Committee For the Protection of Human Subjects

Research Involving Fetal Tissue

POLICY

It is the policy of UT Houston that researchers may conduct research on the transplantation of human fetal tissue. Human fetal tissue may be used in research regardless of whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.

Donor of Human Fetal Tissue

Informed Consent of Donor - Human fetal tissue may be used for research, only if the woman providing the tissue makes a statement, made in writing and signed by the woman, declaring that-

1.       the woman donates the fetal tissue for use in research;

2.       the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; and

3.       the woman has not been informed of the identity of any such individuals.

 

Declaration by Attending Physician of Donor  - Human fetal tissue may be used only if the attending physician with respect to obtaining the tissue from the woman involved makes a statement, made in writing and signed by the physician, declaring that—

1.       in the case of tissue obtained pursuant to an induced abortion

i.         the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for a donation of the tissue for use in such research;

ii.       no alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue; and

iii.      the abortion was performed in accordance with applicable State law;

2.       the tissue has been donated by the woman in accordance informed consent requirements in Item 4.1 above; and

3.       full disclosure has been provided to the woman with regard to-

i.         such physician's interest, if any, in the research to be conducted with the tissue; and

ii.       any known medical risks to the woman or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with the woman's medical care.

 

Recipient

Human fetal tissue may be used only if the individual with the principal responsibility for conducting the research involved makes a statement, made in writing and signed by the individual, declaring that the individual—

1.          is aware that

i.      the tissue is human fetal tissue;

ii.    the tissue may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and

iii.   the tissue was donated for research purposes;

2.          has provided such information to other individuals with responsibilities regarding the research;

3.          will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of such information by such recipient; and

4.          has had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research.

 

PROCEDURE

In addition to the usual initial submission documents as described in policy and procedure for Initial Review, the investigator must submit a completed form for research involving human fetal tissue transplantation, sample informed consent form for donor and declaration of attending physician.

In addition to criteria for approval as described in policy and procedure for Initial Review and elements of disclosure for informed consent as described in policy and procedure for Informed Consent, when reviewing research that involves human fetal transplantation, CPHS shall ensure that the conditions of this policy and procedure are met.

ORSC staff will schedule research involving fetal tissue transplantation for review at a Full Board meeting. When adequate expertise is not available within the CPHS, ORSC Staff will send the proposal for review by an independent consultant as described in the policy and procedure for Initial Review.

 

Availability of Statements for Audit – Documentation for human fetal tissue including informed consent and declaration by attending physician and researchers will be available for audit by the regulatory agencies.

 

APPLICABLE REGULATIONS

1.       42 USC Sec. 289g-1 Title 42 – The Public Health and Welfare Chapter 6A – Public Health Service - Research on transplantation of fetal tissue

REFERENCE TO OTHER POLICIES

1.       Initial Review

2.       Informed Consent

3.       Research Involving Pregnant Women, Fetuses or Neonates

ATTACHMENTS

1.       None

If you find errors in this document, contact clinicaltrials@uth.tmc.edu

 

Document Number:

101-C06

Document Name:

Fetal Tissue

Approved by:

ORSC Director

Effective:

1 Aug 2008

Revision History:

1 Aug 2011


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