Office of Research Vulnerable Populations - Office of Research

Vulnerable Populations

45 CFR 46.111(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards should be included in the study to protect the rights and welfare of these subjects.

When completing the Initial Review Application, you will be asked to identify if any of the following categories of vulnerable participants will be recruited/enrolled into your study. Click on each link for guidance.  


Children

Definition 

Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

What is the requirement? 

Research must be specifically approved to include children. The regulations that the UC Davis IRB follows when reviewing research involving children include: 

Subpart D – Additional Protections for Children Involved as Subject in Research 

How do I comply with this requirement?

Initial Review Application 

On the Vulnerable Participants page of the Initial Review Application, select the box for children if your research will include this group. You will be asked for additional details about the research. 

Regulations require that research fall under an approval category before children can be included. Please select the applicable category for your research and provide protocol specific justification for inclusion. 

  • Minimal Risk Research 
  • Greater than Minimal Risk Research with prospect of direct benefit 
  • Greater than Minimal Risk with no prospect of direct benefit 

 Review our Risk and Benefit guidance for help answering these questions.  

 Parental Permission 

Unless the IRB has issued a waiver, parental permission will be required. Generally, one parent’s signature is required for minimal risk research or greater than minimal risk research with the prospect of direct benefit to the child. In contrast, both parents’ signature are required for greater than minimal risk research with no prospect of direct benefit to the child. Below are the options you will find in the Initial Review Application, you must select what method of permission you intend on using: 

  • Both parents, unless one parent is deceased, unknown, incompetent, or not available, or when only one parent has legal responsibility for the care and custody of the child. (If the research involves greater than minimal risk with no direct benefit); 
  • One parent (or legal guardian); or 
  • Neither parent (nor guardian) as this research meets the requirements for a waiver of consent 

Review our consent process and consent documentation guidance for information about waivers.  

Assent 

Assent should be obtained whenever the children involved in the research are capable of comprehension and agreement. Below is the list of options provided, you should select all that apply: 

  • Assent will be obtained from all children capable of assenting 
  • Assent will not be obtained from children who are too young to understand the research 
  • Assent will not be obtained from children because this research meets the requirements for a waiver of consent 
  • Assent will be documented by the person obtaining assent on the consent document 
  • Children who can read will be given an Information Sheet about the study 

If assent will not be obtained from some or all of the children, you will need to provide justification in a free text field in the initial review application. The UC Davis IRB does not generally require a separate assent document. Assent is documented in the Children’s Signature Block on the consent template. 

Ethical Considerations 

The research team and the IRB will need to consider the following criteria when evaluating research involving children: 

  • Risks presented to the children are not greater than minimal unless the adequate provisions are in place. 
  • In greater than minimal risk research involving children, the risk is justified by the prospective benefit. 
  • The anticipated benefit is favorable to the subjects 
  • There are adequate provisions in place regarding assent and parental permission 

In the case of greater than minimal risk research has no prospect of direct benefit to subjects, but will likely generate generalizable knowledge , the IRB must also consider whether: 

  • The risk is a minor increase over minimal risk 
  • The research procedures presented to the subjects are commensurate to those in their actual or expected medical or educational situations 
  • Generalizable knowledge is likely to be obtained 
  • Adequate provisions are in place for assent and parental permission 
  • Research with no prospect of direct benefit will present an opportunity to understand, prevent, or alleviate a serious problem 

Pregnant Women/Fetuses

Definition 

A woman is assumed pregnant if she exhibits any of the qualified signs of pregnancy, such as missed menses, until the results of a pregnancy test are shown negative or until delivery. 

What is the requirement? 

Research must be specifically approved to include women who are known to be pregnant. The regulations that the UC Davis IRB follows when reviewing such research include: 

Subpart B – Additional Protection for Pregnant Women, Human Fetuses and Neonates in Research 

How do I Comply with this requirement? 

Initial Review Application 

Select the box for Pregnant Women/fetuses only if your research is targeting recruitment of either group. If are not targeting enrollment of pregnant women/fetuses and your research does not allow you to determine a woman’s pregnancy status, you do not need to select the box. 

