Design Decisions in Research

5. Current and Unresolved Issues

Exercise 2

This exercise tests your knowledge of the three principles from the Belmont Report (Respect for Persons, Beneficence, Justice).

Instructions:
For each example below, decide which of the three principles from the Belmont Report is most relevant.

Belmont Report Principles:
Respect for Persons
Beneficence
Justice

Examples:

  1. For a condition that affects population subgroups differentially, an investigator strategizes to include neighborhoods with large minority populations in order to recruit a diverse sample into her study.  She meets with neighborhood residence to explain the study and to encourage broad participation.
  2. A research subject consents to research but halfway through the research says he has to leave and does not wish to continue.
  3. In research on cardiac function and aging, participants between the ages of 70-80 are recruited.  The investigator meets with each participant for 5-10 minutes, and describes the research.  The researcher gives the potential participant a consent form to read and sign, and while leaving the room says that he will be back to pick up the form and begin the research in 10 minutes.  The consent form is 8 point type and 9 pages long.
  4. A study to investigate the effects of prolonged hypothermia recruits normal volunteers and excludes potential participants with a history of heatstroke, seizures, heart disease, or stroke.
  5. A research procedure to halt bleeding in the brain following head trauma has been for in animal trials to be more effective than currently used interventions.  An IRB is reviewing a proposal to use the experimental procedure in humans during emergency transport, to monitor the research subjects closely and to follow with accepted treatment as indicated.  The study will use a randomized design.  It is anticipated that subjects will be unconscious and unable to consent.
  6. A cognitively impaired person has consented to longitudinal research on cognitive impairment.  During the third follow-up, the participant turns away, paces in the room, and appears anxious and agitated.  The investigator asks for assent and the subject appears to nod ‘No’.

Answers:

  1. For a condition that affects population subgroups differentially, an investigator strategizes to include neighborhoods with large minority populations in order to recruit a diverse sample into her study.  She meets with neighborhood residence to explain the study and to encourage broad participation.
    [Justice]  Justice:  The investigator’s recruitment plan includes members of diverse racial and ethnic groups and med and women so she will be able to analyze data for sex, racial and ethnic differences, if any, and so the results will be generalizable.  Justice requires that the benefits and burdens of research participation be equitably distributed. 
  2. A research subject consents to research but halfway through the research says he has to leave and does not wish to continue.
    [Respect for Persons]  Respect for Persons:  Respect for persons requires that research participation is voluntary and that a participant may withdraw from research participation at any time.
  3. In research on cardiac function and aging, participants between the ages of 70-80 are recruited.  The investigator meets with each participant for 5-10 minutes, and describes the research.  The researcher gives the potential participant a consent form to read and sign, and while leaving the room says that he will be back to pick up the form and begin the research in 10 minutes.  The consent form is 8 point type and 9 pages long.
    [Respect for Persons]  Respect for Persons:  Reinforcement of complex written information by discussion and opportunity for questions, perhaps with a research partner or family member present, helps assure that consent is informed, particularly for older persons.  There is no apparent effort to assure that the purposes, procedures, risks and benefits, etc. are fully understood; nor is there an opportunity to ask questions or think about options.  An inadequate consent process implies a lack of respect for persons.
  4. A study to investigate the effects of prolonged hypothermia recruits normal volunteers and excludes potential participants with a history of heatstroke, seizures, heart disease, or stroke.
    [Beneficence]  Beneficence:  This research has no potential benefit to participants but may benefit a class of participants.  The exclusion criteria minimize risks of harm that can be anticipated by the investigators.
  5. A research procedure to halt bleeding in the brain following head trauma has been for in animal trials to be more effective than currently used interventions.  An IRB is reviewing a proposal to use the experimental procedure in humans during emergency transport, to monitor the research subjects closely and to follow with accepted treatment as indicated.  The study will use a randomized design.  It is anticipated that subjects will be unconscious and unable to consent.
    [Beneficence]  Beneficence:  The anticipated benefits are to the individual subjects.  On the basis of existing evidence, there are no known harms of the procedure.  There is no alternative way to proceed to the next phase of the promising intervention.  The IRB approves the research to be done on six subjects with a waiver of consent after which the investigators must report back to the IRB to assess whether or not the research should continue.  The IRB stipulates that the investigator get consent from a surrogate if one is present and inform each subject about the research procedure if s/he recovers enough to understand the research.
  6. A cognitively impaired person has consented to longitudinal research on cognitive impairment.  During the third follow-up, the participant turns away, paces in the room, and appears anxious and agitated.  The investigator asks for assent and the subject appears to nod ‘No’.
    [Respect for Persons]  Respect for Persons:  The participant’s behavior indicates that he does not want to participate.  He is permitted to withdraw from this follow-up.