Human Subjects Research Quiz: Belmont Report and 45 CFR 46
Human subjects research questions for people taking research ethics training: 78 original questions written from the Belmont Report and the Common Rule (45 CFR part 46), each answer backed by a quote from the official text. They are not copies of any course's test items.
Original questions for people taking human subjects research training, grounded in the Belmont Report and the federal Common Rule (45 CFR part 46). Not copies of any course's test items.
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01Belmont Report: which three basic ethical principles does the report identify as particularly relevant to research involving human subjects? A. Autonomy, nonmaleficence and fidelity B. Respect for persons, beneficence and justice C. Confidentiality, consent and compensation D. Privacy, equity and scientific integrity
B. Respect for persons, beneficence and justice.
VERIFIED AGAINST THE SOURCE
“the principles of respect of persons, beneficence and justice”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗02Belmont Report: the three basic principles are applied to the conduct of research through which three applications? A. IRB review, continuing review and record keeping B. Recruitment, enrollment and debriefing C. Informed consent, risk/benefit assessment and the selection of subjects D. Registration, assurance and reporting
C. Informed consent, risk/benefit assessment and the selection of subjects of research.
VERIFIED AGAINST THE SOURCE
“informed consent, risk/benefit assessment, and the selection of subjects of research”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗03Belmont Report: what does the term 'research' designate?
An activity designed to test a hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge.
VERIFIED AGAINST THE SOURCE
“designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗04Belmont Report: how does the report define 'practice', as distinct from research?
Interventions designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.
VERIFIED AGAINST THE SOURCE
“refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗05True or false: under the Belmont Report, a procedure that is new or untested is automatically research because it is experimental.
False. Being experimental in the sense of new, untested or different does not automatically place a procedure in the category of research.
VERIFIED AGAINST THE SOURCE
“in the sense of new, untested or different, does not automatically place it in the category of research”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗06Belmont Report: if an activity contains any element of research, what does the report say should happen?
The activity should undergo review for the protection of human subjects.
VERIFIED AGAINST THE SOURCE
“if there is any element of research in an activity, that activity should undergo review for the protection of human subjects”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗07Belmont Report: the principle of respect for persons incorporates which two ethical convictions?
First, that individuals should be treated as autonomous agents; second, that persons with diminished autonomy are entitled to protection.
VERIFIED AGAINST THE SOURCE
“first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗08Belmont Report: how does the report describe an autonomous person? A. Any adult who has signed a consent form B. An individual capable of deliberation about personal goals and of acting under the direction of such deliberation C. A person who is not institutionalized D. A person who has no legally authorized representative
B. An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.
VERIFIED AGAINST THE SOURCE
“An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗09Belmont Report: why does the report say respect for persons may require protecting prisoners who volunteer for research?
Because under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer.
VERIFIED AGAINST THE SOURCE
“under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗10Belmont Report: what two general rules express the obligation of beneficence?
(1) Do not harm and (2) maximize possible benefits and minimize possible harms.
VERIFIED AGAINST THE SOURCE
“(1) do not harm and (2) maximize possible benefits and minimize possible harms”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗11True or false: the Belmont Report treats beneficence as acts of kindness or charity that go beyond strict obligation.
False. In the report, beneficence is understood in a stronger sense, as an obligation.
VERIFIED AGAINST THE SOURCE
“In this document, beneficence is understood in a stronger sense, as an obligation”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗12Belmont Report: 'Who ought to receive the benefits of research and bear its burdens?' is a question of which principle? A. Respect for persons B. Beneficence C. Justice D. Fidelity
C. Justice.
VERIFIED AGAINST THE SOURCE
“Who ought to receive the benefits of research and bear its burdens? This is a question of justice”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗13Belmont Report: list the five widely accepted formulations of just ways to distribute burdens and benefits.
To each person (1) an equal share, (2) according to individual need, (3) according to individual effort, (4) according to societal contribution, and (5) according to merit.
VERIFIED AGAINST THE SOURCE
“(1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗14Belmont Report: what injustice does the report identify in the Tuskegee syphilis study?
It used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population.
VERIFIED AGAINST THE SOURCE
“the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗15Belmont Report: justice demands scrutiny of whether some classes of subjects are being systematically selected for which improper reasons?
Simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.
