Pregnant women, human fetuses, and neonates
Because researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. may pose additional or unknown risks to pregnant women, fetusFetusa developing human organism from the time of implantation until delivery; generally, refers to later phases of development. , and neonateNeonateare newborns who are 30 days old or younger. , 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: 45 CFR 46, Subpart B
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 institutionInstitutionany public or private entity or agency (including federal, state or other agencies). 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 prisonerPrisonerany individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial or sentencing. 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 consentInformed Consenta person's voluntary agreement based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic therapeutic or preventive procedure. in certain emergency research is not applicable to research involving prisoners
More information regarding research involving prisoners may be found at: OHRP's FAQs
ChildrenChildrena person who has not attained the legal age of majority under the applicable law of the jurisdiction in which the research will be conducted (18 years in the state of Texas), and therefore as a general rule cannot consent to treatment or procedures involved in research.
Children are considered a vulnerable population.
- Not all exemptions apply to research involving children
- Permission by one or both parents or guardianGuardianan individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes participation in research. and the assentAssentaffirmative agreement by an individual not competent to give legally valid informed consent to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as 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 permissionParental Permissionthe agreement of parent(s) or guardian to the participation of their child or ward in research or clinical investigation and includes the elements of consent set forth in federal regulations and outlined in the informed consent template included in the IRB expedited and full review applications. 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: OHRP's FAQs
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 coercionCoercionoccurs when an overt threat of harm is intentionally presented by one person in order to obtain compliance from another. To be coercive, a subject who refuses must be made worse off than if he or she would have been, if never asked even if the harm is only perceived. , undue influenceUndue Influencethe offer of inducements excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. , 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 representativeLegally Authorized Representativea person authorized either by statute or by court appointment to make health care decisions on behalf of another person who is, incompetent, or has impaired decision-making ability. .
More information on decisionally impaired individuals may be found in these policies and SOPs: