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Modifications to Currently Approved Research (Addendum):

All modifications to currently approved research are required to have HSPC review and approval prior to implementation. Minor changes that do not increase the risk to research subjects may receive an expedited review. Modifications to approved protocols that may affect the risk to subjects are forwarded to the full Committee for review. (Please see Chapter 3, "The HSPC Review Process" for information regarding expedited review.) Please include the HS Form 1, a cover letter explaining the requested modifications, and any modified items such as consent forms, protocols, investigator brochures, study instruments, recruitment tools, etc., with the application.

An addendum may require full Committee review if the modification is significant and impacts the risks and benefits to subjects in the research. Changes in the risks or benefits to subjects may require modifications to the consent form and re-consenting of subjects.

The HSPCs may only approve modifications submitted during a current approval year to the end of that period. For example, if the new, renewal, or continuing approval is issued on January 1, 1997 it will have an expiration date of December 31, 1997. If an addendum is approved during this time, the approval still lasts only until December 31, 1997. Please incorporate all modifications and addendums into the continuation application, protocol, and when applicable the informed consent forms for HSPC consideration during the annual review.

Changing Investigators:

When changing investigators, please include an HS Form 1, and a letter from the principal investigator indicating the change in responsibility and a letter from the new investigator accepting responsibility for the research. Changes in investigators usually qualify for expedited review.

Continuation Review:

The federal regulations do not allow an HSPC to approve a study for more than one year. For multi-year research, the principal investigator is responsible for submitting a continuation application prior to the expiration of the current HSPC approval. The OPRS mails a continuation application to investigators 90 and 60 days prior to the expiration of the current HSPC approval. If the approval expires prior to submission of the continuation application, the investigator is required to suspend subject contact and data collection until the continuation is approved by the HSPC. For therapeutic studies where subject safety is a concern, the FDA allows some flexibility towards the continued treatment for currently enrolled subjects. However, no new subjects may be contacted, recruited, or enrolled until the investigator obtains current HSPC approval.

The continuation application should incorporate all of the addenda and modifications submitted to and approved by the HSPC during the previous approval periods. Please include a cover letter indicating the modifications to the study during the previous approval period.

Continuing review and approval is necessary if recruitment of subjects stops but previously enrolled subjects continue to participate in the research or the study is in data analysis at UCLA.

Renewal:

Many studies undergo numerous modifications during the first four years of research. As a result, the HSPCs require a renewal application or the equivalent of a new application at the fifth year of any continuing research.

Completion/Termination:

In order to formally complete a study file, the HSPCs request that investigators officially notify the OPRS when a study is terminated or completed or after data analysis is complete and submit the HS-8, Final Report Form when closing out a study.

Training Grants, Program Projects/Multiple Project Grants, Center Grants:

The federal regulations require that the Committees or their designee certify that human subject related research funded by an "overall" grant such as a training grant, program project, multiple project grant or center grant have current HSPC approval. Please submit one copy of the following:

1. applicable sections of the Form HS-1;
2. the grant application;
3. a cover letter indicating that no funds will be transmitted to the individually supported sub-projects proposing to conduct research with human subjects until the sub-projects have received current approval from the HSPC; and
4. a list of all the human subject related projects supported by the grant. The list should include the following:
   1. The name of the principal investigator(s);
   2. The HSPC numbers of the project(s);
   3. The title of the project(s);
   4. The current approval periods for the project(s).

The HSPCs have delegated certification authority to the OPRS. As a result, the OPRS will certify whether the human subject related projects under the "overall" grant have current approval and perform an administrative approval of the funding submission. BECAUSE THE "OVERALL" GRANT IS INTENDED TO FUND THE SUB-PROJECTS, NO HUMAN SUBJECTS CAN BE ENROLLED IN THE "OVERALL" GRANT. (Please see Chapter 12, "Application Forms: Form HS-1, Application to Involve Human Subjects in Research, Section II(4)" for the appropriate application materials.)