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What is Human Subjects Research?
Any federally funded or regulated research that involves people is considered “human subjects research.” Research involves people (human subjects) when a researcher conducts research by obtaining data or information from a living person.
What is “research” under the regulations?
“Research” under this regulation includes basic research, the results of which most likely will be published or made public. “Research” also means that the research development, testing and evaluation is designed to develop or contribute to generalizable knowledge. This contribution to general knowledge is distinguished from “research” which consists of product testing or consumer or quality surveys, which may lead to a better product or better operation of an organization or program, but does not contribute to generalizable knowledge. This latter type of “research” is not considered research under the federal regulations, and thus is not subject to them.
What are “human subjects"?
Human subjects are living individuals about whom an investigator obtains data through intervention or interaction with the individual, or obtains identifiable private information.
Is training considered to be “research” under the regulations?
Training is not research. If the proposed activity is for training purposes only, it is not research, so does not require Human Subjects review.
Is usability testing with no intention to publish results human subjects research?
Usability testing with no intention to publish results is not human subjects research.
What is the federal human subjects research regulation?
Human subjects research is based on a federal regulation known as the Common Rule. The “Common Rule” is the term used by 17 federal agencies (including NSF) that have adopted the same regulations governing human subjects research. The federal law is set forth at 45 CFR Part 46. Each agency’s regulations use the same text and a similar numbering system. NSF’s regulation is listed at: 45 CFR Part 690.
Local, state and foreign laws may provide additional or different requirements for the protection of human subjects and should also be reviewed for compliance.
What does the HSC consider during its deliberations?
The HSC is concerned with how the research will impact participants. Its decision will be based on whether the research meets the following requirements, which are discussed in the HSC Manual: Risks to participants are minimized; risks to participants are reasonable in relation to anticipated benefits; selection of participants is equitable; when necessary, informed consent will be sought; if necessary, informed consent will be appropriately documented; the research plan makes adequate provision for monitoring data and the safety of participants; where appropriate, privacy of people is protected, and confidentiality of data is maintained.
Can I look up UCAR's approved Federal-Wide Assurance Number online? Is it the same process to look up UCAR's registered IRB number?
To determine if an institution has an approved FWA, or if an institution has a registered IRB, see the OHRP website.
Example: To find UCAR at the above URL, search on "U Corp. for Atmospheric Rsch".
What are my responsibilities as a researcher?
All UCAR researchers must comply with the regulations governing human subjects research. The Human Studies Committee is available for initial consultation, education and to guide the researcher in the process.
What is the Human Studies Committee?
The Human Studies Committee (HSC) is the name of UCAR’s institutional review board or IRB. The federal regulations require that every institution that engages in human subjects research designate one or more IRBs with the sole authority to approve, require modifications or disapprove all research activities covered by the federal regulations. The charge of this committee is to fulfill federal requirements for protecting human research subjects, by reviewing research plans (protocols) before the research is undertaken. It is UCAR’s philosophy that scientific excellence means valid research design and competent research conduct, as well as respect for and protection of human subjects.
The HSC will review proposals with human subjects components, and require informed consent and documentation where applicable. The HSC at UCAR covers all activities within NCAR, UOP and UCAR that involve human subjects research. Examples of past research at UCAR that falls within the purview of human subjects review includes research on the impact of climate change on natives in Alaska and an evaluation of how undergraduate students learn atmospheric related science using certain visualization tools.
Any member of the HSC can assist researchers at any stage of their research in understanding and complying with the federal regulations, UCAR’s policy and more specific requirements, such as informed consent. To review the list of HSC members click here.
How do I know if my research triggers the Human Subjects Research Regulations?
If your research involves getting information from people, you need to consider the implications of the federal regulations. Your research may be exempt, but you need to at least consider these regulations.
How do I get approval of my research project?
The HSC has an on-line questionnaire called a study protocol that is provided on-line from its home web page. You need to complete and submit this study protocol. The “on-call” HSC member will initially review your protocol and respond to you. Most of the communication can occur on-line and over a short period of time. If your research is exempt, the HSC can also approve it on-line. Any disapproval of your research protocol or significant issues, requires the involvement of the entire HSC, and may require a meeting between the researcher and the Committee.
In its evaluation, the HSC is concerned with the impact of your research on participants and will determine that the following requirements are met:
How do I know if my research is exempt?
Where the research activity only involves participants in the following categories (most applicable to UCAR and social science research) the activity may be exempt:
At UCAR, the HSC must decide that an exemption is triggered, and it may be part of an expedited procedure. Further, the responsible federal agency department manager retains the final approval on any exemption from the HSC.
If my research is exempt, why do I have to submit a protocol to the Human Studies Committee?
The researcher is not allowed to make his or her own assessment of whether the research is exempt; only the HSC can make that determination. As a result, you need to submit enough information to the HSC, so that it can make an informed decision about exemptions.
Are evaluations or surveys given to participants at the end of a seminar or class subject to the regulations?
In most cases, the routine evaluations conducted at the end of a seminar or class are not “research” (as defined above) and therefore, do not fall within the regulations. However, if these surveys capture any information that is confidential or private to the participants, the regulations will apply and a protocol should be submitted for further evaluation by the HSC.
Are all questionnaires, educational tests and interview-based studies considered “exempt” under the federal regulations?
Such studies are exempt UNLESS:
AND disclosure of their identity could place them at risk of:
When the participants are public officials or candidates for public office, the research is exempt even when identifiers are included or disclosure might be harmful. However, all research should be bound by professional ethics and respect for respondents to guard their privacy whether or not the research is exempt (unless the participants understand that their information may be made public and permission is granted).
Research on vulnerable populations may not be exempt. The definition of a “vulnerable population” may vary, but the regulation has specifically identified children, prisoners, and pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons under this category.
What is expedited review?
If all of the activities of a project meet the criteria for expedited research, then review by the full HSC is not necessary. (Click here for link to 45 CFR690.110.) The HSC Chair and another HSC member can review the protocol without full HSC review, although anyone (including the researcher) can request a full review. Social science research that is on the published list of research (as printed in the Federal Register) that may be reviewed through an expedited procedure, when it involves no more than minimal risk to the participants includes (note, some of the research in this category may also be exempt):
A federal agency has the right to restrict, suspend, and terminate the use of any expedited procedure.
Collaborative research across institutions.
Where there are projects involving more than one institution, there may be a joint review arrangement for addressing the human subjects research, one institution may rely upon the review of another qualified IRB, or the institutions can make similar arrangements for avoiding duplication of effort.
When a researcher has completed data collection for their project, but has not yet completed data analysis during the approved period (generally 3 years), is the researcher required to request an extension?
If the part of the study that involves human subjects (data collection) is over, and the researcher is analyzing and writing, then researcher will need to continue to be aware of any confidentiality requirements. However, the researcher would not need to request an extension.