CITI Training
In the U.S., the first federal regulations for human subjects research began in 1981 with the codification of the ________.
Common Rule
Which of the following most accurately describes the risks associated with SBR?
Less predictable, more variable, and less treatable than physical harms
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:
No more than minimal risk to the child.
Which of the following practices can be effective in minimizing group harms?
- Collaborative IRB review - Ongoing consultation - Disclosure of the research - Community Consultation
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
Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply.
- Protecting the rights and welfare of human subjects.- Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.- Reviewing subject recruitment materials and strategies.
Which is an example of a situation where deferential vulnerability might be a factor?
A physician recruiting patients to be subjects
Which of the following studies has the LEAST potential to create group harm?
A Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.
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 by stigmatizing members of the group (even for individuals who do not participate in the research) is:
A study of the types and prevalence of sexually transmitted infections (STIs) in small rural towns in a midwestern state.
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.
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 fom both the researcher's US institution and an equivalent entity w/in the host country
An example of an institutional COI is
An industry sponsor pays fro the construction of a new research laboratory at the organization
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
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?
Assent of the child and permission of both parents are required.
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?
Because this research involves individual subjects who would be considered prisoners and examines the possible causes, effects, and processes of incarceration, the IRB should ensure that the additional requirements for prisoner research are met
researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research?
Breach of confidentiality from the focus group subjects (therapists)
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
Recruiting into research ...
Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.
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:
Cognitive or communicative vulnerability
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.
As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of research participants in NIH -funded genetic research for broad research use of data and data sharing, even if the cell lines or specimens are:
De-identified
A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review?
Determination for Exemption
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.
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:
Economic Vulnerability
The national research at of 1974
Established the national comission
Which is true of inducements in research?
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.
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.
A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from:
Health insurance and employment discrimination
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
Honor the child's decision
A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:
Identifiable health information that is created or held by covered entities and their business associates
What is the term for management controls that are built into a research study? (Ex. independent data analysis)
Inherent controls (also include randomization, blinding, etc.)
Which of the following is considered a SBR data collection method?
Interviews
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must
Occur at least annually
When reviewing federally supported research involving prisoners, an IRB must have which of the following, in addition to the standard requirements for IRBs to ensure that the prisoners' perspective is represented:
One member who is a prisoner or prisoner representative
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.
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Prisoners may not be used to conduct research that only benefits the larger society
Significant Risk Device
Presents a potential for serious risk to the health, safety, or welfare of the subject and it: (1) Is intended to be implanted into a human; (2) Is used in supporting or sustaining human life; (3) Is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise prevents impairment of human health; or (4) Otherwise presents serious risk to health, safety, and welfare of a subject.
Due to past abuses, which of the following groups of potential research subjects has specific Department of Health and Human Services (HHS) regulations to ensure additional protections when this population is being considered for research.
Prisoners
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
A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research?
Recruitment of subjects to ensure varied characteristics of the sample size
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
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.
When researchers plan to involve a prisoner population, which answer best describes the type of federally supported research that may be conducted?
Research that is relevant to prisoners and their conditions or situations
Informed consent is considered an application of which Belmont principle?
Respect for Persons
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip. Which of the following is the most appropriate action to take for the investigator?
Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
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
Which of the following studies would need IRB approval?
Studies collecting identifiable information about living individuals.
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
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.
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
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.
A research study aims to evaluate a new experimental type of fetoscopic laser surgery to correct a potentially life-threatening condition for the fetus prior to delivery. This research is to meet the health needs and directly benefit the fetus only. The pregnant woman is otherwise healthy. Per Subpart B, the investigator must obtain consent from whom?
The pregnant woman and the father of the fetus (except if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest).
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 per Subpart B?
The pregnant woman only
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
According to 1994 NIH Guidelines, which of the following is adequate justification for exclusion of women from NIH-funded research?
There is compelling evidence that inclusion would be inappropriate with respect to the health of the subjects.
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
Which choice best describes the purpose of most pharmacogenomic research?
To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs
The purpose of informed consent is
To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.
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
Pregnant women, fetuses, and neonates are often considered vulnerable categories of subjects. Additional protections are provided through regulation, however, the protections are meant to be inclusive and not exclusive of pregnant women 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
Issued in 1974, 45 CFR 46 raised to regulatory status:
US Public Health Service Policy
Which of the following is included in the Nuremberg Code:
Voluntary Consent
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
A researcher wants to examine the efficacy of mushroom extract supplementation on fetal loss, low birth weight, and severe preterm birth in healthy pregnant women. She plans to enroll women who are 12-26 weeks pregnant and randomize them to either receive the intervention or placebo until delivery. The IRB determines this intervention presents greater than minimal risk to the pregnant women subjects, and potential direct benefit to both mother and fetus. Is this research permitted under Subpart B?
Yes - this research is permitted.
Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified?
Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.
An example of an individual financial OCI is
a researcher's spouse holds equity in a publicly traded pharma company that is also the sponsor of the researcher's study
Genetic Determinism
genes have a controlling influence on human health, behavior and disease. However, current thinking is that genes function in a complex relationship with environmental influences, meaning that genes alone are not determinative.
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
minimum 3 years after the study
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.
When does an institutional COI 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.