Frequently Asked Questions

Please note that these Frequently Asked Questions are updated on an annual basis, as needed.

1. Q: Some scientists use the terms human “samples” and “biospecimens” interchangeably. What is the correct nomenclature?
   A: For the purposes of NIH reporting, the terms are interchangeable. According to the Guidelines for Human Biospecimen Storage and tracking within the NIH Intramural Research Program (NIH Guidelines), an “original sample” is a biospecimen. All daughter vials, aliquots, slides, extractions, etc., are still biospecimens and every one should be counted.
2. Q: Will I be required to report my holdings of biospecimens twice, once for this new Biospecimen Report and again, for the Annual Report (NIDB)?
   A: Yes and No. The Biospecimen Report has been separated from the investigator’s Annual Report for purposes of the NIH-wide assessment of storage and tracking practices, mandated by Congress in the NIH Reform Act of 2006. This requires information on just the total number of biospecimens held by the NIH IRP, how they are tracked, and how they are stored.
3. Q: I have four different types of material (DNA, RNA, PBMC, serum) from one parent biospecimen (whole blood). The parent sample is used up/discarded, so, how do I count these derivatives?
   A: These new biospecimens represent four different material types, each of which should be counted. In addition, any aliquots made from one of the material types should also be counted separately.
4. Q: I have 10 aliquots of plasma which I am storing from the same original biospecimen. How should I count these?
   A: These are 10 unique biospecimens and should be counted as a total of 10; or 11 if the parental biospecimen has a volume remaining.
5. Q: I have several 250mL bags of normal human plasma in freezer storage. At such a high volume, I wonder if I count this as one biospecimen.
   A: Yes, each bag is counted as one biospecimen, regardless of its volume.
6. Q: I gave biospecimens to a collaborator at the Johns Hopkins University this year. These originally were counted as my biospecimens last year. Do I count them again this year because they were originally collected as part of an IRP project?
   A: No, these have left your custody and are not your biospecimens. Your inventory system should be updated to reflect that they were transferred out of the NIH.
7. Q: All of my research activities have received exemptions from the Office of Human Subjects Research Protections. Do I need to count the specimens that are a part of these studies?
   A: Yes, these should be reported as human biospecimens for this report.
8. Q: Our lab has samples dating to the 1950s, prior to the establishment of IRBs. How do I enter these, if at all?
   A: All biospecimens, regardless of age, labeling, or storage conditions, should be counted. When entry and tracking of individual specimens is not feasible, they may be counted as a single entity, with proper documentation. It is up to each project PI to determine the best practices for culling and consolidating biospecimens of questionable quality and value, within the guidelines of their respective IRB.
9. Q: I received anonymized biospecimens as part of an MTA from my collaborator at University of Maryland. Do I count these as my biospecimens even though they were not collected under an intramural project originally?
   A: Yes, because they will now be used as part of your research. Even if specimens have been irreversibly stripped of any identifiers or if the specimens were collected without identifiers, they need to be counted as part of your research collection.
10. Q: I purchased human HeLA and K562 cell lines from a company. Do I count these as biospeicmens?
    A: No, since these are commercially available materials they need not be reported.
11. Q: SAIC-Frederick, Inc. repositories house many biospecimens for our laboratory and report the totals differently than we do. How should I deal with this?
    A: It is the responsibility of each project’s PI to report the biospecimens under their custody according to NIH Guidelines. Biospecimens stored in contractor-run repositories are still considered to be under the custodianship of the NIH PI and should be reported
12. Q: There are two PIs on my DIR project. Which one of us will count our biospecimens in our reporting?
    A: Co-PIs must agree who will be the custodian of the biospecimens for reporting purposes so that the numbers are not duplicated in the totals. Then, one PI will count these in their reporting.
13. Q: I have an intramural collaboration in Cambodia and house biospecimens there in freezers. Should I count these in the totals?
    A: Yes, these are human biospecimens collected for an intramural project, where an intramural PI has part custody, and as such, are federal property. They need to be reported unless the collection is officially transferred to another organization.
14. Q: DAIDS/NIAID funds numerous extramural network clinical trials, and biospecimens are being analyzed all over the world. Do we need to count these biospecimens?
    A: Custodianship resides with the extramural investigator(s). However, if biospecimens return to NIH for any analyses, such as at the Vaccine Research Center (VRC/NIAID), they become part of the NIH collection and should be counted at that time.
15. Q: I will be receiving 10,000 biospecimens from our clinical trial immediately after I submit this biospecimen total report. How should I account for these biospecimens?
    A: These totals will be captured during next year’s reporting cycle.
16. Q: The NIH Department Transfusion Medicine (DTM) provides me with normal human lymphocytes from individual donors to use in my experiments. Do I count these as biospecimens?
    A: Yes. The NIH DTM is storing and providing biospecimens for research, collected from human subjects under consent and IRB approval. They were transferred to you, and if they were not completely used in experiments and are still in storage by the report closing date (June 30), they must be counted.
17. Q: The human specimens I receive from DTM are used as controls. Do they need to be bar coded and accounted for in the survey?
    A: Only those cells that remain in storage at the end of the reporting year must be counted.
18. Q: I isolated purified Plasmodium specific antibodies from a patient in 1986, and use these in my research assays. Are these considered biospecimens?
    A: Yes, these antibodies were derived from a biospecimen obtained from a human subject. If you still maintain private identifiable information, the antibodies fall into the category of direct derivatives and should also be considered biospecimens.
19. Q: The iPSCs we have were derived from fibroblasts obtained from Coriel and ATCC. Do these need to be reported?
    A: No, they were generated from commercial materials and have no identifiable PII attached.
20. Q: We also have iPSCs that are from patients as part of my research under an IRB approved protocol. Do these need to be reported?
    A: Yes, these are considered derivatives from human tissues.
21. Q: I have been collaborating with an investigator at JHU who has been sending me (a) iPSCs she made from her patients with ALS and (b) tissue samples from healthy sibling controls, which are reprogrammed at the NIH. Do I need to count both of the iPSC derivatives?
    A: Yes, even if the samples have been blinded, both materials still have PII linked to the code which is retrievable.
22. Q: How do I need to report the lines I have?
    A: Each independent, unique cell line needs to be counted. If you have one vial of 4 different cell lines from one clinical sample of fibroblasts, e.g.L1-4, they are counted as 4 samples.
    If you have 4 uniquely identified cell lines from one clinical sample of fibroblasts, and multiple vials stored for each, e.g. L1=6 vials, L2=2 vials, L3=8 vials, L4=4 vials, then you will report 20 samples.
23. Q: Our lab has been making and storing cells transformed by EBV for years, but never reported them before. Do I count everything that we made in the past
    A: You only need to report those that remain in your possession at the end of this reporting year. Any that have been used up or transferred to others for use and are no longer in your possession are not counted.
24. Q: For our experiments, we regularly get CMV transformed cells, however most often they are used up at the end of our assays. Do I need to report these?
    A: Only if you keep anything that is left over in your freezer, and have materials at the end of the reporting period.
25. Q: We have iPSCs that are immortalized but have lost pluripotency. Do I need to report these?
    A: Yes, if you keep them in your collection, these cells are similar to CMV or EBV transformed cells in that they are continuous cell lines.
26. Q: Our lab has been isolating Ebola virus from human serum sample. Since we report serum, DNA/RNA as biospecimens, should we also report any virus isolated?
    A: No. Although the virus comes from a human sample it is not 'human' material and does not need to be reported.