Human Research Protection Training Quiz

How might society benefit from health and medical research?

a) Gain new ways to improve health

b) Achieve financial gain

c) Find better treatments/social programs

d) Take a break from work

e) Gain a better understanding of human biology and behavior

a) Gain new ways to improve health

c) Find better treatments/social programs

e) Gain a better understanding of human biology and behavior

Which of the following statements best represents the ethical goal of research?

a) Research is done to achieve global recognition

b) Research is done to achieve multiple grants

c) Research should uphold and maintain the public's trust

d) Researchers should only strive for HHS funding

c) Research should uphold and maintain the public's trust

Which set of ethical principles provides the foundation for human research protections in the U.S.?

a) The Vermont Principles of Ethics

b) The Good Clinical Practice (GCP) Guidelines

c) The World Medical Association's Declaration of Helsinki

d) The Belmont Report

e) The International Ethical Guidelines for Biomedical Research

d) The Belmont Report

Who wrote the Belmont Report?

a) University of Belmont Professors

b) National Commission for Protection of Human Subjects of Biomedical and Behavioral Research

c) National Institutes of Health Researchers

d) Office for Human Research Protections Staff

b) National Commission for Protection of Human Subjects of Biomedical and Behavioral Research

What are the main ethical principles from the Belmont Report that are integrated into the Common Rule?

a) Justice

b) Maleficence

c) Respect for persons

d) Right to privacy

e) Compassion

f) Beneficence

g) None of the above

a c f

Which of the following statements is true about the Code of Federal Regulation at 45 C.F.R. part 46?

a) It is referred to as the Common Rule

b) It has 5 subparts including the Common Rule

c) It is the principal set of regulations regulating research misconduct

d) It applies to all research conducted in the United States

b) It has 5 subparts including the Common Rule

What does Subpart A of the HHS regulations for the protection of human subjects in research entail?

a) Additional protections for children, pregnant women and prisoners in research

b) Basic general protections for research subjects

c) Requirements for registration of IRB's

d) Details about responsible conduct of researchers

b) Basic general protections for research subjects

What do Subpart B, C and D of the HHS regulations for the protection of human subjects in research entail?

a) Additional protections for children, pregnant women and prisoners in research

b) Basic protections for research subjects generally

c) Establishment of requirements for registration of IRBs

d) Requirements for managing financial conflict of interests

a) Additional protections for children, pregnant women and prisoners in research

What does Subpart E of the HHS regulations for the protection of human subjects in research entail?

a) Additional protections for children, pregnant women and prisoners in research

b) Basic protections for research subjects generally

c) Establishment of requirements for registration of IRBs

d) Requirements for managing financial conflict of interests

c) Establishment of requirements for registration of IRBs

Why is the main set of federal regulations for the protection of human subjects in research referred to as the Common Rule?

a) Because it applies to all common people who participate in research

b) Because it applies to all research involving human participants

c) Because it provides commonly accepted standards for the protections of research participants

d) Because it is adopted by many U.S. federal departments and agencies

d) Because it is adopted by many U.S. federal departments and agencies

In general, research initiated on or after January 21, 2019 must comply with the revised Common Rule.

a) True

b) False

a) True

It is possible that an institution may need to review and approve different federally-funded research projects using different versions of the Common Rule.

a) True

b) False

a) True

An IRB has a question about how to apply the Common Rule for a research study funded by the U.S. Department of Energy, a Common Rule Department. Who should the IRB contact for more information?

a) The HHS Office for Human Research Protections (OHRP)

b) The U.S. Department of Energy (DOE)

c) The National Institutes of Health (NIH)

d) The U.S. Food and Drug Administration (FDA)

e) The Congressional Research Oversight Office

b) The U.S. Department of Energy (DOE)

Each Common Rule department or agency is responsible for oversight of the research that it supports or conducts.

a) True

b) False

a) True

Each Common Rule department or agency may have its own policies or a slightly nuanced interpretation of certain provisions of the Common Rule that differs from HHS interpretation.

