Confused about Informed Consent and IRB, could anyone help me??

[libraryismyhome]

I am working on a clinical research project. One of FDA approved instrumentation collects the data from patients, and I devised my project to compare and differentiate patients with different neurological diseases.

Previously, I was informed from my Mentor A that I don't have to have IRB approval cause his project was already approved. But my mentor B tells me that I must have IRB approval specifically for my project and informed consent from patients. What is going on?? 😕 The data I am using are deidentified.

Due to the fact that we don't have enough patients with these diseases I am working on, my Mentor B suggests to make this as a multi-consortium study and gather more patients in different facilities. Now Mentor A tells me that these different facilities must be approved by IRB as well, and I must get an IRB approval for multi-consortium study. Yesterday, I visited one of IRB office coordinators, and with her disparaging attitude, she tells me that if I don't obtain patient consent, she won't help me with IRB and threatens me that she will report me for trying to work on a project without getting patient consent. In addition, doing multi-consortium study will cost money and I would need to get informed consent from patients in different facilities as well. (even if it's deidentified??)

Could you help me resolve confusion? I still believe that working on a clinical research project is a great learning opportunity, but this is very confusing to me. 😀

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[kryptonian]

Previously, I was informed from my Mentor A that I don't have to have IRB approval cause his project was already approved. But my mentor B tells me that I must have IRB approval specifically for my project and informed consent from patients. What is going on?? 😕 The data I am using are deidentified.

I think what your Mentor A meant is that he already got IRB's approval and hence you do not need to deal with IRB anymore. On the other hand, your Mentor B probably has generically advised you that you have to have IRB approval and Informed Consent Form ready before beginning the study. In general, before one can begin any study, IRB has to approve every aspect of the protocol, including the design and the content of Informed Consent Form.

Due to the fact that we don't have enough patients with these diseases I am working on, my Mentor B suggests to make this as a multi-consortium study and gather more patients in different facilities. Now Mentor A tells me that these different facilities must be approved by IRB as well, and I must get an IRB approval for multi-consortium study. Yesterday, I visited one of IRB office coordinators, and with her disparaging attitude, she tells me that if I don't obtain patient consent, she won't help me with IRB and threatens me that she will report me for trying to work on a project without getting patient consent. In addition, doing multi-consortium study will cost money and I would need to get informed consent from patients in different facilities as well. (even if it's deidentified??)

Now, as you have made some changes to the protocol (from one facility into multiple facilities), you need to get a new approval from IRB because of this change. IRB also needs to approve the new facilities because these might not qualify for the study. You probably will also need to revise your Inform Consent Form and get IRB;s approval on this new version as well.

I am not sure what happened when you met the IRB coordinator. In any case, the fact that your data are de-identified does not have anything to do with IRB approval or Inform Consent. Clinical data are required to be deidentified per HIPAA Privacy Rule. Consenting patient is required for every single subject before any study procedures can be carried out, regardless it is a study at a single facility or multiple facilities.

I hope this helps in some way. Good luck !

 

[libraryismyhome]

I think what your Mentor A meant is that he already got IRB's approval and hence you do not need to deal with IRB anymore. On the other hand, your Mentor B probably has generically advised you that you have to have IRB approval and Informed Consent Form ready before beginning the study. In general, before one can begin any study, IRB has to approve every aspect of the protocol, including the design and the content of Informed Consent Form.



Now, as you have made some changes to the protocol (from one facility into multiple facilities), you need to get a new approval from IRB because of this change. IRB also needs to approve the new facilities because these might not qualify for the study. You probably will also need to revise your Inform Consent Form and get IRB;s approval on this new version as well.

I am not sure what happened when you met the IRB coordinator. In any case, the fact that your data are de-identified does not have anything to do with IRB approval or Inform Consent. Clinical data are required to be deidentified per HIPAA Privacy Rule. Consenting patient is required for every single subject before any study procedures can be carried out, regardless it is a study at a single facility or multiple facilities.

I hope this helps in some way. Good luck !

Thank you!!!

 

[jissho]

I bet the IRB coordinator face palmed so hard after that meeting. 😀 I'm glad you got a good answer to your questions though.

 

[Ombret]

It sounds like you are not done with IRB approval for this cluster of projects. Do not neglect this; a botched IRB could make you and your mentors look bad and could make your life needlessly complicated when you try to complete the projects.

Without knowing or necessarily wanting to know more details, I suspect that your mentors (presumably the PIs of these projects) need to get involved more closely in the IRB approval process. This is not just a regulatory hurdle; I really do think that the IRB process improves most studies as at a minimum, you are forced to think hard about the protocol that you are proposing before you start doing it.

You may have had a bad experience with a specific IRB staff person, but ultimately their job is to facilitate responsible research within the institution, so I would also suggest finding a nonconfrontational way to enlist their help in getting the project through the IRB.

If you really are proposing a multi-institutional study, you will need a collaborating PI at each institution, and the multi-institutional study will have to be put through the IRB as such at each of the institutions.

Finally, as kryptonian points out, consent is a separate issue from IRB approval, but if you are using a device to collect data from patients, then I have trouble imagining that this could ever be eligible for a waiver of consent.

 

[Anandamide]

Have you done the informed consent process before? It's not difficult, but there are a lot of points that you must hit in order to legally protect yourself, your PI(s) and your subjects. I highly recommend taking some training in the process if your institution offers such a thing.

At minimum, do not assume that an MD will be the best example for how to get informed consent. Subjects tend to trust the MDs more; the subjects often agree to whatever the doctors suggest without considering the whole story. That's one reason that a lot of institutions prefer to have non-MDs consent the patients. An experienced clinical research assistant or research nurse may be a better example for you. This was certainly the case for myself.

edit - If you already have experience consenting patients, I apologize if this comes across as pedantic. I've just seen a lot of people gloss over important details when they consent patients.