FDA Definition of a "Directed Reproductive Donor"

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Last updated 2006-02-24T09:57-0500

"Reproductive cells or tissue from a directed reproductive donor (i.e., the donor and recipient know each other before donation) may be used."

"(l) Directed reproductive donor means a donor of reproductive cells or tissue (including semen, oocytes, and embryos to which the donor contributed the spermatozoa or oocyte) to a specific recipient, and who knows and is known by the recipient before donation. The term directed reproductive donor does not include a sexually intimate partner under § 1271.90."

"We do not prohibit the use of [human cell, tissue, and cellular and tissue-based products] from a donor who has been determined to be ineligible, based on required testing and/or screening, in three instances:
1. . . .
2. the HCT/P consists of reproductive cells or tissue from a directed donor; or
3. . . . ."

"Is [human cell, tissue, and cellular and tissue-based products] from an ineligible donor always prohibited from being used?  No. . . . Reproductive cells or tissue from a directed reproductive donor (i.e., the donor and recipient know each other before donation) may be used."

"The rule does not prohibit the use of reproductive cells and tissue from directed donors determined to be ineligible [1271.65(b)(ii)]."

2. Directed Reproductive Donor (§ 1271.3(l))
The proposed rule contained a definition of ‘‘directed donor,’’ a term used
in proposed § 1271.65(b) to describe a situation in which the use of
reproductive cells or tissue from an ineligible donor would not be prohibited.
In considering the comments on § 1271.65(b), discussed in greater detail in
section III.C.5 of this document, we concluded that, for clarity, we should limit
the definition of ‘‘directed donor’’ to donors of reproductive cells and tissue
and change the term to ‘‘directed reproductive donor.’’ Because the term
‘‘directed reproductive donor’’ is used only in the context of the donation of
reproductive cells and tissue, these changes do not affect the scope of the
exception.
As proposed, a directed donation involved the designation of a specific
potential recipient. We have maintained this part of the definition in the final
rule.
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(Comment 12) Our review of comments indicated that there was some
confusion about whether the designation of a specific recipient could take
place in the context of anonymous semen donation (i.e., a situation in which
the donor and recipient do not know each other).
(Response) We did not intend for the term ‘‘directed donor’’ to refer to
anonymous donations. Rather, our intention was to respect the existence of
relationships between people. To recognize existing relationships between
donors and recipients, we have added language to the definition of ‘‘directed
reproductive donor’’ to indicate that, in a directed donation, the donor knows
and is known by the recipient before donation.
We have also clarified the definition by noting that directed reproductive
donors do not include sexually intimate donors, who are excepted from
screening and testing requirements under § 1271.90. This change is intended
to make clear that, for the purpose of this rule, there are three categories of
reproductive donors, subject to three different sets of requirements listed as
follows: (1) The anonymous donor, to whom all the donor-eligibility
requirements apply; (2) the directed reproductive donor, whose reproductive
cells and tissue may be used even if the donor is determined ineligible; and
(3) the sexually intimate partner, for whom testing and screening are not
required (discussed in section III.D.11 of this document).
(Comment 13) One comment requested that we define an additional
category of anonymous semen donor, the ‘‘Identification Revealed Donor.’’
Under this kind of donation, the identity of an anonymous semen donor may
be revealed to the child and/or mother at some point after birth. (We also
received comments supporting this type of arrangement.) The comment
suggested a related change to proposed § 1271.75 so that screening for risk
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factors for relevant communicable diseases would not be required for donors
whose identities may be revealed later.
(Response) Donor identification is outside our jurisdiction and unrelated
to the purpose of this rule, which is to prevent the transmission of
communicable disease. For these reasons, this rule does not address any
agreements that might be entered into for revealing a donor’s identity at a
future time.
We note that the suggested change to the screening requirement in
§ 1271.75 would exempt the anonymous donors described in the comment
from screening for risk factors for human immunodeficiency virus (HIV),
hepatitis B virus (HBV), hepatitis C virus (HCV), human transmissible
spongiform encephalopathy (TSE), including CJD and vCJD, Treponema
pallidum, HTLV, Chlamydia trachomatis, and Neisseria gonorrhea. We cannot
justify this exception on public health grounds. Whether or not the identity
of an anonymous donor may be revealed later has no bearing on the
appropriate screening and testing of that donor. For the prevention of the
transmission of communicable disease, the same requirements should apply
to all anonymous donors.
We have distinguished between directed reproductive donors and
anonymous donors to respect the existence of relationships between people
who know each other and have made a joint decision for the recipient to
conceive a child. In contrast to the directed reproductive donor who has an
existing relationship with the recipient, only the potential for a future
relationship exists for the anonymous donors described in the comment. Under
the identification-revealed donation arrangement described in the comment,
there is no relationship between donor and recipient at the time of donation.

"Anonymous and directed semen and oocyte donors, and certain embryo donors, are screened and tested for relevant genitourinary disease agents, including Chlamydia trachomatis and Neisseria gonorrhea, at the time of donation. However, anonymous and directed oocyte donors would be exempt from such testing when oocytes are retrieved in a way that ensures freedom from contamination with these disease agents (e.g., nonvaginal laparoscopy)."