Quiz-SBE Refresher-Human Research - Data or Specimens Only Research

Which of the following proposed studies would constitute human subjects research as defined under the federal regulations?

A researcher from a school of social work obtains access to students’ academic records (including identifiable information) to assess the effect of drug awareness programs on student academic achievement.

Which of the following activities meets the federal definitions of research?

Collection of elementary school test scores to evaluate the effectiveness of an experimental program to teach reading

Which of the following is a measure researchers can use to protect the confidentiality of subject data?

Keep sensitive and identifiable data in encrypted files on a password protected hard drive.

Identify the term that refers to the right to control access to ourselves and to our personal information.

Privacy

A method to protect subject’s privacy in research would be:

Conducting research activities in a private setting

Identify the term that refers to agreements made between researchers and subjects, through the consent process, about if and how researchers will protect information provided by the subjects.

Confidentiality

When the primary potential harm is the breach of individually identifiable data, to protect against such disclosures researchers should:

Encrypt the data and store it in password protected files on institutionally maintained servers with limited access.

Which of the following statements about individually identifiable research data is correct?

Researchers may be required to release individually identifiable information outside the research setting.

Which of the following research activities with children qualifies for exemption?

A researcher observing children on a playground to identify bullying behaviors.

In accordance with federal regulations, which of the following statements best describes when research with children may be exempt?

Only certain exemption categories can be used with research involving children.

Which of the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

If federally funded research involves collaboration with an organization that is “engaged” in research in a foreign country, the foreign organization can rely on the U.S. institution’s IRB for its review.

true

According to the Belmont Report, implementing the principle of respect for persons involves:

Making it clear to subjects that they may withdraw from a study.

The Belmont principle of beneficence requires that:

The use of procedures that increase benefits and decrease harms whenever consistent with sound research design.

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

  Justice

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.

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 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

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

None of the above

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.

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.

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.

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.

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.

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?

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

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

Undue influence on the subjects

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

If fully deidentified data are used for research, then:

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

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

All direct identifiers removed

HIPAA requires that all covered entities designate:

A privacy official

A researcher may use fully de-identified health information without any authorization from individual subjects.

true

When does an investigator’s 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

The PHS regulations require:

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

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

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.

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

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

Individual financial COIs