a) True

b) False

a) True

Which of the following are agencies within HHS? (Select all that apply)

a) National Institutes of Health (NIH)

b) Social Security Administration (SSA)

c) Department of Defense (DOD)

d) Food and Drug Administration (FDA)

e) Centers for Disease Control and Prevention (CDC)

a) National Institutes of Health (NIH)

d) Food and Drug Administration (FDA)

e) Centers for Disease Control and Prevention (CDC)

The Office for Human Research Protections (OHRP) is part of the National Institutes of Health (NIH).

a) True

b) False

a) True

Investigators do not need to know which regulations are applicable for a research project. True or false?

a) True

b) False

a) True

Federal law requires that any research conducted in the U.S. must comply with the Common Rule.

a) True

b) False

b) False

Many research institutions choose to apply the Common Rule regardless of funding source.

a) True

b) False

a) True

What does FWA stand for?

a) Federalwide Applicability

b) Federalwide Assurance

c) Federalwide Access

d) Federalwide Acceptance

b) Federalwide Assurance

Which of the following statements is true about FWAs? (Select all that apply)

a) An institution must have an active FWA before it can receive funds from NIH to conduct human subjects research unless the latter is exempt

b) When an institution files an FWA, it assures the federal government that it has the facility to conduct the research

c) When an institution files an FWA, it assures the federal government that it will comply with the Common Rule when applicable

d) All of the above

a) An institution must have an active FWA before it can receive funds from NIH to conduct human subjects research unless the latter is exempt

c) When an institution files an FWA, it assures the federal government that it will comply with the Common Rule when applicable

What is non-exempt human subjects research?

a) Human subjects research that does not qualify for an exemption under the Common Rule

b) Activities that are considered part of a clinical trial

c) Activities that are funded by HHS

d) Human research studies that cannot be done unless a fee has been paid to the government

a

All research involving human volunteers in the United States is required to follow the Common Rule.

a) True

b) False

b

An investigator plans to do a research project involving human subjects that is not funded by the Federal government. Can she proceed with her proposed project without IRB review?

a) Yes. Since it is not Federally funded, no IRB review is needed.

b) It depends. She should contact her HRPP or IRB office to find out what other regulatory or institutional requirements must be met.

c) No. She will need to submit for IRB review regardless of funding or other rules since her project involves human volunteers.

b) It depends. She should contact her HRPP or IRB office to find out what other regulatory or institutional requirements must be met.

In an institution, who usually determines whether a research study is non-exempt human subjects?

a) OHRP

b) IRB administrator

c) HRPP staff

d) FDA

b c

In deciding whether a project is non-exempt human subjects research under the Common Rule, what is the first question you should ask?

a) Whether the statistical method in the research is sound

b) Whether the research involves human subjects according to the regulatory definition

c) Whether the activity meets the regulatory definition of research

d) Whether the human subjects research is exempt

c) Whether the activity meets the regulatory definition of research

The Common Rule defines research as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalize knowledge."

a) True

b) False

a) True

What are the criteria for the regulatory definition of research? (Select all that apply)

a) An observational occurrence

b) A systematic investigation

c) Designed to contribute to generalizable knowledge

d) Intended to be published in a peer reviewed scientific journal

b c

Select all activities deemed not to be research under the Common Rule. (Select all that apply)

a) Certain public health surveillance activities

b) Certain criminal justice or criminal investigative purposes activities

c) Certain operational activities in support of national security missions

d) Certain scholarly & journalistic activities that focus on information about certain individuals

e) Systematic investigations

a b c d

A proposed research project involves studying tissue samples from cadavers being used in a local medical school to train students. Personal information about the deceased individuals will be used in the research. Is this human subjects research?

a) Yes

b) No

b) No

A proposed research project involves asking participants to complete a task and answer questions on a computer. No identifiable information will be recorded about participants. Is this human subjects research?

