Expedited Procedures

Bob CraigJune 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

CriteriaNo more than minimal risk to

participantsNo “classified” research.Identification of participants would

not place them at social or legal risk

Proceduresfor 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 1200.5 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