9. Subject Considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them (including the language/claims used and whether or not the mention of open-label products is permitted)?

In May 2023, NMPA issued a draft guideline for consultation on “Measures for the Administration of Advertisement Review”. This guideline has not yet been implemented but it is expected to be implemented in the next 12 months. 

The new guideline makes a distinction between the advertisement of clinical trials for the purposes of recruitment and the advertisement of medicines. Advertisements for clinical trials are allowed as long as they have gained ethics approval. The adverts cannot promote an unapproved medicine. Adverts cannot involve influencers or endorsers and cannot make reference to the names of scientific institutions, experts, or physicians.

9.2 Vulnerable Subjects 

Children/Minors 

When the research participant is a child, the informed consent form (ICF) must be signed by the child’s legal representative(s) or guardian(s). If the child can decide whether he/she is willing to participate, the ICF should also be approved by the child. The age of consent for children and minors is not defined in the currently available regulatory resources.

Clinical trials may be conducted on children depending on existing knowledge of and extrapolation by research results in adults. Drugs that are intended for use in children should be evaluated in the appropriate age group for children and start in the high-age group followed by the low-age group. The EC-Guide stipulates the following conditions when children can participate in research:

• Only when it is shown that the research may be aimed at the prevention and mitigation of serious problems that affect the health and well-being of children
• Research that does not exceed the minimum risk
• Research that moderately exceeds the minimum risk, but is expected to directly benefit the child participants
• Research that moderately exceeds the minimum risk limit, but children may benefit from a population of participants

Pregnant Women, Foetuses and Neonates

There are no special consent procedures for pregnant women, fetuses, or neonates.

Any research studies of pregnant women should include a follow-up evaluation of these participants during pregnancy, as well as the fetuses and the children from that pregnancy.

If a research study is intended for lactating women, the researchers should test the secretion of the drug or its metabolites in human milk, if feasible. If lactating women are recruited into a clinical trial, the effects of the drug on their infants should be monitored and, if necessary, followed.

Pregnant women should be excluded from any research study if the investigational product is not intended for use during pregnancy. In this case, if a pregnancy occurs during the clinical trial, the study should be terminated and reported to the ethics committee for follow-up and evaluation of the pregnancy, fetus, and child.

In accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Required Elements section. Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

Prisoners

The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) lists prisoners as a vulnerable population. Per CHN-37, incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and given the opportunity to make their own decisions without any interference from a higher authority. The ethics committee must also ensure that the study will be independently monitored to ensure the dignity and rights of the prisoners involved in the research. Informed consent requirements for conducting clinical trials with prisoners should follow the general requirements listed in the Required Elements section.

Mentally Impaired

Mentally impaired people are listed as a vulnerable population. However, there are no relevant provisions regarding any special consent procedures for them. International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37) allows the ethics committee to approve the participation of research participants who are incompetent, or mentally or physically incapable of giving consent under certain conditions. The informed consent form must be signed and dated by the participant’s legal representative(s) or guardian(s).

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

Paragraph 3 of Article 15 in “Good Clinical Practice” stipulates that for children to be subjects, researchers must obtain the informed consent of the child's legal guardians or parents (both parents), who must sign the informed consent form on behalf of their children.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4132579/

9.4 Financial Disclosures 

According to GCP, PIs must disclose any real or perceived financial conflicts.

9.5 ICF translations – Are certificates required? 

No. Translation certificates are not required.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study, and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

Under Chinese law, insurance taken out by the sponsor to cover any injuries to the test subject due to the study drug is mandatory. However, there is no requirement to take out local insurance for that purpose. Usually, global clinical trial insurance that includes China will be sufficient.

A sponsor shall provide insurance for the test subjects participating in the clinical trial and cover the expenses of treatment and corresponding compensation for the subjects who sustain injuries due to the study drug.