Special Regulations for At-risk Populations

Populations are categorized as at risk if their members typically have diminished autonomy due to cognitive, emotional, health, or situational constraints which may impair their ability to provide informed consent. At risk populations include, but may not be limited to:

  • children under 18 years of age

  • cognitively or emotionally compromised adults

  • pregnant women and fetuses

  • prisoners

Any research intentionally including members of these populations as subjects must be submitted to the IRB Executive Committee for Full Review and must comply with the special regulations applicable to the relevant intended population. In addition to these identified populations, the IRB retains the right to extend the at risk designation to other populations as it deems necessary. The special regulations enumerated below are derived from the Code of Federal Regulations (OHRP), Title 45, Part 46, subparts B, C, and D.

A) CHILDREN UNDER 18 YEARS OF AGE

These special regulations apply to all research involving children as subjects except in the case of educational research which satisfies the criteria for Exempt Status as specified in Section A, Part 6 of Levels and Procedures of Review. The following definitions apply in this section -

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.
Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research. Parent means a child's biological or adoptive parent.
Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

(1) Children may be involved in research if any of the following conditions are met:

(a) the research involves no more than minimal risk to children and adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in Parts 2 and 3 below.

(b) the research involves greater than minimal risk to children but presents the prospect of direct benefit to the individual subjects and -

(i) the risk is justified by the anticipated benefit to the subjects;

(ii) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(iii) adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in Parts 2 and 3 below.


(c) the research involves greater than minimal risk and no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition and -

(i) the risk represents a minor increase over minimal risk;

(ii) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(iii) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(iv) adequate provisions are made for soliciting assent of the children and the permission of their parents or guardians, as set forth in Parts 2 and 3 below.


(2) Requirements for permission by parents or guardians and for assent by children.

(a) The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that 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 children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research.

(b) The IRB shall determine that adequate provisions are made for soliciting the permission of each child's parents or guardian. Normally, when permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

(c) If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further 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.

(d) Permission by parents or guardians shall be documented by the use of a written consent form approved by the IRB and signed by the subject's legally authorized representative. A copy shall be given to the person signing the form.

(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

(3) Requirements for wards.

(a) Children who are wards of the state or any other agency, institution, or entity can be included in research only if such research is -

(i) related to their status as wards; or

(ii) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

(b) If the research satisfies the criteria in part (a), the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

B) COGNITIVELY OR EMOTIONALLY COMPROMISED ADULTS

Compromising conditions affect cognitive and/or emotional functions to the extent that capacity for judgment and reasoning are significantly diminished. A person may be cognitively or emotionally compromised due to any of the following:

  • psychiatric disorder (e.g., psychosis, neurosis, personality or behavioral disorder)

  • organic impairment (e.g., dementia or Alzheimer’s disease)

  • developmental disorder (e.g., mental retardation or autism)

  • severe acute or chronic physical illness (e.g., coma or AIDS)

  • drug intoxication

(1) Compromised adults may be involved in research if any of the following conditions are met:

(a) the research involves no more than minimal risk and adequate provisions are made for soliciting their assent when possible and the permission of their legal guardians, as set forth in Part 2 below.

(b) the research involves greater than minimal risk but presents the prospect of direct benefit to the individual subjects and -

(i) the risk is justified by the anticipated benefit to the subjects;

(ii) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(iii) adequate provisions are made for soliciting their assent when possible and the permission of their legal guardians, as set forth in Part 2 below.

(c) the research involves greater than minimal risk and no prospect of direct benefit to individual subjects, but is likely to yield generalizable knowledge about the subject's disorder or condition and -

(i) the risk represents a minor increase over minimal risk;

(ii) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(iii) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(iv) adequate provisions are made for soliciting their assent when possible and the permission of their legal guardians, as set forth in Part 2 below.

(2) Requirements for permission by legal guardians and for assent by subjects.

(a) The IRB shall determine that adequate provisions are made for soliciting assent when in the judgment of the IRB the subjects are capable of providing assent. In determining whether subjects are capable of assenting, the IRB shall take into account their physical and psychological states. This judgment may be made for all subjects to be involved in research under a particular protocol, or for each individual, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the subjects is so limited that they cannot reasonably be consulted or that 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 subjects and is available only in the context of the research, the assent of the subjects is not a necessary condition for proceeding with the research.

(b) The IRB shall determine that adequate provisions are made for soliciting the permission of each subject's legal guardian.

(c) If the IRB determines that a research protocol is designed for conditions or for a subject population for which guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused individuals), it may waive the consent requirements of this section, provided an appropriate mechanism for protecting the subjects is substituted, and provided further 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 physical and psychological condition.

(d) Permission by legal guardians shall be documented by the use of a written consent form approved by the IRB and signed by the subject's legally authorized representative. A copy shall be given to the person signing the form.

(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

C) PREGNANT WOMEN AND FETUSES

Pregnant women or fetuses may be involved in research if all of the following conditions are met:

(1) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant 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 informed consent provisions;

(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 informed consent provisions 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 is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;

(7) For children who are pregnant, assent and permission are obtained in accord with the special regulations of section A - Children Under 18 Years of Age;

(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.

D) PRISONERS

Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make truly voluntary and uncoerced decisions whether or not to participate as subjects in research, it is the purpose of this section to provide additional safeguards for the protection of prisoners involved in research. Prisoner is defined as any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

(1) Special IRB Composition Requirements

An IRB reviewing prisoner-based research must meet the following specific requirements:

(a) A majority of the IRB (exclusive of prisoner members) shall have no association with the prison(s) involved.

(b) At least one member of the IRB shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one IRB, only one need satisfy this requirement.

(2) A duly composed IRB may approve prisoner-based research only if it finds that:

(a) it represents one of the following categories of permissible research -

(i) Study 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;

(ii) Study 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;

(iii) 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 IRB has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice in the FEDERAL REGISTER of his intent to approve such research;

or

(iv) Research on practices, both innovative and accepted, which 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 which may not benefit from the research, the study may proceed only after the IRB has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice in the FEDERAL REGISTER of the intent to approve such research;

(b) Any possible advantages accruing to the prisoner through his/her 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 his/her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;
(c) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;

(d) 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 principal investigator provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;
(e) The information is presented in language which is understandable to the subject population;

(f) 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 his or her parole; and

(g) Where the IRB finds there may be a need for follow-up examination or care of subjects 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.

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