The following are additional requirements that must be followed when enrolling any vulnerable populations or other populations that need additional safeguards. These requirements are in addition to the requirements listed in the Informed Consent Process section of the Investigator’s Guidebook.
Children
Prisoners
Pregnant Women
Disabled
Persons of Limited Mental Capacity
Educationally Disadvantaged/Illiterate
Patient in Emergency Situations
Patients with Incurable Disease
Unemployed/on Public Assistance
Homeless
Employees (Site/Sponsor/CRO)
Other
Children
The investigator should ensure that safeguards are in place for the protection of children enrolled in research studies. For more information see the Children section of the Investigator’s Guidebook.
Prisoners
The IRB does not review studies in which prisoners will be enrolled as research participants.
Pregnant Women
The Investigator must inform the potential subject of possible risks to the subject and fetus.
Disabled
The investigator should ensure that the research participants are aware that the decision to participate in a study or to withdraw from the study will not influence the availability of their future medical care and will involve no penalty or loss of benefits to which they are otherwise entitled.
Persons of Limited Mental Capacity
The decision-making capacity of a potential research subject should be evaluated when there are reasons to believe that the subject may not be capable of making voluntary and informed decisions about research participation. The investigator and research staff must have adequate procedures in place for assessing and ensuring subjects’ capacity, understanding, and informed consent or assent. For more information see the Investigator’s Guidebook.
Educationally Disadvantaged/Illiterate
The Investigator must ensure that the Informed Consent From is properly read to the potential subject and provide additional time for the subject to ask questions and comprehend the information contained in the Informed Consent Form.
Patients in Emergency Situations
The IRB does not review studies in which investigational drugs/device or biological products are used as emergency intervention (in a life threatening situation) for which no standard acceptable treatment is available.
Patients with Incurable Disease
The Investigator must inform the potential subject that participation in a research study may not cure their incurable disease and that there is a potential that their participation in a research study may cause their disease to worsen.
Unemployed/on Public Assistance
The Investigator must consider the possibility of undue influence due to financial incentive to participate in a research study. A moderately low or no compensation may be decided in order to eliminate this possibility of undue influence.
Homeless
The Investigator must consider the possibility of undue influence due to financial incentive to participate in a research study. A moderately low or no compensation may be decided in order to eliminate this possibility of undue influence.
Employees (Site/Sponsor/CRO)
The Investigator must ensure and inform the employee that participation will not affect the subject’s current employment status. In addition, policies to ensure confidentiality of data and the privacy of the subject should be considered. If the investigator or the IRB determines that there is a high possibility of a breach in confidentially or privacy, the subject should not be enrolled in the study. In addition, if the investigator or the IRB determines that the potential of a conflict of interest due to the relationship of the investigator and potential subject is evident and the possibility that the safety and welfare of the subject may be jeopardized due to this relationship, the subject should not be enrolled in the study.
Other
The informed consent process will be free from coercion and will assure the research participant that the decision to not participate or decision to end participation will not result in a retaliatory response from a hierarchal structure. (For example employees, students, persons in nursing homes, and members of the armed forces). In addition, the investigator must ensure that potential subjects understand that the decision to participate in a study or to withdraw from the study will not influence the availability of their future medical care and will involve no penalty or loss of benefits to which they are otherwise entitled.
