Neuropathology workload and IRB

[Enkidu]

So my interest in neuropathology is largely based on my interest in basic science research, but I'm having a hard time figuring out the type of work that neuropathologists do.

Is the bulk of the work autopsy-related, or surgical? Surgical pathology is obviously more exciting, but it seems to me that a large portion of the neuropathology texts I've looked at deal with weird diseases that must have been found on autopsy.

On a similar note, how does a pathologist use tissue for their own research, say after an autopsy? I suppose they have to get IRB approval in some fashion, but is that at the level of individual pathologists or at a higher level? Is it generally the case that pathologists can just keep the tissue and do whatever they want with it?

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[pathstudent]

So my interest in neuropathology is largely based on my interest in basic science research, but I'm having a hard time figuring out the type of work that neuropathologists do.

Is the bulk of the work autopsy-related, or surgical? Surgical pathology is obviously more exciting, but it seems to me that a large portion of the neuropathology texts I've looked at deal with weird diseases that must have been found on autopsy.

On a similar note, how does a pathologist use tissue for their own research, say after an autopsy? I suppose they have to get IRB approval in some fashion, but is that at the level of individual pathologists or at a higher level? Is it generally the case that pathologists can just keep the tissue and do whatever they want with it?

Most common to least common clinical specimens:

1. Brain Tumors (which even general community pathologists see quite a bit of)

2. Autopsy Brain (usually normals but sometimes with secondary effects and a few true acquired and rare congenital neuropatholoy entities)


3. Medical Brain (dementia, epilepsy etc...)


4. Muscle and Nerve Biopsies.

The amount of reserach that can be done in neuropath is just short of infinite. It would be a very rewarding career.

 

[KCShaw]

The trap that has ended a few careers here and there is feeling like you can do anything you want with tissue once you've signed out the reason it came to you in the first place. There's a little more freedom in the clinical side of research, in that you may be able to use information gathered during the course of regular daily workload, piece that together, do some statistics, and publish the results. But in the realm of basic science, where you're generally spending more time trying something new, different, or otherwise not standard daily practice, you have to be very careful with how you use tissue.

Most academic institutions have very well established rules for research and tissue. Ultimately it depends on what you want to do with the tissue you have or are trying to obtain. You may want access to as many whole brains as possible, meaning you would want autopsy consent forms to include language to allow that. You may want access to certain primary brain tumors, meaning you would need IRB approval +/- explicit consent from each individual patient or their next of kin -- depending on exactly what you intended to do with the tissue. It goes on and on, but the bottom line is that most academic institutions should have channels you can go through to ask & answer those questions specific to your cause, and generally will make you err on the side of extensive pre-planning, specifying what you will be doing, obtaining explicit consent, etc. The whole management side of research has been known to drive some people away from it, but consequently some institutions go out of their way to help you get set up and obtain approvals, etc.

 

[Circumflex]

As has been said, neuropathologists evaluate tumor specimens from surgeries and are on call to read frozen sections of tumors during surgery. The other significant activity is cutting brains from autopsies. There are very few institutions that have neuropathologists who only do clinical neuropathology. Because there are relatively few brain specimens and autopsies (compare to other types of specimens), most neuropathologists have to do other things to justify their salary, such as sign out other types of surgical cases or write grant applications to fund research.

One of the big obstacles as a pathologist to using human tissue, is that if the treating physician does research and the patient is under their protocol, the tissue belongs to them to use as they wish. Brain tumor resection specimens are usually relatively small and their are usually many labs who want to get their hands on a piece of it. It is difficult as a pathologist to be in control of tissue specimens. However, pathologists are in a good position to be a collaborator on projects. This can be very fruitful.

 

[Freak]

A slight aside, but along similar lines, it may be worth looking into caTissue.

It is a database management system for tissue (the biobank). If an institution has basically put the infrastructure in for specimen management, they probably will also be amenable to research and have the appropriate protocols set up.

 

[KCShaw]

On the same tangent, there are a number of tissue banks & brain banks around which one can try to access.

 

[deleted314957]

The trap that has ended a few careers here and there is feeling like you can do anything you want with tissue once you've signed out the reason it came to you in the first place. There's a little more freedom in the clinical side of research, in that you may be able to use information gathered during the course of regular daily workload, piece that together, do some statistics, and publish the results. But in the realm of basic science, where you're generally spending more time trying something new, different, or otherwise not standard daily practice, you have to be very careful with how you use tissue.

Most academic institutions have very well established rules for research and tissue. Ultimately it depends on what you want to do with the tissue you have or are trying to obtain. You may want access to as many whole brains as possible, meaning you would want autopsy consent forms to include language to allow that. You may want access to certain primary brain tumors, meaning you would need IRB approval +/- explicit consent from each individual patient or their next of kin -- depending on exactly what you intended to do with the tissue. It goes on and on, but the bottom line is that most academic institutions should have channels you can go through to ask & answer those questions specific to your cause, and generally will make you err on the side of extensive pre-planning, specifying what you will be doing, obtaining explicit consent, etc. The whole management side of research has been known to drive some people away from it, but consequently some institutions go out of their way to help you get set up and obtain approvals, etc.

