CRAP with Patients

1.24 lab draws with vital signs in 24 hours

2.30 hour study - pts were expected to stay on site during study period; but were expected to sit in a chair while waiting for next round of labs

3.Pain study - pt had have a catheter put in their backs in one dept.; then needed to get an x-ray, in a different dept � in a different building. When asked how pt went from one place to another, their plan was to roll them down the street on a gurney.

4.Randomizing pts based on self-report rather than qualitative testing

5.Leaving out non-English speaking pts.

CRAP with Data

1.Physician-investigators who say they are going to do their own data entry.

2.Storing data on a �Sutter Network Drive� when, what they really mean a computer hard-drive.

3.For the data download in phase 1 of his study, I�ve asked for the prevalence of the disorders. He could request the number of patients (not the number of events) who have had these codes in a 6 month or 1 year period � best if it is 2008. This number will tell me if downloading information on all of those patients with personal identifiers is nearly the same as his calculated sample size. If he asked IT to download de-identified patient data to a PC, then this issue is less relevant.

4.No information provided on data storage, how long data will be stored or where, when destroyed and if so by who

General CRAP

1.Not clarifying what is research and what is standard of care. If standard of care (SOC) is to call patients using these questions, then consent can be waived, even though these questions will be used in research. This would seem to be a yes or no question. If yes, then in the waiver application he can simply state that this is SOC and therefore consent is unnecessary. If no, he could argue that obtaining face-to-face consent is impractical due to the nature of the questions or the number of patients to be contacted.

2.Methods of informed consent - I really liked Kaiser's approach in the event a written consent is waived, to either require that the researcher: 1) send the patient a letter with a return addressed postage-paid opt out response card; or 2) send the patient a letter informing him/her of the study the telephone survey and the kinds of questions to be asked (no patient response will be necessary), then using language in the initial moments of the call to allow the patient a chance to decide if he/she wanted to participate in the telephone interview. These methods provide the patient with information about the study and the opportunity to decide if they want to be involved and spares the researcher the inconvenience or cost of face-to-face patient consent. If we decide that Dr. Mainwarring's study should receive a HIPAA waiver, then he could chose to use either of the Kaiser approaches and submit the letter to the patient, the opt card or the text for the interview introduction to the IRC.