9.0 Vulnerable Research Populations

The regulations specify additional protections for certain classes of human research involving children (45CFR46.401 and 21CFR50.50 and 56.101), pregnant women, human fetuses, and human in vitro fertilization (45CFR46.201) and prisoners (45CFR46.301 and 21CFR56.107). In addition, other vulnerable populations, such as members of Native American tribes, the mentally disabled, and economically or educationally disadvantaged persons may require special protections and procedures as set forth in this policy or as required by the IRB.

9.1 Research Involving Children
        9.1.1 Categories of Research
        9.1.2 Research Involving Minor Students
9.2 Research Involving Pregnant Women, Fetuses, or Neonates
        9.2.1 Pregnant Women or Fetuses
        9.2.2 Neonates
        9.2.3 Research Involving, after Delivery, the placenta, The Dead Fetus or Fetal Material
        9.2.4 Research Not Otherwise Approvable by the IRB
9.3 Research Involving Prisoners
9.4 Research Involving other Vulnerable Populations
        9.4.1 Members of Native American Tribes
        9.4.2 Mentally Disabled Persons or Economically/Educationally Disadvantaged Persons

9.1 RESEARCH INVOLVING CHILDREN

9.1.1 Categories of Research
There are four basic categories of research that may be conducted on minors. In all cases adequate provisions must be made for soliciting the assent of the minor subjects and permission of their parents or guardians (See Section 7.5). The four categories of research are based on the level of risk and benefit, as follows:

Research involving minimal risk

Research involving greater than minimal risk that presents the prospect of direct benefit to individual minor research subjects. The IRB may approve the research only if the following conditions are met:

The risk is justified by the anticipated benefit

The relation of the anticipated benefit to the risk is at least as favorable to the minor subjects as that presented by available alternative approaches

Research involving greater than minimal risk with no prospect of direct benefit to minor subjects, but likely to yield generalizable knowledge about the minor subject. The IRB may approve such research only if all the following conditions are met:

The risk represents a minor increase over minimal risk

The research presents experiences to minor subjects that are reasonably commensurate with those inherent in their actual physical or social conditions

The research is likely to yield generalizable knowledge about the minor subject and is of vital importance for the understanding of the research

Research not otherwise approvable by the IRB that the IRB determines presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children. The IRB may approve such research only if the Secretary of DHHS (or the FDA Commissioner for FDA-regulated research), after consultation with a panel of experts, determines that the research meets defined criteria (45CFR46.407(b)).

When planning a research project that will involve minors as subjects, the Principal Investigator is responsible for making the initial determination regarding which of the above categories applies to his/her research. The IRB shall make the final determination regarding the category of research prior to approval of the research.

9.1.2 Research Involving Minor Students
The U.S. Department of Education (ED) issued guidelines under the Protection of Pupil Rights Amendment regarding research involving minor students. Here and throughout this document, a "minor" is defined to be a person under eighteen years of age. The amendment applies to programs that receive funding from ED, and it is intended to protect the rights of parents and students in the following ways:

It seeks to ensure that schools and contractors make instructional materials available for inspection by parents if those materials will be used in connection with an ED-funded survey, analysis or evaluation in which their children participate.

It seeks to ensure that schools and contractors obtain written parental informed consent before minor students are required to participate in any ED-funded survey, analysis or evaluation that reveals information concerning:

Political affiliations

Mental and psychological problems potentially embarrassing to the student or his/her family

Sexual behavior and attitudes

Illegal, anti-social, self-incriminating and demeaning behavior

Critical appraisals of other individuals with whom the respondents have close family relationships

Legally-recognized privileged or analogous relationships, such as those of lawyers, physicians and ministers

Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such programs)

9.2 RESEARCH INVOLVING PREGNANT WOMEN, FETUSES OR NEONATES
DHHS has established certain criteria that must be met before pregnant women, fetuses or neonates can be involved as subjects in research. According to DHHS criteria, “fetus” and neonate” are defined as follows: fetus means the product of conception from implantation until delivery and neonate means a newborn.