a) Yes

b) No

a) Yes

A proposed research project will use leftover blood samples from clinical tests to check for levels of a certain metabolite. Investigators will also review patients' identifiable medical records to obtain other necessary health information. Is this human subjects research?

a) Yes

b) No

a) Yes

Which of the following activities, when carried out for the purpose of research, would constitute research involving human subjects under the Common Rule? (Select all that apply)

a) Interacting with a living individual

b) Having living individuals to take part in a research intervention

c) Manipulating a living individual's environment

d) Using identifiable private information or biospecimens about living individuals

a) Interacting with a living individual

b) Having living individuals to take part in a research intervention

c) Manipulating a living individual's environment

d) Using identifiable private information or biospecimens about living individuals

Research that only involves specimens from deceased persons would not be considered human subjects research.

a) True

b) False

a) True

What does it mean for a research project to be exempt?

a) The research was reviewed according to the same criteria as expedited review

b) The research is not required to undergo initial or continuing IRB review

c) The research doesn't meet the regulatory definition of human subjects research

d) The research does not have to comply with institutional policies

e) The research is exempt from the Belmont Report principles

b) The research is not required to undergo initial or continuing IRB review

The Common Rule specifies who should make determinations about exemptions.

a) True

b) False

b) False

Where should a researcher go to inquire whether something qualifies as an exemption? (Select all that could apply)

a) The institution's Institutional Animal Care and Use Committee (IACUC)

b) Their institution's IRB

c) Their institution's HRPP

d) The American Medical Association

b) Their institution's IRB

c) Their institution's HRPP

Once a research study is determined to be exempt, it will always be exempt regardless of any subsequent changes that might be made to it.

a) True

b) False

b) False

What are some important reasons for having IRBs?

a) The law requires it for all research

b) They provide independent review of research to help ensure that research is ethical and research participants are protected

c) They monitor research data collection

d) All of the above

b) They provide independent review of research to help ensure that research is ethical and research participants are protected

What are some reasonable objectives for IRB review? (Select all that apply)

a) Minimizing risks to human subjects

b) Ensures financial benefits to participants

c) Ensures public trust in research is upheld

d) Ensures improvements to the Common Rule

a) Minimizing risks to human subjects

c) Ensures public trust in research is upheld

Under the Common Rule, what is the minimum number of members required for an IRB?

a) 3

b) 5

c) 6

d) 7

e) It depends

b) 5

The Common Rule requires that an IRB must have which of the following types of members? (Select all that apply)

a) IRB administrator

b) Scientist

c) Institutional official

d) Nonscientist

e) Representative of a minority group

b) Scientist

d) Nonscientist

Only people with a graduate degree can serve as an IRB member. True or false?

a) True

b) False

b) False

What are some of the characteristics of an effective HRPP or IRB office?

a) Has experienced IRB administrative staff

b) Has written institutional policies for research oversight

c) Provides relevant education and advice on human research protections to investigators

d) Communicates effectively with investigators

e) All of the above

e) All of the above

When would an investigator want to reach out to their institution's HRPP office?

a) When they have questions about applicable regulations, laws, and institutional policies

b) When preparing a protocol for submission to the IRB for review

c) When determining whether a research project is non-exempt human subjects research

d) All of the above

e) None of the above

d) All of the above

Single IRBs are becoming less common in the field of research.

a) True

b) False

b) False

The Common Rule requires that all federally funded research be reviewed by an IRB.

a) True

b) False

b) False

The Common Rule requires that the IRB Chair make determinations about whether a research study is non-exempt human subjects research.

a) True

b) False

b) False

An HRPP or IRB office is responsible for the following:

a) Making sure that research complies with applicable regulations, relevant ethical standards, and institutional requirements

b) Publishing research

c) Interviewing potential research participants

d) All of the above

a) Making sure that research complies with applicable regulations, relevant ethical standards, and institutional requirements

