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Levels of Review

Applications submitted to the HSPC may undergo one of two levels of Committee review or the OPRS may make a determination of exemption from HSPC review. The two committee review levels are:

1. Full Committee
2. Expedited

Full Committee Review

Most protocols submitted to the HSPC require full Committee review. Please note that this level of review usually takes a minimum of 21 days from the date ofsubmission until the Committee identifies necessary clarifications and modifications. In the event that no additional information or modification is required, the HSPC mayapprove a study within this time period. Investigators should be aware that initial Committee review most often does not result in outright approval of the research.

The HSPCs perform a detailed examination of the protocol, informed consent form, and all supporting documentation, including any questionnaires or survey instruments. Consideration, discussion, and a vote regarding the proposed research must occur during a properly convened meeting of an HSPC. Results of Committee decisions are reflected in correspondence sent to investigators within approximately ten working days following the HSPC meeting. Letters sent to investigators will justify any conditions required for approval, may request additional information, and will indicate the next step in the review process.

The HSPCs may come to one of four determinations regarding an application:

1. Approved without questions or requests for modifications;
2. Acceptable with requests for clarification and/or modifications. The Committee will draft correspondence to investigators requesting clarification of minor points and/or modifications to the informed consent form. An investigator’s response to HSPC correspondence may be approved by a designated Committee member or sub-committee without review by the full Committee. The designated member or sub-committee may not disapprove a response, instead, they may request additional information from the investigator or refer the response to the full Committee for review ;
3. Deferred. Studies are deferred when the HSPC has substantive concerns or significant requests for clarification. Responses to HSPC correspondence in this category must return to full Committee for deliberation.
4. Disapproved.

Investigators have the right to discuss HSPC requests for revision and decisions of disapproval directly with the Committee. The HSPC, however, retains the final authority for approval of proposed research with human subjects.

The Committee review process allows investigators various levels of appeal from the time a study receives initial review through approval or disapproval. Any and all HSPC decisions are contingent upon the response of the investigator. If the Committee finds that the negotiation is at an impasse, they may request an intramural and/or extramural independent consultant review. The HSPCs wish to respect the investigator’s intellectual property, therefore, prior to assigning a consultant, investigators are asked if there is anyone they would NOT like to review their study.

NOTE: Written responses to HSPC correspondence should be submitted directly to the OPRS. Materials for the HSPC are only reviewed in the OPRS. Submitting HSPC materials to any office other than the OPRS will lead to a delay in the review process and may lead to the loss of the submission.

HSPC Meetings

When submitting a study for full Committee review, investigators should allow enough lead time for processing of the human subjects application by the OPRS prior to the HSPC meeting. The OPRS staff log-in each submission and check to ensure it fulfills all of the application requirements. The staff will inform investigators by telephone and letter if the application is missing elements. All complete applications are copied and distributed to the Committee. A thorough and intelligent analysis of the application requires that each Committee member receive a complete set of materials to review prior to the meeting. A typical meeting agenda includes at least thirty discussion items. The members receive materials six to eight days prior to the scheduled meeting.

Investigators should be aware that it may take at least three weeks from submission to Committee review to initial correspondence. Since many sponsors require HSPC approval prior to consideration of proposals for funding, researchers are strongly advised to prepare their HSPC applications concurrently with their submissions for funding.

Investigators are urged to contact the OPRS regarding HSPC submission deadlines and the current HSPC meeting schedule. Usually, Medical HSPC meetings are conducted weekly on Wednesdays at 3:00 p.m. Usually, the General Campus HSPC convenes twice a month on the second and fourth Monday at 3:00 p.m. The Committee meetings last approximately three and a half hours. Typical meetings include discussions of new, continuing, and renewal applications, amendments to approved projects, reviews of adverse events, complaints from subjects, and possible violations. The Committees also discuss current ethical issues, new regulations, and national trends in the field of human subject research.

Expedited Review

Expedited review as defined by 45 CFR 46 allows an individual Committee member or a designated sub-committee of an HSPC to evaluate and approve specific types of research. All studies received by the HSPC are evaluated for possible expedited review. Research that involves no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories may receive expedited review. Reviewers conducting an expedited review may exercise all of the authority of the HSPC except that they may not disapprove a study. When a reviewer or sub-committee cannot approve the research under expedited review, the study is referred to the full Committee for review at the next scheduled meeting. Investigators should note that some of the expedited review categories may not apply to "vulnerable" populations, such as pregnant women, in vitro fertilization, children, prisoners, or mentally incompetent persons. (Please see Chapter 8, "Special Classes of Research Subjects," for an explanation of vulnerable populations.)

Interim requests or addenda, submitted between scheduled continuing reviews, that involve only minor changes in previously approved protocols or minor changes in consent forms also may qualify for expedited review. Only 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.

Investigators will receive written notification of HSPC action resulting from an expedited review. Such action may include approval or a request for further information. All research approved under expedited review must receive ratification during a legally convened meeting of the full Committee.

The categories eligible for expedited review in accordance with 45 CFR 46.110 are:

1. Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth and permanent teeth if patient care indicates a need for extraction.
2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
3. Recording of data from subjects 18 years of age or older using non invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic exhography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week from subjects 18 years of age or older and who are in good health and not pregnant.
5. Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of teeth and the process is accomplished in accordance with accepted prophylactic techniques.
6. Voice recordings made for research purposes such as research of speech defects.
7. Moderate exercise by healthy volunteers.
8. The study of existing data documents, records, pathological specimens, or diagnostic specimens.
9. Research on individual or group behavior or characteristics or individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.