9.2.1 Pregnant Women or Fetuses
DHHS has established the following criteria (45CFR46.201, 66 FR 56775, November 13, 2001) that must be met prior to conducting research activities that involve pregnant women or fetuses as research subjects:

Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses
Risk to the fetus is caused solely by interventions or procedures that hold out the prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means
Any risk is the least possible for achieving the objectives of the research
The woman’s consent or the consent of her legally authorized representative is obtained in accord with the informed consent provisions, unless altered or waived by the IRB as allowed under the regulations. If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father must be obtained in accord with the informed consent provisions, unless the father is unable to consent because of unavailability, incompetence or temporary incapacity or the pregnancy resulted from rape or incest
Individuals providing consent are fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate
For pregnant minors, assent and permission are obtained in accord with the provisions for assent of minors (Section 7..5)
No inducements, monetary or otherwise, will be offered to terminate a pregnancy
Individuals engaged in the research will have no part in 1) any decisions as to the timing, method or procedures used to terminate a pregnancy, or 2) determining the viability of a neonate

9.2.2 Neonates
DHHS has established the following criteria (45CFR46.201, 66 FR 56775, November 13, 2001) that must be met prior to conducting research activities that involve neonates:

Neonates of uncertain viability and nonviable neonates may be involved in research if ALL of the following conditions are met:
- Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates
- Individuals providing consent are fully informed regarding the reasonable foreseeable impact of the research on the neonate
- Individuals engaged in the research will have no part in determining the viability of the neonate
- The requirements set forth below have been met as applicable
Neonates of uncertain viability may not be involved in research unless the following additional conditions are met:
- The research must hold out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or
- The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research, and
- Informed consent of either parent or either parent’s legally authorized representative is obtained, unless altered or waived by the IRB as allowed under the regulation
Nonviable neonates may not be involved in research unless the following additional conditions are met:
- Vital functions of the neonate will not be artificially maintained
- The research will not terminate the heartbeat or respiration of the neonate
- The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means, and
- Informed consent of both parents is obtained, unless one parent is unable to consent because of unavailability, incompetence or temporary incapacity, in which case the consent of one parent is sufficient. The consent of a legally authorized representative cannot be substituted for parental consent and informed consent cannot be waived or altered
Viable neonates may be included in research only to the extent permitted by and in accord with informed consent requirements, IRB approval and requirements for research involving children (See Section 9.1)

9.2.3 Research Involving, after Delivery, the Placenta, The Dead Fetus or Fetal Material
If information associated with the placenta, the dead fetus or fetal material is recorded for research purposes in a manner such that living individuals can be identified, then those individuals are research subjects and all pertinent consents and IRB approval requirements apply and research must be conducted in accordance with any applicable Federal, Iowa or local laws regarding such activities.

9.2.4 Research not Otherwise Approvable by the IRB
If the IRB determines that the research presents a reasonable opportunity to further the understanding, prevention of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates, the IRB may approve the research only if the Secretary of DHHS, in consultation with experts, determines that certain criteria (45CFR46.207) are met.

9.3 RESEARCH INVOLVING PRISONERS
Involvement of prisoners in behavioral or biomedical research requires additional safeguards (45CFR Sec 46.301), as prisoners may be unduly influenced to participate as subjects in research because of their incarceration. The following must be met as specific requirements for prisoner research:

The IRB must have at least one member who has a background in prisoner matters (e.g., a former prisoner, social worker)

A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from membership on the Board.

Drake University IRB does not meet the above requirements and has no plans to review any research involving prisoners.

9.4 RESEARCH INVOLVING OTHER VULNERABLE POPULATIONS

9.4.1 Members of Native American Tribes
The research investigator is responsible for obtaining approval from the appropriate tribal counsel(s) for research involving members of Native American tribes prior to submitting the protocol to the IRB for review and approval.

9.4.2 Mentally Disabled Persons or Economically/Educationally Disadvantaged Persons
Involvement of persons in research who are mentally disabled or economically/educationally disadvantaged requires additional safeguards as those individuals may, because of their conditions, be susceptible to undue influence during the enrollment process or be unable to understand the informed consent process. The IRB will review each case where research may involve mentally disabled or economically/educationally disadvantaged persons and may require additional safeguards to protect these vulnerable segments of the population.

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Last Modified: 11/15/2008 02:38:33 by content editor