CITI Training University of Utah: Biomedical Research Investigators and Key Personnel

A group of elderly men, whose government disability benefits are the sole source of income, is approached to consider an experimental research study for their current colon cancer. The study involves more than minimal risk, but offers substantial financial incentives that are equal to two months of disability benefits. The IRB will be most concerned about the possibility of:

Undue influence on the subjects

HIPAA requires that all covered entities designate:

A privacy official

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it not be appropriate to provide subjects with information:

A study in which subjects were assigned to study conditions based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

Which of the following activities would not constitute human subjects research under the Common Rule?

A study of cancer rates across various states using only public health records.

A data use agreement is required when a researcher uses a Limited Data Set (LDS). An LDS must have:

All direct identifiers removed

A research study involving 13 to 16-year-old girls who have given birth to a first child is designed to assess the effects of a behavioral intervention intended to reduce unprotected sex. The study includes twelve weeks of participation, either in the intervention or in standard individual counseling. The intervention focuses on positive imaging, education and career planning, and increasing familial and community connections. The research will occur in an area where the fact that the girls are parents does not affect their rights with respect to their own treatment or participation in research and they are not emancipated minors; therefore, they may only assent for research in which they will be subjects. The IRB has determined that the study presents no greater than minimal risk. Which of the following is true?

Because the study presents no greater than minimal risk, the IRB may find that the permission of only one of the parents is sufficient.

A researcher is investigating the genetic biomarkers of adult subjects with autism. The research study involves a single blood draw (about one teaspoon of blood) and then genetic analysis of the specimen. How should the researcher inform prospective subjects about the potential risks of harm of this genetic research study?

By carefully disclosing (without overstating) the possibilities of economic or insurance bias and of social stigma to the subject and potentially to others in the subject's family.

A nonviable neonate may be involved in research as long as the neonate is maintained on life support for no more than 72 hours after delivery.

False

As per Subpart B, a physician who is a member of the research team on a study involving nonviable neonates may assist the treating physicians in determining whether neonates are nonviable.

False

The Public Health Service (PHS), U.S. Food and Drug Administration (FDA), and National Science Foundation (NSF) regulations address:

Individual financial COIs

Which of the following meets the regulatory definition of prisoner?

Individuals detained in treatment centers as a condition of parole.

If fully deidentified data are used for research, then:

No authorization is required, because fully deidentified data are no longer considered PHI

Which of the following research scenarios would present no likelihood of harm to the participants?

None of the above

Which of the following is a reason that prisoners need special protection?

Prisoners have limited free choice because their autonomy is restricted.

A waiver of the requirement for documentation of informed consent may be granted when:

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

For research that does not entail a demonstration project conducted by or subject to the approval of state or local government officials, an IRB may waive or alter the regulatory elements of informed consent if it finds and documents a number of items, including:

The waiver or alteration will not adversely affect the rights and welfare of the subjects

Why did I make this Quizlet set?

To pay tribute to the hundreds of Quizlet college students that I have stood on the backs of in years past, and for the hundreds of future students who will stand on my back. God speed, all.

Under what circumstances is a HIPAA authorization (consent) for research use of PHI generally always required?

When the research involves more than minimal risk

A medical researcher is comparing the results of two surgical techniques to correct a skeletal deformity. There are many obvious risks of participating in this treatment trial, and participants are carefully informed about the likelihood of infection, poor treatment outcome, further damage, etc. The research design includes a questionnaire given to patients about their quality of life before and after the surgery. Because this is just a simple paper and pencil questionnaire, it does not add any risks to the overall study design. Is this true or false?

false

Dr. Young, who previously decided to give a single patient with both depression and ADHD a medication (drug X) that was indicated for depression but appeared to also be beneficial for ADHD, has now treated several patients with drug X and they have all reported improvement in their ADHD symptoms. He now proposes to investigate in a larger group of patients to determine whether the drug X is effective for ADHD. He contacts the pharmaceutical company who produces the drug X, and they have expressed interest in funding a trial in order to apply to the FDA for approval to extend the labeling of drug X for ADHD treatment. Which of the following is required?

An IND and IRB approval

Which of the following research scenarios would present no likelihood of harm to the participants?

An interview of elementary school children about their preferred literary genres.

