IRB Continuation
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.
Which of the following is the least important activity when protecting human subjects in international research?
Assessing transportation conditions
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.
Under HIPAA, a "disclosure accounting" is required:
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?
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.
A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?
Significant risk device
What must be included in a FERPA-compliant consent form?
Specificity about the data being collected and used for the study
Under FERPA, which of the following types of studies are eligible for an exception from consent?
Studies that focus on improving instruction
What three questions must an IRB include in its FERPA checklist?
Is there written permission to collect the data? Will the use of the data be for a legitimate educational interest? Will the disclosure be to another educational institution?
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 full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers interact with their children with learning disabilities. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. The committee considers that the risks to the children could be more than minimal, but the proposal does not include adequate information to make a final determination regarding the risks. Which of the following best describes how the IRB should proceed?
Table the protocol and ask the investigator to provide the needed information for review by the full board at the next convened meeting.
"Scrambling identifiers" refers to what procedure?
Distorting student IDs using an algorithm, so that researchers can conduct longitudinal studies
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.
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study
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.
An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
A breach of confidentiality
What is PPRA?
A federal law that seeks to protect the rights of parents and students in ED-funded programs
The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) are intended to:
Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.
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.
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:
Data that does not cross state lines when disclosed by the covered entity.
A full IRB committee meeting is convened. The IRB committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. One of the IRB members is Principal Investigator for one of the studies being reviewed and receives a portion of her salary from the supporting grant. The IRB member who is the Principal Investigator, must recuse herself from the room during both the final deliberations and the vote on the study. Which of the following best describes the committee's action after the member leaves the IRB meeting?
Defer the proposal to the next meeting because of a loss if quorum.
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.
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.
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.
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.
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
An academic medical center is selecting a new database system for clinical research. The system needs to be "Part 11 compliant" in order to allow:
The medical center to replace the use of paper records with electronic records for its research.
In order to grant a waiver or alteration of the requirements of informed consent, an IRB must find which of the following:
The research could not practicably be carried out without the waiver of consent.
According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action?
Treat the patient with the drug based on physician's best medical judgment
A HIPAA authorization has which of the following characteristics:
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because:
Both subparts apply, as these individuals are under the legal age of consent and are incarcerated
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
The federal regulation, 45 CFR 46, Subpart A (the Common Rule) also includes a number of subparts (Subpart B, C, D, and E), which IRBs are required to follow. Which one of the following is not included in these subparts?
Elderly
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually.
An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. Which of the following is the investigator's most appropriate course of action?
Submit the research protocol to the IRB for review and submit an IND application to the FDA before conducting the research
During the course of a study, the researcher reports to the IRB that the consent form needs to be changed to reflect her new contact information. Who can approve this change?
The chair of the IRB
A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
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.
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.
A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
Not approve this project because the prisoners are merely a population of convenience for the student.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
The changes must be immediately implemented for the health and well-being of the subject.
Which of the following IRB members must be present during the IRB's discussion and vote on a proposal?
The non-scientist member.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
must be more detailed for disclosures that involve fewer than 50 subject records.
