Belmont Report (1979)

summarizes the basic ethical principles and guidelines for the protection of human subjects of research. (Respect for persons, beneficence and justice)

released in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, provides the ethical framework for the federal regulations designed to protect human research subjects.

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
A.Ensuring that the selection of subjects includes people from all segments of the population.
B. Providing detailed information about the study and obtaining the subject's consent to participate.
C. Determining that the study has a maximization of benefits and a minimization of risks.
D. Ensuring that persons with diminished autonomy are protected.

C. Determining that the study has a maximization of benefits and a minimization of risks.

(The principle of beneficence includes the obligation of researchers to strive to do no harm and to maximize benefits and minimize harms. "Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being" (The National Commission 1979). The principle of beneficence can be applied to a study employing human subjects by determining that the study has a maximization of benefits and a minimization of risks. Providing detailed information during consent and ensuring persons with diminished autonomy are protected would be examples of applying the principle of respect for persons. Ensuring the selection of subjects is equitable is an example of applying the principle of justice).

The Belmont Report’s principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:

A. Persons involved in research cannot financially benefit.

B.Persons with diminished autonomy are entitled to protection.

C. Persons with diminished autonomy should only participate in no more than minimal risk research.

D.. Persons with diminished autonomy should be excluded from research.

B.Persons with diminished autonomy are entitled to protection.

The Belmont Report’s principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. Persons with diminished autonomy should not be excluded from participating in research, because then they would be excluded from receiving the benefits of research. The Belmont Report does not limit persons with diminished autonomy with participating in greater than minimal risk research. The Belmont Report also does not limit persons involved in research from benefitting financially.

Which of the following are the three principles discussed in the Belmont Report?

A. IRB Review, Federal Regulations, Declaration of Helsinki

B. Respect for Persons, Beneficence, Justice

C. Informed Consent, Institutional Assurance, Researcher Responsibility

C. Privacy, Confidentiality, Equitable Selection of Subjects

B. Respect for Persons, Beneficence, Justice

The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice.

Nuremberg Code

a set of ethical principles essential for a medical experiment to be "permissible", these codes were subsequently created after the Nuremberg trials at the end of the Second World War.

The National Research Act of 1974

A.Identified guidelines to ensure the ethical conduct of research.

B. Established the National Commission.

C. Identified the basic ethical principles of human subjects research.

D. Required that all federal agencies have the same regulations governing human subjects research.

Established the National Commission.

The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identification of guidelines, ethical principles and regulations came as a result of the deliberations of the National Commission.

Which of the following is included in the Nuremberg Code:
A. Additional protection for vulnerable subjects
B. Equitable selection of subjects
C.Voluntary consent
D.Confidentiality of data

C. Voluntary Consent

The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.

Issued in 1974, 45 CFR 46 raised to regulatory status:
A. US Public Health Service Policy
B. The Nuremberg Code
C. The 1974 National Research Act
D. Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act

A.US Public Health Service Policy

45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".

Which of the following brought increased public attention to the problems with the IRB system?
A. Death of Research Subject (Jesse Gelsinger)
B. HHS Inspector General Report of 1998
C. 1983 Presidential Commission Report"
D. Shut Downs" by OHRP

A. Death of Research Subject (Jesse Gelsinger)

Although all of these are related to the problems with the IRB system, the death of a research subject (Jesse Gelsinger) was what received public attention

Which of the following was the result of the Beecher article?
A. An identification of basic ethical principles
B. Multiple Congressional hearings
C.Additional FDA regulations
D. Realization that ethical abuses are not limited to the Nazi regime

D. Realization that ethical abuses are not limited to the Nazi regime

The primary result of the Beecher article was to expose ethical abuses occurring in research involving human subjects in the US, well after the revelations about research by the Nazi regime.

Informed consent is considered an application of which Belmont principle?
A. Justice
B. Beneficence
C. Respect for Person
D. Non-maleficence

C. Respect for Persons

Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent

The use of prisoners in research is a concern under the Belmont principle of Justice because:
A.Prisoners are less educated that the general population and have difficulty understanding research
B. Prisoners are not free to say no
C. Prisoners may not be used to conduct research that only benefits the larger society
D. Prisoners are not a representative sample of the general population

C. Prisoners may not be used to conduct research that only benefits the larger society

The Belmont Principle of Justice requires the equitable distribution of both the benefits and burdens of research. Prisoners should not bear the burden of participating in research that only benefits the larger society.

