Subject Selection/Vulnerable Populations Flashcards
(40 cards)
A research study wants to determine the effectiveness of two prenatal care group programs as compared to individual prenatal care in reducing the risk for HIV in young women during and after pregnancy. The IRB determines the research is no greater than minimal risk for the pregnant women and the fetuses. Is this research permitted under Subpart B?
Yes – this research is permitted.
This research would be permitted per Subpart B because it is not greater than minimal risk to pregnant women and fetuses. Not greater than minimal risk research does not need to present direct benefit to be allowed with pregnant women and fetuses.
A researcher wants to collect data about fetuses that were exposed to high levels of lead during their mother’s pregnancy. The researcher plans to review the medical records for a control group (not known to be exposed to high levels of lead) and an experimental group (exposed to high levels of lead) of fetuses from 12 weeks of gestation through delivery. Is this research permitted under Subpart B?
Yes – research with neonates of uncertain viability may be involved because there is no additional risk
Neonates of uncertain viability may be involved in research only if there is no added risk to the neonate, or the research’s purpose is to enhance the possibility of survival of the particular fetus to the point of viability.
Can research subject to Subpart B and that includes pregnant women as subjects be exempt from the regulations, per 45 CFR 46, if all of the conditions of the exemption are met?
Yes, each of the exemptions in 45 CFR 46.104 may be applied to research subject to Subpart B.
Each of the exemptions in 45 CFR 46.104 may be applied to research subject to Subpart B if the conditions of the exemption are met (Protection of Human Subjects 2018). There are no specific limits on blood draw amounts or categories.
A research study will compare a new combined behavioral and pharmacologic treatment with the standard behavioral treatment alone for individuals with severe seasonal affected disorder (SAD). The researcher wants to include pregnant women in the study. However, the pharmacologic treatment has not been previously studied in non-pregnant women, nor have preclinical studies on pregnant animals been conducted. Is this research permitted under Subpart B?
No – this research is not permitted with pregnant women.
This research would not be permitted per Subpart B because the following condition could not be met from 45 CFR 46.204(a), “ 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.”
An IRB determines a research study is greater than minimal risk with no potential direct benefit to subjects. The study includes pregnant women. Per Subpart B, can the IRB approve this study?
A. Yes because there is not a scientific justification to exclude pregnant women from the study.
B. No, because greater than minimal risk research is not allowed to include pregnant women.
C. Yes because there are appropriate safeguards in place.
D. No, because this study presents no potential benefit and it is more than minimal risk.
D. No, because this study presents no potential benefit and it is more than minimal risk.
For research subject to Subpart B, the IRB could not approve research that is greater than minimal risk and presents no benefit to subjects.
According to 1994 NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research?
A. The woman is of child-bearing potential.
B. There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.
C. Inclusion of women would complicate analysis of the results and increase the costs of conducting the clinical trial.
B. There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.
According to the 1994 NIH Guidelines, the only justification for exclusion of non-pregnant women of childbearing potential was compelling evidence that inclusion would be inappropriate with respect to the health of the subjects, or to the purpose of the research.
A research study aims to evaluate a new experimental type of fetoscopic laser surgery to correct a potentially life-threatening condition for the fetus prior to delivery. This research is to meet the health needs and directly benefit the fetus only. The pregnant woman is otherwise healthy. Per Subpart B, the investigator must obtain consent from whom?
A. The state court where the research is taking place
B. The father of the fetus only.
C. The pregnant woman only.
D. The pregnant woman and the father of the fetus (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest).
D. The pregnant woman and the father of the fetus (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest).
When the more than minimal risk research intends to directly benefit only the fetus, the consent of both the pregnant woman and the father of the fetus must be obtained per Subpart B (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest).
Per 45 CFR 46.204:
(e) 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.
The research study is no greater than minimal risk for the pregnant woman and the fetus, and holds the prospect of direct benefit to both the pregnant woman and the fetus. Who needs to provide consent under Subpart B?
A. The mother
B. The mother and the legally authorized representative for the fetus
C. The mother and the father
D. The father (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest)
A. The mother
Only the mother would provide consent per Subpart B.
Investigators wish to evaluate a new treatment for eclampsia (a life-threatening condition in pregnant women) in women 30 – 50 years of age. The research is intended to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator must obtain consent from whom per Subpart B?
