Pregnant women, human fetuses, and neonates
Because research may pose additional or unknown risks to pregnant women, fetus, and neonate, the regulations require additional safeguards in research. The application of funding should describe inclusion of the population along with the plan to protect the subjects. Safeguards for this population may be found:
Prisoners
The IRB's review of prisoner research requires additional regulatory requirements including:
- the exemptions that generally apply to certain types of research involving human subjects do not apply to research involving prisoners;
- in order to approve research involving prisoners, the IRB must find that the proposed research falls into one of the permissible categories of research, and make six other findings;
- the institution must certify to OHRP that an IRB has reviewed the proposal and made seven required findings, and receive OHRP permission prior to initiating any research involving prisoners;
- the IRB must include a prisoner or prisoner representative, and meet a membership requirement concerning the number of IRB members not associated with a prison involved in the research; and
- Secretarial waiver of informed consent in certain emergency research is not applicable to research involving prisoners
More information regarding research involving prisoners may be found at:
Children
Children are considered a vulnerable population.
- Not all exemptions apply to research involving children
- Permission by one or both parents or guardian and the assent of the child form the basis of "informed consent".
- The overall risks and benefits of the research will determine whether the study can be approved by the IRB and whether parental permission and the assent of the child will be required.
- In Texas, a child is considered an individual under the age of 18. However, there are a few exceptions to this rule.
For more information about consent, please review the IRB Policy on Informed Consent.
For more information about children as a vulnerable population, please review the IRB policy on Individuals with Impaired Decision Making Ability.
Safeguards for this population may be found:
Decisionally Impaired Individuals
Although not specifically addressed in the regulations as a vulnerable population, UTHSA IRB requires additional safeguards for research involving persons with decisional impairment.
The IRB regards protections from coercion, undue influence, manipulation and physical control as critically important to protecting human subjects. An individual with Impaired Decision-Making Ability refers to an individual who, for a variety of reasons, lacks the ability to understand the research, appreciate the consequences of their participation, consider alternatives, and/or make reasoned choices, such that they cannot provide informed consent for themselves. The IRB will consider whether the research incorporates sufficient safeguards to ensure that the rights of the individual participants are protected. Ensure the application/proposal of funding includes safeguards and process for obtaining informed consent from the subject or the subject’s legally authorized representative.
More information on decisionally impaired individuals may be found in these policies and SOPs:
- Research Involving Individuals with Impaired Decision-Making Ability Policy and Procedure
- Informed Consent Policy and Procedure
- Obtaining Informed Consent standard operating procedure