VERIFIED AGAINST THE SOURCE
“are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗16Belmont Report: the consent process can be analyzed as containing which three elements? A. Information, comprehension and voluntariness B. Disclosure, signature and witness C. Notice, choice and access D. Recruitment, screening and enrollment
A. Information, comprehension and voluntariness.
VERIFIED AGAINST THE SOURCE
“the consent process can be analyzed as containing three elements: information, comprehension and voluntariness”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗17Belmont Report: the report finds the disclosure standards used in medical practice insufficient for research subjects. What standard does it suggest may be proposed instead?
A standard of 'the reasonable volunteer'.
VERIFIED AGAINST THE SOURCE
“It may be that a standard of "the reasonable volunteer" should be proposed”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗18Belmont Report: incomplete disclosure is justified only if which three conditions are clear?
(1) Incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects.
VERIFIED AGAINST THE SOURCE
“(1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗19True or false: under the Belmont Report, information about risks may be withheld when doing so is needed to secure subjects' cooperation.
False. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects.
VERIFIED AGAINST THE SOURCE
“Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗20Belmont Report: which describes coercion? A. An offer of an excessive or improper reward to obtain compliance B. An overt threat of harm intentionally presented by one person to another in order to obtain compliance C. Any payment to research subjects D. A consent form that is too long
B. An overt threat of harm intentionally presented by one person to another in order to obtain compliance.
VERIFIED AGAINST THE SOURCE
“Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗21Belmont Report: how does undue influence differ from coercion?
Undue influence occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance, rather than through a threat of harm.
VERIFIED AGAINST THE SOURCE
“Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗22True or false: under the Belmont Report, an inducement that would ordinarily be acceptable can become an undue influence if the subject is especially vulnerable.
True.
VERIFIED AGAINST THE SOURCE
“inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗23Belmont Report: the moral requirement that informed consent be obtained is derived primarily from which principle? A. Justice B. Beneficence C. Respect for persons D. Scientific validity
C. Respect for persons.
VERIFIED AGAINST THE SOURCE
“the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗24Belmont Report: the requirement that research be justified by a favorable risk/benefit assessment bears a close relation to which principle?
Beneficence.
VERIFIED AGAINST THE SOURCE
“The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗25Belmont Report: which kinds of harm does the report list as the most likely types of risk for an IRB to consider?
Psychological, physical, legal, social and economic harm.
VERIFIED AGAINST THE SOURCE
“risks of psychological harm, physical harm, legal harm, social harm and economic harm”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗26True or false: under the Belmont Report, brutal or inhumane treatment of subjects can be justified if the expected benefits to society are large enough.
False. Brutal or inhumane treatment of human subjects is never morally justified.
VERIFIED AGAINST THE SOURCE
“Brutal or inhumane treatment of human subjects is never morally justified”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗27Belmont Report: at which two levels is justice relevant to the selection of research subjects? A. Federal and state B. Social and individual C. Institutional and departmental D. Scientific and nonscientific
B. The social and the individual levels.
VERIFIED AGAINST THE SOURCE
“Justice is relevant to the selection of subjects of research at two levels: the social and the individual”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗28Belmont Report: what does the report say institutionalized persons, already burdened by their condition, should be protected against?
Being involved in research solely for administrative convenience; less burdened classes of persons should be called upon first to accept the risks of research.
VERIFIED AGAINST THE SOURCE
“other less burdened classes of persons should be called upon first to accept these risks of research”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗29Belmont Report: the National Research Act (Pub. L. 93-348), which created the National Commission that wrote the report, was signed into law on what date? A. December 10, 1948 B. July 12, 1974 C. April 18, 1979 D. June 18, 1991
B. July 12, 1974.
VERIFIED AGAINST THE SOURCE
“On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗3045 CFR 46: a human subject is a living individual about whom an investigator conducting research does which of the following?
Either (i) obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes them, or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
VERIFIED AGAINST THE SOURCE
“Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3145 CFR 46: private information includes information about behavior that occurs in what kind of context?
A context in which an individual can reasonably expect that no observation or recording is taking place.
VERIFIED AGAINST THE SOURCE
“Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3245 CFR 46: which statement matches the regulatory definition of minimal risk? A. No risk of any kind to subjects B. Risk no greater than that approved by the sponsor C. The probability and magnitude of harm or discomfort are not greater in and of themselves than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests D. Risk that the subject has agreed to in writing
C. The probability and magnitude of harm or discomfort are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.
VERIFIED AGAINST THE SOURCE
“Minimal risk means that 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”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3345 CFR 46: how does the Common Rule define 'research'?