It is best practice to allow investigators to make the determination regarding whether their research is non-exempt human subjects research.

a) True

b) False

b) False

Some journals require proof that research involving humans had undergone an independent review for ethics and human research protections.

a) True

b) False

a) True

What are some common activities of an HRPP or IRB office? (Select all that apply)

a) Make determinations about whether a research study can be exempt from the Common Rule

b) Assist investigators with submitting protocols to the IRB for review

c) Conduct audits of research data

d) Provide administrative support for IRB full board meetings

e) Help ensure that research submitted by investigators complies with applicable regulations, institutional policies, and ethical standards

a) Make determinations about whether a research study can be exempt from the Common Rule

b) Assist investigators with submitting protocols to the IRB for review

d) Provide administrative support for IRB full board meetings

e) Help ensure that research submitted by investigators complies with applicable regulations, institutional policies, and ethical standards

The Common Rule prohibits communications between IRBs and investigators in order to preserve the IRBs' independence.

a) True

b) False

b) False

For a convened or full-board IRB review meeting, the Common Rule includes specific requirements for which of the following?

a) IRB committee membership

b) Quorum

c) Voting

d) Documentation of IRB actions

e) All of the above

e) All of the above

IRB decisions include which of the following potential outcomes? (Select all that apply)

a) Approve

b) Disapprove

c) Request changes

a) Approve

b) Disapprove

c) Request changes

In order to proceed with a meeting, IRBs require a majority of their voting members to be present, including at least one non-scientist.

a) True

b) False

a) True

A common reason for delays in approval of research is protocol submissions that are missing required information.

a) True

b) False

a) True

Which actions can a reviewer conducting an expedited review of research take about a research protocol? (Select all that apply)

a) Approve the research

b) Disapprove the research

c) Request changes to the research

d) Request changes to the informed consent form

e) All of the above

a) Approve the research

c) Request changes to the research

d) Request changes to the informed consent form

Which of the following statements is true?

a) Expedited review requires complying with a simpler set of review criteria

b) Expedited review can be done by one designated IRB member

c) Full board committees review only high risk research

d) Full board review can only be done with all IRB members present

b) Expedited review can be done by one designated IRB member

Expedited reviews can be "expedited" because the review criteria are fewer and less stringent.

a) True

b) False

b) False

The Common Rule requires the IRB to review research using which of the following criteria? (Select all that apply)

a) Risks to subjects are minimized

b) Target enrollment numbers

c) Investigators' conflict of interest

d) Selection of subjects is equitable

e) Additional protections for vulnerable populations

a) Risks to subjects are minimized

d) Selection of subjects is equitable

e) Additional protections for vulnerable populations

Recruitment of human participants can begin prior to IRB approval.

a) True

b) False

b) False

After an IRB administrator confirmed to the investigator that her protocol submission package was complete, the investigator began asking people to participate in her NIH funded study. This is:

a) Consistent with the regulations because the investigator is only asking people to participate; research activities have not begun yet

b) Consistent with the regulations because the IRB administrator confirmed completeness of the submission, so IRB approval is imminent

c) Inconsistent with the regulations because the investigator must complete a human subjects protection training first

d) Inconsistent with the regulations because asking people to participate is considered a human subjects research activity and may not begin prior to IRB approval

d) Inconsistent with the regulations because asking people to participate is considered a human subjects research activity and may not begin prior to IRB approval

IRBs are not allowed to request changes to research and consent documents.

a) True

b) False

b) False

For research that was approved under an expedited category, which of the following statements is true?

a) Continuing review is required once a year

b) Continuing review is required if the research is more than minimal risk

c) Continuing review is required every two years

d) Continuing review is not required under the revised Common Rule, unless the IRB determines otherwise

d) Continuing review is not required under the revised Common Rule, unless the IRB determines otherwise

