Contact Information

Organization

THE COMMITTEE ON HUMAN RESEARCH (CHR)

WORKING WITH OTHER INSTITUTIONS AND UNITS

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) (February 2005)

 • Brief Overview
 • Protocol Development and Submission Responsibilities
 • CDC and Institutional Review Board (IRB) Determinations
 • Research vs. Non-Research (Public Health Practice)
 • Routing after CDC Research/Non-Research Decision
 • Joint CDC and UCSF IRB Review
 • Deferral of CDC IRB Review to UCSF IRB
 • Prospective Review
 • Retrospective Review
 • Other CDC Review Options for SFDPH Investigators
 • CDC Funding

Brief Overview

Special considerations apply to research projects undertaken in conjunction with or funded by the Centers for Disease Control and Prevention (CDC), an agency of the U.S. Department of Health and Human Services.

For UCSF, these are usually projects that:

•  Involve UCSF investigators working in the area of public health and/or with the San Francisco Department of Public Health (SFDPH); or



• Do not involve UCSF investigators, but involve designated SFDPH investigators. These research projects come under the purview of UCSF because the CHR serves as the institutional review board (IRB) for SFDPH for projects involving designated SFDPH faculty (see list of Designated SFDPH Investigators Authorized to Submit Applications for CHR Review).

Following is information about the scope and specific requirements for such work. (For main references see http://www.cdc.gov/od/ads/procphrp.pdf and http:///www.research.ucsf.edu/chr/index.asp.

Protocol Development and Submission Responsibilities

Many research studies funded by the CDC involve cooperative agreements and therefore must have a CDC principal investigator (PI).

There are two types of cooperative projects that fall under UCSF guidelines:

• Projects that involve a CDC PI and a UCSF investigator (a UC academic appointee as defined in UC Academic Policy, "Who May Submit Proposals," 1-530), and possibly a designated SFDPH investigator as well.



• Projects that involve a CDC PI and a designated SFDPH investigator, but not a UCSF investigator (as defined above).

  APPLICATION NOTE: In these cases, the protocol, consent form(s), and ancillary documents should be developed jointly by the CDC PI and the other investigator(s).

The CDC PI is responsible for routing the protocol to the CDC Deputy Associate Director for Science (DADS), and then through the CDC IRB process (if needed). IRB review and/or determination should proceed as indicated below, according to the type of case.

IMPORTANT NOTE: CDC decisions on issues such as review category do not automatically apply at the local level. The UCSF PI may need to submit the protocol to the CHR for parallel determinations. If there is no UCSF investigator involved, the designated SFDPH investigator may need to submit the protocol to the CHR, depending on the circumstances (see Other CDC Review Options for SFDPH Investigators).

[Note: The above information applies to studies involving a cooperative agreement between CDC and UCSF and/or SFDPH. For other types of CDC-funded studies, e.g., investigator-initiated R-01 research, the PI should check funding agency instructions and policy as usual.]

CDC and Institutional Review Board (IRB) Determinations

Research vs. Non-Research (Public Health Practice)

The first issue for the investigator to consider is whether a project constitutes public health research or public health practice (non-research).

The CDC provides much useful guidance on the issue in CDC OADS Newsletter, “Defining Research and Non-Research" 4/02, and CDC Guidelines for Defining Public Health Research and Public Health Non-Research (10/99), including a chart, “Guidance for Compliance with 45 CFR 46 in Classifying Public Health Activities” (6/99).

Problematic cases: If the investigator has consulted the CDC guidelines carefully but is still unsure which category the project fits, he/she should seek guidance or a determination on the matter from the CDC.

If the study does not involve CDC (i.e., it is neither funded by nor includes any investigators from the CDC), the UCSF or SFDPH investigator may contact the Director of the UCSF HRPP office (415-476-1814) or the Director of SFDPH (415-554-2500) for advice.

1) Research: The CDC will generally make this determination for projects that:

• Fit the regulatory definition of “research” (see guidance chart above);



• Are designed with the primary intent of generating new and generalizable knowledge;



• Follow scientific principles and methodology to test/generate hypotheses.

2) Non-research: The CDC will generally make this determination for projects that fall into the following categories:

• Program evaluation



• Surveillance



• Emergency response/disease control and prevention activity.

3) Mixed public health practice/research: Some projects are a combination of both types of activity (e.g., data are gathered as part of routine practice and then used by CDC for research purposes). According to CDC policy, IRB review and institutional assurances are not required for routine public health practice at the local site, even when human subject regulations apply to CDC personnel using the derived data for research purposes.

