research in a clinic

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    Is a clinical research nurse able to practice as an RN as licensed, in a clinic that they have received privileges at, before the consents are signed outside of the protocol?
    also if during recruitment you have the pt. primary MD do a measurement to report the result back to you for inclusion exclusion purposes, you have a partial hipaa waiver, is that not recruitment of pt and that MD have to be on the DOA log?


    Im new to research and alot of it seems to be a shade of grey.
  2. 3 Comments so far...

  3. 0
    Quote from dhellwege
    Is a clinical research nurse able to practice as an RN as licensed, in a clinic that they have received privileges at, before the consents are signed outside of the protocol?


    I don't understand what you're asking here. Can you rephrase the question?

    also if during recruitment you have the pt. primary MD do a measurement to report the result back to you for inclusion exclusion purposes, you have a partial hipaa waiver, is that not recruitment of pt and that MD have to be on the DOA log?

    I don't know what a DOA log is, but are you asking if it's okay for an MD to report to you a patient's measurement to you as part of an inclusion/exclusion so that you know if they're eligible for approach? And does that mean that that MD who is reporting the info to you recruiting the patient? No, as far as I know, the MD is not recruiting the patient, he's simply asking permission for YOU to approach the patient. You would need to check with your IRB, but it's okay to receive de-identified information, such as a measurement, without the need for a HIPAA waiver.
  4. 0
    If you have a signed informed consent form, the measurement is okay to be reported back to you. Does this study have a screening consent form? If not, does the partial HIPAA waiver cover the doctor or medical group where the potential participant is a patient?If the PCP is doing a measurement as part of a potential participant's routine medical care, then the PCP does not need to be on the delegation of authority log. If the measurement is being done solely for study recruitment, and is not part of the participant's routine medical care, then the physician should be included on the DOA log, or the participant should be sent to a physician who is already listed on the DOA log, as long as there is no conflict.I know this question is over a month old, but did you just ask your CRA or monitor (if this is an industry-sponsored trial)? That would be the first source you should consult when you have questions that cannot be answered by reading the protocol.
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    i guess it is somewhat of a interesting area because best practice i suppose would be to measure the arm to make sure you are using the proper cuff size on all pts but I have never actually seen it in gen practice so they would be gathering and reporting simply for the fact of the study inclusion and ex. I feel like the monitors sometimes push things for the benefit of the sponsor reducing cost so I try to think on my own in addition to protect myself from the FDA. from what I understand our partial HIPAA waiver supports any data that has already been done on the pt that is related to the IN and EX. So I think we are in the clear on that.


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