CITI Training

Pragmatic trials assess which of the following:

The effectiveness of an intervention by comparing it to commonly accepted therapy ("usual care")

Decisional impairment creates vulnerability in research subjects by:

Affecting a person's ability to adequately protect their own interests

Your informed consent form must describe _______.

All foreseeable risks and discomforts.

There are intrinsic and extrinsic barriers to subject comprehension. An example of an intrinsic factor that may affect consent is:

Anxiety

Socially or economically disadvantaged research subjects are:

Best protected when an IRB with expertise in local conditions has reviewed the protocol

In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.

Common Rule

When considering the applicability of the Americans with Disabilities Act (ADA) and other disability-related laws to research activities involving subjects who are decisionally impaired, researchers must:

Determine if the research is 'targeting' a disabled population.

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?

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

When IRBs are applying the federal regulatory criteria for approval to protocols involving socially or economically disadvantaged persons:

Each criterion should be analyzed in relation to the special characteristics of the populations

Which example of research with prisoners would be allowable under the regulations?

Examining age at first arrest as a predictor of adult criminal history.

Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)?

Exempt

In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:

FERPA, PPRA, and Subpart D of the federal regulations

According to the author, a strategy researchers may use to determine a child's ability to assent is:

Having the researcher speak with both the parent and child to establish if the child appears to have sufficient maturity to understand the basics of what will happen to them, and whether they are able to articulate an unambiguous choice.

In certain circumstances, the federal regulations permit researchers to enroll subjects without a written translation by using a "short form" written consent document, in a language the subject understands. Researchers should know that the use of a short form is conditioned upon:

IRB approval of a written summary of information to be presented

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

Federal regulations (21 CFR 50.20 and 45 CFR 46.116) state that the information given in the consent process must be:

In language understandable to the subject

The informed consent process with older adults can be improved by:

Including a limited number of alternatives

A researcher's study uses an identifiable dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision:

Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.

Which is not true regarding the cognitive impairment that often occurs near the end-of-life?

It always interferes with ability to provide consent.

A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?

Justice

The general practice of excluding older adults from research, clinical trials in particular, may represent an unintended breach of the principle of _________.

Justice

A medical record is an example of:

Private information

The "Teach-back" method, when used in the consent process has been shown to improve understanding, especially when:

Questions are pre-imbedded in the process

If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?

Research about aptitude testing

Which of the following statements about prison research is true?

Researchers may study the effects of privilege upgrades awarded by the prison.

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

Respect for Persons, Beneficence, Justice

Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

Respect for persons

Payments to research subjects must be:

Reviewed and approved by the IRB

Which of the elements listed below is acceptable for a study including individuals with a physical disability?

Scheduling study visits for individuals in wheelchairs in a building that includes a wheelchair ramp and an elevator.

Which of the following is something an IRB should do with respect to review of GSD research?

Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities.

Which is NOT true regarding voluntariness in potential research subjects near the end-of-life?

Since patients are near the end-of-life, gratitude or a sense of obligation is seldom an incentive for patients for participate in research.

Which of the following is true for definitions of the term "disability?"

The United Nations definition includes individuals who have long-term physical, mental, intellectual or sensory impairments.

The future of medicine is likely to be personalized to an individual's:

Genetic make-up

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:

Workers

The diversity in sexuality includes

Gays, Lesbians, Heterosexuals, Bisexual people, Pansexual people, and Asexual people

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB?

Will the researchers have collaborators at the research site abroad?

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C because the research does not meet the criteria for prison research --- individuals on parole are not considered prisoners. The definition applies to both minors and adults.

A recognized retention strategy for research involving marginalized populations is:

"Collateral contacts" such as family and friends

A research university in California is concerned that the high number of Asian immigrants may result in enrollments in research due to a cultural deference to authority. The university wishes to write a policy for informed consent that will help assure that the cultural deference to authority is addressed by researchers. The best solution would be to include a requirement for:

A "cooling off" period of at least one day between providing consent information and signing the consent form

In studies requiring informed consent, if an adult lacks consent capacity the consent of a legally authorized representative (LAR) is required. The LAR is:

A person authorized under State law to consent to the procedures involved in the research.

A person's consent capacity has been evaluated for a study. What factors should be considered when determining whether that evaluation can be applied to another research study?

All of the above

Challenges for obtaining consent from subjects who are critically ill include:

All of the above

What are acceptable consenting practices when including individuals with a physical disability?

All of the above

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research funded by HHS

A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?

Not Human Subjects

A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:

Not an excessive incentive.

Which of the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

Parental Permission should be waived for research in GSD youth when:

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.

Informed consent in research with homeless youth is:

Often carried out with waiver of documentation when risk is no greater than minimal

In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research developed ethical principles and guidelines for the protection of human subjects for research. The purpose of these guidelines was to:

Provide a framework for use in the resolution of ethical problems arising from research involving human subjects.

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

Provide parents certain rights over their children's educational records.

The consent process must allow subjects to consider whether or not to participate. Which of the following would be the best way to enhance subject understanding for non-English speakers?

Providing interpreters and time for discussion with advocates during the consent discussion.

A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:

Public information

One way to enhance the understanding of research through the consent process for non-English speakers is to train research assistants to use which of the following when explaining the purpose of the research study and study procedures to potential subjects.

Teach-back method

Older adults have been excluded from research participation because:

Their conditions are considered to confound research protocols

Clinicians find it difficult to care for older adults because:

They have not been included in studies so prescribing drugs involves a lot of unknown risk

The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research.

True

When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.

