Design Decisions in Research

6. Research Ethics Committees

Exercise 4

This exercise tests your knowledge of evolving ethics issues.

Instructions:
For each of the following scenarios, identify which evolving ethics issue should be considered.

Evolving Ethics Issues:
Breadth and competence of committees
Community involvement
International research
Federally or non-federally funded research
Sociocultural differences
Mission creep
Scientific misconduct

Scenarios:

  1. Research on diabetes prevention plans to recruit from four Native American tribal groups.  Informed consent is sought from each potential participant.  The investigators are surprised when participants report they cannot consent to research without consent of the tribe following review and approval by a tribal committee.
  2. An IRB is reviewing a study on the impact of parent’s imprisonment on 10-13 year old children.  The composition of the IRB is: 4 MDs in the areas of infectious diseases, psychiatry, oncology, and hematology; 3 behavioral/social scientists in psychology, sociology, and research methods; 4 non-scientists including 1 ethicist, 1 lawyer, 1 member of clergy, and 1 executive director of an advocacy organization.  A member moves to defer the review pending input from 1 or more pediatricians and child psychologists.
  3. A study of breast cancer screening is being done.  To increase recruitment in the Hispanic community, the investigators hold community meetings to publicize their study.  They invite comments on community concerns and solicit suggestions on how to encourage participation and on appropriate incentives.
  4. University researchers receive industry support to conduct a clinical trial.  The researchers are unsure of whether or not their research must be reviewed by the university IRB.
  5. An IRB discusses serious flaws in the research design and analytic plan.  The proposal is returned for amendment of scientific weaknesses.  The investigators are furious that the IRB has reviewed the science as well as the ethics, claiming it is out of the committee’s scope of responsibilities.
  6. An investigative team has developed a vaccine for a tropical disease and has successfully completed animal studies and safety and efficacy studies in humans.  The vaccine is to be tested in a tropical developing country with a poor health services delivery system.  The clinical trial is a randomized design.  It does not include a provision to vaccinate the larger population or members of the control group at the end of the trial.  The investigators say that there is no adequate public health delivery system to vaccinate the larger population.
  7. An audit of study records done as part of a continuing review reveals discrepancies in the dates some subjects were tested and the dates on the signed consent forms.  On closer examination, it appears that the participant’s signatures, from the handwriting, appear to be those of a single individual.  A research assistant, when questioned, admits to having forged signatures and dates.

Answers:

  1. Research on diabetes prevention plans to recruit from four Native American tribal groups.  Informed consent is sought from each potential participant.  The investigators are surprised when participants report they cannot consent to research without consent of the tribe following review and approval by a tribal committee.
    [Sociocultural differences]  Sociocultural differences:  The investigators were not aware of the tradition of tribal consent or of the existence of tribal review.
  2. An IRB is reviewing a study on the impact of parent’s imprisonment on 10-13 year old children.  The composition of the IRB is: 4 MDs in the areas of infectious diseases, psychiatry, oncology, and hematology; 3 behavioral/social scientists in psychology, sociology, and research methods; 4 non-scientists including 1 ethicist, 1 lawyer, 1 member of clergy, and 1 executive director of an advocacy organization.  A member moves to defer the review pending input from 1 or more pediatricians and child psychologists.
    [Breadth and competence of committees]  Breadth and competence of committees:  The member who asked for deferral did so because the committee did not have expertise in child health and behavior.
  3. A study of breast cancer screening is being done.  To increase recruitment in the Hispanic community, the investigators hold community meetings to publicize their study.  They invite comments on community concerns and solicit suggestions on how to encourage participation and on appropriate incentives.
    [Community involvement]  Community involvement:  The researchers demonstrate by their behavior that they want input from the community and solicit that input.  They inform the community about the research, demonstrating respect.
  4. University researchers receive industry support to conduct a clinical trial.  The researchers are unsure of whether or not their research must be reviewed by the university IRB.
    [Federally or non-federally funded research]  Federally or non-federally funded research:  Most universities and other organizations require ethics review for all research involving humans.  However, the review may be by the university IRB, a central IRB, a free-standing IRB, or another organization’s IRB if the university has an agreement with the other organization to accept its review.  The university policy should provide guidance on how to proceed.
  5. An IRB discusses serious flaws in the research design and analytic plan.  The proposal is returned for amendment of scientific weaknesses.  The investigators are furious that the IRB has reviewed the science as well as the ethics, claiming it is out of the committee’s scope of responsibilities.
    [Mission creep]  Mission creep:  A scientifically flawed proposal is unlikely to contribute to new knowledge or answer the research questions it poses.  Involving human participants in research that has little merit can be viewed a lack of respect for persons and as detrimental to science.
  6. An investigative team has developed a vaccine for a tropical disease and has successfully completed animal studies and safety and efficacy studies in humans.  The vaccine is to be tested in a tropical developing country with a poor health services delivery system.  The clinical trial is a randomized design.  It does not include a provision to vaccinate the larger population or members of the control group at the end of the trial.  The investigators say that there is no adequate public health delivery system to vaccinate the larger population.
    [International research]  International research:  Implementing the ethical principles of respect for persons, beneficence and justice should lead to actions that improve the health of those who participated in the research (including the control group) if the intervention proves effective.
  7. An audit of study records done as part of a continuing review reveals discrepancies in the dates some subjects were tested and the dates on the signed consent forms.  On closer examination, it appears that the participant’s signatures, from the handwriting, appear to be those of a single individual.  A research assistant, when questioned, admits to having forged signatures and dates.
    [Scientific misconduct]  Scientific misconduct:  Forging signatures is scientific misconduct.