The guidance is on the OHRP website under "Guidance on Research Involving Coded Private Information or Biological Specimens". We have also had to revise a submission due to indicating use of de-identified secondary data as human subject research exempt under category 4. We had to revise and resubmit the face page, checking "no" to human subjects, and redo the human subjects section - this was not a grants.gov submission so was all mailed paper copies. I think it's great to see they are following their own guidance! Sharon McWhorter Interim Director Research Services and Sponsored Programs The University of Akron Akron, OH 44325-2102 -----Original Message----- From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of Anna Dore Sent: Friday, June 02, 2006 9:19 AM To: xxxxxx@HRINET.ORG Subject: Re: [RESADM-L] Human subjects e-applications to NIH That's interesting! Do you know where I can find that policy? The proposal in question does indeed fall into category 4. The NIH G.g application guide says nothing about this, though it does specify that human subjects research in category 4 is not "clinical research" and so it doesn't require the information about inclusion of women, minorities, children, etc. Using the exemption application makes perfect sense - thanks for the idea. Anna -----Original Message----- From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of Elsa Nadler Sent: Thursday, June 01, 2006 4:25 PM To: xxxxxx@HRINET.ORG Subject: Re: [RESADM-L] Human subjects e-applications to NIH You need to be careful about what you call human subjects research. I found out only recently that NIH no longer considers research with publicly available datasets--what used to be category 4--to be research with human subjects. I think this also includes deidentified data, but I can't find the file I was looking for. So...if you are using that kind of data, you would answer "no" to the question about human subjects. Other exempt research has an exemption approval attached to it (and we get a letter from an administrator), so I use that date if the research has been through some kind of administrative process and has been approved for exemption; otherwise approval is pending. Elsa >>> Anna Dore <xxxxxx@BC.EDU> 06/01/06 3:45 PM >>> I have a related question: When a project is exempt from IRB review, how do you answer the question "Is IRB review pending?" When I answer "No," the IRB approval date becomes a required field. I tried entering "N/A," but was told that it was an "invalid entry" - seems it will only accept a date. Ultimately, I answered "Yes" as that seemed my only option. The helpdesk hasn't responded adequately to my inquiry and the G.g application guide instructions don't address this either. Has anyone else encountered this dilemma? How have you handled it? Thanks so much for your replies, and all the information posted here daily. I've learned so much by just watching! Anna Dore Boston College -----Original Message----- From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of Patricia Byers Sent: Thursday, June 01, 2006 11:52 AM To: xxxxxx@HRINET.ORG Subject: Re: [RESADM-L] Human subjects e-applications to NIH We also got an warning message stating that our FWA number didn't match what was in the eRA Commons. The problem is that the field for this number on the application form is not long enough for the complete number. We left out one of the zeros in the middle thinking that this would be better than loosing the last number....and then just ignored the warning. Not a good solution, but we just didn't' now what to do. Pat Charlie Hathaway wrote: Help. What format should be used for the human subject assurance number (Item 1a, Research and Related Other Project Information) in PureEdge for an NIH proposal? We have discovered conflicting guidelines concerning inclusion or exclusion of the FWA prefix. When we left it out we got a warning. When we left it blank (by accident) there were no errors or warnings (??!! so helpful) Am about to keep the FWA but would like comments thanks Charlie Hathaway ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== -- Patricia Byers Contracts Manager SRI International 333 Ravenswood Avenue, BS-310 Menlo Park, CA 94025 PH: 650-859-3571 FAX: 650-859-3387 The information contained in this message is intended only for the use of the individuals or entity named above, and may contain information that is privileged, confidential, or exempt from disclosure. 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