training that they conduct for designated 
requestors. 
The Tissue Banking Industry 
At the time of obtaining consent, tissue banks should provide families with 
written materials that provide fuller disclosure about the uses of tissue and the 
nature of the gift. 
Tissue banks could do a better job of providing basic information to families, either at the 
time they ask them to consent to donation, or in the days immediately following that 
decision.  At a minimum, this material should include: 
C	 A copy of the signed consent form.  We believe that this is a basic legal protection for the 
family, as well as a recognition of the nature of the gift to which they have consented; 
C	 Written information to the family on how it can follow up with the tissue bank in the case 
concerns arise; 
C  A full description of the uses to which donated tissue may be put; and 
C	 A list and description of other entities with which the bank has relationships for processing 
and distributing tissue. 
Written materials should be appropriately thorough.  Such materials would serve as a way 
to supplement the information that requestors provide to the family during their 
conversation about donation, while providing requestors with the flexibility to adapt that 
discussion to the unique needs and responses of each donor family. 
Tissue Donation: Informed Consent  14  OEI-01-00-00440  Tissue processors and distributors should ensure that information 
accompanying their product clearly indicates it is derived from donated human 
tissue. 
The FDA does not currently have labeling requirements for packaged tissue, and the 
AATBs standards (which apply only to banks accredited by the association) address 
labeling within the context of ensuring that users know it is a biologically-based product, 
capable of transmitting disease.  Neither set of standards addresses donor families 
concerns that recognition be given to the fact that the products are the result of a freely 
made donation of human tissues. 
The following steps could help to address perceived concerns that donated human tissue is 
no different from any other medical product.  Tissue banks should: 
C	 Indicate clearly on all tissue packaging that the contents derive from donated human 
tissue; and 
C	 Indicate clearly on all marketing and informational brochures that these products derive 
from donated human tissue. 
This recommendation responds to concerns that tissue is viewed as a commodity, rather 
than an altruistic donation.  Implementing it would require only minor changes in 
packaging and marketing materials.  But it would go a long way towards showing ongoing 
respect for the donor and the gift of donation. 
Tissue banks should foster greater accountability for the performance of those 
who request consent for donation. 
We found wide variation in practices among tissue banks with respect to how consent for 
donation is requested, who requests consent, and how these individuals are trained and 
monitored.  There is no doubt that the responsibility for ensuring that requestors are 
providing accurate, sensitive, and appropriate information rests directly with the tissue 
bank.  To ensure greater accountability of requestors, tissue banks should: 
C	 Ensure that their requestors are fully and appropriately trained.  This applies both to 
requestors from their own organizations as well as other entities, such as hospitals; 
C  Provide continuing education for requestors; and 
C	 Conduct ongoing assessments of requestor performance to ensure that they are providing 
full and accurate information to families approached for donation. 
The tissue banking industry should work with representatives of groups 
representing donor families to explore a process for periodic public disclosure 
about tissue banks financing. 
Non-profit entities are already required to disclose information about the sources and uses 
of funds received; publicly-owned businesses submit annual public reports to the Securities 
and Exchange Commission.  These disclosures contribute to public accountability 
Tissue Donation: Informed Consent  15  OEI-01-00-00440  and can serve as a basis for building greater trust among donors, families, and tissue 
banks. 
The purpose of the examination we recommend here is to respond to family and general 
public concerns about knowing the type and extent of financial arrangements which the 
tissue bank has with other entities, both nonprofit and for profit.  The examination would 
consider whether financial information would be useful as part of a package of information 
provided to donor families.  The examination would consider: 
C  What types and how much financial information would be useful for families and 
individuals in making decisions about donation; 
C  The advantages and disadvantages of financial disclosure, including its potential impact 
on donation; and 
C  The content, style, and format of disclosure. 
COMMENTS ON THE REPORT 
We received comments on a draft of this report from the Department of Health and 
Human Services.  They are supportive of our findings and recommendations.  The full text 
is included in Appendix C. 
Our work in tissue banking continues.  We will maintain an active watch on how the tissue 
banking community responds to the concerns that we have raised. 