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
VERIFIED AGAINST THE SOURCE
“Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3445 CFR 46: which of these is listed among the activities deemed not to be research for purposes of the rule? A. A randomized drug trial B. Scholarly and journalistic activities such as oral history, journalism, biography and historical scholarship C. A survey designed to contribute to generalizable knowledge D. Secondary research with identifiable biospecimens
B. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship); public health surveillance activities are also on that list.
VERIFIED AGAINST THE SOURCE
“Public health surveillance activities”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3545 CFR 46: how is a 'clinical trial' defined?
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
VERIFIED AGAINST THE SOURCE
“Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3645 CFR 46: who is a 'legally authorized representative'?
An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research.
VERIFIED AGAINST THE SOURCE
“Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3745 CFR 46: what is the minimum number of members an IRB must have? A. Three B. Five C. Seven D. Nine
B. Five, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
VERIFIED AGAINST THE SOURCE
“Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3845 CFR 46: an IRB must include at least one member whose primary concerns are in scientific areas and at least one member of what other kind?
At least one member whose primary concerns are in nonscientific areas.
VERIFIED AGAINST THE SOURCE
“Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗3945 CFR 46: what must be true of the IRB member often called the unaffiliated member?
The member is not otherwise affiliated with the institution and is not part of the immediate family of a person who is affiliated with the institution.
VERIFIED AGAINST THE SOURCE
“Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗40True or false: under 45 CFR 46, an IRB member with a conflicting interest in a project may take part in its initial review as long as the member discloses the conflict.
False. No IRB member may participate in the initial or continuing review of a project in which the member has a conflicting interest, except to provide information requested by the IRB.
VERIFIED AGAINST THE SOURCE
“No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗4145 CFR 46: an IRB may invite individuals with competence in special areas to help review complex issues. May those individuals vote?
No. These individuals may not vote with the IRB.
VERIFIED AGAINST THE SOURCE
“These individuals may not vote with the IRB”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗4245 CFR 46: except when expedited review is used, what must be present at a convened IRB meeting for research to be reviewed, and what vote approves it?
A majority of the IRB's members, including at least one member whose primary concerns are in nonscientific areas; approval requires a majority of those members present at the meeting.
VERIFIED AGAINST THE SOURCE
“it shall receive the approval of a majority of those members present at the meeting”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗4345 CFR 46: if an IRB decides to disapprove a research activity, what must its written notification include?
A statement of the reasons for its decision, and the investigator must be given an opportunity to respond in person or in writing.
VERIFIED AGAINST THE SOURCE
“If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗4445 CFR 46: when continuing review is required, how often must the IRB conduct it at minimum? A. Every 3 years B. Every 2 years C. At intervals appropriate to the degree of risk, not less than once per year D. Only when the protocol changes
C. At intervals appropriate to the degree of risk, not less than once per year.
VERIFIED AGAINST THE SOURCE
“at intervals appropriate to the degree of risk, not less than once per year”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗45True or false: under the 2018 Requirements of 45 CFR 46, every study approved by an IRB must undergo continuing review at least once a year.
False. Unless an IRB determines otherwise, continuing review is not required in certain circumstances, such as research eligible for expedited review.
VERIFIED AGAINST THE SOURCE
“Research eligible for expedited review in accordance with”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗4645 CFR 46: who may carry out an expedited review?
The IRB chairperson, or one or more experienced reviewers designated by the chairperson from among members of the IRB.
VERIFIED AGAINST THE SOURCE
“the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗4745 CFR 46: which IRB authority may expedited reviewers NOT exercise? A. Approving the research B. Requiring modifications C. Disapproving the research D. Reviewing minor changes
C. Disapproving the research. Expedited reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research.
VERIFIED AGAINST THE SOURCE
“the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗4845 CFR 46: under the criteria for IRB approval, risks to subjects must be reasonable in relation to what?
Anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
VERIFIED AGAINST THE SOURCE
“Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗49True or false: under 45 CFR 46, in evaluating risks and benefits an IRB should weigh possible long-range effects of applying the knowledge gained in the research, such as effects on public policy.
False. The IRB should not consider possible long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility.
VERIFIED AGAINST THE SOURCE
“The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗50Which IRB approval criterion in 45 CFR 46.111 most directly carries out the Belmont Report's principle of justice?
The criterion that selection of subjects is equitable; the Belmont Report says justice requires fair procedures and outcomes in selecting research subjects.
VERIFIED AGAINST THE SOURCE
“the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects”
— The Belmont Report (National Commission, 1979), HHS Office for Human Research Protections ↗51True or false: under 45 CFR 46, institutional officials may approve research that has not been approved by an IRB.
