Reference:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 | ||
| | |module=3 | ||
| | |unit=3.1.4 | ||
| | |scope=G | ||
| | |doc_part=GUIDELINE 18 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00154-Vul-eil ++ TAG-00071-Pre-nis ++ TAG-00025-Sub-mer | |||
|tags_display=[[Glossary:TAG-00154-Vul-eil|Vulnerable participants]], [[Glossary:TAG-00071-Pre-nis|Pregnancy]], [[Glossary:TAG-00025-Sub-mer|Trial participant]] | |||
|comment=Vulnerability of women as research participants | |||
|content=WOMEN AS RESEARCH PARTICIPANTS | |||
| | |||
| | |||
WOMEN AS RESEARCH PARTICIPANTS | |||
[...] | [...] | ||
Vulnerability of women. | Vulnerability of women. | ||
| Line 48: | Line 18: | ||
Women who become pregnant during research. | Women who become pregnant during research. | ||
Many biomedical protocols call for terminating the participation of women who become pregnant during the research. In cases where a drug or biological product is known to be mutagenic or teratogenic, pregnant women must be removed from the study, and followed up and provided care through the duration of their pregnancy and delivery. Access to diagnostic tests must be provided to reveal any fetal anomalies. If anomalies are detected, women who wish may be referred for an abortion. When there is no evidence on the basis of which a potential harm to the fetus can be assumed, women who become pregnant should not automatically be removed from the study, but must be offered the option to continue or end their participation. For instance, in some cases it may be appropriate for a woman to stay in the study for safety monitoring but removed from the study drug. If the woman opts for continued participation, researchers and sponsors must offer adequate monitoring and support. | Many biomedical protocols call for terminating the participation of women who become pregnant during the research. In cases where a drug or biological product is known to be mutagenic or teratogenic, pregnant women must be removed from the study, and followed up and provided care through the duration of their pregnancy and delivery. Access to diagnostic tests must be provided to reveal any fetal anomalies. If anomalies are detected, women who wish may be referred for an abortion. When there is no evidence on the basis of which a potential harm to the fetus can be assumed, women who become pregnant should not automatically be removed from the study, but must be offered the option to continue or end their participation. For instance, in some cases it may be appropriate for a woman to stay in the study for safety monitoring but removed from the study drug. If the woman opts for continued participation, researchers and sponsors must offer adequate monitoring and support. | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| Document information | |
|---|---|
| Reference | CIOMS CIOMS - International Ethical
Guidelines for Health-related Research Involving Humans 2016 |
| Validity area | CIOMS |
| Scope(s) | G |
| Document name | CIOMS - International Ethical
Guidelines for Health-related Research Involving Humans |
| Version / Revision | 2016 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | International Ethical Guidelines for Health-related Research Involving Humans
Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.4 |
| Scope | G |
| Document part | GUIDELINE 18 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Vulnerable participants, Pregnancy, Trial participant |
Content
WOMEN AS RESEARCH PARTICIPANTS [...] Vulnerability of women. Despite the current general presumption that favours the inclusion of women in research, in many societies women remain socially vulnerable in the conduct of research. […] Women who become pregnant during research. Many biomedical protocols call for terminating the participation of women who become pregnant during the research. In cases where a drug or biological product is known to be mutagenic or teratogenic, pregnant women must be removed from the study, and followed up and provided care through the duration of their pregnancy and delivery. Access to diagnostic tests must be provided to reveal any fetal anomalies. If anomalies are detected, women who wish may be referred for an abortion. When there is no evidence on the basis of which a potential harm to the fetus can be assumed, women who become pregnant should not automatically be removed from the study, but must be offered the option to continue or end their participation. For instance, in some cases it may be appropriate for a woman to stay in the study for safety monitoring but removed from the study drug. If the woman opts for continued participation, researchers and sponsors must offer adequate monitoring and support.
