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So what do you actually *do* all day?
8:30 Mark time on time sheet. Check phone messages, check Palm Pilot schedule, check work e-mail. Two-page message from someone at the IRB [Institutional Review Board; aka the Human Subjects Committee]. The project for which we submitted a modification request, which used to be exempt from IRB review, is no longer exempt under the new rules. Print out message for later reference.
8:35 http://mywashingtonpost.com
8:50 "This program has performed an illegal operation and will be shut down. There has been an internal error. We recommend that you save your work and restart your computer." Restart. Add new items to Palm Pilot to do list: "Contact IRB re NARA" [Nonadherence Risk Assessment - that's the project we're trying to modify]. "Biodisparity paper in final form."
8:55 http://mywashingtonpost.com
9:30 Get lost trying to navigate the IRB website to figure out what we need to do now. Call Angela at the IRB office. Long conversation in which she explains that because the project used to be exempt and isn't anymore, we can't file a [relatively simple] modification request by e-mail. We need to submit 18 hard copies of a new project request instead. If only we didn't need to make any changes, our exemption would continue to be grandfathered in. Think negative thoughts about Stacey, who wrote the original protocol and forgot to specify that we wanted to review medical records. At least Angela at the IRB has good advice about things to change and/or include to get the damned thing passed.
10:15 Call over to radiation oncology to find out if today's research subject is ready. They have no idea who I'm talking about. Try to track her down.
10:40 Discover that research subject is in the Cardiac ICU. Decide not to try to collect any data today.
10:45 E-mail Lydia with bad news about the IRB debacle. Add new item to Palm Pilot to do list: "Revise & resubmit IRB forms by 8/24." Call Angela back with questions and leave a message. Hunt for IRB forms on lab computers.
11:00 Modify IRB proposal according to Angela's advice.
12:00 Print out modified RPN [Research Project Notification] form. Enjoy short-lived feeling of satisfaction.
12:10 In reviewing RPN, discover that because this is now considered a "new project," it will need to be certified by our department as "scientifically valid" and signed by the department chair. That would be the psychiatry department, which hates us. Become despondent.
12:15 E-mail Lydia with worse news about scientific review. Makes some suggestions about how to handle it. Harbor extremely dark thoughts about Stacey for not specifying that we wanted to review medical records in her original proposal.
12:30 Go to lunch with Bill. Drown sorrows in Indian food.
1:30 Return to find "where are you" e-mail from Lydia. Discuss muddled IRB situation with her. Receive instructions to re-modify modified RPN, involving complicated measures to assure confidentiality.
2:10 Remodel RPN to Lydia's specifications. Develop Data Extraction Form, which Angela assures me will be required for review. All it is, is a form with spaces on it to enter the data we intend to extract from the medical record. Obviously this is a critical human subjects issue.
2:50 Show Data Extraction Form to Lydia. Notice error. Get stylistic suggestions from Lydia.
3:00 Revise form, return it to Lydia, strategize about how to get the damned thing signed by the department. She disappears with it, looking for the division head.
3:10 Review the Lancet's publication guidelines and start making a list of things that need to be changed.
3:15 Angela from the IRB calls back to answer my questions. Fortunately the answers don't mean any additional work.
3:25 Lydia sends Lauren [the intern] over to Donna's [the cafe] to buy chocolate and caffeine for all. Lauren brings me back a big cookie and an iced coffee. Decide that she's my new best friend.
4:00 Finish list of things that need to be changed for the Lancet and start working on the cover letter. Discover that Lydia wants to submit the paper to the London office instead of the New York office, which means that I have to Britishize all the spellings. Discover that changing the "language" setting in MS Word does not apparently adjust the spellchecker. Go back to working on the cover letter. "We are pleased to submit for your consideration..." Spell "behavioural medicine" with a "u." Make up an author statement form ("...and I declare that I have no conflict of interest...") and sign it. Give it to Lydia so she can chase down Big Red and make him sign it too.
5:15 E-mail cover letter to Lydia. Mark time on time sheet. Shut down the computer. Run into her in the hall. She appears mildly dismayed that I'm not staying to make the final changes to the paper. Set firm boundaries. Mark items "done" in to do list: "Contact IRB re NARA" "Make NARA data entry form" "Revise IRB forms." New item: "E-mail Nonna about ink jet." Go out into the courtyard to read Mansfield Park and wait for Misha.
