Research Ethics & IRB Part 1

Three principles of Belmont Report

The Belmont Report
Principle of Beneficence

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Belmont Report indicates it is necessary to rigorously avoid conflicts of interest

The Belmont Report
Respect for Person

The Belmont Report defines and delineates...

The Belmont Report
The Principle of Justice

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The Belmont report describes the necessity to effectively manage conflicts of interest

Students in Research
The history of ethical regulations in human subjects research began with the

Nuremberg Code

Year of the Nuremberg Code

Additional resources regarding IRB approval process

What element must be included in an informed consent?

Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB?

Another name for the "Exempt" status

How can faculty researchers avoid coercion of student subjects?

Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information.

Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects.

Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal

Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a business

Federal regulations define human subjects as "living individual about whom an investigator conducting research obtains"...? (2 components)

Name the 3 responsibilities the IRB is charged with

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IRB's investigate scientific misconduct

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IRB's do not review manuscripts prior to submission for publication

DHHS
FDA

Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately the Belmont Report and Federal regulations for human subject protection

The Tuskegee Study relates to which Belmont principle?

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

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

How is the principle of beneficence applied to a study involving human subjects?

Human subject study or not?
Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression

Human subject study or not?
The study of a list with deceased passengers

Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases?

Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog

Human subject study or not?
A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledge

Human subject study?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors

Human subject study or not?
Questioning a superintendent of schools to acquire data about the ethnic composition of a school

Human subject study or not?
Study of 20 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over 3-month period

Human subject study or not?
Info collected by play ground designer

Human subject study or not?
An analysis of aggregate data

Human subject study or not?
An economic feasibility study

According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or:

Subpart of DHHS regulations provides additional protections for which vulnerable populations?

Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations?

The expedited review process may be used when the study procedures pose:

The expedited review process may NOT be used when the study procedures pose:

Continuing review of an approved and ongoing protocol...?

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Officials of the institution may overrule an IRB approval

An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate meausre will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful?

The primary purpose of a Certificate of Confidentiality is to:

Certificates of Confidentiality protect sensitive info provided by research subjects from:

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Risk should be evaluated solely by the magnitude or severity of expected harm, not probability

Risks are specific to:

A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will:

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The fact that a therapist has access to her clients' records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assent

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School authority's permission to conduct research replaces the need for permission and assent

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Children's right to choose cannot be overridden in the pursuit of an indeterminate community interest

Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the study

A waiver of the requirement for documentation of informed consent may be granted when:

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