During the onset of the COVID-19 pandemic, an investigator conducting a series of in-person interviews at the hospital quickly switched to online interviews to avoid unnecessary exposure to the novel coronavirus. The investigator also added a supplemental research survey. She will notify the IRB of these changes in the near future. Which is true about the two changes to the protocol:

a) The new survey could be implemented without prior IRB approval, but the switch to online interviews requires prior IRB approval

b) The switch to online interviews could be implemented without prior IRB approval, but the new survey requires prior IRB approval

c) Both the switch to online interviews and the new survey require prior IRB approval

d) Both the switch to online interviews and the new survey could be implemented without prior IRB approval

b) The switch to online interviews could be implemented without prior IRB approval, but the new survey requires prior IRB approval

Which of the following statements about what investigators should do is true?

a) Report all adverse events to OHRP

b) Obtain IRB approval before making changes to approved research, unless there are immediate hazards to subjects

c) Report monthly enrollment numbers to the IRB

d) Report serious unanticipated problems to the IRB only at the annual continuing review

e) All of the above

b) Obtain IRB approval before making changes to approved research, unless there are immediate hazards to subjects

What is the purpose of a Federalwide Assurance (FWA)?

a) Obtain IRB approval for certain research projects

b) Put together an IRB with accurate number of individuals

c) Assure the Federal Government of the institution's commitment to comply with the Common Rule

d) Obtain funding from NIH

c) Assure the Federal Government of the institution's commitment to comply with the Common Rule

What does an institution need to have or do in order to receive HHS funding to conduct non-exempt human subjects research? (Select all that apply)

a) Be covered by an active Federalwide Assurance (FWA) with OHRP

b) Certify to the federal funding agency, when appropriate, that the research has been reviewed and approved by an IRB

c) Obtain a memorandum of understanding

d) Ensure all participants have undergone ethics training

a) Be covered by an active Federalwide Assurance (FWA) with OHRP

b) Certify to the federal funding agency, when appropriate, that the research has been reviewed and approved by an IRB

An institution that is the primary awardee of federal funds for conducting non-exempt human subjects research is generally considered to be "engaged" in human subjects research.

a) True

b) False

a) True

What are some other circumstances in which an institution is generally considered to be engaged?

a) Its employees or agents undertake any activities that OHRP considers to constitute human subjects research that comes under the Common Rule

b) Its employees obtain the informed consent of research subjects

c) Its agents obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens for the purpose of the research

d) Its staff intervene or interact with individuals to obtain their private information or biospecimens for the purpose of the research

e) All of the above

e) All of the above

Institutions are required to establish their own internal IRBs to review research.

a) True

b) False

b) False

Institutions may rely on external IRBs, such as the IRB of another institution or an independent IRB, to review research.

a) True

b) False

a) True

Which of the following statements is true?

a) The Common Rule dictates how institutions must document their reliance agreements

b) The relying institution and the reviewing IRB do not need to establish clear channels of communication

c) The Common Rule is flexible regarding how institutions choose to document their reliance agreements

d) None of the above

c) The Common Rule is flexible regarding how institutions choose to document their reliance agreements

Please select from the list below what the Common Rule requires regarding institutional policies and procedures for research that comes under its jurisdiction.

a) The Common Rule requires IRBs to establish and follow certain written procedures to conduct their functions and operations

b) The Common Rule requires IRBs to ensure that the research will get funded one way or another

c) The Common Rule requires IRBs to ensure that all IRB members have doctoral degrees

d) None of the above

a) The Common Rule requires IRBs to establish and follow certain written procedures to conduct their functions and operations

It is best practice for IRB written procedures to be as broad as possible, lacking extensive details.

a) True

b) False

b) False

Institutions are encouraged to develop written policies and procedures that simply restate the regulations.

a) True

b) False

b) False

Compliance with the Common Rule means that...?

a) The research study is ethical

b) The research study was funded by HHS

c) The research study has followed the requirements of the Common Rule

d) The research is done by academics

c) The research study has followed the requirements of the Common Rule