CITI Modules 9-17 Review Guide Q&A
- Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (DHHS) regulations to ensure additional protec
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CITI Modules 9-17 Review Guide Q&A
- Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (DHHS) regulations to ensure additional protections when this population is being considered for research.
- The purpose of a federally supported research study is to examine the effect of scheduled cell searches on gang violence among men confined to drug treatment facilities under court order. Which of the following best describes the IRB's duties when reviewing this research?
- When reviewing federally supported research involving prisoners, an IRB must have at least the following member, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented:
- When researchers plan to involve a prisoner population, which best describes the type of federally supported research that may be conducted?
- A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). Your IRB has determined that assent of children age 8 and older is required for the study. A 10 year old firmly declined to participate in the study described above. Which of the following procedures best describes the action to be taken by the investigator?
- A federally funded research study involving children 8 to 12 years old involves collecting a single voided urine sample to assess the frequency of asymptomatic proteinuria (higher amounts of protein in the urine without any signs or symptoms of illness or infection). According to 45 CFR 46, an IRB's risk assessment would likely conclude that this study involves:
. - An investigator proposes a study to determine the clinical relevance of a new assay technique to measure minimal residual disease (MRD) in adolescent (age 14-16) cancer patients undergoing chemotherapy. The study requires that two additional bone marrow aspirates be performed during the course of chemotherapy. The subject's chemotherapy will not be altered based on the results of the assay technique measures. However, future patients with cancer would benefit from improved interventions based on study findings. The IRB determined that the activity was a minor increase over minimal risk. Which of the following statements best describes the IRB approval requirements for involving adolescent cancer patients in the research study?
- A research project is designed to evaluate a new experimental type of fetal surgery to correct diaphragmatic hernia in the fetus (a potentially life-threatening condition for the baby) prior to delivery. This research is directed toward the fetus as subject to meet the health needs of the fetus. The pregnant woman is otherwise healthy. The investigator must obtain consent from whom?
- According to current NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH funded research?
- Investigators wish to evaluate a new treatment for eclampsia (a life threatening condition in pregnant women) in women 30 - 50 years of age. The research is intended to directly benefit the pregnant woman who is otherwise healthy and competent. The investigator must obtain consent from whom?
- The results from research have been known to produce harms to members of the sampled population who do not actually participate in the research study. An example of the type of research that could result in group harms is:
Which of the following practices can be effective in minimizing group harms?
- Which of the following studies has the LEAST potential to create group harm?
- 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?
- 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?
- 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?
- The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) is intended to:
- 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:
- Under HIPAA, a "disclosure accounting" is required:
- 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 covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for:
- Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
- Recruiting into research ...
- HIPAA includes in its definition of "research," activities related to ...
- When required, the information provided to the data subject in a HIPAA disclosure accounting ...
- HIPAA's protections for health information used for research purposes...
- A HIPAA authorization has which of the following characteristics:
- HIPAA protects a category of information known as protected health information (PHI). PHI includes:
- The HIPAA "minimum necessary" standard applies...
- If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
- Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, EXCEPT:
- What are the vulnerable populations?
- When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
. - 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:
- True or False: 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.
- A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
- A conflict of interest implies:
- Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
- The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
- According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
- A financial conflict of interest could involve:
- The most important ethical concerns related to conflicts of interest in research are:
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