Words of wisdom from a fellow forensic pathologist. The only thing that has gotten more of them in trouble is their mouths/egos when the press is around.

 

[BU Pathology]

Human tissue is available through the National Cancer Institute Cooperative Human Tissue Network.

www.chtn.nci.nih.gov

The point raised by others needs to be emphasized, one should not use human tissue without appropriate approval. You should ALWAYS ask the IRB for advice about whether consent is needed if you have any question. As an investigator, you do decide whether approval is required or not, that responsibility lies with the IRB. In many instances the IRB will waive consent, such as using de-indentified tissue for immunohistochemistry projects. But you should still consult with the IRB.

If tissue is obtained from the NCI, they still require appropriate IRB approval.

Commercial sources of tissue are available, such as cell lines from the American Type Culture Collection www.atcc.org and commercial companies will sell microarrays. These purchased products from a commercial vendor should not require human use approval from your IRB. Samples can also be used for quality control, such as validating instruments. But again, if in doubt contact your IRB. Most IRBs have tracking software that maintains a record if you email, so that an email response saying your work is exempt is usually sufficient.

 

[pathstudent]

You don't need consent on autopsy tissue. Dead men aren't considered human (similar to how you can't be sued for malpractice for doing an autopsy without consent. You can't committ malpractice on a corpse. However, you can get charged with desecration of a corpse) That is one useful way to conduct studies. Some of my biggest papers came from going to evey autopsy and getting tissue.

Also I don't think you need consent on a case report.

 

[BU Pathology]

You don't need consent on autopsy tissue. Dead men aren't considered human (similar to how you can't be sued for malpractice for doing an autopsy without consent. You can't committ malpractice on a corpse. However, you can get charged with desecration of a corpse) That is one useful way to conduct studies. Some of my biggest papers came from going to evey autopsy and getting tissue.

Also I don't think you need consent on a case report.

Sorry, but both of these answers are wrong. I have served for several years on IRB boards, in addition to developing a biospecimen archive.

Use of autopsy tissue is governed by individual state laws, and some states such as Massachusetts have legal requirements for permission from the next of kin, which needs to be approved by your local IRB. Even if you only use tissue from the dead person, if you used any information from the medical chart (such as age), that information was obtained while the person was alive and therefore subject to IRB approval prior to use.

Case reports do require IRB approval, although it is usually expedited and waived.

If in doubt, contact your IRB.

 

[pathstudent]

That's true, I do remember filling out hippa waivers for the autopsy studies.

Tissue taken from autopsy and from hospital specimens should be less rigorously regulated as the stuff is in essence garbage that is destined to get thrown away, ground in a garbage disposal, or incinerated. It is different than when you are trying to get people to voluntarily submit blood/tissue or perform activities simply for the point of research. That is the stuff that needs rigorous oversight.

Those gallbladders were coming out no matter what. We are just picking over the trash, in essence, because that is where the specimens/autopsy organs are headed.

 

[KCShaw]

For the most part even trash tissue retains assumed rights to the patient/next of kin. Depending on what it is, family believe it's going in the trash and only in the trash, so if it does not..you could have a problem. Or, in the case of autopsies, they may believe it's returned with the body (many institutions do this, though some do not as a matter of procedure -- most funeral homes also leave organs in, though a few do not). It's not quite the same as evidence taken by police from someone's trash placed out on the curb, essentially for public consumption.

Even in the forensic world there are enough problems with next of kin complaining someone retained the entire heart or brain without explicit notification; generally these problems are covered under local laws for tissue required for determination of cause and manner of death, so lawsuits -generally- don't pan out if all actions were completed under existing statutes. But many jurisdictions are heavily political, so it can still lead to people losing their jobs.

Hospital autopsies at academic institutions require autopsy consent forms; in many cases those forms include language allowing for research activities, even renouncing rights to profit related to that tissue. But they are so broad that I believe there has at least been talk that the door remains open for lawsuits for lack of adequately informed consent. Usually if there is a specific project in the works additional paperwork is filled out. You need to know your local forms.

Point being -- don't underestimate the legal, ethical, or political impact of failure to be exquisitely careful regarding retention &/or use of human tissue in research. If you avoid one or two of those problems, you may not avoid the other. If you go through IRB, however, that board essentially protects you even if some issue arises.

 

[GFAP]

I echo the words of BU pathology (Loved the NIH loan repayment post by the way). IRB IRB IRB if you are unsure just ask them. They are not to hard to write. It can be helpful for you to clarify your goals by writing the IRB. I have written one for a tissue based study.

This posting reminds me of the story of HeLa cells and Ms. Lacks.
http://www.smithsonianmag.com/science-nature/Henrietta-Lacks-Immortal-Cells.html

 

[zao275]

This posting reminds me of the story of HeLa cells and Ms. Lacks.http://www.smithsonianmag.com/science-nature/Henrietta-Lacks-Immortal-Cells.html

Wow. Fascinating. I had no idea about the additional details in that story. Sounds like a cool book.