False. Officials may further review and disapprove IRB-approved research, but they may not approve research that has not been approved by an IRB.
VERIFIED AGAINST THE SOURCE
“However, those officials may not approve the research if it has not been approved by an IRB”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5245 CFR 46: on what grounds may an IRB suspend or terminate approval of research?
When the research is not being conducted in accordance with the IRB's requirements, or has been associated with unexpected serious harm to subjects.
VERIFIED AGAINST THE SOURCE
“An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5345 CFR 46: for cooperative research, what does the single IRB requirement say about institutions located in the United States?
Any U.S. institution engaged in cooperative research must rely upon approval by a single IRB for the portion of the research conducted in the United States.
VERIFIED AGAINST THE SOURCE
“Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5445 CFR 46: how long must records required by the policy, including records relating to conducted research, be retained? A. 1 year after IRB approval B. At least 3 years, and for conducted research at least 3 years after completion of the research C. 7 years after publication D. Indefinitely
B. At least 3 years; records relating to research that is conducted must be retained for at least 3 years after completion of the research.
VERIFIED AGAINST THE SOURCE
“The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5545 CFR 46: before involving a human subject in covered research, what must an investigator obtain?
The legally effective informed consent of the subject or the subject's legally authorized representative.
VERIFIED AGAINST THE SOURCE
“an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5645 CFR 46: under what circumstances may an investigator seek informed consent?
Only under circumstances that provide the prospective subject (or representative) sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
VERIFIED AGAINST THE SOURCE
“An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5745 CFR 46: the Common Rule requires prospective subjects to receive the information that whom would want to have to make an informed decision about whether to participate? A. The investigator B. The sponsor C. A reasonable person D. The IRB chairperson
C. A reasonable person, along with an opportunity to discuss that information.
VERIFIED AGAINST THE SOURCE
“the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5845 CFR 46: with what must informed consent begin (other than broad consent)?
A concise and focused presentation of the key information most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate.
VERIFIED AGAINST THE SOURCE
“Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗5945 CFR 46: which of these may NOT appear in an informed consent? A. A description of reasonably foreseeable risks B. Exculpatory language through which the subject is made to waive or appear to waive any legal rights C. A statement that participation is voluntary D. Whom to contact about research-related injury
B. No informed consent may include exculpatory language through which the subject is made to waive or appear to waive legal rights, or that releases or appears to release the investigator, sponsor or institution from liability for negligence.
VERIFIED AGAINST THE SOURCE
“No informed consent may include any exculpatory language through which the subject or the legally authorized representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6045 CFR 46: what must the basic elements of informed consent say about risks, and about voluntary participation?
A description of any reasonably foreseeable risks or discomforts, and a statement that participation is voluntary, that refusal involves no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue at any time without penalty.
VERIFIED AGAINST THE SOURCE
“A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6145 CFR 46: for research involving more than minimal risk, what must the consent explain about injury?
Whether any compensation and whether any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained.
VERIFIED AGAINST THE SOURCE
“For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6245 CFR 46: name two of the additional elements of informed consent that are provided when appropriate.
Examples: a statement that the treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable; and any additional costs to the subject that may result from participation.
VERIFIED AGAINST THE SOURCE
“Any additional costs to the subject that may result from participation in the research”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6345 CFR 46: broad consent may be obtained in lieu of study-specific informed consent only with respect to what?
The storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens.
VERIFIED AGAINST THE SOURCE
“only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6445 CFR 46: which is NOT one of the findings an IRB must make to waive or alter informed consent under the general waiver provision? A. The research involves no more than minimal risk to the subjects B. The research could not practicably be carried out without the waiver or alteration C. Subjects will be paid for their participation D. The waiver or alteration will not adversely affect the rights and welfare of the subjects
C. Payment is not a waiver criterion. The IRB must find minimal risk, impracticability without the waiver, no adverse effect on rights and welfare, and (when appropriate) that subjects will get additional pertinent information after participation; if identifiable information or biospecimens are used, the research could not practicably be carried out without using them in identifiable form.
VERIFIED AGAINST THE SOURCE
“Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6545 CFR 46: for a clinical trial conducted or supported by a Federal department or agency, what must be posted on a publicly available Federal Web site?
One IRB-approved informed consent form used to enroll subjects.
