Protections for Vulnerable Populations
Overview
Research Ethics and Compliance at the University of Northern Iowa is guided by the Belmont Report. Two of its central principles, Respect for Persons and Beneficence, dictate that researchers must avoid designs that endanger, exploit, or harm individuals with vulnerabilities. Simultaneously, the principles of Justice and Respect for Persons demand that these populations are not arbitrarily excluded from the benefits of research when participation is safe and feasible.
What is a "Vulnerable" Population?
People with vulnerabilities may include individuals who are susceptible to coercion or undue influence, or who are at greater risk of harm when participating in research. This often includes populations who are unable or have limited capacity to provide voluntary informed consent.
Researchers must balance necessary protections with practicable accommodations. Federal regulations require additional considerations for the following groups:
(1) Children - see Research with Children and Youth and Research in K-12 Educational Settings
(2) Prisoners
Why this population is protected:
Prisoners are vulnerable to coercion and undue influence due to their incarceration. Coercion is the IRB’s primary concern when reviewing these studies.
Definitions:
- Prisoner: Any individual involuntarily confined or detained in a penal institution
- Incidental Incarceration: If a current research participant becomes a prisoner after the research has commenced, they fall under these regulations immediately.
Permissible Research Categories:
Research involving prisoners is strictly limited to four categories
- Causes/Effects of Incarceration: Study of criminal behavior or incarceration
processes (Minimal risk/inconvenience only). - Prisons as Institutions: Study of prison structures or prisoners as incarcerated
persons (Minimal risk/inconvenience only). - Conditions Affecting Prisoners: Research on conditions prevalent in prisons
(e.g., hepatitis, substance abuse, sexual assault). - Practices Improving Health/Well-being: Research on innovative or accepted practices with a reasonable probability of improving the participant's health or well-being.
Investigator & IRB Requirements
- Prisoner Representative: Any IRB meeting reviewing prisoner research will include a prisoner representative with appropriate background and experience.
- Risk Assessment: The study must generally present no more than minimal risk and inconvenience.
(3) Pregnant Women
Why this population is protected
This group receives special attention to manage health concerns during pregnancy and avoid unnecessary risk to the fetus. However, inclusion is important to ensuring research findings are generalizable and beneficial to women.
Definitions
- Pregnancy: The period from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (delivery).
- Minimal Risk to Fetus: The risk is no more than that from established procedures routinely used in an uncomplicated pregnancy or a pregnancy with
comparable complications.
Types of Research & Requirements
Informed Consent Note:
In studies involving pregnant women, the IRB must determine if the informed consent of the father is necessary. Generally, the mother's consent is sufficient if the research benefits her or involves minimal risk.
(4) Fetuses
Why this population is protected:
The fetus shares a unique relationship with the mother and cannot consent. It must be treated with dignity, recognizing its genetic heritage and vulnerability.
Definitions:
- Fetus: Product of conception from implantation until delivery.
- Viable Infant: Once delivered, if the fetus is likely to survive to the point of sustaining life independently, it is designated an infant and subject to regulations regarding Children.
Permissible Research:
- In Utero: Permitted if the purpose is to meet the health needs of the fetus (minimizing risk) OR if the research is minimal risk and develops knowledge unobtainable by other means.
- Ex Utero (Nonviable): Research is forbidden if the fetus is unable to survive to the point of sustaining life independently.
- Dead Fetuses/Material: Research on dead fetuses, fetal material, or placenta is governed by state laws and regulations.
Risk Standard:
Risks to the fetus may not be more than minimal unless justified by anticipated health benefits to the mother or fetus. If risks are higher without direct benefit, special provisions apply, requiring proof that data is unobtainable by other means.
(5) Persons with Cognitive Impairment
Why this population is protected:
Individuals with psychiatric, cognitive, or developmental disorders, or substance dependence, may have limited capacity to understand information and make reasoned decisions.
Definitions & Scope
- Cognitive Impairment: Includes psychiatric disorders, organic impairments (e.g., dementia), developmental disorders, or temporary impairment due to substance use.
- Physical Disabilities: Persons with severe physical disabilities or degenerative diseases may also be compromised in their ability to make decisions in their best interest.
- Spectrum of Impairment: Impairment ranges from minimal to significant. A minimal risk study (e.g., anonymous survey) requires fewer precautions than high-risk studies.
Investigator Requirements:
- Capacity Assessment: There should be specific evidence of incapacity before a person is deemed unable to consent. If impairment is unclear, mental status testing should be included in the design.
- Consent Process:
- Capable: Obtain consent from the participant.
- Capable but Impaired: Obtain consent from both the participant and a parent/guardian/advocate.
- Not Competent: Guardian consent alone is sufficient. - Assent: The IRB will consider requiring "assent" (affirmative agreement) from the participant even if they are not legally competent to consent.
(6) Economically or Educationally Disadvantaged Persons
See separate guidance: Compensation of Participants
(7) Other Potentially Vulnerable Groups
It is the investigator's responsibility to remain alert to other potential vulnerabilities (e.g., power dynamics, language barriers) that affect the ability to give voluntary informed consent. These must be disclosed to the IRB during the review process.