Human Research Protection Foundational Training

How might society benefit from health and medical research? (Select all that apply)

- Gain new ways to improve health

- Find better treatments/social programs

- Gain a better understanding of human biology and behavior

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

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.?

The Belmont Report

Who wrote the Belmont Report?

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? (Select all that apply)

- Justice

- Respect for persons

- Beneficence

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

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?

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?

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?

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?

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. True or false?

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. True or false?

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?

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. True or false?

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. True or false?

True

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

- National Institutes of Health (NIH)

- Food and Drug Administration (FDA)

- Centers for Disease Control and Prevention (CDC)

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

False

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

False

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

False

Many research institutions choose to apply the Common Rule regardless of funding source. True or false?

True

What does FWA stand for?

Federalwide Assurance

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

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

- 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?

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

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

False

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?

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? (Select all that apply)

- IRB Administrator

- HRPP Staff

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

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." True or false?

True

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

- A systematic investigation

- Designed to contribute to generalizable knowledge

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

- Certain public health surveillance activities

- Certain criminal justice or criminal investigative purposes activities

- Certain operational activities in support of national security missions

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

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?

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?

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?

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)

- Interacting with a living individual

- Having living individuals to take part in a research intervention

- Manipulating a living individual's environment

- Using identifiable private information or biospecimens about living individuals

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

True

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

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

The Common Rule specifies who should make determinations about exemptions. True or false?

False

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

- Their institution's IRB

- 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. True or false?

False

What are some important reasons for having IRBs?

- 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)

- Minimizing risks to human subjects

- Ensures public trust in research is upheld

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

5

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

- Scientist

- Nonscientist

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

False

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

All of the above!

- Has experienced IRB administrative staff

- Has written institutional policies for research oversight

- Provides relevant education and advice on human research protections to investigators

- Communicates effectively with investigators

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

All of the above!

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

- When preparing a protocol for submission to the IRB for review

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

Single IRBs are becoming less common in the field of research. True or false?

False

The Common Rule requires that all federally funded research be reviewed by an IRB. True or false?

False

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

False

An HRPP or IRB office is responsible for the following:

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. True or false?

False

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

True

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

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

- Assist investigators with submitting protocols to the IRB for review

- Provide administrative support for IRB full board meetings

- 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. True or false?

False

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

All of the above!

- IRB committee membership

- Quorum

- Voting

- Documentation of IRB actions

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

- Approve

- Disapprove

- 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. True or false?

True

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

True

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

- Approve the research

- Request changes to the research

- Request changes to the informed consent form

Which of the following statements is true? (IRB)

Expedited review can be done by one designated IRB member

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

False

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

- Risks to subjects are minimized

- Selection of subjects is equitable

- Additional protections for vulnerable populations

Recruitment of human participants can begin prior to IRB approval. True or false?

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:

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. True or false?

False

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

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:

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? (Select the best answer)

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)?

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)

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

- 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.

True

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

All of the above!

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

- Its employees obtain the informed consent of research subjects

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

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

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

False

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

True

Which of the following statements is true? (Common Rule)

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.

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.

False

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

False

Compliance with the Common Rule means that...?

The research study has followed the requirements of the Common Rule

Still learning (10)

You've started learning these terms. Keep it up!