VERIFIED AGAINST THE SOURCE
“one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6645 CFR 46: unless documentation is waived, how must informed consent be documented, and who receives a copy?
By a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the legally authorized representative; a written copy is given to the person signing the form.
VERIFIED AGAINST THE SOURCE
“A written copy shall be given to the person signing the informed consent form”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6745 CFR 46: an IRB may waive the requirement for a signed consent form in which situation? A. The investigator is short on time B. The only record linking the subject and the research would be the consent form and the principal risk would be potential harm from a breach of confidentiality C. The sponsor requests it D. The study enrolls more than 1,000 subjects
B. The other grounds are research that presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context, and minimal risk research with members of a distinct cultural group or community in which signing forms is not the norm (with an alternative way to document consent).
VERIFIED AGAINST THE SOURCE
“members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗68True or false: under 45 CFR 46.104, the exemption categories generally apply to research involving prisoners under subpart C.
False. The exemptions do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners.
VERIFIED AGAINST THE SOURCE
“The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗6945 CFR 46.104: research in established or commonly accepted educational settings is exempt when it specifically involves normal educational practices meeting what condition?
Practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction.
VERIFIED AGAINST THE SOURCE
“normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7045 CFR 46.104: which of these is one of the listed exemption categories? A. Phase 1 drug trials B. Taste and food quality evaluation and consumer acceptance studies C. Research with prisoners as the target population D. Any study that pays subjects
B. Taste and food quality evaluation and consumer acceptance studies.
VERIFIED AGAINST THE SOURCE
“Taste and food quality evaluation and consumer acceptance studies”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗71True or false: under 45 CFR 46 subpart B, investigators may offer payment to encourage termination of a pregnancy if the IRB approves.
False. No inducements, monetary or otherwise, will be offered to terminate a pregnancy.
VERIFIED AGAINST THE SOURCE
“No inducements, monetary or otherwise, will be offered to terminate a pregnancy”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7245 CFR 46 subpart C: what two special composition requirements apply to an IRB reviewing research involving prisoners?
A majority of the Board (exclusive of prisoner members) must have no association with the prison(s) involved apart from Board membership, and at least one member must be a prisoner or a prisoner representative with appropriate background and experience.
VERIFIED AGAINST THE SOURCE
“At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7345 CFR 46 subpart D: who are 'children'?
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.
VERIFIED AGAINST THE SOURCE
“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”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7445 CFR 46 subpart D: what is the difference between 'permission' and 'assent'? A. They mean the same thing B. Permission is the agreement of parent(s) or guardian to the child's participation; assent is the child's own affirmative agreement C. Permission is given by the IRB; assent by the investigator D. Assent is only required for adults
B. Permission is the agreement of parent(s) or guardian to the participation of their child or ward; assent is the child's affirmative agreement to participate.
VERIFIED AGAINST THE SOURCE
“Assent means a child's affirmative agreement to participate in research”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7545 CFR 46.405: research with children involving greater than minimal risk but presenting the prospect of direct benefit may be approved only if the IRB finds what about the risk?
The risk is justified by the anticipated benefit to the subjects, and the relation of the anticipated benefit to the risk is at least as favorable as that of available alternative approaches (with assent and permission provided for).
VERIFIED AGAINST THE SOURCE
“Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7645 CFR 46.406: for research with children involving greater than minimal risk and no prospect of direct benefit, how large may the risk be? A. Any level the IRB accepts B. A minor increase over minimal risk C. No more than minimal risk D. Moderate risk with parental permission
B. A minor increase over minimal risk, and the research must be likely to yield generalizable knowledge about the subjects' disorder or condition of vital importance.
VERIFIED AGAINST THE SOURCE
“is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7745 CFR 46 subpart D: for research approved under 46.406 or 46.407, when may permission from just one parent suffice?
Both parents must give permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or only one parent has legal responsibility for the care and custody of the child. (For 46.404 or 46.405 research the IRB may find one parent's permission sufficient.)
VERIFIED AGAINST THE SOURCE
“the IRB may find that the permission of one parent is sufficient for research to be conducted under § 46.404 or § 46.405”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗7845 CFR 46 subpart E: how often must an IRB renew its registration with OHRP, and when does registration become effective?
Every 3 years; registration becomes effective when reviewed and accepted by OHRP.
VERIFIED AGAINST THE SOURCE
“IRB registration becomes effective when reviewed and accepted by OHRP”
— 45 CFR part 46, Protection of Human Subjects (eCFR) ↗Know questions we're missing?
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