Combo with "CITI" and 1 other

Name the 3 responsibilities the IRB is charged with

1. Protecting the rights and welfare of human subjects 2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed 3. Reviewing subject recruitment materials and strategies

Year of the Nuremberg Code

1949

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

What element must be included in an informed consent?

All foreseeable risks and discomforts

Which of the following elements must be included in an informed consent?

All foreseeable risks and discomforts.

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

Ensuring that risks are reasonable in relationship to anticipated benefits.

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

Exempt

A student is conducting a research project that involves using a survey. The survey asks participants 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

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

Exempt Review category 2

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

Expedited review

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

Experience emotional or psychological distress.

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

FALSE

Additional resources regarding IRB approval process

Faculty advisor/Research Mentor IRB office Human subjects research websites

All research is expected to include both sexes and members of every racial/ethnic group and subpopulations as participants.

False

An increase in cost is an acceptable reason for excluding women, minorities, and their subpopulations in clinical research

False

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

Nuremberg Code

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

Nuremberg Code

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 of the following would be most helpful:

Obtain a waiver of documentation of informed consent.

T/F IRB's investigate scientific misconduct

False

A student working on his dissertation 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, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?

Full Board Review

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.

Full Board Review

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval.

In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?

Prisoners

A medical record is an example of:

Private information.

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

The Belmont Report Respect for Person

Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent)

The Belmont Report The Principle of Justice

Research benefit and burden distribution and that selection of subjects is fair.

Three principles of Belmont Report

Respect for Persons Beneficence Justice

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice.

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:

Respect for persons Belmont Report

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

Which of the following studies need IRB approval?

Studies collecting data about living individuals.

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

TRUE

Another name for the "Exempt" status

the Common Rule stated in Title 45 Part 46 Subpart A

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

"1.data through intervention or interaction with the individual 2. identifiable private information"

The Belmont Report defines and delineates...

"Practice" and "Research"

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? (There may be more than one correct answer. Please be sure to select all correct answers.)

- Faculty Advisor/Research Mentor - IRB Office

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, which of the following studies meets the definition of research with human subjects?

An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. A study of twenty 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 a three-month period. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

Identify the example of when situation and time is key to assessing risk of harm in a research study:

Asking women if they have had an abortion

How can faculty researchers avoid coercion of student subjects?

Avoid using their own students in their research

DHHS FDA

Depts. IRB's review for current policies -Department of Health and Human Services -Food and Drug Administration

Nuremberg Code

Human subjects research guidelines and regulations

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

Identifiable private information.

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

If the study qualifies for EXEMPTION

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Invasion of privacy, breach of confidentiality, and study procedures

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

Justice

The Belmont Report Principle of Beneficence

MAXIMIZATION of benefits and MINIMIZATION of risks

Continuing review of an approved and ongoing protocol

Must occur within 12 months of the approval date.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

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 stock and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?

Not Human Subjects

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

Not Human Subjects

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.

All of the following are true regarding the Belmont Report, EXCEPT:

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

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?

The IRB will not review this study because it is not research as defined by the federal regulations.

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 Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male

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.

The Tuskegee Study relates to which Belmont principle?

The principle of beneficence: Potential benefits justify the risks of harm

According to the federal regulations, research is eligible for exemption, if

The research falls into one of six categories of research activity described in the regulations.

A minority group is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.

True

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

True

The Code of Federal Regulations (45 CFR 46.111), the U.S. Food and Drug Administration (FDA) and the National Institutes for Health (NIH) address the inclusion of women and minorities in research.

True

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

Yes

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

at the study has a maximization of benefits and a minimization of risks.