CITI IRB (Conflicts of Interest & Basics of Info Security), Internet-Based research SBE CITI, Citi Questions

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study (2006-2009)

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

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.

To speed up the approval process, an IRB administer can be the sole reviewer of __ proposals.

Form A

A Researcher proposes to conduct a study at a foreign site that 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.

Which of the following is the main reason why proper training in euthanasia techniques is important?

Improper techniques can cause unnecessary pain and distress in animals.

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

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

Justice

The age of majority in international research is determined by the

Laws, customs, and norms in the area in which the research will be conducted.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

Must occur within 12 months of the approval date.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

Prisoners

Which of the following is empowered by the U.S. federal government to review and approve research activities involving vertebrate animals?

The Institutional Animal Care and Use Committee (IACUC)

What is the primary purpose of the "3Rs" concept from Russell and Burch?

To decrease the use of animals in research and to minimize pain and distress caused by animal experiments.

Which of these is not a good practice for physical security?

To preserve good customer relations, visitors are generally allowed access to all areas of a facility unless it appears they are doing something suspicious.

A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

Experience emotional or psychological distress.

A Departmental Review Board (DRB) can review

Form A and B

Security measures are sometimes described as a combination of physical, technical, and administrative (PTA) safeguards. Which of these would be considered a technical safeguard?

Measures including device data encryption, anti-malware software, and communications encryption.

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.

What is the term for management controls that are build in to a research study (for example, independent data analysis)?

Inherent controls

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.

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.

No later than the time of proposal submission

Which type of research cannot be submitted on Form A

No risk experiment

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

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?

A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success

What procedures must be described in an agreement called an "assurance of compliance" with OHRP?

Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

The Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm.

Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?

A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.

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

Parental notification, in lieu of active parental permission, is allowed when:

An IRB has approved a waiver of the requirement for parental permission.

An example of a COI is:

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

The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?

An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals?

Any procedure that causes pain or distress in human beings may cause pain or distress in other animals.

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 availably 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.

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.

Prior to implementing any significant change in the use of animals, what is the most important thing that the research team must do?

Obtain IACUC approval for the change.

Which of the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval.

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

PPRA applies.

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

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

The COI management plan aims to:

Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed

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.

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

Which of these is not generally a good practice for fax machine use?

Sensitive faxes -- inbound or outbound -- are left sitting in or around the machine.

The specific 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

Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?

The Family Educational Rights and Privacy Act.

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?

The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.

According to the federal regulations, research is eligible for exemption, if:

The research falls into one of eight categories of research activity described in the regulations.

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations?

The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.

One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should NOT be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?

The researcher should contact prison authorities of the medical issue , and report the events to the IRB of record.

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

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.

Which of these is not generally a good practice for telephone use?

Using voicemail systems and answering machines that do not require a password or PIN for access.

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 researcher have collaborators at the research site abroad?

A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:

Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

What procedures must be described in an agreement called an "assurance of compliance" with OHRP?

procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

Which entity is responsible for monitoring institutional compliance with PHS Policy?

The Office of Laboratory Animal Welfare (OLAW)

To minimize potential risks of harm, a researcher conducting an on-line survey can:

Design the survey so that no direct or indirect identifiers are collected.

Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?

Designing the survey so that subjects are not forced to answer one question before going to the next.

Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?

Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group.

A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:

Confidentiality of the prisoners' health status is maintained.

Which type of research must be submitted on Form C

Both research involving children and risk beyond everyday life

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

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection?

The Public Health Service Study of Untreated Syphilis

Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?

Directory information.

Which of the following is the LEAST important activity when protecting human subjects in international research?

Assessing transportation conditions

Which of the following is true regarding the use of animals in research?

The attending veterinarian must be allowed to have access to all research animals at all times.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true?

This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.

Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities?

Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification.

Which type of research must be submitted on Form B - no risk beyond everyday life and

Both recording participant identity and experimental procedures

Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems since Wardens of Juvenile prisoners - unlike those for adult prisoners - act in loco parentis for juvenile offenders. This statement is false because:

Both subparts apply since these individuals are under the legal age of consent and are incarcerated

During an Institutional Review Board (IRB) meeting, an IRB member who may have a potential COI with a study under review should:

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

Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:

Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.

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

Do nothing in regards the Subpart C since 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.

The University of Scranton IRB or its designated reviewers must review all research involving

Both simple anonymous surveys and class assignments outside of class

A researcher's study uses a 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. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.