Consider the following situation. Patients with Smith-Lemli-Opitz have an inborn error of cholesterol biosynthesis, which results in severe to mild cholesterol deficiency, and accumulation of cholesterol precursors. An investigator proposes to determine if pure crystalline cholesterol in an oil suspension will increase cholesterol levels and decrease cholesterol precursors. The investigator proposes to obtain cholesterol, mix it with soy oil, and administer it to subjects. The study then involves follow-up evaluations and assessments. Which option would be the best choice regarding an IND?

Contact the FDA directly to discuss whether an IND is necessary.

Dr. Jones works as a cardiologist at a Midwest University Medical Center and earns approximately $15,000 per year from Big Medicines Pharmaceuticals giving talks to other doctors about one of the company's marketed drugs that is used to treat heart infections. Dr. Jones has a SFI with Big Medicines Pharmaceuticals because he receives non-salary compensation of over $5,000 from the company. Big Medicines has approached Dr. Jones about his organization participating as a site in a clinical trial. Dr. Jones would be the local principal investigator. The research is a large multi-site, randomized, double-blind, placebo-controlled trial to examine the efficacy of an investigational drug to prevent heart attacks with 3,000 subjects total. It is expected that three to four subjects would be enrolled at Dr. Jones's site. In the following scenario, some existing safeguards against bias are described. By the time Dr. Jones is approached by Big Medicine, the drug company has already designed the research plan and the study is ongoing. The research design itself is randomized and double-blinded. This is one way to guard against manipulation of the study results. Restricting recruitment and thus the contribution of three or four sets of subject data to the study, out of the 3,000 needed to meet research aims, would also guard against significant impact solely by Dr. Jones. Finally, assuming there are no "subjective measurements" that Dr. Jones would be expected to obtain that would introduce bias ("How does the subject seem to be feeling at this visit?"); his role would be to collect the data and send it to the company for analysis. It is unlikely that the reporting of the results would be impacted by his FCOI. How could the organization further add protection against bias in this scenario?

Disclose Dr. Jones' remuneration from the sponsor in the consent document and the consent process

Dr. Jones works as a cardiologist at a Midwest University Medical Center and earns approximately $15,000 per year from Big Medicines Pharmaceuticals giving talks to other doctors about one of the company's marketed drugs that is used to treat heart infections. Dr. Jones has a SFI with Big Medicines Pharmaceuticals because he receives non-salary compensation of over $5,000 from the company. Big Medicines has approached Dr. Jones about his organization participating as a site in a clinical trial. Dr. Jones would be the local principal investigator. The research is a large multi-site, randomized, double-blind, placebo-controlled trial to examine the efficacy of an investigational drug to prevent heart attacks with 3,000 subjects total. It is expected that three to four subjects would be enrolled at Dr. Jones's site. Who determines if Dr. Jones has a FCOI with this proposed research?

Dr. Jones' organization

Consider the following scenario: Drug X is an approved drug that is labeled to treat depression. Several reports in the literature suggest that patients with a diagnosis of depression and ADHD who were treated with drug x for their depression also reported a decrease in their ADHD symptoms. Dr. Young has an ADHD patient that he has followed for several years. Despite attempts with other drugs and behavioral therapy, her ADHD symptoms continue to persist. During one visit, the patient advises Dr. Young that during an ADHD support group, several other attendees mentioned the possibility of drug X as a treatment. She asks whether Dr. Young would prescribe Drug X. Dr. Young does a literature search and notes the multiple reports in the literature and agrees that based on the scientific literature it may be desirable to try drug X for this individual patient. Which of the following would apply?

Dr. Young may write a prescription for the patient and follow the patient in accordance with standard clinical care.

The PHS regulations require:

Each "investigator" named on a proposal to disclose "significant financial interests" to a designated official at the applicant organization.

A large HMO has teamed up with several other large HMOs to study falls and footwear. The investigator proposes to review 5,000 medical records across 10 institutions of individuals injured during the last three years from a fall, so she has enough power to detect whether there is a greater number of falls among people who wear clogs. Because individuals wear so many different types of shoes, she will need to review a large number of records to find those few individuals who fit this category. From the medical records, she plans to extract the type of shoe the individuals wear. She will not re-identify the individuals and will not contact the individuals. Which of the following is likely to be the level of review determined as appropriate by the IRB?

Exempt from the regulation, as the study presents no greater than minimal risk and does not collect identifying information.

