Condition: Requesting Consent
(Proposed § 486.342)
In the February 5, 2005 proposed rule,
we proposed that OPOs must encourage
discretion and sensitivity with respect
to the circumstances, views, and beliefs
of potential donor families. We also
proposed requiring that OPOs have a
written protocol to ensure that the
individual(s) responsible for making the
donation decision are informed of their
options to donate organs and tissues
(when the OPO is also requesting
consent for tissue donation) or to
decline to donate. We proposed several
items of information that OPOs would
be required to provide in requesting
consent. The specific items we proposed
were: A list of the organs or tissues that
may be recovered; all possible uses for
the donated organs or tissues;
information that the individual(s) have
the right to limit or restrict use of the
organs or tissues; a description of the
screening and recovery processes; the
information (such as for-profit or nonprofit
status) about the organizations
that will recover, process, and distribute
the tissue; information regarding access
to and release of the donor’s medical
records; an explanation of the impact
the donation process will have on burial
arrangements and the appearance of the
donor’s body; information about the
procedure for filing a complaint; contact
information in case the individual(s)
making the donation decision have
questions; and a copy of the signed
consent form, if the donation is made.
In addition, we proposed that if the
OPO does not request consent because
the donor previously completed a donor
document that satisfies applicable state
law, the OPO would be required to
provide information to the donor’s
family upon their request.
Comment: Some commenters believed
the provision was overly prescriptive
and too detailed concerning the
minimum amount and types of
information that are required for
informed consent. However, other
commenters endorsed the principles
expressed in the requesting consent
requirements and said that the provision
reflected current practices in the
industry.
Response: In general, we disagree
with the commenters who stated that
the provision is overly prescriptive and
too detailed concerning the amount and
types of information that is required for
informed consent. Donor families need
a certain amount of information upon
which to base their donation decision.
We believe there must be a minimum
standard to assure that when families
provide consent, they are providing
informed consent. However, after
analyzing the comments we received on
some specific proposed items of
required information, we have changed
or eliminated some of the requirements.
These items are discussed below in the
following comments and responses.
Comment: Some commenters stated
that the requirements for requesting
consent are unnecessary. They noted
that each State’s anatomical gift law has
requirements for informed consent and
that the applicable state law should
determine the standard for each OPO.
Response: We disagree with the
commenters. We are not aware of any
State anatomical gift legislation that has
detailed requirements for information
that must be provided to potential donor
families to ensure informed consent. We
believe there must be a minimum
standard that will apply to all of the
OPOs and ensure that when an OPO
requests consent, potential donor
families receive the information they
need to make an informed decision
about donation.
Comment: One commenter provided
the following alternative language for
§ 486.342(a): ‘‘* * *. The OPO must
provide adequate information to the
individual(s) responsible for making the
donation, which may include the
following if appropriate and if sensitive
to the individual(s) circumstances,
views, and beliefs * * * .’’
Response: The commenter has
provided very subjective language that
does not appear to establish any
minimum requirements. Section
486.342 in this final rule states, ‘‘An
OPO must encourage discretion and
sensitivity with respect to the
circumstances, views, and beliefs of
potential donor families.’’ We believe
that OPOs can tailor the informed
consent requirement in this final rule,
so that it can be conveyed in a sensitive
and appropriate manner based upon the
circumstances of each potential donor
family’s situation. Thus, we are not
adopting the commenter’s suggested
language.
Comment: Some commenters noted
that the language requiring ‘‘information
about the procedure for filing a
complaint’’ could be problematic. A
commenter pointed out that to their
knowledge ‘‘the doctrine of informed
consent has never included a procedural
component for filing a complaint.’’ The
commenter noted that adding
information about a complaint process
could adversely affect an OPOs’ efforts
to obtain consent for donation and said
that ‘‘introducing an unnecessary
element, particularly one that suggests
subsequent failure, unhappiness, or
change of mind, will likely undercut the
consent success rate that OPOs are
struggling so hard to improve.’’ The
commenter said that their experience
has shown that parties who are unhappy
about something that occurred during
the donation process have not had any
difficulty with locating the OPO to
discuss their concerns.
