Citi Training Social, Behavioral & Educational Researchers:

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 about missing elements of consent:

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

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.

Data are made anonymous by

Destroying all identifiers connected to the data.

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.

A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?

No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.

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.

The HIPAA "minimum necessary" standard applies...

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

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

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

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 employer may encourage or deny participation of workers. The research study's finding could affect an employee's pay, benefits, or promotion potential. All of the above

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:

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

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

The age of majority in international research is determined by the

Laws, customs, and norms in the area in which the research will be conducted.

Which of the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

A general requirement for informed consent is that no informed consent may 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?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

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

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.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

The researcher cannot control what participants repeat about others outside the group.

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?

There was neither a violation of privacy nor a breach of confidentiality.

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.

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?

Securing a Certificate of Confidentiality

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