ICCVAM conducts interagency technical reviews of proposed new, revised, and alternative test
methods and coordinates issues across agencies relating to the validation, acceptance, and
national and international harmonization of toxicological test methods. ICCVAM places
priority on test methods that may improve predictions of adverse human, animal, or
ecological effects and to those that may reduce, refine, or replace animal use.
Advancement of a proposed test method from concept to regulatory acceptance involves
a number of stages. The ICCVAM Test Method Evaluation Process addresses the
critical stage of independent evaluation of the validation status (i.e., the usefulness
and limitation of the test method for a specific purpose), including independent scientific peer review. This process is
illustrated in the table below.
Evaluation Stage |
Action |
Receipt of Nomination or Submission of Test Method by ICCVAM for Evaluation |
- Sponsor submits test method nomination or submission
- ICCVAM drafts recommended review activity and priority
- ICCVAM solicits additional data, peer panel nominations, and comment from public
- Opportunity for public comment
- SACATM meets in public session and comments on ICCVAM recommendation of review activity and priority
- Opportunity for public comment
- ICCVAM decides on test method review activity:
- Peer review
- Workshop
- Expert panel
|
Prepare Draft Background Review Document (BRD) and Test Method Recommendations |
- ICCVAM Working Group (with ECVAM and JaCVAM liasons) prepares:
- Draft BRD with all available data
- Draft test method recommendations including:
- Uses and limitations
- Protocol
- Performance Standards
- Additional Studies
- ICCVAM distributes draft BRD and test method recommendations to Independent Peer Review Panel ("Panel"), and
also makes these available to public
- Opportunity for public comment
|
Conduct Independent Peer Review |
- Independent Peer Review Panel meets in public session, and comments on draft BRD and draft test method recommendations
- Opportunity for public comment
- Independent Peer Review Panel prepares and releases report
- Opportunity for public comment
- SACATM meets in public session and comments on draft BRD, draft test method recommendations, and Panel report
- Opportunity for public comment
|
Prepare and Transmit Final Test Method Recommendations |
- ICCVAM considers Panel report, and SACATM and public comments
- ICCVAM approves final BRD and test method recommendations
- ICCVAM transmits final recommendations to Federal agencies (through the Secretary of Health and Human Services or his/her
designee)
- Federal agencies/International organizations (e.g., ISO, OECD, UN, ICH) consider
ICCVAM recommendations and make acceptance decisions
|
Test Sponsors are industry or government entities or other ICCVAM stakeholders that may make nominations or submissions to ICCVAM. Nominations or submissions
can consist of a request for a review of proposed test methods,
a request for ICCVAM comments on pre-validation/validation studies, or a proposal for a workshop with appropriate rationale.
View more information about test method Nominations and Submissions
ICCVAM Working Groups are groups of government scientists with appropriate scientific and regulatory expertise that are assembled
by ICCVAM to evaluate the test method. The working group works with NICEATM to prepare a comprehensive draft BRD on the
test method under consideration. This draft BRD provides the rationale and scientific basis for use of the test method,
components of the test method protocol, and descriptions of substances used to evaluate the test method and comparable in vivo reference data.
The draft BRD contains information submitted by the sponsor in support of the nomination or submission. It may also contain relevant data submitted
by other interested parties, information on use of the test method obtained from searches of the scientific literature, analyses of accuracy and
reliability of the test method, and discussions of animal welfare considerations and other parameters, such as time, cost and infrastructure
requirements, to be considered when putting the test method into practice. The ICCVAM working group, working with NICEATM, considers the draft
BRD as it develops draft recommendations on the use of the test method.
Independent Peer Review Panels are composed of research scientists, clinicians, test method developers, statisticians, and other
professionals with relevant expertise, drawn from industry, academia, animal welfare organizations and regulatory entities that are
normally other than those represented on ICCVAM. ICCVAM’s goal is for its Peer Review Panels to have an international scientific
composition representing the viewpoints of all interested parties in consideration of the test method. The Peer Review Panel meets
in public session, and comments from the public are welcomed during the meeting.
|