A. The pregnant woman and the father of the fetus.
B. The father of the fetus only.
C. The pregnant woman and her legally authorized representative.
D. The pregnant woman only.
D. The pregnant woman only.
According to 46.204(d), if the purpose of the activity is to meet the health needs of the mother, then the consent of the father is NOT required.
A researcher wants to examine the efficacy of mushroom extract supplementation on fetal loss, low birth weight, and severe preterm birth in healthy pregnant women. She plans to enroll women who are 12-26 weeks pregnant and randomize them to either receive the intervention or placebo until delivery. The IRB determines this intervention presents greater than minimal risk to the pregnant women subjects, and potential direct benefit to both mother and fetus. Is this research permitted under Subpart B?
A. No – this research is not permitted because it involves fetuses.
B. No – this research is not permitted with pregnant women.
C. Yes – this research is permitted because it presents the prospect of benefit to mother and fetus.
D. Yes- This research is permitted if it may benefit the fetuses.
A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10-year-old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?
A. Request the child reconsider assenting to the study.
B. Honor the child’s decision.
C. Consent both of the child’s parents instead.
D. Seek permission from one of the child’s parent instead.
B. Honor the child’s decision.
The assent of minors to participate in research is required, unless 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” (45 CFR 46.408). The IRB determined that an 8-year-old was capable of providing assent for participation in this study, and in this situation, the child’s decision cannot be overruled by the permission from one or both parents.
A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB’s risk assessment would likely conclude that this study involves:
A. More than minimal risk with no prospect of direct benefit to the child.
B. More than minimal risk with prospect of direct benefit to the child.
C. No risk to the child and no further IRB review is required.
D. No more than minimal risk to the child.
D. No more than minimal risk to the child.
45 CFR 46.102(i) defines minimal risk as the “probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Because the risk associated with collection of a single voided urine specimen is not greater than risks encountered in the course of a routine physical examination, this research constitutes “minimal risk.”
An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject’s chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study?
A. Assent of the child and permission of both parents are required.
B. Assent of the child only is required.
C. Assent is not required, however, both parents must give permission for the inclusion of the adolescent child.
D. Assent is not required, however, one parent must give permission for the inclusion of the adolescent in this study.
A. Assent of the child and permission of both parents are required.
The research, as described presents 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. It is therefore potentially approvable under 45.406, provided: (1) the risk represents a minor increase over minimal risk; (2) 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; (3) 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 (4) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
Community-based participatory research is a good way to address the Gender and Sexuality diversity in research because it
A. Enables researchers to gain insight into cultural issues for that community as well as community priorities
B. Enables researchers to access the community without having to consent subjects individually
C. Enables researchers to work with the community to design and execute the research without worrying about dissemination
D. Enables community residents to tailor the results to their individual needs
A. Enables researchers to gain insight into cultural issues for that community as well as community priorities
Community-based participatory research enables community residents to more actively participate in the full spectrum of research (from conception – design – conduct – analysis – interpretation – conclusions – communication of results) with a goal of influencing change in community health, systems, programs or policies. It does not necessarily mean that individual consent is waived. While community residents may work with researchers to design research meaningful to the community, it does not mean that the residents can tailor the results to meet individual needs. An important facet of community-based participatory research is that it includes the community in all three elements of research—design, execution, and dissemination.
In general, research procedures for GSD individuals must be careful to consider which of the following in particular:
A. The educational level of individuals.
B. The degree of “outness” of subjects.
C. The access of GSD to community resources.
D. The number of GSD members that may participate.
B. The degree of “outness” of subjects.
Research procedures must always consider the degrees of “outness” of subjects. Some people are open about their sexual orientation of gender identity in all contexts; some are not open at all; others are open in certain contexts and not others. Level of “outness” also varies by age and ethnicity and other socio-cultural factors. The access of GSD to community resources is a much larger concern, and not necessarily related to research procedures. The educational levels of subjects, in general, may be a concern particularly for the informed consent process where the educational level may affect comprehension. However, it is not necessarily specific to GSD individuals. The degree of participation of GSD members in a particular study may be important to that study, especially with respect to validity; however, the number of participants is not a general concern.