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
A.Waiving documentation of consent
B. Securing a Certificate of Confidentiality
C. Using data encryption for stored files
D. Using pseudonyms in research reports

B. Securing a Certificate of Confidentiality

Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:
A, Keeping the key linking names to responses in a secure location.
B. Destroying all identifiers connected to the data.
C.Requiring all members of the research team to sign confidentiality agreements.
D. Reporting data in aggregate form in publications resulting from the research.
E. All of the above

E. All of the above

Reporting data in aggregate form can help protect the identity of subjects(but does not make the data anonymous. Keeping keys in secure locations and requiring members of the research team to sign confidentiality agreements are methods for protecting identifiable information. Researchers can also remove all identifying information from the data and completely disconnect any links between the subjects and data about the subjects.)

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

A. The researcher cannot control what participants repeat about others outside the group.

B. If group members know each other confidentiality is not an issue

C. .Using pseudonyms in reports removes the concern about any confidences shared in the group.

D. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.

A. The researcher cannot control what participants repeat about others outside the group. (It is not possible for a researcher to promise confidentiality in a focus group setting. Participants may choose to repeat sensitive information outside the group setting even if they have signed confidentiality agreements. This is true even if the participants know each other. Using pseudonyms in the report does not remove concerns about what group members might say outside the group.)

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
A. The subjects' privacy has been violated.
B.There was both a violation of privacy and a breach of confidentiality.
C. There was neither a violation of privacy nor a breach of confidentiality.
D. Confidentiality of the data has been breached.

C. There was neither a violation of privacy nor a breach of confidentiality.

The subjects' privacy has not been violated because the identity of subjects was not included in the file. The confidentiality of the data has not been breached because the data could not be linked to identifiers. Therefore, the correct answer is that there was neither a violation of privacy nor a breach of confidentiality. The release of aggregate data with no identifiers does not constitute a violation of privacy or a breach of confidentiality.

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study
B.In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
C. A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
D. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.

C. A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

No agreements were made regarding confidentiality with the subjects who were unknowingly audio-taped; whose interactions were recorded, or whose cocaine use was revealed by another. Therefore, there was no breach of an agreement about confidentiality, but the subjects' right to decide who can access their personal information was violated. If a researcher told subjects that only he or she would have access to identifiable data and then gives identifiable data to others that action constitutes a breach of confidentiality and a violation of privacy - the subjects' right to control who has access to personal information.

Which is an example of a situation where deferential vulnerability might be a factor?

A.A physician recruiting patients to be subjects

B. An employer recruiting among persons who directly report to them

C. An army medical officer recruiting subjects among lower ranks

D. A college professor recruiting among their students

A. A physician recruiting patients to be subject

In deferential vulnerability, the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. The power relationship may be based on gender, race, or class inequalities, or they can be inequalities in knowledge (such as, in the doctor-patient relationship). Like institutional vulnerability, deferential vulnerability increases the risk of harm that informed consent would be compromised because it is not fully voluntary

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

A. Are the research procedures greater than minimal risk of harm?

B. Is there a power differential between researchers and subjects?

C. Has the researcher completed required training?

D. Are there adequate resources to conduct the study?

B. Is there a power differential between researchers and subjects?

IRBs should assess if there is a power differential and if it would affect the potential subjects, making them vulnerable to coercion. According to the module authors, it is important for IRBs to ask researchers to fully describe the population to be studied and the situations in which the potential research subjects find themselves. This should answer both the question about the intrinsic factors or attributes as well as the situational forces that may give rise to different types of vulnerability. The other responses should also be considered by the IRB during their review of the research, but do not relate to identifying if the subject population is vulnerable.

Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C, and D with additional protections:

A. Pregnant women, prisoners, children

B. Pregnant women, prisoners, and mentally disabled

C. Prisoners, children, and elderly

D. Children, prisoners, and terminally ill

A.Pregnant women, prisoners, children

(The HHS federal regulations at 45 CFR 46 includes three subparts (B, C, and D) that specifically provide additional protections to vulnerable groups. The vulnerable groups identified are:

Subpart B. Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

Subpart C. Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Subpart D. Additional Protections for Children Involved as Subjects in Research.

The regulations do not provide specific additional protections for elderly, mentally disabled or terminally ill).

The NBAC looks at characteristics individuals might have that would prevent them from being able to provide voluntary informed consent. The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:

A. Physical vulnerability

B. Cognitive or communicative vulnerability

C. Institutional vulnerability

D. Economic or social vulnerability

B. Cognitive or communicative vulnerability

(Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a cognitive or communicative vulnerability).

Subjects with a serious illness may be at risk for exploitation because they may be desperate for a possible cure. This is an example of:

A. Therapeutic misconception

B. Economic vulnerability

C. Medical vulnerability

D. Deferential vulnerability

C.Medical vulnerability

The medical vulnerability arises when prospective subjects have serious health conditions for which there are no satisfactory standard treatments. Subjects with serious health problems may not be able to adequately weigh the risks and potential benefits of the research. Subjects are at risk of exploitation because they may overestimate potential benefit. Deferential vulnerability is similar to institutional vulnerability, but the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Therapeutic misconception occurs when subjects blur the roles played by physician-researchers and fail to appreciate the difference between research and treatment.

