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THE COMMITTEE ON HUMAN RESEARCH

FREQUENTLY ASKED QUESTIONS ABOUT APPLYING TO THE COMMITTEE ON HUMAN RESEARCH ( Revised February 2008)

•  What is the Definition of Research?
•  What is the Definition of Human Subjects?
•  Who Must Have CHR Approval Before Conducting Human Subjects Research?
•  Does Research With Stem Cells Require CHR Review?
•  Does Research Using Data Death Files Require CHR Review?
•  How Do I Determine What Type of Application to Submit?
•  What If I have NIH Just In Time Review?
•  Does a Pilot Study Have To Be Reviewed By the IRB?
•  Does Research on Samples From Cadavers Require IRB Review?

What is the Definition of Research?

DHHS Regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. DHHS definition of “research” (45 CFR 46.102(d))

FDA Regulations defines clinical investigation as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA n under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.  (21 CFR 50.3(c), 21 CFR 56.103(c), 21 CFR 312.3(b), and 21 CFR 812.3(h))

What is the Definition of Human Subjects?

DHHS Regulations define human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. (45 CFR 46.102(f))

• Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject.
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

FDA Regulations define a human subject as an individual who becomes a participant in research, either as a recipient of the test article or as a control. (21 CFR 50.3(g), 21 CFR 56.103(e), 21 CFR 312.3(b), and 21 CFR 812.3(p))

• A subject may be either a healthy individual or a patient.
• If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control..

Who Must Have CHR Approval Before Conducting Human Subjects Research?

UCSF faculty, staff, students, or others accesses UCSF facilities, patients or personnel must have CHR Approval. (Neither the site of the study nor the source of funding, or if there is funding, matters.)

Stem Cells

Yes. Further guidance can be found at the UCSF Human Stem Cell Research website.

Data Death Files

Yes, a new California law effective January 1, 2003 requires IRB approval for any research using individually identifiable information from death data files held by the State Registrar, local registrars, and county recorders. Further guidance can be found at Research Using Data Death Files.

How Do I Determine What Type of Application to Submit?

The level of risk to the human subject determines the type of review. Anything more than minimal risk is considered full-committee review. Anything minimal risk or less may qualify for expedited review or exempt certification.

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.” (45CFR46.102)

Studies involving treatments or procedures that are more invasive than a routine blood draw generally have more than minimal risks. Risks are also greater than minimal when identifiable information, if revealed outside the study, could be a risk to a subject’s employment, insurance, financial standing or reputation or put a subject at legal risk.

What If I have NIH Just In Time Review?

Effective January 2001, NIH changed its policies so that approval by an Institutional Review Board (IRB) is no longer required before NIH peer review of a grant application. In the new system, researchers are encouraged to submit their research for IRB review only after they have received their Summary Statement (“pink sheet”) notification of priority score/percentile. If the pink sheet indicates the application is in a fundable range, IRB review should proceed. The complete policy can be found at the NIH web site, document NOT-OD-00-031.

The Committee on Human Research (CHR), which is UCSF’s IRB, encourages researchers to hold their CHR applications until they receive their pink sheet. Because fewer than half of NIH grant applications are funded, delaying CHR review can save considerable effort for researchers as well as the committee.

As a suggestion to researchers, but not a requirement at this time, the CHR recommends that one copy of the pink sheet be included with CHR applications. The information on pink sheets often addresses questions that commonly arise and that the CHR would otherwise need to ask in a letter to the researcher. Thus including the pink sheet may result in a speedier approval.

If you have questions about this policy, please call the CHR office at 476-1814 and ask for the Analyst of the Day.

Does a Pilot Study Have To Be Reviewed By the IRB?

Yes. It isn't the numbers that determines if review is needed. The determining factor is whether or not human subjects are involved. Make sure the aims of study are clear in the Purpose and Background section of the protocol.

Does Research on Samples From Cadavers Require IRB Review?

No, IRB review is not needed if the materials do not contain personal identifiers (PHI).

However, if personal identifying information is linked to the materials, then expedited IRB review is required.