An investigator has proposed a multi-site study of PSA (Prostate Specific Antigen) test results among patients with prostate cancer. The research involves only review of medical records at institutions in several states. The investigator will not collect any identifying information on the subjects, only their PSA scores and ages (which will be collected in a range format so as to not have the person's specific age). The investigator may correctly conclude that:

IRB review, or similar process, may be required because generally investigators are not able to determine for themselves if their own research is exempt.

A director of a smoking cessation service at a university decided to publish a paper on whether quit rates were higher among clients who were offered as an incentive either a Moonbeams Coffee Shop's latte coupon or a pre-paid telephone card. The director was testing a hypothesis that coffee drinkers were less likely to quit smoking than telephone users. To do this, he proposed using outcome data on smoking cessation collected by the service, which would be extracted from the university's files and placed in a separate database with no identifying information other than sex, date of birth, zip code of Moonbeams where the coupons were used, and the telephone number of the research subject. Would this research be eligible for exemption?

No. The investigator may be able to identify subjects based on telephone numbers and birth dates, so this should not be considered exempt.

Where research is approved under 45 CFR 46.406 (more than minimal risk and no direct benefit to subjects) and permission is to be obtained from parents, both parents must give their permission unless one parent is dead, not known, judged to be incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Which of the following is an example of a justified reason for obtaining consent from only one parent?

One of the child's parents suffers from early onset of dementia and has been determined by the courts to be incompetent.

A researcher proposes to conduct a survey about sexual attitudes, beliefs, and practices. The survey will be mailed out by an HIV/AIDS prevention group to people randomly selected from a commercial mailing list. All of the following are potential harms to participants except:

That researcher might receive incomplete data from participants who do not complete the survey.

An investigator proposes to conduct a study of severe eczema in children to further understand the disease's interaction with normal skin cells. As a part of the study, an operation will remove a 5mm punch biopsy of skin from children in the study. The children will receive no treatment or benefit from participating in the study. The IRB has determined that the study presents greater than minimal risk with no direct benefit to the subjects, but may lead to generalizable knowledge about severe eczema in children. Only children who are capable of assenting will be recruited for the study. Which of the following is true regarding assent and the IRB's determination?

The assent of the child is required.

Hospitals routinely and systematically collect information on various services they provide. For example, they may collect data from the pharmacy to see if drugs are being dispensed accurately, or they may hand out satisfaction questionnaires to assess if patients are happy with the service being provided to them. Which of the following is the best reason to explain why these data collections may not require prior IRB approval?

The hospitals are collecting these data with the intent to maintain or better their individual services and facilities programs, with no intent to share or report the results with any other entity.

A researcher conducting a study on the incidence of mutations to the MDR-1 gene in breast cancer has preliminary evidence of a link between mutated MDR-1 and early recurrence. The researcher begins a new trial using prospectively collected tissue samples to further examine the link between the genetic abnormality and disease progression. He believes that he may want to re-contact some or all of the tissue donors (subjects) if the research indicates a positive link between MDR-1 mutation and early disease recurrence. What is the best procedure for an investigator planning to re-contact study subjects who provided tumor tissue for the study?

The investigator should disclose the intention to re-contact during the consent process. That is, before acquiring and analyzing the sample for research.

Who determines whether an authorization is required or whether the requirement for an authorization may be waived?

The organization's IRB, privacy board, or a designated privacy official, depending on the circumstances

Dr. Jones works as a cardiologist at a Midwest University Medical Center and earns approximately $15,000 per year from Big Medicines Pharmaceuticals giving talks to other doctors about one of the company's marketed drugs that is used to treat heart infections. Dr. Jones has a SFI with Big Medicines Pharmaceuticals because he receives non-salary compensation of over $5,000 from the company. Big Medicines has approached Dr. Jones about his organization participating as a site in a clinical trial. Dr. Jones would be the local principal investigator. The research is a large multi-site, randomized, double-blind, placebo-controlled trial to examine the efficacy of an investigational drug to prevent heart attacks with 3,000 subjects total. It is expected that three to four subjects would be enrolled at Dr. Jones's site. When does Dr. Jones' significant financial interest (SFI) become a possible financial conflict of interest (FCOI)?

When the SFI could directly and significantly affect the design, conduct or reporting of the funded research