Expedited Procedures Bob Craig June 2008

Expedited problems Usually individual investigators (rather than trained coordinators) Individuals not “ active researchers ” Because “ no more than minimal ” risk, both investigators and IRB reviewers may consider it to be not as important as full-board protocols.

Criteria for research by the expedited procedure Criteria No more than minimal risk to participants No “ classified ” research. Identification of participants would not place them at social or legal risk

Procedures for Review Must be one or more experienced IRB members to review in depth. All IRB members should review the full protocol and proposed changes. Use check list provided until incorporated into BRAAN II. May not disapprove the research

Requirements for consent Standards for informed consent (or its waiver, alteration, or exception) are the same for expedited procedure as for full-board.

Categories of research that may be reviewed by expedited procedure MINOR CHANGE ASSESSMENT Yes No The changes do not result in a more than minimal increase in risk. The regulatory definition of “ minimal risk ” is that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Yes No The changes do not involve the addition of procedures outside of categories (1)-(7) below.

Category 1 Research on medical devices in which an IDE is not required or if the device is approved for marketing and it is used in accordance with its labeling.

Category 2 Blood Samples Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non- pregnant adults where: The participants weigh at least 110 pounds; AND The amounts drawn will not exceed 550 ml in an 8-week period; AND Collection does not occur more frequently than 2 times per week. There are other amounts and frequency for participants weighing less than 110 pounds.

Category 3 Prospective collection of biological specimens for research purposes by noninvasive means.

Category 4 Collection of data through noninvasive procedures routinely employed in clinical practice where: The procedures do not involve general anesthesia or sedation; AND The procedures do not involve x-rays or microwaves; AND If medical devices are employed, they are cleared/approved for marketing.

Category 5 Research involving materials (data, documents, records, or specimens) that have been collected; OR Research involving materials (data, documents, records, or specimens) that will be collected solely for non-research purposes (such as medical treatment or diagnosis).

Category 6 Collection of data from voice, video, digital, or image recordings made for research purposes

Category 7 Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior).

Categories 8a, 8b, 8c 8a The research is permanently closed to the enrollment of new participants; AND All participants have completed all research-related interventions; AND The research remains active only for long-term follow-up of participants. 8b No participants have been enrolled; AND No additional risks have been identified. 8c. The remaining research activities are limited to data analysis.

Category 9 Medical Devices The research is not conducted under an investigational new device application (IDE); AND The IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Regulatory criteria Research meets the regulatory criteria for approval. (Use checklist for regulatory criteria)

Continuing review Must determine if any changes have occurred that alter risk to participants Must determine if need to review in less than 1 year. Must meet regulatory criteria for approval.

Amendments Proposed changes must not result in greater than minimal risk. Proposed changes do not involve the addition of procedures outside of approved categories. Meets regulatory criteria for approval.

Expedited research - VA VHA Handbook states that approval for VA research conducted by the expedited procedure is effective only after approval by the VA R&D Committee

Expedited research & BRAAN II Problems that we have observed 1. Not all boxes filled out Information on facilities Risks (yes or no) Privacy Coercion Children Recruitment not explained Procedures not step-by-step 2. Nonsense in boxes Investigators put in something to allow them to go on.

Expedited problems 3. Redundancies in boxes Fail to remove instructions

BRAAN II Consequences These errors, if allowed to continue, will give the impression to auditors that no one looked at protocols and that they were, for all intents and purposes, approved without a complete review.

BRAAN II Summary Investigator did not read or follow directions. Staff put too much reliance on PI and IRB and did not check to make sure boxes were filled in IRB either did not notice or chose to ignore blank boxes and nonsense in boxes.

Solution Specific training to investigators about filling out protocol and consent form in BRAAN II Better instructions in BRAAN II Research Compliance staff will check more thoroughly IRB members must also check to make sure each obligatory box is filled in correctly.

Finis