8:35 http://mywashingtonpost.com
8:50 "This program has performed an illegal operation and will be shut down. There has been an internal error. We recommend that you save your work and restart your computer." Restart. Add new items to Palm Pilot to do list: "Contact IRB re NARA" [Nonadherence Risk Assessment - that's the project we're trying to modify]. "Biodisparity paper in final form."
8:55 http://mywashingtonpost.com
9:30 Get lost trying to navigate the IRB website to figure out what we need to do now. Call Angela at the IRB office. Long conversation in which she explains that because the project used to be exempt and isn't anymore, we can't file a [relatively simple] modification request by e-mail. We need to submit 18 hard copies of a new project request instead. If only we didn't need to make any changes, our exemption would continue to be grandfathered in. Think negative thoughts about Stacey, who wrote the original protocol and forgot to specify that we wanted to review medical records. At least Angela at the IRB has good advice about things to change and/or include to get the damned thing passed.
10:15 Call over to radiation oncology to find out if today's research subject is ready. They have no idea who I'm talking about. Try to track her down.
10:40 Discover that research subject is in the Cardiac ICU. Decide not to try to collect any data today.
10:45 E-mail Lydia with bad news about the IRB debacle. Add new item to Palm Pilot to do list: "Revise & resubmit IRB forms by 8/24." Call Angela back with questions and leave a message. Hunt for IRB forms on lab computers.
11:00 Modify IRB proposal according to Angela's advice.
12:00 Print out modified RPN [Research Project Notification] form. Enjoy short-lived feeling of satisfaction.
12:10 In reviewing RPN, discover that because this is now considered a "new project," it will need to be certified by our department as "scientifically valid" and signed by the department chair. That would be the psychiatry department, which hates us. Become despondent.
12:15 E-mail Lydia with worse news about scientific review. Makes some suggestions about how to handle it. Harbor extremely dark thoughts about Stacey for not specifying that we wanted to review medical records in her original proposal.
12:30 Go to lunch with Bill. Drown sorrows in Indian food.
1:30 Return to find "where are you" e-mail from Lydia. Discuss muddled IRB situation with her. Receive instructions to re-modify modified RPN, involving complicated measures to assure confidentiality.
2:10 Remodel RPN to Lydia's specifications. Develop Data Extraction Form, which Angela assures me will be required for review. All it is, is a form with spaces on it to enter the data we intend to extract from the medical record. Obviously this is a critical human subjects issue.
2:50 Show Data Extraction Form to Lydia. Notice error. Get stylistic suggestions from Lydia.
3:00 Revise form, return it to Lydia, strategize about how to get the damned thing signed by the department. She disappears with it, looking for the division head.
3:10 Review the Lancet's publication guidelines and start making a list of things that need to be changed.
3:15 Angela from the IRB calls back to answer my questions. Fortunately the answers don't mean any additional work.
3:25 Lydia sends Lauren [the intern] over to Donna's [the cafe] to buy chocolate and caffeine for all. Lauren brings me back a big cookie and an iced coffee. Decide that she's my new best friend.
4:00 Finish list of things that need to be changed for the Lancet and start working on the cover letter. Discover that Lydia wants to submit the paper to the London office instead of the New York office, which means that I have to Britishize all the spellings. Discover that changing the "language" setting in MS Word does not apparently adjust the spellchecker. Go back to working on the cover letter. "We are pleased to submit for your consideration..." Spell "behavioural medicine" with a "u." Make up an author statement form ("...and I declare that I have no conflict of interest...") and sign it. Give it to Lydia so she can chase down Big Red and make him sign it too.
5:15 E-mail cover letter to Lydia. Mark time on time sheet. Shut down the computer. Run into her in the hall. She appears mildly dismayed that I'm not staying to make the final changes to the paper. Set firm boundaries. Mark items "done" in to do list: "Contact IRB re NARA" "Make NARA data entry form" "Revise IRB forms." New item: "E-mail Nonna about ink jet." Go out into the courtyard to read Mansfield Park and wait for Misha.