Tissue Donation: Informed Consent  16  OEI-01-00-00440  APPENDIX A 
NATIONAL DONOR FAMILY COUNCIL 
EXECUTIVE COMMITTEE 
POSITION STATEMENT ON TISSUE DONATION 
The National Donor Family Council (NDFC) of the National Kidney Foundation recognizes 
and supports tissue donation as an end-of-life option for donor families and recognizes its life-
enhancing capacity to help thousands who are awaiting tissue transplantation. 
The NDFC strives to enhance the sensitivity and effectiveness of the organ and tissue 
procurement process. To further this mission, the NDFC believes that tissue donation should 
always be treated as a gift of life. We believe that the tissue community as a whole must 
promote sensitivity to and support for organ and tissue donor families. 
While the NDFC recognizes that financial resources are an important factor in maintaining the 
highest quality of tissue services, it is our position that tissues must be collected, processed, 
stored and distributed in an efficient manner that minimizes costs and maximizes the benefit 
to patients.  The NDFC believes that donated tissue must be used in a way that promotes 
healing for people with the greatest need. 
The tissue community should resist the tendency to make the generous gift of donated tissue 
a commodity. Professionals should refrain from referring to donated tissue as a product. All 
packaging for donated tissue should include a statement indicating that the package contains 
donated tissue and is a gift of life.  The tissue community should educate health care 
professionals, including physicians who use donated tissue, about the donor family perspective 
and the nature of the gift. The tissue community should also work to raise awareness among 
funeral services professionals and strengthen their commitment to follow the wishes of donor 
families.  The tissue community must pay all expenses incurred by the donor family that are 
directly associated with tissue donation, including any increased funeral charges. 
As approved by the NKF National Donor Family Council Executive Committee and the NKF Board of Directors, 
September 25, 2000 
NOTE: This Policy Statement is subject to further revision based on a survey of donor families currently in 
progress 
Tissue Donation: Informed Consent  17  OEI-01-00-00440  APPENDIX A 
NATIONAL DONOR FAMILY COUNCIL 
EXECUTIVE COMMITTEE 
INFORMED CONSENT POLICY FOR TISSUE DONATION 
As with organ donation, the National Donor Family Council (NDFC) of the National Kidney Foundation 
believes that a crucial element of the tissue donation process is the informed consent of the donor family. 
With respect to tissue donation, the informed consent of the donor family must, at an absolute minimum, 
include a voluntary decision based on full disclosure of the facts. 
Full disclosure includes the following elements: 
1. Donor families should be given a general explanation of the tissue process, including: 
C  medical and social history 
C  communicable disease testing 
C  laboratory testing 
C  medical suitability 
C  how tissue is recovered, processed, stored and distributed 
2.	 Donor families must be told what tissue can be recovered from their loved ones based on 
medical suitability. If heart valves will be recovered, families must be informed that the heart 
will be removed from the donors chest and sent to a facility where the valves will be removed. 
If the entire eye will be removed for corneal donation, families should be informed. 
3.	 Donor families must be informed that tissue can be used or modified in various ways for 
transplantation  in a life-saving capacity, transplantation in a life-enhancing capacity, and 
medical research or education. 
4.  Donor families must be told that they have the right to limit or restrict the use of the tissue. 
5.	 Donor families must be told about the likelihood that the donated tissue will be stored, how it 
will be stored, the duration of storage, and the possibility that the tissue may not be utilized. 
6.	 The completed consent form must be reviewed with the donor family before final consent, and 
a copy should be offered to the family.  Other written material explaining tissue donation 
should be offered to the family. 
7.	 Donor families must be given the option of receiving acknowledgment of their gifts.  This 
acknowledgment should include both disposition and any recipient information available at that 
time, while protecting the anonymity of both donor and recipients.  To obtain additional 
information about the gift, the donor family should be provided with contact information 
(including phone number and address) for the recovery agency. 