The diversity in sexuality includes
A. Bisexuals, Transgender, and Intersex individuals
B. Transsexual, cisgender, and intersex individuals
C. Gays, Lesbians, and Intersex individuals
D. Gays, Lesbians, Heterosexuals, Bisexual people, Pansexual people, and Asexual people
D. Gays, Lesbians, Heterosexuals, Bisexual people, Pansexual people, and Asexual people
Sexuality diversity include those who define themselves as heterosexual as well as those who have other sexual orientations, including gays, lesbians, bisexuals, and pansexuals. Transgender, cis-gender, and intersex individuals reflect diversity in gender identity and sex development.
Which of the following is something an IRB should do with respect to review of GSD research?
A. Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities.
B. Require justification for including GSD individuals in general research.
C. Consider only the harms that individual subjects may be exposed to, but not community harm.
D. Disapprove any research protocol that excludes GSD subjects.
A. Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities.
An IRB should seek consultants with expertise in specific segments of the GSD community to provide information on research in those communities. The IRB should ensure that research does not systematically exclude subjects, but seeking to systematically include subjects goes against the spirit of “justice” (as articulated by the Belmont Report) because inclusion of GSD members, as a de-facto practice, has the potential of disproportionally exposing those individuals to the burdens of research. The IRB should require justification for the exclusion of GSD individuals from general research, not the inclusion. GSD community members are a part of the larger community. When research on the larger group excludes (either intentionally or by oversight in design) the burdens and benefits of that research are not being applied equally. The IRB should consider both the harm to individual subjects as well as “community harm,” as it would consider the potential of community harm within a larger population.
Researchers should do which of the following with respect to GSD individuals and general research (research not directly focusing on GSD issues)?
A. Design study materials, measures, and procedures in a way that ensures that GSD subjects are comfortable participating.
B. Hire only GSD staff to conduct GSD research.
C. Use a research subject advocate for all consent conferences that include GSD people.
D. Exclude GSD subjects as their participation should be focused on GSD-specific research.
A. Design study materials, measures, and procedures in a way that ensures that GSD subjects are comfortable participating.
While researchers generally work to be sure that all subjects are comfortable, particular attention must be made for GSD individuals who might be participating in research not focused on GSD issues. For example, researchers studying prostate cancer using a quality of life measure should be sure that questions are not worded using “heteronormative” or “cisgender normative” language (“How has your cancer treatment affected the relationship with your wife?” or “When your partner became pregnant, did your relationship with her change?”) and instead should use language that makes all subjects comfortable (“How has your cancer treatment affected the relationship with your spouse/partner?” or “Did your relationship with your partner change when they became pregnant?”). This consideration is demonstrated by researchers in the designing of study materials, measures, and procedures. The use of research subject advocates may or may not be needed, depending on the vulnerabilities of potential subjects. This is not a GSD-specific issue. In some instances, hiring individuals who are a part of the community that is the focus of the research may be helpful; however, limiting the study staff to only members of the group that is the focus may be both impractical and may adversely affect not only research design but also the ability to conduct research with the group. Excluding without reason GSD individuals from non-GSD research runs counter to the Belmont Report’s principal of justice.
Researchers should be particularly sensitive of which of the following when potentially working with GSD subjects, regardless of the type of research?
A. Educational level of the subjects
B. Hetero-normative or cisgender-normative language
C. Subject access to transportation
D. Primary language of the subjects
B. Hetero-normative or cisgender-normative language
While all of these are important issues for researchers to consider generally, in terms of GSD subjects, “hetero-normative” or “cisgender-normative” language in elements of the research—including recruitment letters, consent forms, and instruments, is of particular concern.
What can “gender expression” tell you about a particular subject?
A. Their sexual orientation
B. How they interpret their gender identity
C. Whether or not that person is transgender
D. Their sex assigned at birth
B. How they interpret their gender identity
Gender expression is the outward reflection of gender identity. Gender expression can match one’s sex assigned at birth, so it does not necessarily reflect a transgender identity. All people present gender signifiers to the world – some are just more aligned with cultural expectation than others. Sexual orientation is independent of gender expression as much as who you are does not define whom you love. Sex assigned at birth reflects how the medical personnel attending your birth interpreted your external sex characteristics, which is a separate issue from how you choose to express your gender identity as a human being.
Why should researchers and IRBs be concerned with the legal status of GSD people?
A. Researchers should advocate in the political arena for the subjects they intend to enroll in human subjects research.
B. Researchers are required under the regulations to set aside money to defend human subjects in court for legal-related risks of subject participation.
