Frequently Asked Questions
1.What qualifies as research? Research is defined as “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
2. What is a Human Subject? A Human Subject is defined as “A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through Intervention or Interaction with the individual, or (2) information that is both Private Information and Identifiable Information.”
3. Does my project need IRB review? If your project meets the regulatory definition of research and involves human subjects or obtaining private identifiable information about a human subject, YES your project requires IRB review.
4. Can we refer to the risks section of the informed consent when completing the investigator study plan? No, the risks section of the investigator study plan typically addresses the risks in greater detail. The risks section of the informed consent is typically tailored to what the subjects need to know to provide informed consent.
5. What should we do if a Sponsor requests that all protocol deviations are submitted to the IRB? You can inform the Sponsor that the IRB policy regarding Reportable New Information requires that only the information listed in HRP-801 Investigator Guidance: Prompt Reporting Requirements is reported to the IRB. The form explicitly states that if it is not one of those categories, it does not require prompt reporting. Neither the Prompt Reporting Requirements nor the Continuing Review asks Investigators to report all protocol deviations.
6. How do I conduct a chart review that meets exemption category #4?
1) Create a data collection sheet with data recorded such that subjects cannot be readily identified from looking at the recorded data.
2) Create a separate identifier list the medical record numbers of the subject pool. This is only a list of identifiers. No other information.
3) Get the existing records for one, some, or all subjects.
4) Take a random medical record number, look at the records, record the information on the data sheet, do all verification at this time, and then mark on the identifier list that the subject is done.
5) Repeat step (4) for all subjects.
In the end, you will have a list of medical record numbers, a separate list of data, and no link between the identifiers and the data. Note that the investigator will not be able to go back and verify the accuracy of the data. It all has to be done in one pass.
7. How do I close out a study in eIRB?
In order to close out human research, you must create and submit a Continuing Review application in eIRB and indicate the applicable protocol status. For more information about the obligations of individuals who conduct human research, refer to the Investigator Manual.
8. Do I need to use the stamped version of the consent form with research subjects?
Yes, stamped consent documents included with an IRB approval must be used. The IRB approval stamp for research that documents consent in writing will include the following watermark in the footer: Approved UMass Medical school IRB Do not sign this form after this date: mm/dd/yyyy.
1. What do I do if study staff, study Sponsor, Location, Drug, Disease/Condition, etc. is not listed in the drop down menu?
From the IRB website, select eIRB Data Request. Click the appropriate hyperlink to access the web form to request the user or data to be added. Please include as much information as possible where applicable, such as the sponsor web address and drug reference or ID number.
Once the form is submitted and verified, you will be notified that the user or data has been added to eIRB.
Click here to access to the forms http://www.umassmed.edu/ccts/irb/access
2. How can I update my personal information in eIRB? Log into eIRB, click on your name in the upper right corner to access your profile and update your information.
3. What Web Browsers support eIRB? You may experience difficulty using the system if you are using a Web Browser other than the following:
Microsoft Windows XP, Vista, 7, 8, Server 2008 R2, and Server 2012
Internet Explorer: versions 8*, 9, 10, and 11
Apple Mac OS X 10.6, 10.7, and 10.8
Safari: 5 or 6
|Apple iOS 5, 6, and 7 (iPhone and iPad)||Safari|