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
A. Physical control, coercion, undue influence, and neglect
B. Prejudice, physical control, manipulation, and coercion
C.Physical control, coercion, undue influence, and manipulation
D. Coercion, undue influence, neglect, and disrespect

C. Physical control, coercion, undue influence, and manipulation

There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least (Nelson and Merz 2002, V69-80). The other abuses– prejudice, neglect, and disrespect – should still be avoided in research).

In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
A. Capacity-related cognitive vulnerability
B. Economic vulnerability
C. Situational cognitive vulnerability
D. Communicative vulnerability

C. Situational cognitive vulnerability

(Subjects who do not lack capacity, but are in situations that do not allow them to exercise their capacities effectively, may suffer situational cognitive vulnerability. This might occur when a subject is distracted or during an emergency situation, such as an acute illness or injury. Capacity-related cognitive vulnerability can occur when subjects to some extent lack capacity to make informed choices. Communicative vulnerability can occur when subjects do not lack capacity, but due to limited ability to communicate with the researchers are not able to exercise their capacities effectively. Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare).

Which is an example of a situation where deferential vulnerability might be a factor?
A. An employer recruiting among persons who directly report to them
B. An army medical officer recruiting subjects among lower ranks
C. A college professor recruiting among their students
D. A physician recruiting patients to be subjects

B.An army medical officer recruiting subjects among lower ranks

In deferential vulnerability, the authority over the prospective subject is due to informal power relationships rather than formal hierarchies. The power relationship may be based on gender, race, or class inequalities, or they can be inequalities in knowledge (such as, in the doctor-patient relationship). Like institutional vulnerability, deferential vulnerability increases the risk of harm that informed consent would be compromised because it is not fully voluntary).

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

A. Has the researcher completed required training?

B. Is there a power differential between researchers and subjects?

C. Are there adequate resources to conduct the study?

D. Are the research procedures greater than minimal risk of harm?

Is there a power differential between researchers and subjects?

(IRBs should assess if there is a power differential and if it would affect the potential subjects, making them vulnerable to coercion. According to the module authors, it is important for IRBs to ask researchers to fully describe the population to be studied and the situations in which the potential research subjects find themselves. This should answer both the question about the intrinsic factors or attributes as well as the situational forces that may give rise to different types of vulnerability. The other responses should also be considered by the IRB during their review of the research, but do not relate to identifying if the subject population is vulnerable).

Which is true of inducements in research?

A. Like coercion, undue inducement is easy for IRBs to determine.

B. Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.

C. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons.

D. Offering $10 for an hour long research study constitutes undue inducement.

...

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:
A. Social vulnerability
B. Economic vulnerability
C. Communicative vulnerability
D.Institutional vulnerability

B. Economic vulnerability

Economic vulnerability arises when prospective subjects are disadvantaged in the distribution of social goods and services (income, housing, or healthcare). Participation in research offers the possibility of payment or attainment of healthcare or other services that are otherwise not available, and induce persons to enroll in a research study when it might be against their better judgment and when otherwise they would not do so. These inducements to enroll threaten the voluntary nature of consent and raise the danger of exploitation.Prospective subjects who belong to undervalued social groups may be subject to social vulnerability. The perception of these groups as less valuable to society could lead to reduced concern (by researchers) for risks of harm and burdens on those groups, and increase the risk of exploitation. Prospective subjects in research who are subject to the formal authority of others may have an institutional vulnerability. These individuals have the cognitive capacity to consent but may not be able to make a truly voluntary choice, and may be unduly influenced (or coerced) to participate when they otherwise might not have done so. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a cognitive or communicative vulnerability.

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
A. Does not meet the definition of research, and so requires no HIPAA authorization or meeting one of the criteria for waiving authorization.
B. Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
C. Is covered by Common Rule/FDA requirements, but not HIPAA's.
D. Must meet HIPAA requirements only if the data collection is in a different jurisdiction (state) than the researcher accessing it.

B. Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

HHS has reiterated in its guidance that use or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board. However, remember that you generally cannot proceed on your own without some approval from an IRB, Privacy Board, or other designated governing entity.

HIPAA's protections for health information used for research purposes...
A. Only apply to research conducted inside covered entities.
B. May be used at the institution's discretion instead of the Common Rule and FDA protections.
C. Replace those of the Common Rule and FDA for human subjects protection.
D. Supplement those of the Common Rule and FDA.

