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What is the Children's Hospital & Research Center Oakland (CHRCO) Institutional Review Board (IRB)?
The IRB is a federally-mandated committee established to review and approve research involving the use of human subjects. Members are appointed by the President of Children's Hospital & Research Center Oakland (CHRCO). There is no limit on the number of members that may serve on the IRB. There are members who are affiliated with CHRCO or Children's Hospital Oakland Research Institute (CHORI), as well as unaffiliated members. Some members have a scientific background, and others do not. There are physicians, a pharmacist, an attorney, behavioral scientists, and community advocates for vulnerable populations such as children, prisoners, women and the elderly. Federal regulations require that all research projects involving human subjects and materials of human origin be reviewed and approved by an IRB before initiation. Among the members of the IRB is a Chair and Vice-Chair.
When does the IRB need to approve my research?
- Any research activity involving human subjects that is conducted by a CHRCO or CHORI investigator or employee, regardless of location, is subject to review and approval by the CHRCO IRB. Persons under contract to CHRCO or CHORI to conduct research on all or any part of a study are considered the same as an employee for this purpose.
- Any research activity involving human subjects that occurs within a CHRCO or CHORI facility, regardless of who performs it, is subject to review and approval by the CHRCO IRB.
- Any research activity involving human subjects who are clients or patients of CHRCO or CHORI is subject to review and approval by the CHRCO IRB.
- Any research activity involving human subjects that is funded, in full or in part, by CHRCO or CHORI, is subject to review and approval by the CHRCO IRB.
Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102d). The “generalizable knowledge” criteria may include developing publications/papers, theses/dissertations, making public presentations, etc.
A human subject of research is: a) a living individual from whom an investigator obtains data by interaction or intervention or; b) identifiable private information (45 CFR 46.102f).
At times, it may be difficult to determine whether any given activity constitutes research. If an investigator interacts with an individual, or collects data about that individual, for other than the sole purpose of providing clinical care, that activity may constitute research and should be discussed with the IRB Administrative Staff. Also, the evaluation component of an existing demonstration and/or service program may include research activities that should be reviewed by the IRB. When in doubt, ask.
How does the review process work?
The review process begins when an investigator submits a complete application to the IRB office. Application forms are available on the Web here. The application is assigned a study number. Please reference the assigned IRB # and the Principal Investigator's name when corresponding with or submitting documents to the IRB. Applications are assigned to either full committee review, expedited review, or meet the qualifications for an exempt study. Investigators should indicate on the application which risk level they believe their project falls into. However, upon review by the IRB staff, any protocol may be assigned to another category if appropriate. Federal regulation defines research activities that may be categorized as Exempt or are eligible for Expedited Review. All other research falls under full IRB review. If the IRB staff has concerns, or corrections need to be made, they will be conveyed to the applicant. The applicant(s) must then send a response to each comment, in writing, to the IRB office. The comment and response process can be facilitated by using e-mail and corrected documents with changes "tracked." Please be sure to include your IRB # in the subject line of e-mail correspondence.
An approval letter is issued for protocols qualifying for exempt and expedited review as soon as the Chair has approved them. Protocols requiring IRB review at a convened meeting receive approval letters after the protocol has been discussed and approved by vote of the IRB, and all clarifications and requested changes have been made and approved by the Chair. If the IRB does not specify that the Chair can approve the changes, the protocol will be deferred and re-reviewed at the next convened IRB meeting. Investigators may begin gathering data from human subjects only after receiving a signed approval letter from the Chair of IRB.
How long does the review process take?
Applicants may submit a protocol for review at any time. However, please refer to the Calendar of Meeting Dates & Submission Deadlines. The full IRB review process typically requires a minimum of one month to complete, longer when modifications are necessary to meet the concerns of IRB reviewers. If a project qualifies for exempt status or expedited review and requires no modifications, the process normally takes 10 working days.
What review criteria must the IRB abide by?
IRBs are required to review and approve protocols against the following criteria according to federal regulations at 45 CFR 46.111 and 21 CFR 56.111:
- Procedures and research design do not unnecessarily expose subjects to risks.
- Risks to subjects are reasonable in relation to anticipated benefits, if any.
- Selection of subjects is equitable, taking into account special problems of research involving vulnerable populations (e.g. pregnant women, prisoners, handicapped persons, etc.)
- Informed consent will be sought from each prospective subject or subject's guardian.
- Informed consent will be documented in writing (except in special circumstances).
- Where appropriate, adequate provisions are in place to monitor the collected data to ensure safety of subjects.
- Adequate provisions are in place to protect the privacy of subjects and maintain confidentiality of data.
Why do I have to do a literature search?
Ideally, a PI should always be well informed of the literature relating to his/her particular field of study and should be conducting reviews of the available literature on a regular basis. The need for a literature search to assess the risk level and alternatives to participation of each study was given additional emphasis following the federally-imposed halt on research at Johns Hopkins University. A volunteer on a Hopkins research study died after being exposed to a drug for which the government determined that risk information had not been adequately researched.
Consequently, the federal agencies governing research have heightened their emphasis on the need for a thorough review of available applicable literature both before research is started and as an ongoing process throughout the research. The Children's Hospital & Research Center Oakland IRB therefore requires that a literature search be conducted and the results presented to the IRB at the time of original submission as well as at each continuing review (renewal).
How should I conduct the literature search? What does the IRB require?
PIs should search on one or more web-based search engines for articles relating to 1) the condition being studied and 2) the specific drug/device/process being studied. For example, for studies of a new drug, PIs should not only search for articles on the risk of that drug, but should also search for articles on new treatments that would present available alternatives to study procedures. The IRB is also concerned with the applicability of the proposed research; that is, if a literature search reveals that the study being proposed replicates studies that have already been completed with definite results, the PI should consider whether his or her study is likely to yield new information and if not, if the study should be done.
While the IRB has faith that investigators are responsibly conducting research, the IRB does not accept merely a statement that a literature search has been done. The IRB requests that PIs provide the IRB with the name of the search engine that is used, the search strategy (keywords), and the results of the search, along with a description of the results’ impact on the risk level and/or alternatives to participation of the research.
Example of an acceptable literature search for a renewal:
SEARCH ENGINE: PubMed
SEARCH TERMS: Drug Name (generic), Drug Name (brand), Disorder Name
RESULTS: 1200 articles.
SUMMARY: Most of the articles were not applicable to the study at hand as they dealt with the risks of or descriptions of standard of care drugs for this disorder. Searching on the drug itself yielded only a few results having to do with animal studies; these are already covered in the investigator’s brochure. One article, “DRUG XYZ in Disease Y” by A. Jones, indicated a possible new alternative therapy, but this is still in Phase I development. Overall, there is nothing in the literature to indicate any new information on the risks or benefits of this study. Risks found in the literature are already covered in the protocol and consent form for this project.
My study is closed to enrollment. Do I still need to do a literature search?
If your study is still enrolling subjects OR if enrollment is closed, but subjects are still actively participating in study procedures or receiving study drug, then a literature review should be submitted.
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