ENG367 - CITI Program Module 1

A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. The student will not collect identifiable information. This study would be subject to which type of review?

Determination for Exemption.

The Belmont Report

1. Respect for persons 2. Beneficence 3. Justice

The Common Rule Subpart D

Children.

Interaction

Communication occurs directly with the participant (for example, in person or by phone, email, videoconference, or online survey).

About Whom

Data are about living individuals (for example, their beliefs, habits, practices, or blood or saliva specimens). You are gathering information about someone not something.

Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)?

Exempt.

Facebook Emotional Contagion Study (2014)

For approximately a week, some individuals' Facebook news feeds were altered to show mostly positive content, whereas others saw primarily negative content. Researchers then studied the "emotional contagion" effect of whether individuals subsequently posted positive or negative items themselves (Kramer et al. 2014).

Beneficence

Doing good or causing good to be done; kindly action.

Snowball Sampling

Recruitment of participants based on word of mouth or referrals from other participants.

Convened Review

Research activities pose significantly higher risks to subjects than those that might occur in daily life, the project will need convened review.

Tuskegee Syphilis Study

Research study conducted by a branch of the U.S. government, lasting for roughly 50 years (ending in the 1970s), in which a sample of African American men diagnosed with syphilis were deliberately left untreated, without their knowledge, to learn about the lifetime course of the disease.

Institutional Review Board (IRB)

A committee at each institution where research is conducted to review every experiment for ethics and methodology.

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Expedited Review

A review of study proposals that pose minimal risk to subjects; one or two IRB members participate.

Exempt Review

A review of study proposals that pose no risk to subjects; the full IRB is not required to participate.

The Nuremburg Code

A set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War.

Identify one way faculty researchers can possibly avoid undue influence of student subjects? A) Avoid recruiting their own students in the research. B) Provide extra credit to those who participate. C) Conduct research for less than ten minutes during class. D) Offer more monetary compensation to those who participate.

A) Avoid recruiting their own students in the research.

Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. A) Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects. B) Reviewing subject recruitment materials and strategies. C) Conducting inquiries into scientific misconduct. D) Protecting the rights and welfare of human subjects. E) Reviewing manuscripts prior to submission for publication.

A, B, D.

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. A) Faculty Advisor/Research Mentor. B) Export Control Office. C) The Student Union. D) IRB Office

A, D.

Subject Pools

An established group of people who have agreed to be contacted about participating in research studies.

The Declaration of Helsinki

An international standard providing physician guidelines for conducting biomedical research.

Human Subjects Research

Any study of persons that is a systematic investigation designed to develop or contribute to generalizable knowledge.

Justice

That equals should be treated equally. In research studies, it means no one should unfairly receive benefits or experience burdens.

Jesse Gelsinger

The first person publicly identified as having died in a clinical trial for gene therapy.

Intervention

The study involves some procedure or action that affects the individuals or their environment to measure "before and after" results.

Respect for Persons

Treating persons as autonomous agents and protecting those with diminished autonomy.

Identifiable Private Information

You or another member of the research team can easily determine the participant's identity. Private means that the individual does not reasonably expect observation (in contrast to a public space such as a restaurant or bus), has shared the information for study purposes, and can assume identifiers will not be published without explicit permission.

The Common Rule Subpart B

Pregnant women, fetuses and neonates/newborns.

A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review?

Convened Review

Which of the following studies would need IRB approval? A) Studies that involve cadavers. B) Studies that use data collected for internal department use only and the aim of the study is quality improvement for the department only. C) Studies that use publicly available census data from the years 1890-1910. D) Studies collecting identifiable information about living individuals.

D) Studies collecting identifiable information about living individuals.

Living Individual

Data must originate from live people; specimens or information from dead people or cadavers do not count.

Biospecimens

Data taken from a living body such as saliva, urine, blood, tissues, or cells.

The Common Rule

In the United States, researchers often cite the Common Rule, which is the informal name of the U.S. Department of Health and Human Services (HHS) Policy for the Protection of Human Subjects (45 CFR 46, Subpart A) codified in 1981 and revised in 2018.

A graduate student 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 to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review?

Not Human Subjects

The Common Rule Subpart C

Prisoners.