D. Supplement those of the Common Rule and FDA.

HIPAA's relatively new data-focused protections, which took effect starting in 2003, supplement Common Rule and FDA protections; they are not a replacement. Institutional Review Board (IRB) protocol reviews using Common Rule and FDA criteria remain as before, including aspects related to data protection. IRBs may have the responsibility for addressing HIPAA's additional requirements in their reviews when those apply; or some responsibilities may be given to another kind of body that HIPAA permits (a Privacy Board) or to an institutional official that HIPAA requires (a privacy officer). These federal standards complement states' and accreditation bodies' requirements.

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:
A. Identifiable health information that is created or held by covered entities and their business associates, provided the data subject is a US citizen.
B. Any identifiable health information.
C. Identifiable health information that is created or held by covered entities and their business associates that operate across state lines.
D.Identifiable health information that is created or held by covered entities and their business associates.

A.Identifiable health information that is created or held by covered entities and their business associates.

HIPAA's protections reach only a subset of individually identifiable health information - formally called protected health information or simply "PHI" - created in or by what HIPAA calls covered entities. Covered entities include individual health providers, health provider organizations, health plans, and health information clearinghouses that engage in electronic healthcare transactions. (See Health and Human Services Covered Entity Decision Charts.) HIPAA's protections for PHI extend to non-U.S. citizens' information as well.

HIPAA includes in its definition of "research," activities related to:
A. Anything a researcher does in a federally-supported laboratory.
B. Development of generalizable knowledge.
C. Population health.
D. Quality assessment and improvement.

B. Development of generalizable knowledge.

Like the Common Rule, HIPAA defines research as a "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge" (Protection of Human Subjects 2018; Security and Privacy 2013).

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
A. Use of decedents' information, with certain representations by the researcher.
B. Activities preparatory to research, with certain representations by the researcher.
C. Data that does not cross state lines when disclosed by the covered entity.
D. Limited data set with an approved data use agreement.

A. Use of decedents' information, with certain representations by the researcher.

If the data in question meet the definition of PHI and are being used for purposes that fall within HIPAA's definition of research, HIPAA generally requires explicit written authorization (consent) from the data subject for research uses. However, HIPAA provides several alternatives that can bypass such authorizations:

The research involves only minimal risk.

The research is used solely for activities preparatory to research.

Only deceased persons' information is used.

Only de-identified data is used.

Only a "limited data set" is used, under an approved "data use agreement."

It is research where all legal permissions were in place before HIPAA took effect.

What is the term for management controls that are built in to a research study (for example, independent data analysis)?
A. Objective controls
B. Mandated controls
C. Inherent controls
D. Required controls

C. Inherent controls

When developing conflict of interest management plans, COI committees typically examine the study design to determine whether it includes inherent controls that mitigate the researcher's opportunity to bias the research. Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial.

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
A. Sponsor
B. Organization
C. IRB Member
D. Researcher
E. Applicants submitting marketing applications for drugs, biologics, or devices

D.Researcher

The PHS regulations about financial conflict of interests require the researcher to disclose significant financial conflicts of interest to the organization. The FDA's regulation governing disclosure of individual COI requires applicants submitting marketing applications for drugs, biologics, or devices to certify the absence of certain financial interests or disclose financial interests of researchers who conducted clinical studies covered by the regulation.

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
A. Disclose their potential COI and may answer questions, but recuse themselves from voting
B. Disclose their potential COI, but not answer any questions about the study
C. Disclose their potential COI and not participate in any action
D. Leave the meeting immediately

A. Disclose their potential COI and may answer questions, but recuse themselves from voting

IRB policies and procedures generally specify that members with conflicts of interest related to an agenda item must disclose their conflicts of interest, and may answer questions from the IRB about the item with which they have a conflict, but are prohibited from voting on that item.

An example of an institutional COI is:
A. An industry sponsor pays for the construction of a new research laboratory at the organization
B. The organization gives scholarships to some post-doctoral researchers
C. One of the organization's deans is the vice-chair of the organization's IRB
D. The organization's president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the

A.An industry sponsor pays for the construction of a new research laboratory at the organization

An institutional COI can arise when the financial interests of an organization or institutional official (acting within his or her authority on behalf of the organization) may affect or appear to affect the research conducted under the organization's auspices. This could include significant gifts received by the organization from the sponsor of human subjects research.

A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
A. Not until a notice of award is received
B. Never -- the PHS regulation does not require researchers to submit COI disclosures
C. No later than the time of proposal submission
D. Researchers must only submit COI disclosures if they have a significant financial interest related to the research

C.No later than the time of proposal submission

The NIH is a PHS agency. Therefore, this proposed research is subject to the PHS regulation regarding objectivity in research, which requires researchers to submit COI disclosures no later than the time a proposal is submitted to a PHS funding agency