Response: We believe the commenters
have a good point. OPOs approach
potential donor families during an
extremely sensitive time: the death or
imminent death of a loved one. It is
important that the decision maker(s) for
organ and/or tissue donation receive all
the information they need for informed
consent; however, there is no reason to
introduce unnecessary information that
may adversely affect the donation
decision. Therefore, we have removed
the proposed 486.342(a)(8) and revised
the proposed § 486.342(a)(9). Thus, in
the final rule § 486.342(a)(7) reads,
‘‘Contact information for individuals
with questions or concerns.’’
Comment: Some commenters felt that
the requirement for informed consent to
include ‘‘All possible uses for the
donated organs or tissues’’ was
unreasonable and overly burdensome.
One commenter questioned to what
degree the OPO had to go to satisfy this
requirement. The commenter asked the
following questions:
• Does every research project have to
be disclosed?
• Does every type of therapeutic
surgical procedure for which donated
gifts can be used have to be disclosed
to the family?
One commenter noted that the typical
standard under State law is whatever a
‘‘reasonable person’’ would want to
know. Another commenter felt that
complying with this provision could
result in the consent process being
lengthy, time consuming, and too
graphic to be appropriate considering
the sensitive nature of the consent
process and the need for compassion for
the potential donor family. One
commenter recommended that we
simply remove the word ‘‘all’’ from
(a)(2).
Response: We agree with the
commenters that informing families of
potential donors and other decision
makers of all possible uses for the
donated organs and tissues may be more
information than they need or want to
know. However, the decision makers
should be informed in general terms of
the ‘‘most likely’’ uses of the organs
and/or tissues they are being asked to
donate. We believe this can be done
without going into the detail that the
above questions posed by the
commenter suggest. For example, we
believe most families would be satisfied
with knowing that the organs and/or
tissue might be used for research
without wanting to know the specific
research projects or that tissue might be
used for therapeutic surgeries without
wanting to know the specific types of
surgeries. However, if a family requests
additional or more detailed information,
we would expect the OPO to provide
that information. We believe that OPOs
need the flexibility to determine what is
appropriate to disclose concerning the
most likely uses of donated organs and
tissue and that they can tailor this
information so that it is presented in a
sensitive and appropriate manner.
Thus, in § 486.342(a)(2) we are
deleting the words ‘‘all possible’’ before
‘‘uses’’ and inserting the words ‘‘the
most likely’’ before ‘‘uses.’’ The revised
§ 486.342(a)(2) reads as follows: ‘‘The
most likely uses for the donated organs
or tissues.’’
Comment: One commenter stated that
the requirement to describe the
screening and recovery processes, as
well as give information about all of the
potential organizations that may be
involved in the recovery, process, and
distribution of tissues could generate a
substantial amount of paperwork. And,
rather than being helpful and
informative, it could actually be more
confusing and distracting to the
potential donor family or perhaps too
graphic.
Response: We disagree with the
commenter that any of these
requirements would generate a
substantial amount of paperwork. Once
an OPO has developed a standard
consent form, the OPO’s staff needs to
explain only the applicable sections to
the donor family during the consent
process. We believe OPOs can explain
the screening and recovery process to
potential donor families and decision
makers in a manner that is not too
graphic, confusing, or upsetting to the
potential donor family.
Comment: A large number of
commenters objected to the
parenthetical language in
§ 486.342(a)(5), ‘‘Information (such as
for-profit or non-profit status) about
organizations that will recover, process,
and distribute the tissue.’’ While a few
commenters felt that disclosing the
profit status of tissue banks involved in
the donation process conformed to the
tissue banking industry’s standards,
others did not. Some commenters noted
that informed consent guidelines
developed by the Association of Organ
Procurement Organizations, the
American Association of Tissue Banks,
and the Eye Bank Association of
America, the Model Elements of
Informed Consent for Organ and Tissue
Donation (adopted November 30, 2000)
(Model Elements of Informed Consent),
indicate that disclosing whether
businesses involved in the donation
process are non-profit or for-profit
should be viewed as an additional or
supplemental element rather than
included in minimum requirements for
informed consent.