True

Capacity to make decisions regarding research participation requires that subjects exhibit which of the following attributes?

Understanding

A subject who does not speak English in the U.S. may indicate other areas that must be considered and addressed by researchers. Which of the following is most typically an associated concern?

cultural differences

The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study

Subjects who are critically ill may have limitations in their ability to process information, make complex decisions, or communicate their wishes. These limitations may be related to a number of factors including (check all that apply):

- Altered states of consciousness due to the underlying illness - The effect of drugs or other medical interventions - Fear and uncertainty about their condition

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply.

- Faculty Advisor/Research Mentor - IRB Office

When reviewing research funded by the U.S. Department of Education (ED) that involves children with mental disabilities, an IRB must:

- Include an individual in the review who is primarily concerned with the welfare of these subjects. - Apply the HHS Subpart D of 45 CFR 46 that calls for additional protections of children participating in research.

Overcoming challenges to cultural competence in research requires that: (Check ALL that apply)

- Investigators examine and understand historical contexts for study populations before initiating research study design. - Early-phase study design should take into account race, ethnicity and cultural factors. - IRB membership should include representatives of large communities and cultural groups as representatives.

A 2011 report from the conference "Dialogues on Diversifying Clinical Trials," sponsored by FDA's Office of Women's Health and the Society for Women's Health Research found that:

African Americans account for 5 percent of clinical trial participants and Hispanics 1 percent

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

All of the above Workers who serve as research subjects at their place of employment are vulnerable to numerous kinds of pressure from their co-workers, unions, and employers. Pressure can be applied to workers in subtle ways (such as, an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs).

In most cases, a U.S. researcher affiliated with an academic institution, proposing to conducted funded research outside of the U.S., must have the approval of which of the following entities:

An IRB from both the researcher's U.S. institution and an equivalent entity within the host country

Who might be a good disability representative who can consult with or be a member of an IRB?

An advocate for individuals with disabilities.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

Which of the following is a commonly used resource for international ethical guidelines for human subjects research?

CIOMS International Ethical Guidelines for Health-related Research Involving Humans

What is the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research's suggestion regarding assent in children?

Children seven years of age and above are capable of assent

Regarding risks of harm and benefits of participation in research at the end-of-life, which of the following is true?

Control is increasingly important near the end-of-life; randomization and protocol-driven dosing may need to be seen as a risk of participation.

Community-based participatory research is a good way to address the Gender and Sexuality diversity in research because it

Enables researchers to gain insight into cultural issues for that community as well as community priorities

A research study is targeting a disabled population when it does which of the following?

Enrolls only individuals who are legally blind in order to study their attitudes towards the workplace for reasonable accommodations of their blindness.

A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?

No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.

PPRA gives parents some level of control over their child's:

Participation in third-party survey research or exposure to instructional materials developed by researchers

The 1991 CIOMS guidelines for epidemiological studies state, that at the level of the individual, ethics governs how one person should relate to another and the moral claims of each member of a community, and at the level of the community, ethics applies to how one community relates to another and members of other groups with different cultural values. When it comes to research, the best statement about procedures is that:

Procedures that are unethical at one level cannot be justified merely because they are considered ethically acceptable at the other.

A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:

Public behavior

Researchers designing studies to be conducted in host countries outside the U.S. should:

Remember that in some populations an individual cannot make a decision about medical care without the full engagement of relatives, friends and those in authority in the community

Regarding barriers to research at the end-of-life, which of the following is true?

Subjects may be difficult to recruit since they are often frail and burdened by symptoms, and unable to complete study requirements.

Which of the following statements about assessment of decision-making capacity or capacity to consent in critically ill patients is correct:

The assessment of both decision-making capacity and capacity to consent can be difficult.

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

Enhanced consent forms may improve comprehension in subjects with low literacy skills. This may include:

Using plain and simple language

Trust and transparency are critical to successful and culturally competent research. In the research setting, establishing trust in diverse communities does NOT require:

Limiting public transparency and accountability

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

Why should researchers and IRBs be concerned with the legal status of GSD people?

Legal vulnerabilities may increase the risks to subjects from a breach of confidentiality.

An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?

Justice

Which is true regarding consent and assent?

Subjects who are not fully capable of providing consent deserve the opportunity to provide assent (that is, affirmative agreement to participate), and to have their expression of dissent respected by the researcher.

NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. This inclusion is to ensure that:

Valid analyses of differences in intervention effects can be accomplished.

Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:

All of the above Researchers must recognize that the primary harm in social and behavioral research is the breach of confidentiality. This risk of harm is especially significant when the data being collected involves an employee's experiences at their place of employment (for example, a situation where the employers have ongoing efforts to reduce healthcare costs by getting rid of employees who they believe will cause their healthcare insurance premiums to rise).

According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:

Justice

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Obtains, uses, studies, analyzes, or generates identifiable private information.

If research in a private school is directly funded by the Department of Education, then:

PPRA applies.

According to federal regulations, "children" are defined as:

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

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.

Cultural competence in research is defined as the ability of researchers to provide high quality research that takes into account:

The diversity of population's values, beliefs and behaviors when developing research ideas, conducting research and exploring applicability of their findings.

Research with older adults should include:

Provisions for assessing capacity to consent

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Federal regulations do not require the documentation of minors' assent.

One of the suggested safeguards to be included in proposals for research involving subjects who are critically ill is a "necessity requirement." This is defined as:

A requirement that it is necessary to enroll subjects who are critically ill; that is, that the research cannot be performed without enrolling this vulnerable population