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?

There is no specific guidance on this matter.

9.2 Vulnerable Subjects

Populations traditionally viewed as vulnerable include minors, women, persons with disabilities, the elderly, those suffering from mental illness, immigrants, those who are illiterate, those belonging to ethnic or racial minorities, the unemployed, the homeless, and reclusive individuals. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. The principal investigator (PI) is required to comply with the Guideline for Good Clinical Practice (MEX-32), which similarly characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from not participating. 

Pregnant Women, Fetuses & Neonates

Studies involving women of childbearing age; women who are in any stage of pregnancy or are postpartum; or studies involving treatments or procedures using embryos, fetuses, or newborns, are required to obtain an informed consent form (ICF) from the woman and her spouse or partner. In addition, consent from the spouse or partner may only be waived in the case of his/her incapacity (or irrefutable or manifest inability) to provide it, or when there is an imminent risk to the health or life of the woman, embryo, fetus, or newborn.

Investigations to be carried out on pregnant women should be preceded by studies carried out on non-pregnant women to demonstrate the study’s safety, with the exception of studies requiring the specific condition. Those investigations classified as higher than minimum risk and will be conducted using women of childbearing age should implement the following measures:

• Certify the women are not pregnant prior to their acceptance as research participants; and
• Decrease the chances of pregnancy as much as possible during the development of the investigation.

In studies conducted with pregnant women, the following requirements must be met:

• The investigators will not have the authority to decide on the time, method, or procedure used to terminate the pregnancy, nor will they participate in decisions regarding the viability of the fetus.
• The Research Ethics Committee (REC)’s authorization is required prior to any modification of the method used to terminate the pregnancy. These modifications mean that there will be minimal risk to the mother’s health and do not represent any risk to the survival of the fetus, and
• In any case, it is strictly forbidden to grant monetary or other incentives to interrupt the pregnancy, for the interest of the investigation or for other reasons.

Investigators must comply with the following additional criteria when conducting studies with women who are in any stage of pregnancy or are postpartum:

• Research without therapeutic benefit in pregnant women, whose objective is to obtain general knowledge about pregnancy, should not represent a risk greater than the minimum for the woman, the embryo, or the fetus.
• Investigations in pregnant women that imply an intervention or experimental procedure not related to pregnancy, but with therapeutic benefit for women (e.g., cases of toxemia gravidarum, diabetes, hypertension, and neoplasms, etc.) should not expose the embryo or the fetus to a greater than minimum risk, except when the use of the intervention or procedure is justified to save the life of the woman.
• For investigations during labor, informed consent must be obtained prior to initiating the study and must expressly state that consent may be withdrawn at any time during labor.
• Investigations in women during the puerperium will be allowed when they do not interfere with the health of the mother and the newborn.
• Research on women during lactation will be authorized when there is no risk for the infant, or when the mother decides not to breastfeed, she ensures her feeding by another method and provides informed consent.

Mentally Impaired

When the mental capacity and psychological state of the participant permit, his/her acceptance must also be obtained after the investigator(s) explain what they intend to do during a clinical study. The Research Ethics Committee (REC) may waive compliance with these requirements for justified reasons. All studies must also comply with the general ethics requirements that must be fulfilled prior to research involving humans.

Investigations classified as risky and without direct benefit to the mentally incompetent will be allowed in the following circumstances:

• When the risk is minimal: The intervention or procedure must represent a reasonable experience for the incompetent participant and be comparable with those characteristics of his/her current or expected medical, psychological, social, or educational situation. The intervention or procedure should also have a high probability of obtaining generalizable knowledge about the condition or illness of the mentally incompetent participant to benefit others with this disorder.
• When the risk is greater than the minimum: The research should offer a good chance of understanding, preventing, or alleviating a serious problem affecting the health and well-being of the mentally incapacitated. In addition, the head of the health institution should establish strict supervision to evaluate the magnitude of the risks anticipated or others that may arise, and immediately suspend the investigation when the risk could affect the biological, psychological, or social welfare of the mentally incompetent participant.

https://clinregs.niaid.nih.gov/sites/default/files/documents/mexico/HlthResRegs-GoogleTranslation.pdf 

https://clinregs.niaid.nih.gov/country/mexico#pregnant_women,_fetuses_&_neonates 

https://clinregs.niaid.nih.gov/country/mexico#mentally_impaired 

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

Assent is required when the minor is older than seven years but less than 18 years of age. Assent must also be obtained from a minor who is deemed capable of providing assent, and the minor must be informed about the study in a manner tailored to his/her emotional and intellectual maturity level, considering at all times the seriousness of the decision. The assent should be personalized in Spanish for each participating research center including the version and date, center name and address, corporate name, and management of the involved committees.

A minor is defined as older than seven years but less than 18 years of age.

Additionally, in all cases, written informed consent must be obtained from those exercising parental authority, or the legal representative(s) or guardian(s) of the minor, except in the case of emancipated minors over 16 years of age. Moreover, when the mental capacity or psychological state of the minor or incapacitated person permits, their acceptance must also be obtained after the investigator(s) have explained what they intend to do in the study. However, the REC may waive compliance with these requirements for justified reasons.

When two persons exercise the parental authority of a minor, only the consent of one of them must be permitted if there is irrefutable or manifest proof that the other is unable to provide it, proof of his/her negligence, or imminent risk to the minor’s health or life.

A research study involving minors must ensure that similar studies have been previously done in older people and in immature animals, except when it comes to studying conditions that are specific to the neonatal stage or specific conditions associated with certain ages.

Research studies classified as risky and likely to benefit the minor directly will be admissible when the following requirements are met:

• The risk is justified by the importance of the benefit that the minor will receive.
• The benefit is equal to or greater than other alternatives already established for its diagnosis and treatment.
• When the mental capacity and psychological state of the minor allow, informed assent must also be obtained, after explaining what is intended to be done. The REC may waive compliance with these requirements for justified reasons.

9.4 Financial Disclosures

Investigators are required to disclose any financial matters that may be perceived as a conflict of interest.

9.5 ICF translations – Are Certificates Required?

No. The ICF must be completed in Spanish.

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?

Yes.