C. Legal vulnerabilities may increase the risks to subjects from a breach of confidentiality.
D. IRBs are required to have GSD members in states where there are no legal protections for GSD people.
C. Legal vulnerabilities may increase the risks to subjects from a breach of confidentiality.
Unintended disclosure of GSD status can have wide-ranging legal implications for individuals, including child custody, employment status, and the ability to serve in the military. Although respect for subjects is required of researchers, political advocacy is not. There is no requirement under the regulations for IRBs to include GSD members under any circumstances. However, it is best practice for IRBs to consult with GSD experts when GSD issues come up in IRB review. There are no requirements under the regulations for researchers to set aside money to address harm to subjects of any kind.
Parental Permission should be waived for research in GSD youth when:
A. Obtaining permission will disclose GSD status to the parent when the child has not yet disclosed to them AND the disclosure might put the child at risk for violence, bullying or being kicked out of their family home.
B. The GSD youth are wards of the state, since that means the parents no longer have legal rights.
C. For all GSD youth, since all are vulnerable and at risk of violence from their family of origin.
D. Research is conducted through LGBT Community Centers. Since these youth are independent enough to come out of the closet while still minors, they deserve the respect of being treated as adults.
A. Obtaining permission will disclose GSD status to the parent when the child has not yet disclosed to them AND the disclosure might put the child at risk for violence, bullying or being kicked out of their family home.
A waiver of parental permission should only be considered for those GSD youth for whom disclosure to their parents of their child’s GSD identity would put them at risk for harm. Many GSD youth have families that love and respect them, with full knowledge of their child’s GSD identity. Respect for subjects and families means that parental permission for research with minors should be sought unless there is a pressing reason not to. Not all GSD youth are wards of the state. Furthermore, wards of the state are a special class of vulnerable subjects and the courts act in the place of parents to provide permission for these subjects. GSD youth who understand their GSD identity(s) before adulthood deserve respect, but respecting child subjects means respecting their families and including their parents in decision-making processes. GSD youth shouldn’t be asked to grow up any sooner than cis-gender, heterosexual youth.
Which is not true regarding the cognitive impairment that often occurs near the end-of-life?
A. It always interferes with ability to provide consent.
B. It may be worsened by clinical depression.
C. It may vary over time.
D. It may be attenuated or exacerbated by the research intervention under study.
A. It always interferes with ability to provide consent.
Cognitive impairment does not always interfere with the ability to provide consent in subjects near the end-of-life. Although cognitive impairment occurs in 10–40% of patients in the final months and in up to 85% of patients in the last days of life (Breitbart 1995), it does not occur in all patients. It is true that the effects of cognitive impairment on comprehension may be worsened by clinical depression, which occurs in between 5% and 25% of patients near the end-of-life (Kathol 1990). Impairment may also vary over time and may be attenuated or exacerbated by the research intervention under study, so researchers should include a plan for ongoing assessment of capacity.
Regarding risks of harm and benefits of participation in research at the end-of-life, which of the following is true?
A. Questionnaires and surveys are likely to be well tolerated and can be considered minimal risk in this population.
B. Control is increasingly important near the end-of-life; randomization and protocol-driven dosing may need to be seen as a risk of participation.
C. Once a subject has decided that the risks of harm associated with research are acceptable in relation to potential benefits, this assessment is unlikely to change and revisiting the decision is unnecessary.
D. Survival continues to be the key benefit which causes subjects to participate in end-of-life research.
B. Control is increasingly important near the end-of-life; randomization and protocol-driven dosing may need to be seen as a risk of participation.
The response “Control is increasingly important near the end-of-life; randomization and protocol-driven dosing may need to be seen as a risk of participation” is true. The response “Questionnaires and surveys are likely to be well tolerated and can be considered minimal risk in this population” is not true because though minimal risk to a healthy individual, may be burdensome to a patient in the last days of life. The responses “Survival continues to be the key benefit which causes subjects to participate in end-of-life research” and “Once a subject has decided that the risks of harm associated with research are acceptable in relation to potential benefits, this assessment is unlikely to change and revisiting the decision is unnecessary” are not true, as Casarett and Karlawish (2000, 130-9) note, “the risks and benefits that are important to patients near the end-of-life may be much more difficult to define because patients’ goals for care change substantially as they near death. Broadly, these changes can be characterized by a decreased emphasis on survival, and a new focus on symptom relief, dignity and meaning, social relationships, and control. It is likely, therefore, that patients’ preferences about the risks and potential benefits of research may change as well.”