Routing after CDC Research/Non-Research Decision

Once the CDC PI has submitted the protocol to the CDC DADS office and the research/non-research determination has been made, the protocol must be correctly routed to complete review. Routing will depend on the research or non-research decision, whether or not a UCSF principal investigator is involved, and several other factors, as explained below. Please note:

• If the CDC makes a “non-research” determination for the entire protocol, no further CDC IRB or CHR review is required.



• The CDC may decide that an element of a protocol otherwise determined to be non-research still requires IRB review (e.g., HIV incidence surveillance).



• See Flow Chart for Collaborative Protocol Review-CDC/ UCSF/ SFDPH for overview of routing process/options.

Joint CDC and UCSF IRB (CHR) Review

CDC-funded protocols determined to be “research” require review by the CDC IRB (unless the CDC agrees to defer to another IRB—see below) and the local institution’s IRB (in this case, UCSF’s Committee on Human Research, CHR). The CDC IRB review should be conducted first.

Level of review: Applications may qualify for exempt certification, expedited review, or full committee review with the CDC or the UCSF IRB (CHR) (see criteria guidelines for CDC, pp. 28-36 and UCSF CHR). While the CDC IRB and the CHR often agree on such decisions, one IRB may require a lower or higher level of review than the other. If there is any question about appropriate level of IRB review for a given protocol, the PI should defer to the higher level of review.

Modification or amendments before or after approval: Any changes to the protocol or supplementary documents required by one IRB during review need to be submitted to and approved by the other IRB. Any changes proposed for an active protocol need to be submitted to and approved by both IRBs.

Continuing review/renewal: Each institution must perform annual continuing review of the research and submit documentation to the CDC Procurement & Grants Office for funded studies or the CDC Assurance Coordinator for non-funded studies. (See CDC guidelines, pp. 29-32 and “Applying to the CHR” guidelines regarding renewal applications).

IMPORTANT NOTE: A final decision on any joint application—initial review, amendment or renewal—must be approved by both IRBs prior to implementation.

Deferral of CDC IRB Review to UCSF IRB (CHR)

There are two types of situations where the CDC may defer to local IRB review.

1. Prospective Review. The CDC may determine that the protocol is research but that review can be deferred to the local IRB (UCSF’s CHR), provided all of the following criteria are met:
   • CDC’s role is limited (e.g., the P.I. is not an employee, contractor, visiting scientist or fellow of CDC);
   
   
   
   • CDC investigators do not have direct interaction with study participants or have access to individually identifiable data from the study;
   
   
   
   • The study involves no more than minimal risk and does not address a controversial or sensitive topic (e.g., illegal behaviors, sexual activity, psychiatric illness; a vulnerable population per 45 CFR 46);
   
   
   
   • The study will be reviewed by the IRB of an organization that has an Assurance from the DHHS Office for Human Research Protections (OHRP) and is responsible for participant recruitment; and
   
   
   
   • The study has not begun.

   In this case, the CDC Deputy Associate Director for Science prepares an IRB Authorization Agreement for an Individual Protocol (AAIP) to be signed by the UCSF institutional official or designee. (The CHR keeps the original of the signed AAIP and sends a copy to the CDC.)

2. Retrospective Review. The CDC may decide to defer review to an outside IRB when CDC investigators are invited to participate in a research project that has already been initiated, provided all the following criteria are met:
   • The institution to which the CDC defers holds an OHRP Assurance;
   
   
   
   • The outside IRB provides ongoing monitoring of the study at all participating sites and submits documentation of amendment approval, review of adverse events, and continuation of the protocol to the CDC on a periodic basis (the latter not to exceed yearly on the date of annual review);
   
   
   
   • All other conditions for reliance on another IRB are met; and
   
   
   
   • The investigator provides clear justification as to why the protocol was not submitted for CDC review prior to initiation of contact with subjects.

Other CDC Review Options for SFDPH Investigators

The CDC offers two other options to avoid multiple IRB reviews when possible. According to the terms of the SFDPH’s Federal-Wide Assurance (FWA), designated SFDPH investigators may seek one of these options as appropriate, provided they obtain prior permission from the Director of the SFDPH.

1. Local IRB deferral of IRB review to CDC: The CDC will consider a request from an outside institution to defer protocol review to the CDC IRB.



2. Central CDC-IRB review: Cooperative research projects involving more than one institution (multi-site protocols) may be eligible for central CDC IRB review only, if the local institution chooses that option. The local sites retain the ability to review any amendments at the local level when needed.

   IMPORTANT NOTE: Currently, UCSF does not allow either of these options for protocols involving UCSF investigators

CDC Funding

The CDC may fully or partially restrict funds for human subjects research pending approval from all necessary IRBs. Deferred funds are not available for use until a separate notification of award of the funds is made to the institution.