Lesson 2: What is Human subjects research?

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

What is non-exempt human subjects research?

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

In an institution, who usually determines whether a research study is non-exempt human subjects? (Select all that apply)

IRB administrator HRPP staff

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?

Maybe. She should contact her HRPP or IRB office to find out what institutional requirements must be met.

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

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

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

a systematic investigation designed to contribute to generalzable knowledge

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)

all of the above

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

false

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

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

false

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

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

true

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

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