CITI Modules 9-17

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 officer ("Privacy Officer"), or privacy official ("Privacy Official"), depending on the issue.

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:

Any equity interest in a publicly held company that exceeds $50,000

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:

Designated institutional officials

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for:

- Activities preparatory to research, with certain representations by the researcher. - Limited data set with an approved data use agreement. - Use of decedents' information, with certain representations by the researcher.

Which of the following practices can be effective in minimizing group harms?

- Collaborative IRB review - Ongoing consultation - Planning disclosure of research results - Community consultation

What are the vulnerable populations?

- Pregnant Women - Human Fetuses and Neonates - Prisoners - Children

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

- The employer may encourage or deny participation of workers - Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. - Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results - The research study's finding could affect an employee's pay, benefits or promotion potential.

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:

- Who will have access to the data. - If the study results, if any, will be included in the employee's personnel records - How the data will be collected and secured - If personal identifiers will be retained and used in the data analysis.

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:

A study of the genetic links between DNA samples found at a prehistoric central Asian archeological site and west coast Native American tribes.

The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) is intended to:

Allow the use of electronic documents and signatures in the regulatory process for drugs and devices.

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.

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.

The most important ethical concerns related to conflicts of interest in research are:

Ensuring the objectivity of research and the protection of human subjects

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:

Greater than $5,000 of ownership in any single public entity/public company.

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 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 studies has the LEAST potential to create group harm?

Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer

A financial conflict of interest could involve:

Receiving stock in a company funding your research

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

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?

Since 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

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

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 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?

The pregnant woman and the father of the fetus.

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 pregnant woman only.

According to current 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

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

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

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.

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:

Workers

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.

A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:

conflict of interest

HIPAA includes in its definition of "research," activities related to ...

development of generalizable knowledge.

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.

HIPAA protects a category of information known as protected health information (PHI). PHI includes:

identifiable health information that is created or held by covered entities and their business associates

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...

is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization

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:

one member who is a prisoner or prisoner representative

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.

prisoners

When researchers plan to involve a prisoner population, which best describes the type of federally supported research that may be conducted?

research that is relevant to prisoners and their conditions or situations

HIPAA's protections for health information used for research purposes...

supplement those of the Common Rule and FDA.

A conflict of interest implies:

the potential for bias

The HIPAA "minimum necessary" standard applies...

to all human subjects research that uses PHI without an authorization from the data subject.

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.

true