Tutorial Chapter 13: How must researchers deal with protected populations?

Case Study:

Researchers in a school of social work are working to understand what effect the personal relationships of male prisoners have had on those with identified antisocial and psychopathic personalities. They have started an IRB approved study using incarcerated men over the age of 21 who are native speakers of English and have completed at least the seventh grade. Some of the subjects have been identified as having psychopathic or antisocial personalities, and some have not.

Information from the study, researchers believe, will help to improve anti-recidivism programs since current programs have not been found effective with prisoners with psychopathic or antisocial personalities.

As part of the research, each participant is being interviewed and asked to complete three short questionnaires. All participants are fully informed about the purpose of the project, their rights, including the protection of their privacy and sign a consent form.

During one of the interviews, a researcher is startled when the participant unexpectedly starts describing a plan to take one of the guards hostage in retaliation for privileges which have been revoked after a disturbance in the dining area.

What should the researcher do, having been given this information?

  • A: Since the researcher has assured the participant of his right to protection of privacy, she is not sure whether she can reveal this information to anyone. She decides that it is a ruse to provoke her and she ignores the comments and continues with the interview.
  • B: The researcher decides that the potential for harm outweighs her responsibility to protect the participant's privacy and notifies the authorities about the plan to take a guard hostage.

Federal regulations require that human subjects committees give special consideration to protecting the welfare of protected subjects. Special provisions exist for research involving:

  • children and minors
  • prisoners
  • pregnant women and fetuses.

In addition, the UCAIHS pays particular attention to such populations as:

  • the institutionalized mentally disabled
  • the elderly
  • the economically or educationally disadvantaged.

In general, these regulations allow IRBs to approve research with these populations that is of minimal risk or that will benefit the subjects directly. Review and approval of research involving vulnerable populations may require additional time if outside expertise is needed for further evaluation of the application for approval.

For a full discussion of guidelines for research with protected populations, please refer to the OHRP's IRB Guidebook.

How do researchers protect minors?

A minor in New York State is defined as an individual who is under the age of 18. In order to participate as subjects in research, all minors must have formal parental permission, received by the researcher in an approved format and a process approved by the IRB. For details, read the NIH policy concerning parental permission.

Written consent is also required from children if they are age 12 to 18. Those younger than 12 need to agree (give their assent) to the research. This assent process should be verbal. For details, read the NIH policy concerning assent.

Special considerations when working with minors include:

  • The subject's ability to comprehend the consent form or assent procedure: The language in the consent form or assent procedure must be tailored to the age and educational level of the children so that they will be able to understand all the information required for informed consent.
  • Vulnerability of minors to coercion: The consent or assent process should take into account the vulnerability of minors to obeying adults and giving in to peer pressure. The researcher should take special care to emphasize the voluntary nature of the participation, stress the fact that no penalties will result from nonparticipation. For example, researchers who work with young children often use a phrase in the assent process such as "if you do not want to be in the study, that is okay. Everyone will like you just as much anyhow." Using one's own students or patients as subjects is strongly discouraged due to the high potential for coercion.
  • The need for affirmative consent or assent: When a minor age 12 or older or an adult signs a consent form, they are making an affirmative consent; that is, it is clear that they are giving active consent to participate. The assent process for children under 12 years of age also requires active consent, although it must be verbal. Researchers should always ask children directly, "Do you want to do this?" and accept as assent only a definite yes. Again, researchers should stress voluntary participation and take special care to make sure the language of the assent is appropriate to the age of the subjects.

How do researchers safeguard other protected populations?

Prisoners

Special regulations have been designed to protect prisoners because of their vulnerability due to incarceration. Their imprisonment could affect their ability to make a truly voluntary decision without coercion as to whether or not to participate as subjects in research. A prisoner is any individual involuntarily confined or detained in a penal institution. This includes individuals who have been:

  • sentenced to such an institution under a criminal or civil statute
  • detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution
  • detained pending arraignment, trial, or sentencing.