As approved by the NKF National Donor Family Council Executive Committee and the NKF Board of Directors, September

25, 2000

NOTE: This Policy Statement is subject to further revision based on a survey of donor families currently in progress

Tissue Donation: Informed Consent  18  OEI-01-00-00440  APPENDIX B 
Model Elements of Informed Consent for Organ and 
Tissue Donation 
American Association of Tissue Banks 
Association of Organ Procurement Organizations 
Eye Bank Association of America 
Human organ and tissue transplantation has become an important and growing part of 
modern medical practice.  Advances in medical science have made it possible for millions 
of Americans to receive these life-saving and life-enhancing gifts.  None of this would be 
possible, however, were it not for the tens of thousands of donors and donor families who 
give their organs and tissues to help their fellow men and women. 
The decision to donate must, therefore, be an informed consent, and it must be conducted 
under circumstances that are sensitive to the consenting persons situation. Information 
concerning the donation should be presented in language and in terms that are easily 
understood by the consenting person.  The consent should be obtained under 
circumstances that provide an opportunity to ask questions and receive informative 
responses.  An offer should be made regarding the availability of a copy of the signed 
consent form, and information should be provided regarding ways to reach the recovery 
organization following donation. Consent should be obtained in accordance with federal, 
state and/or local laws and/or regulations.  The person seeking the consent should be 
trained to appropriately answer any questions that the consenting person may have.  In 
addition, coercion should not be exerted in any manner, nor monetary inducement offered 
to obtain consent for donation.  The identification of who may be the appropriate person to 
consent to donation, and whether the consent of any person in addition to the donor 
needs be obtained, should be evaluated in accordance with the applicable laws and 
organizational policy and is not addressed in this statement. 
The following list of Basic Elements of Informed Consent is intended to highlight the 
information that may be considered critical to informed decision making by a family 
member or other legally authorized person, who is being approached for consent to organ 
and/or tissue donation.  This listing, whether communicated verbally or included on 
consent forms, is not intended to preempt any applicable federal, state, or local laws or 
regulations that may require more or less information to be disclosed for informed consent 
to be legally effective. 
Basic Elements of Informed Consent 
In seeking informed consent, the following information should be provided to the person(s) 
being approached for consent: 
C	 A confirmation/validation of the donors identity and his or her clinical terminal 
condition. 
C  A general description of the purposes (benefits) of donation. 
Tissue Donation: Informed Consent  19  OEI-01-00-00440  APPENDIX B 
Policy Statement on Informed Consent 
Page 2 
C	 Identification of specific organs and/or tissues (including cells) that are being 
requested for donation (with subsequent information provided on specific gifts 
recovered). 
C	 An explanation that the retrieved organs/tissues may be used for transplantation, 
therapy, medical research, or educational purposes. 
C	 A general description of the recovery process (including timing, relocation of donor 
if applicable, contact information, etc.). 
C	 An explanation that laboratory tests and a medical/social history will be completed 
to determine the medical suitability of the donor, including an explanation that 
blood samples from the donor will be tested for certain transmissible diseases. 
C	 An explanation that the spleen, lymph nodes, and blood may be removed, and 
cultures may be performed, for the purpose of determining donor suitability and/or 
used to determine compatibility of donor and recipient. 
C	 A statement granting access to the donors medical records, and that the medical 
records may be released to other appropriate parties. 
C	 An explanation that costs directly related to the evaluation, recovery, preservation, 
and placement of the organs and tissues will not be charged to the family. 
C	 An explanation regarding the impact the donation process may have on burial 
arrangements and on appearance of the body. 
C	 Any additional information required by federal, state and/or local laws and/or 
regulations. 
Additional Elements of Informed Consent 
In some situations, there may be additional information that should be known by the 
consenting person(s), or that might be helpful for family decision making. At a minimum, if 
the donor family inquires about any of these or additional matters, explanations should be 
provided. 
The guiding principle for the use of these Additional Elements of Informed Consent is to 
advance simplicity and reasonableness in seeking informed consent, i.e. include these 
elements or additional comments if they are appropriate and might clarify any 
Tissue Donation: Informed Consent  20  OEI-01-00-00440  APPENDIX B 
Policy Statement on Informed Consent 
Page 3 
exigencies.  For example, if there is the likelihood that the patient will become a Medical 
Examiners case, then it should be appropriate to so inform the family.  If it is unlikely that 
donated tissue is going to be used for aesthetic surgery, then it would not be reasonable 
to address this issue in the family approach. 
