For the past two years similar issues have been coming up in the lab about consent forms, filing etc. This is a preventative plan that should should be followed.
This wiki page will break down in sections of what issues have come up and what our preventative plan is. This is important so please read over carefully and keep in mind. Please reference back to this and make sure you and your RAs are following procedures.
Several regulatory documents were not present in the Drop Box
This is for the study coordinator. For every continuing review/ amendment :
- Create a new folder in dropbox under the respective protocol with the respective name, ie Continuing Review 6 or Amendment 13.
- Go to the amendment/ continuing review and click on Approval Letter : view, control P (on mac) and save letter as pdf. Upload into dropbox folder.
Any materials that were submitted (protocol, forms) put into the dropbox folder. For forms make sure they are the 'watermarked' copy.
- Currently working with IT to retrieve the previous items that we no longer have access to [check on this]
Inaccurate numbers for number of subjects
I think this has mostly been resolved. We have much better scripts for Mechanical Turk and a new system to store subjects who have come in for experiments by putting their information in RedCap. [See Experimental Guidelines for information about RedCap]
- Keep in mind to store the demographic information and number of subjects so you can easily give the information to the study coordinator.
- Properly train RAs, have the study coordinator do a semester training.
Errors in Properly Signing a Consent Form
We had issues last year [put more detail in here] and this year properly signing consent forms also came up.
- The standard date form is MM/DD/YYYY, Full name of the subject, and check over to make sure you have the right date.
Remember to sign the consent form immediately after the subject and filing it immediately after you have signed it. The extra 2 minutes will not interfere with your experiment
We will have the study coordinator go through 10% of a random sample of the consent forms and use the form [ConsentFormCheckList_MultipleConsents] found in the dropbox folder [or in the wiki if I figure out how to link it] in order to check that consent forms are being properly marked. This will be done on a monthly basis.
- Train and re train yourself and the RAs. Be conscious and don't speed through this process
RA signed a consent form when not on protocol
Standard procedure is now to add all RAs/ Grad Students to every protocol. This will minimize risk and avoid these problems when an RA decides to switch projects.