Developing guidance for pregnancy testing of adolescents participating in research: ethical, legal and practical considerations.

Adolescents need safe effective drugs that have undergone ethically approved testing in clinical trials; such studies often require pregnancy testing in 'women of childbearing age' which includes children/adolescents. There is a lack of consistent standard operating procedures for pregnancy testing in these individuals, in either research or clinical (ie, both preprocedure and clinical emergency) settings. Some harmonisation between a selective or universal testing approach based on a risk analysis of the trial drug or procedure would seem sensible. The need for pregnancy testing and the reasons for the method chosen (universal or selective) should be clearly defined in the research protocol. Research ethics committees (RECs) need to satisfy themselves that the selection of subjects to be tested, the procedures for obtaining consent and the respecting of the young person's confidentiality are appropriate and that management of any positive tests are in accord with local safeguarding policies and procedures. Researchers should have core competencies necessary to manage sensitive questioning and child safeguarding training. Clinical trials of medicinal product (CTIMP) pregnancy testing in females 13-15 years of age requires parental consent and the child's active involvement in the decision-making process ('assent') the implications of a positive test should be discussed in advance Children under 13 years should not normally be subject to pregnancy testing in CTIMPs, unless there are exceptional circumstances, for example, a trial of contraceptive agents of a high teratogenicity risk, as reviewed by a specialist paediatric REC. We analyse the ethical, legal and practical aspects of this issues and supply guidance to support those involved.

Ethical challenges of pregnancy prevention programs.

Certain useful pharmaceutical agents carry a high risk of embryopathy. The US Food and Drug Administration (FDA), in cooperation with drug manufacturers, has established pregnancy prevention programs (PPPs) to reduce the incidence of birth defects for thalidomide (STEPS [System for Thalidomide Education and Prescribing Safety]) and isotretinoin (iPLEDGE) but not for other teratogenic drugs in clinical use. These programs are complex and raise important concerns regarding privacy, the clinician-patient relationship, and convenience of medical care. Furthermore, pregnancies continued to occur in isotretinoin-exposed females during the first full year of the iPLEDGE program. We review the design and application of STEPS and iPLEDGE and consider the ethical issues raised by the introduction of these programs. The goal is to eliminate birth defects caused by teratogenic agents, without making procedures so onerous that they result in restricted access to useful agents. Confidentiality must be maintained, and the rights of disadvantaged populations and individuals with special religious concerns must be protected. Informed consent must be complete and include all risks of treatment, including risks of contraceptive methods. All teratogenic agents should be covered by PPPs, which then must be no more burdensome than requirements that have existed for many years for other controlled substances.

Is truth a supreme value?

Is truth a supreme value? At times, we doctors have to contend with a complex dilemma in which we face the value of truth on the one hand and conflict with another value on the other. Is it sometimes permissible and even necessary not to report the truth in favour of another, more important value? This is a description of an experience in which a doctor had to handle such an issue when a pregnant Muslim woman asked for a document that she wasn't pregnant when in fact she was, in order to avert the possibility of being murdered to preserve the honour of the family. The doctor decided that the value of life was more important than the value of truth.