One or more of the following elements of information may also be appropriate for 
communication to the person(s) being approached for consent, depending upon the 
circumstances surrounding the donation and the potential gift(s): 
C	 A description of any involvement by the Medical Examiner and/or Coroner, 
including an explanation that an autopsy may be performed. 
C	 An explanation that transplantation may include reconstructive and aesthetic 
surgery. 
C	 A reference to the possibility that the final gift may take a different form than 
originally recovered. 
C	 An explanation that multiple organizations (nonprofit and /or for profit) may be 
involved in facilitating the gift(s). 
C  Reference to the possibility that tissue and/or organs may be transplanted abroad. 
American Association of Tissue Banks 
Association of Organ Procurement Organizations 
Eye Bank Association of America 
November 30, 2000 
Tissue Donation: Informed Consent  21  OEI-01-00-00440   Comments from the 
APPENDIX C 
Department of Health and Human Services 
Tissue Donation: Informed Consent  22  OEI-01-00-00440  APPENDIX D 
Endnotes 
1.  The National Organ Transplant Act specifies that organ procurement organizations must be 
nonprofit entities, establishes requirements for their service area, and imposes certain 
organizational and staffing requirements.  (42 U.S.C., Section 273(b)) 
2.  Of the tissue bank officials we interviewed, five banks only process and distribute tissue; they 
do not recover tissue and would not be directly involved in obtaining consent.  In addition, eight 
banks that recover tissue also do some processing and distribution. 
3.  AATB Statement of Ethical Principles, adopted November 1994. 
4.  42 U.S.C., Section 274e.  This is the one provision of the National Organ Transplant Act that 
specifically addresses human tissue.  The act defines organ to include bone marrow, cornea, eye, 
bone, and skin or any subpart thereof, as well as vascular organs such as kidney, liver, heart, 
lung, and pancreas. 
5.  The Act specifies that the term valuable consideration does not include the reasonable 
payments associated with the removal, transportation, implantation, processing, preservation, 
quality control, and storage of a human organ. 
6.  The web sites of the major processing firm contain information and press releases on new 
products and uses.  Web sites of all the for-profit firms that we examined have a prominently 
displayed category addressing investor relations, as well. 
7.  Often cited examples include enhancements of lips or other body parts among Hollywood 
starlets.  During our visit to one tissue processing firm, we were struck by framed blowups of 
covers from various fashion magazines that were displayed prominently on the walls of the 
reception area. 
8.  American Medical Association Policy H-475.992 
9. 21 C.F.R. 1270.21, added at 62 Fed.Reg. 40,445, July 29, 1997. 
10. Organ donation generally requires that the donor be declared brain dead (i.e., death through 
cessation of neurologic function), rather than suffering cardiac death.  A small number of total 
deaths  perhaps 12,000 - 15,000 at the most  meet this criteria in any given year. 
11.  U.S. Department of Health and Human Services, Office of Inspector General, Medicare 
Conditions of Participation for Organ Donation: An Early Assessment of the New Donation 
Rule, (OEI-01-99-00020), August 2000. 
12.  42 C.F.R., section 283.45, added at 63 Fed.Reg 33,875, June 22, 1998. 
Tissue Donation: Informed Consent  23  OEI-01-00-00440  APPENDIX D 
13.  U.S. Department of Health and Human Services, Roles and Training in the Donation 
Process: A Resource Guide, September 2000, available at http://www.organdonor.gov. 
14.  21 C.F.R., Parts 16 and 1270, added at 62 Fed. Reg. 40,429, July 29, 1997.  The FDA issued 
these regulations under the legal authority of section 361 of the Public Health Service Act.  This 
section authorizes the Secretary to make and enforce regulations judged necessary to prevent the 
introduction, transmission, or spread of communicable diseases. 
15.  The original Uniform Anatomical Gift Act was first developed in 1968 by the National 
Conference of Commissioners on Uniform State Laws.  Many States have incorporated the 
features of a revised version developed in 1987. 
Tissue Donation: Informed Consent  24  OEI-01-00-00440