Frequently Asked Questions

What is the Children's Hospital & Research Center Oakland (CHRCO) Institutional Review Board (IRB)?

The Institutional Review Board (IRB) at Children's Hospital & Research Center Oakland (CHRCO) is a Hospital Committee that serves both the Hospital and Children's Hospital Oakland Research Institute (CHORI). It is a federally-mandated committee established to review and approve research involving human subjects.  The IRB is registered with the Office of Human Research Protections (OHRP) and has a Federal Wide Assurance (FWA00000094). The hospital requires that all research involving human subjects or identified human material (tissues, cells, serum, etc.) of living or deceased human subjects must be reviewed and approved by the CHRCO IRB before initiation of any research-related activities, including recruitment and screening activities.

The purpose and responsibility of the IRB is to protect the rights and welfare of human subjects.  It is guided by the ethical principles applied to all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, titled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report").  The IRB reviews and oversees research to ensure that it also complies with applicable federal regulations, including the U.S. Department of Heath and Human Services and the U.S. Food and Drug Administration.  It also follows the Good Clinical Practice (GCP) Guideline (E6) of the International Conference on Harmonisation (ICH) and the State of California Health and Safety Code. 

The board meets every third Thursday of the month.  The members are comprised of individuals with a scientific background and those with no scientific background.  There are members affiliated with CHRCO and CHORI, as well as members from the community. 

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 the 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.

Do I need IRB approval for a case report?

Data concerning one individual, their family, and/or environment, including medical history and any other information, collected for the purposes of analyzing and diagnosing the individual’s condition or for instructional purposes, is considered a “case study.”  Although this case reporting does involve the intent to publish results, it does not involve a testable hypothesis. Consequently, the wish to publish a single case report is not considered to be research and the IRB does not require the submission of a protocol to publish the case report.

If more than one case occurs of the specific condition or medical anomaly, or the investigators begin to formulate a hypothesis or attempt to gather further information on cases of this type with the intent to publish the results, activities cross into what would be considered “research” and it becomes necessary to submit a research proposal to the IRB.

Although publishing a single case report may not require submission to the IRB, investigators should be aware of the use of individually identifiable health information in their publications. Under HIPAA, the disclosure of an individual’s protected health information must be authorized by that individual. In other words, if a case report contains any identifiers as defined by the HIPAA regulations, authorization to disclose this information in a publication must be sought from the individual whose information is being disclosed. The subject must sign a consent form (or authorization) to disclose this information. This authorization/consent must be reviewed by the IRB, which serves as the Privacy Board for Children's Hospital & Research Center Oakland. Many journals now require authorization/consent from the subject of the article before publication.

Case reports often involve reporting on a rare disorder, condition, or course of treatment. In such cases, individuals may be more easily identified as being the subject of a publication than individuals with a more common disease or condition. Consequently, this rare disorder may fall under the category of “any other unique identifying characteristic” under the HIPAA regulations, and thus be considered Protected Health Information. Researchers must then obtain a subject’s authorization before publishing a report, even when no other identifiers are being disclosed, because the subject may be able to be identified by their disorder. This authorization again must be reviewed by the IRB before use.

Is it Research or Program Evaluation?

Why do I have to do literature search?

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revised: Thursday, November 5, 2009 11:18 AM