NNTC Requests

Specimens or data obtained from the NNTC cannot be distributed to third-party companies or institutions without prior consent from the NNTC Executive Committee.

Please visit https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html#c1 to determine if your study requires a human subject research application that must be reviewed by an IRB.

This subpopulation of the NNTC cohort includes subjects on antiretroviral treatment with documentation of prolonged viral suppression. These cases may be exceptional utility for research into the eradication of HIV from persistent reservoirs. As such, the specimens, including tissues and fluids, from these participants are reserved for allocation to investigators performing well-justified research into the eradication of reservoirs where HIV persists despite treatment.

The NNTC does not charge requestors for samples provided. Requestors do, however, assume the cost of shipping. In certain cases where special sample processing above and beyond the standard NNTC protocol is required, the requestor may be asked to cover the cost of the additional processing and/or collection.

During the formation of the consortium in the early 2000's, the project targeted for recruitment those individuals who were thought to be good candidates for the tissue bank, near death, or were a post-mortem donation. Participants enrolled were likely to die within the first 6 months or year of enrollment and therefore have minimal ante-mortem data, however, following increased administration of anti-retroviral medications, many participants survived and continue to be followed actively today. 

 

A majority of our active participants (average age of 65) now have more than 8 years of clinical characterization which is useful for longitudinal analysis and investigations into the impact of aging and long-term ARV use. Participants who have died and contributed samples to the brain banks, however, have significantly less ante-mortem data with a majority having been on-study for <1 year with an average age of 50.  Additional characteristics of the cohort are that most individuals enrolled have multiple comorbidities, have a history of polysubstance use, have cognitive impairments and interference in day-to-day functioning, and may have depression and/other mood disorders. 

 

If you are interested in acquiring data and/or specimens from participants who are younger, healthier, or have no cognitive impairments, substance use, or multiple comorbidities, we suggest approaching other brain banks, including but not limited to the following:

 

Yes, please ensure that all grant information (awarding agency, grant #, period of funding, etc…) entered onto your application.  This is a good example of why it is important to use the Request Processing Checklist as you create your application.  We have included a similar reminder for projects with existing funding there as well.

Use the template concept outline provided to you via hyperlink as you navigate the application process:

The NNTC has a template Concept Outline that must be used for any application submitted to the NNTC.  

As you write your concept outline, ensure that your concept outline is aligned well with the details of your application:

The concept outline is a critical companion document to your application. The DCC and Site PIs regularly compare the justification provided in this document against the details of your application.  If inconsistencies are noted, it is likely that this will generate feedback from either the DCC or the Site PIs during the review of your application.  This is likely to introduce additional time to the review/approval process for your application.

 

If you end up revising your application in response to feedback (or for any other reason) ensure that alignment between the concept outline and request application is maintained:

Because alignment between concept outline and request is such an important element of any given application during review, it is critical that the concept outline not only be aligned to the original application.  If you end up re-working any element of your application, it is equally important for you to ensure that the concept outline is updated, as appropriate to maintain alignment with any changes in the application itself.

Defining time period appropriately:

For any historical criteria for a clinical group (e.g. no SUD diagnosis, “normal” neuropsych), always specify the timeframe over which the criterion should apply.  For example, instead of stating that a clinical group should have “no history of SUD”, investigators should state “no history of SUD over their entire lifetime”, “no history of SUD within 2 years prior to death”, etc….

Defining means of diagnosis/detection:

It is critical to define how drug use should be defined. For example, is it critical that the NNTC only consider cases with a formal diagnosis of substance use disorder, as diagnosed by CIDI/PRISM?  Alternatively, would it be acceptable for some cases to have one or more instances where drug use was detected via urine toxicology.

As appropriate, be specific about the substance(s) of interest for your research:

If you only specify that you are seeking cases of SUD, the NNTC will seek cases that have a documented history of any substance use disorder.  Alternatively, if you need cases that have a history of, let’s say, cocaine and/or cannabis, it is critical that you define this clearly in your application.  For example, instead of simply stating “SUD history”, it would be more accurate to state “…history of either cocaine or cannabis abuse”.

Define HIV-suppression:

Please include a specific definition that is being used to define HIV suppression among your cohort (i.e. <2000 copies/ml, etc…).  The NNTC standard definition for suppression is <1000 copies/ml.  If this aligns with your research needs, we would still advise including this detail as part of the parameters you define for the pertinent clinical group(s).

 

Define the period of HIV-suppression:

When requesting an HIV-suppressed group, it is important to specify appropriate timing information for this group requirement.  For example, if you are looking for anyone suppressed (<1000 copies/ml) for the entire 5 years prior to death, you would specify something to the effect of “Individuals for this group should have <1000 copies/ml for 5 years prior to death.”

This is indeed something the NNTC has encountered in the past, although for HIV-related work we do not frequently encounter this issue. 

  • Pulmonary arterial hypertension (PAH)
  • Cause of Death

Ensure non-overlapping study groups:

When creating your study group criteria, please be sure to avoid overlapping group definitions.  In other words, ensure that your study groups, as you have defined them, are mutually exclusive. Particularly with more complex requests, we have seen this as a common issue introducing additional time to review.

 

Pay attention to any detail that would be important for identifying cases that meet your group definitions:

Please see below for additional guidance if your clinical groups include any more-specific criteria that the NNTC has commonly encountered in the past. If any of your groups include these parameters, the NNTC strongly advises following the guidance provided here as you complete your application. 

The NNTC notes that there are many types of research for which anatomically limited regions of the brain (e.g. nucleus accumbens, hippocampus, etc…) are indeed required.  It is also true that applications requesting tissue from these regions will be carefully reviewed to ensure that the scientific approach/methodology I your application require tissue from any of these regions.

 

As a requestor, the most important thing is to ask yourself is whether tissue from alternate brain regions (e.g. frontal lobe) may suit your current research needs.  If this is the case, the NNTC strongly advises that you submit your application requesting tissue from these alternate regions.

Yes, in most cases.  In general, the less complex any given request is, the less time it is likely to take for review, approval, and fulfillment of your request.  We encourage all requestors to ask for what is needed to achieve their scientific objectives, we strongly encourage requestors to avoid ‘over-asking’ when it comes to the number of cases, number of specimens per case, etc… 

The fact that you are here, reading through our FAQ document is a great start.  There are some other critical reference materials that you should have on hand as you complete your application.

Use the Request Processing Checklist:

All requestors are required to utilize the Request Processing Checklist to document their progress as they complete their application.  As part of each application submitted, the NNTC requires that a completed, signed copy of the checklist be submitted as part of your application.  This document is designed to provide you with enough detail to help avoid submission of an incomplete application.

 

One simple, but common, example of incomplete application documentation is submitting User Agreements without signature on every page.  This is something that would result in the return of your application upon initial shaping review, due to the application being incomplete.

Consult our other training materials posted to the study website:

  • Requestor Processing Checklist
  • NNTC Request Processing and Fulfillment Guidelines