CITI IRB Training

According to federal regulations, an IRB must have at least two community members to fulfill membership requirements; one member whose expertise is not in a scientific area and one member who is not affiliated with the institution.

False

The IRB Administrator would be responsible for which of the following tasks:

Professional development for IRB members and supporting staff

Which of the following IRB submissions require review and approval by the convened IRB ?

Continuing review of activities that involve more than minimal risk

What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.)

- Protecting the rights and welfare of human subjects. - Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. - Reviewing subject recruitment materials and strategies.

According to the federal regulations (45 CFR 46 Subpart A, also known as the "Common Rule") which of the following IRB review criteria must be met in order for an IRB to approve a study?

All of the above; The federal regulation sets forth certain criteria that must be met in order for the IRB to approve a study.

A staff member approaches the IRB administrator about a researcher submitting a new HIV prevention study that involves multiple performance sites in different countries. The researcher also proposes to be the coordinating center for this multisite trial. The staff member asks for help with preparing the IRB for review of this more than minimal risk, intervention study. Which of the following best describes the IRB administrator's action to prepare the study for IRB review?

Determine if an IRB consulting reviewer is required

A master's degree candidate needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stocks and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?

Not Human Subjects

Which of the following activities constitutes engagement in research

Obtaining informed consent and conducting research interviews.

What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?

Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

Provide parents certain rights over their children's educational records.

A television news reporter contacts the IRB Administrator after reading a press release describing a federally funded breast cancer prevention study coordinated by an institutional researcher. Study findings might lead to the identification of new genes that might predispose an individual or their family members to breast cancer. The reporter would like to interview the study subjects and their family members who are enrolled in this new study.

Refer the inquiry to the media spokesperson

If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?

Research about aptitude testing

Which of the following studies need IRB approval?

Studies collecting data about living individuals.

Indicate which of the following statements is correct:

The IRB administrator ensures that the interpretation of policies or SOPs is made available to researchers and research staff.

Which one of the following statements is true?

The IRB administrator is responsible for ensuring the development and maintenance of policies or standard operating procedures that provide consistency and structure to the human research protection program.

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

The HIPAA "minimum necessary" standard applies...

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

Dr. Jones has submitted a study for review by the IRB. He is an active member of the organization's IRB and is listed as a Co-Investigator in the section detailing study personnel. As a member of the IRB, he must leave the room before the final discussion and voting at the IRB meeting when this study is reviewed.

True

One of the community members on the IRB is assigned as the secondary reviewer for a new study sponsored by a company that produces standardized educational tests for school systems. During her review, she is surprised to note that the company is one in which her husband owns $20,000 worth of stock and she must tell the IRB that she has a conflict. As a member of the IRB she may answer questions from the committee, but must leave the room prior to the final deliberation and vote on the project.

True

A student is conducting a research project that involves using a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?

Exempt Review

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research funded by HHS

How can faculty researchers avoid undue influence of student subjects?

Avoid using their own students in their research