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Institutional Research Board

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Part V: Special Subject Groups

The rights of some subjects (see Vulnerable Populations) require special attention, including special consideration of the consent process, in addition to adherence to principles, policies, and regulations otherwise applicable to human subjects research. Some special subject groups include:
  1. children, because of their vulnerability, diminished autonomy, and incomplete understanding. Persons under the age of 18 (except for emancipated minors) are not able to give legally effective consent for research participation.
  2. subjects with limited civil freedom, such as prisoners and persons subject to military discipline.
  3. people with limited capacities or mental disabilities, such as those with intellectual disabilities or the mentally ill.
  4. pregnant women, neonates, fetuses, both in utero and ex utero, and fetal material.

A. Children

All research involving children must be reviewed by the IRB in accordance with Subpart D of 45 CFR 46. Children are persons who have not attained the legal age for consent, under the applicable law of the jurisdiction in which the research will be conducted. The term children includes all individuals under the age of eighteen, except for emancipated minors.

Exempt Research

The categories of research that can be considered exempt are limited when children serve as subjects. Note particularly that the exemptions for research employing survey or interview procedures do not apply to projects involving children. The exemption involving observation of public behavior can be given only if the investigator does not participate in the activity being observed.

Assent of Children

In addition to parental permission, the investigator must obtain the assent of all children who are to be subjects in the research when those children are capable of providing assent. Assent means a child's voluntary, affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. The requirements for obtaining a child's assent are essentially the same as those for obtaining informed consent—all the requirements for informed consent must be satisfied. A child's desire not to participate in a given research project should be respected by the investigator. In determining whether children are capable of providing assent, the investigator and the IRB committee should take into account the age, maturity, cognitive level, and psychological state of the children involved.

For research involving children who are capable of providing assent, the responsible principal investigator (RPI) must describe in the Web-based application form what will be taken as evidence of assent on the part of the children and how their assent will be obtained. The investigator must also describe what the children will be told about the research and how that information will be presented. The level of the information will vary as a function of the age and sophistication of the children involved. All children capable of assent must be informed that they are free to withdraw from participation at any time. For children who are not capable of providing assent, the investigator must take care that the subjects' rights are in no way abridged.

Assent of child subjects may not be necessary when the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the individual children and is available only in the context of the research. This determination shall be made by the IRB.

Permission of Parents or Guardians

For all research involving children, whether exempt or not, the permission of the child's parents or guardian must be obtained prior to the child's participation. The requirements for obtaining parental permission are essentially the same as those for obtaining informed consent—all the requirements for informed consent must be satisfied. The responsible principal investigator (RPI) must describe in the IRB-1 application how parental permission will be obtained and must include a copy of the relevant consent form(s). If appropriate justification is given, an oral process can be approved by the IRB as an exception to the written consent requirement.

The permission of one parent is sufficient if (a) the research does not involve greater than minimal risk or (b) the research involves greater than minimal risk, but presents the prospect of direct benefit to the individual subjects.

For research that involves greater than minimal risk and no prospect of direct benefit to the individual subjects, the permission of both parents is required, unless only one parent has legal responsibility for the custody of the child or the second parent is incompetent or not reasonably available. Special provisions must be met before children who are wards of the state may participate as subjects in research.

Waiver of parental permission

The IRB may waive the requirement for obtaining consent from a parent or legal guardian if:

  • The research meets the provisions for waiver in 45 CFR 46.116(d)(1-4) and if the IRB determines that the research protocol is designed for conditions or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children).
  • An appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

B. Prisoners

All research involving prisoners must be reviewed by the IRB according to Subpart C of 45 CFR 46. None of the federal exemptions apply to research that involves prisoners.

Permitted Research Involving Prisoners

The only types of research involving prisoners that may be approved by the IRB are the following:

  1. studies of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
  2. studies of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
  3. research on conditions particularly affecting prisoners as a class (for example,vaccine trials and other research on hepatitis, which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults), provided that the study may proceed only after the Secretary of Health and Human Services (HHS) has consulted with appropriate experts, including experts in penology, medicine, and ethics and has published notice in the Federal Register of her or his intent to approve such research; or
  4. research on practices, both innovative and accepted, that have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups that may not benefit from the research, the study may proceed only after the Secretary of Health and Human Services has consulted with appropriate experts, including experts in penology, medicine, and ethics and has published notice in the Federal Register of her or his intent to approve such research.

Criteria for Approval

Research studies where prisoners are involved may only be approved if:

  1. any possible advantages accruing to the prisoner through her or his participation in the research, when compared to the general living conditions, medical care, quality of food, amenities, and opportunity for earnings in the prison, are not of such a magnitude that her or his ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.
  2. the risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.
  3. procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the responsible principal investigator (RPI) provides to the IRB committee justification in writing for using other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.
  4. the information is presented in language that is understandable to the subject population.
  5. adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on her or his parole; and
  6. where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences and for informing participants of this fact.

C. Pregnant Women, Human Fetuses (and Fetal Material), and Neonates

All research involving pregnant women, fetuses (and fetal material), and neonates must be reviewed by the IRB in accordance with Subpart B of 45 CFR 46.

Exemptions

The six exemptions at 45 CFR §46.101(b)(1) through (6) are applicable to research involving pregnant women, fetuses (and fetal material), and neonates.

Definitions

For purposes of human subjects research, the following apply:

Pregnancy is the period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy, such as missed menses or a positive pregnancy test.

Fetus means the product of conception from implantation until delivery.

Fetal material includes dead fetuses, the placenta, amniotic fluid, fetal membranes, and umbilical cord.

Neonate means a newborn.

General Limitations

Pregnant women, human fetuses (and fetal material), and neonates may be involved in research only if all the following conditions are met:

  1. Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
  2. The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such 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 any other means;
  3. Any risk is the least possible for achieving the objectives of the research;
  4. If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of subpart A of this part;
  5. If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this part, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest;
  6. Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
  7. For children as defined in §46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part;
  8. No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
  9. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
  10. Individuals engaged in the research will have no part in determining the viability of a neonate.

Additional Criteria for Neonates

  1. Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:
    1. Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates.
    2. Each individual providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed regarding the reasonably foreseeable impact of the research on the neonate.
    3. Individuals engaged in the research will have no part in determining the viability of a neonate.
    4. The requirements of paragraph (b) or (c) of this section have been met as applicable.
  1. Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the following additional conditions are met:
    1. The IRB determines that:
      1. The research holds 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
      2. 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
    1. The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative is obtained in accord with subpart A of this part, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.
  1. Nonviable neonates. After delivery, a nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met:
    1. Vital functions of the neonate will not be artificially maintained;
    2. The research will not terminate the heartbeat or respiration of the neonate;
    3. There will be no added risk to the neonate resulting from the research;
    4. The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
    5. The legally effective informed consent of both parents of the neonate is obtained in accord with subpart A of this part, except that the waiver and alteration provisions of §46.116(c) and (d) do not apply. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this paragraph (c)(5).
  1. Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.

Additional Criteria for Fetal Material

  1. Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
  2. If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.

D. Research in Foreign Countries

VU research that takes place in foreign countries must provide the same human subjects protection as research conducted in the United States. In addition, such research may raise special issues related to cultural differences.

Guidance on human research in foreign countries may be found at the Office for Human Research Protection International Compilation of Human Research Protections website at www.hhs.gov/ohrp/international/HSPCompilation.pdf.