Research involving prisoners is only allowed when:

  • any possible advantages accruing to the prisoner through participation in research are not so great 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
  • the risks involved in the research are commensurate with risks that would be acceptable to nonprisoner volunteers
  • procedures for selecting subjects within the prison are fair to all and not subject to arbitrary intervention by prison authorities or prisoners. Control subjects if included must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project
  • the information about participation in the study is presented in language which is understandable to the prison population
  • adequate assurance exists that parole boards will not take into account a prisoner's participation in the research when making decisions about parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his / her parole.

All research with prisoners must be reviewed by a designated prisoner advocate member of the IRB. A prisoner advocate is someone with the appropriate background and experience to represent the best interests of prisoners who might be recruited as subjects in research. Such a person could be a current or former prisoner, an attorney or other professional who has dealt extensively with prisoners' rights, or someone with similar experience.

Biomedical or behavioral research may involve prisoners as subjects only if the proposed research solely involves the following:

  • 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
  • study of prisons as institutional structures or of prisoners as incarcerated people, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects
  • 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
  • research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or wellbeing of the subject.

Pregnant Women and Fetuses

For clinical or drug studies, no pregnant woman may be involved as a subject in research unless:

  • the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs
  • the risk to the fetus is minimal.

No fetus in utero may be involved as a subject in any activity unless:

  • the purpose of the activity is to meet the health needs of the particular fetus and it will be placed at risk only to the minimum extent necessary to meet such needs
  • the risk to the fetus imposed by the research is minimal
  • the purpose of the activity is to develop important biomedical knowledge which cannot be obtained by any other means.

Special regulations that are particularly important in clinical research also exist for the involvement of Fetuses ex utero, including nonviable fetuses, dead fetus, fetal material, or the placenta.

Researchers should also be sensitive to the fact that potential and current subjects may not yet know that they are pregnant. Thus the researcher in any study in which activities might impact a pregnancy or fetus, for example, involving X-rays or fMRI, should make clear that if a subject thinks she might be or might become pregnant during the study, she should not participate.

For further information, read the Federal regulations about research involving pregnant women and fetuses.

Cognitively Impaired or Mentally Disabled Persons

As a general rule, all adults, regardless of their diagnosis or condition, should be presumed competent to consent unless there is evidence of serious mental disability or cognitive impairment that would impair reasoning or judgment. Mental disability alone should not disqualify a person from consenting to participate in research; rather there should be specific evidence of incapacity. In such cases, a guardian or legal representative may give consent for the individual.

This presents significant difficulties for researchers, particularly when dealing with the institutionalized. Firstly, there are no commonly accepted criteria for determining competence to consent to participation in research, particularly in those persons whose mental or intellectual state may fluctuate. Additionally, some individuals who may be incompetent or of doubtful competence may have no legal guardian to consent to or refuse participation on their behalf and there may be no clear legal guidance available on who might serve as a guardian or representative.

Given these difficulties, researchers are expected to have a very strong justification for using cognitively impaired persons in research and must clearly make the case that this population is not being included simply because of convenience or availability.

Additional Categories

Special consideration may also be needed when research is proposed with terminally ill, traumatized, and elderly/aged persons.

Chapter Review

Question 1

Which of the following groups constitute protected populations (select all that apply)?

  • public officials
  • prisoners
  • mentally disabled
  • employees

Question 2

In general, protected populations are permitted to participate in human subjects research if:

  • all subjects are adults
  • risk is minimal
  • payment for participation is adequate
  • their physicians agree

Question 3

Research involving greater than minimal risk carries further restrictions, depending on the amount of risk involved and the direct benefit to subjects.

Question 4

Research involving children under 12 years of age requires which of the following (choose all that apply):

  • parental permission
  • third party agreement
  • teacher's approval
  • the child's agreement

Question 5

Minors are particularly vulnerable to which of the following:

  • lack of understanding of the procedures
  • desire to please the researcher
  • peer pressure
  • all of the above

Question 6

Prisoners may participate in research when the direct financial benefits to them are substantial.

Question 7

Biomedical or behavioral research may involve prisoners as subjects if the proposed activity has the intent and reasonable probability of improving the health or wellbeing of the participants.

Next Chapter: How do researchers protect subject privacy and confidentiality?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Take the Certification Exam!
  • Glossary
  • References