Some commenters felt that the
requirement would be contrary to the
statute, saying that the OPO
Certification Act of 2000 mandates that
process performance measures must be
based on empirical evidence obtained
through reasonable efforts of organ
donor potential and other related factors
in each service area of qualified organ
procurement organizations. These
commenters stated that the proposed
requirement had the potential to impede
efforts to increase organ donation.
Although some commenters suggested
specific language that could be used to
inform families about the profit status of
tissue banks, other commenters stated
that disclosing profit status is not
relevant or meaningful information for
the donor family. Some commenters
pointed out that the organizations
involved in the tissue donation process
(tissue banks) are inherently a mixture
of both for-profit and non-profit entities.
Further, commenters said that there is
no realistic way to assure a potential
donor family that a for-profit entity will
not at some point be involved in
handling the tissue they donate.
Most commenters’ chief concern was
that informing potential donor families
that for-profit entities will be involved
in the tissue donation process could
result in fewer families consenting to
tissue and even organ donation or to
decision makers restricting their
donation to non-profit tissue banks.
Commenters pointed out that many
people have misconceptions about forprofit
tissue banks. One commenter
pointed out that technological advances
in tissue donation generally are made by
for-profit, not non-profit, tissue banks.
Commenters also noted that there was a
common misconception that non-profits
are more altruistic and more deserving
of the donation. However, other
commenters stated that it was important
to explain the differences between forprofit
and non-profit tissue banks so
that families can appreciate the
important contributions of both.
Response: Based upon these
comments, we believe that requiring
OPOs to disclose that for-profit entities
will be involved in recovering,
processing, and distributing tissue is not
necessary. Both for-profit and non-profit
tissue banks contribute significantly to
the tissue industry and to the benefits
that patients receive from donated
tissue. However, explaining the nuances
of for-profit and non-profit tissue
banking to the families of potential
donors being asked to consent to organ
and/or tissue donation simply is not
feasible.
We believe the most appropriate
course of action is to allow each OPO
to determine independently what
information it needs to disclose about
the various organizations that will be
involved in the donation process. Thus,
we have not finalized a requirement for
OPOs to disclose the profit status of
tissue banks to families of potential
donors and other decision makers.
In addition, in reviewing the Model
Elements of Informed Consent, we noted
that neither the basic elements nor the
additional elements of informed consent
contain any requirement to inform
decision makers about the right to limit
or restrict the use of organs and/or
tissue. As noted above, we believe there
should be a minimum standard for
informed consent. However, there is no
reason to introduce unnecessary
information that may adversely affect
the donation decision. The disclosure of
the decision maker’s right to limit or
restrict the use of organs and/or tissue
could result in unreasonable or
unnecessary limitations on donated
organs and tissue. Since this could have
an adverse effect on organ and/or tissue
donation and availability, this
requirement has been removed from the
final rule. We believe it should be up to
each individual OPO if and how the
right to limit or restrict the use of
donated organs and/or tissue should be
handled.
§ 486.342 Condition: Requesting consent.
An OPO must encourage discretion
and sensitivity with respect to the
circumstances, views, and beliefs of
potential donor families.
(a) An OPO must have a written
protocol to ensure that, in the absence
of a donor document, the individual(s)
responsible for making the donation
decision are informed of their options to
donate organs or tissues (when the OPO
is making a request for tissues) or to
decline to donate. The OPO must
provide to the individual(s) responsible
for making the donation decision, at a
minimum, the following:
(1) A list of the organs and/or tissues
that may be recovered.
(2) The most likely uses for the
donated organs or tissues.
(3) A description of the screening and
recovery processes.
(4) Information about the
organizations that will recover, process,
and distribute the tissue.
(5) Information regarding access to
and release of the donor’s medical
records.
(6) An explanation of the impact the
donation process will have on burial
arrangements and the appearance of the
donor’s body.
(7) Contact information for
individual(s) with questions or
concerns.
(8) A copy of the signed consent form
if a donation is made.
(b) If an OPO does not request consent
to donation because a potential donor
consented to donation before his or her
death in a manner that satisfied
applicable State law requirements in the
potential donor’s State of residence, the
OPO must provide information about
the donation to the family of the
potential donor, as requested.