Ethical Considerations 

Research must be considered ethically justified and satisfy a variety of conditions:  

    • Reasonable prospects the investigation will produce the desired results; 
    • A balance of potential benefits in relation to the potential risks; 
    • A justification for why the research is necessary; 
    • Monitoring for outcomes and the protection of human subject; and 
    • The benefits and burdens of the research are distributed evenly among potential subject groups. 


Prisoners

Definition 

A Prisoner is any individual involuntarily confined or detained in a penal institution. 

What is the requirement? 

Research must be specifically approved to include prisoners. The regulations that the UC Davis IRB follows when reviewing such research include: 

Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects 

How do I Comply with this requirement?

Initial Review Application 

On the vulnerable participants page of the Initial Review Application select the box for prisoners if this group may be recruited for your research. Note, the state of California does not allow state prisoners to be enrolled in clinical trials or other biomedical studies.  

Ethical Considerations 

Along with the requirements of subpart A, an IRB must make the following seven additional findings required by the regulations in order to review and approve research involving prisoners: 

  • The proposed research must fall into one of the categories under 45 CFR46.306(a)(2); 
  • The advantages associated with participation in the research should not be of such a magnitude that his or her ability to weigh the risks of the research against the value of receiving such advantages in the limited-choice prison environment is impaired; 
  • The risks are commensurate with risks that would be accepted by nonprisoner volunteers; 
  • Selection of subjects in the prison are fair to all prisoners, unless justification is provided by the principal investigator; 
  • The information presented in language that is understandable; 
  • Adequate assurances are in place that prevent a prisoners participation in the research to be taken in account by the parole board; 
  • If there is a need for follow-up with the prisoner after the research has concluded, provisions will be put in place for those examinations, and prisoners will be informed of this beforehand. 

 

Cognitively Impaired Adults

Definitions 

Cognitively Impaired Adult means a person who has reached the legal age of consent but lacks the decision making capacity to comprehend the consent process and voluntarily choose to participate in research.  

Legally Authorized Representative (LAR) means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research. 

What is the requirement?

Adults who lack capacity to consent may only be enrolled in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions specific to the research subjects when the necessary study cannot be conducted using subjects who are not cognitively impaired. 

How do I Comply with this requirement?

Initial Review Application 

Select this box when some or all of the research subjects may be adults who lack capacity to provide consent for participation in research. You will be asked to provide the following details about your consent process: 

  • Describe your process for determining whether an adult has capacity to consent: 
  • Will you follow California requirements for surrogate consent? 
  • Will assent be obtained from all adults who lack capacity to consent and are capable of assenting? 
  • Will you obtain consent from the participant when s/he regains capacity? 

Review our surrogate consent guidance for more information on this topic. 

Ethical Considerations 

 The IRB may approve the use of an LAR only in research studies relating to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of the research subjects when the necessary study cannot be conducted using subjects who are not cognitively impaired. 



Students of the Principal Investigator

What is the Requirement?

Investigators should not use students of their classes as a convince sample for research. Whenever possible, researchers should collect information from participants who are not subject to the power dynamic of a teacher-student relationship.  

How do I Comply with this Requirement? 

Initial Review Application 

Select the “Students of The Principal Investigator” box only when the research seeks to enroll students of the PI. If your research is not targeting students of the PI and the data you are collecting does not allow you to determine a if the participants are students of the PI, you do not need to select the box. 

Ethical Considerations 

 Because of the power relationship between students and their teachers, students may feel pressured to participate in research. The IRB will determine if there are adequate protections to allow students to choose to participate in research without undue influence or coercion 



Employees of UC Davis

What is the Requirement?

Investigators should not use employees as a convince sample for research. Whenever possible researchers should collect information from participants who are not subject to the power dynamic of an employee-employer relationship.  

How do I comply with this requirement? 

Initial Review Application 

Select the “Employees of UC Davis” box only when the research seeks to enroll employees who report directly to the PI. If your research is not targeting employees of the PI and the data you are collecting does not allow you to determine if the participants are employees of the PI, you do not need to select the box. 

Ethical Considerations 

Because of the power relationship between employees and their supervisors, employees may feel pressured to participate in research. The IRB will determine if there are adequate protections to allow employees to choose to participate in research without undue influence or cohesion.  

 

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