Chapter 4.1: Women who are pregnant and the human fetus

This chapter provides guidelines for the ethical conduct of research involving women who are pregnant, the human fetus ex utero, and human fetal tissue after the separation of the fetus from the woman. The chapter is arranged to reflect the following established categories of such research:

• research on the woman who is pregnant and the fetus in utero; and
• research on the separated human fetus or on fetal tissue.

This chapter does not apply to research involving:

• gametes, embryos and/or participants in assisted reproductive treatments – this research is covered by the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (NHMRC 2004);
• embryos excess to the needs of those for whom they were created using assisted reproductive technology – this research is covered by Australian legislation.

For the purpose of this chapter, the term fetus applies to the developing human being from fertilisation to delivery, and whether alive or dead at delivery.

Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid, and other tissue that contains the genome of a fetus. Fetal tissue is regarded as part of the fetus prior to separation of the fetus from the woman.

After separation, the following chapters of this National Statement may also be relevant to the design and conduct of research involving fetal tissue: Chapter 3.4: Human biospecimens in laboratory based research.

Research to which this chapter applies must be reviewed and approved by a Human Research Ethics Committee (HREC) rather than by one of the other processes of ethical review described in paragraphs 5.1.7 and 5.1.8, except where that research uses collections of non-identifiable data and involves negligible risk, and may therefore be exempted from ethical review.

Values, principles and themes that must inform the design, ethical review and conduct of all human research are set out in Sections 1 and 2 of this National Statement. The guidelines and headings below show how those values, principles and themes apply specifically in research that is the subject of this chapter.

Guidelines

The woman who is pregnant and the fetus in utero

4.1.1 The wellbeing and care of the woman who is pregnant and of her fetus always takes precedence over research considerations.

4.1.2 The research participation of a young person who is pregnant should be guided by the requirements of Chapter 4.2: Children and young people.

4.1.3 Research involving the woman may affect the fetus, and research involving the fetus will affect the woman. The risks and benefits to each should be carefully considered in every case, and should be discussed with the woman. This must include the effect of the research on the fetus in utero (including consideration of fetal stress) and on the child who may subsequently be born.

4.1.4 The possibility of providing access to counselling for the woman about these issues should be part of this discussion.

4.1.5 Reseachers should ask the woman whether, in her decisions about the research, she wishes to involve others for whom the research may have implications.

4.1.6 Except in the case of therapeutic innovative therapy, the process of providing information and obtaining consent for involvement in research should be separate from clinical care. Information about research projects should also be separate from information about routine clinical care.

4.1.7 If it is consistent with promoting the life and health of the fetus, research on the fetus in utero may be ethically acceptable. Such research may, for example, provide information about the health of the fetus.

4.1.8 Research should be designed so as to minimise pain or distress for the fetus, and should include steps for monitoring for signs of fetal pain or distress, and steps for suspending or ceasing the research if necessary.

4.1.9 ‘Innovations in clinical practice’, in Chapter 3.3: Interventions and therapies, including clinical and non-clinical trials, and innovations, should be considered for any innovative therapy involving the fetus. See also paragraph 3.3.15.

4.1.10 It is ethically unacceptable to conduct non-therapeutic research that involves administering drugs or carrying out a procedure on the woman or her fetus, where the research carries risk for the fetus.

The human fetus, or fetal tissue, after separation

4.1.11 Research involving a fetus or fetal tissue should be conducted in a manner that maintains a clear separation between the woman’s clinical care and the research. Where a treating health professional is also involved in the research, any conflict of interest (for example, one which may arise from a financial or contractual relationship) will need to be managed in accordance with paragraph 5.4.3 of this National Statement. In cases where pregnancy is to be terminated, the possibility of contributing fetal tissue to research must not be raised until a decision to terminate has been made. Proposals for research must include procedures to ensure that the process of providing information and obtaining consent for involvement in the research is clearly separated from clinical care. For example:

• A researcher who is also the treating health professional should not be the person who seeks the consent of the potential participant unless there is a specific justification for doing so (see paragraph 3.3.17).
• Information sheets for research projects must be completely separate from, and capable of being read independently of, written information provided to a patient in the course of routine clinical care.

4.1.12 should demonstrate that there are no suitable alternatives by which the aims of research using the separated human fetus or fetal tissue can be achieved.

4.1.13 There should be no trade in human fetal tissue.

4.1.14 Those who conscientiously object to being involved in conducting research with separated fetuses or fetal tissue should not be compelled to participate, nor should they be put at a disadvantage because of their objection.

4.1.15 Where research involves a separated fetus, researchers should ask the woman whether, in her decisions about the research, she wishes to involve others for whom the research may have implications.

4.1.16 A fetus or fetal tissue may become available for research as the result of termination. The process through which the woman is approached, informed about, and her consent sought for research on that fetus should be separate from the process under which she decides whether to terminate her pregnancy, and should not begin until a decision to terminate has been made. Consenting to the research must not compromise the woman’s freedom to change that decision.

4.1.17 Where research involves her separated fetus or its fetal tissue, arrangements should be made for the woman to have access to counselling and support.

4.1.18 Research on a terminated fetus or its tissues, including the timing and content of the process of seeking the woman’s consent for the research, should be designed so as not to compromise the woman’s decisions about the timing and method of termination.

4.1.19 Consideration of a woman’s wishes and her physical, psychological and emotionalwelfare should inform:

1. a decision whether to approach her about proposed research involving her, her separated fetusor its tissue; and
2. if she is approached, the way information is provided about the research and her consent for it sought.

4.1.20 In addition to the information required to be disclosed under paragraph 2.2.2 and 2.2.6 of this National Statement, the woman should also be informed:

1. that she should consider whether to seek consent to the proposed research from any other person (see paragraphs 4.1.5 and 4.1.15);
2. whether it is possible to store the fetus or fetal tissues for later use in research;
3. that she is free to withdraw her consent to the research at any time, whether before or after a termination or other loss of a fetus;
4. whether there is potential for commercial application of outcomes of the research, including the development of cell lines;
5. that she will not be entitled to a share in the profits of any commercial applications; and
6. whether fetal organs or stem cell lines developed from them will be exported to another country.

4.1.21 A fetus delivered alive is a child, and should be treated as a child and receive the care that is due to a child.

4.1.22 Organs and tissues may be removed from a fetus delivered dead and used for research only if the conditions of paragraphs 4.1.11 and 4.1.12 are met, and:

1. the woman and any others she wishes to involve (see paragraph 4.1.15) have given consent to the removal and the research;
2. the fetus is available for research only as a result of separation by natural processes or by lawful means; and
3. death of the fetus has been determined by a registered medical practitioner who has no part (or financial interest) in the research.

4.1.23 If, for research purposes, fetal cells are to be derived from the fetal tissue and stored or propagated in tissue culture, or tissues or cells are to be used in human transplantation, the woman’s consent is required. Others whom the woman identifies (see also paragraph 4.1.15) may also need to be involved in decisions about these matters.