Frequently Asked Questions

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

1. Q: What is the “Biospecimen Report”?
   A: Annually, the Office of Intramural Research (OIR) distributes an electronic survey, asking Intramural Research Program (IRP) researchers to identify what biospecimens they are storing. This used to occur at the beginning of July, but now occurs in late September. The collated survey responses are used to write the Biospecimen Report, an intramural NIH-wide assessment of storage and tracking practices, mandated by Congress in the NIH Reform Act of 2006.
2. 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.
3. Q: How do I report four different types of material (DNA, RNA, PBMC, serum) from one parent biospecimen (whole blood)?
   A: These biospecimens represent four different material types, each of which should be reported.
4. Q: I have 10 identical aliquots of plasma which I am storing from the same original biospecimen. How should I report these?
   A: These should be recorded as one type of sample – plasma.
5. Q: How do I report biospecimens that I transferred to another institution this year?
   A: These have left your custody, are not your biospecimens, and should not be reported. Your inventory system should be updated to reflect that they were transferred out of the NIH.
6. Q: Do I need to report the biospecimens that are from activities that are “Exempt” from IRB review?
   A: Yes, these should be reported.
7. Q: Do I need to report samples collected back to the 1950s, prior to the establishment of IRBs?
   A: All biospecimens, regardless of age, labeling, or storage conditions, should be recorded. It is up to each project PI to determine the best practices for culling and consolidating biospecimens of questionable quality and value, consistent with the IRB protocol under which the samples were collected or used.
8. Q: Do I need to report anonymized biospecimens received as part of an MTA from my collaborator, 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 reported as part of your research collection.
9. Q: Do I need to report human HeLA and K562 cell lines purchased from a company?
   A: No, for two reasons: 1) these cell lines or biospecimens were and are commercially available; and, the purchased cell lines or biospecimens have not been reprogrammed or transformed into iPSCs.
10. Q: Do I need to report samples housed at an NIH-contracted repository such as at the SAIC-Frederick, Inc.?
    A: Yes, biospecimens stored in such locations are still considered to be under the custodianship of the NIH PI and should be reported.
11. Q: How do I report samples that are collected or stored under two PIs?
    A: Co-PIs must agree who will be the custodian of the biospecimens for reporting purpose, and only that person should report the samples.
12. Q: Should I report samples that were collected as part of an intramural collaboration with researchers in a foreign country, but are stored in that country?
    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.
13. Q: Do I report samples collected from extramural clinical trial sites, stored at those sites, and being analyzed all over the world?
    A: In this scenario, 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 reported at that time.
14. Q: Do I report biospecimens that are planned to arrive after the survey period closes?
    A: No, these samples will be captured during next year’s reporting cycle.
15. Q: Should I report normal human lymphocytes provided to my lab by the NIH Department Transfusion Medicine (DTM) from individual donors, to be used in my experiments?
    A: Yes. The NIH DTM transferred the samples to you, and if they were not completely used in experiments and are still in storage by the report closing date, they must be reported.
16. Q: Should I report samples such as purified Plasmodium specific antibodies isolated from a patient in 1986 that are being used in my research assays?
    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.
17. Q: Should I report iPSCs that were derived from fibroblasts obtained from Coriel and ATCC?
    A: Yes, even if the cells were acquired commercially, if they were then reprogrammed at NIH, they should be reported as NIH-generated iPSCs.
18. Q: Should I report iPSCs that are from patients as part of my research under an IRB approved protocol?
    A: Yes, these are considered derivatives from human tissues.
19. Q: Should I report iPSCs from the patients of a collaborator outside NIH patients that were reprogrammed there and then transferred to the NIH, as well as healthy control tissue that was reprogrammed at the NIH?
    A: Yes, both materials should be reported.
20. Q: Should I report older samples that I never reported before, that were newly discovered in the freezer?
    A: Yes, report any samples that remain in your possession at the end of this reporting year.
21. Q: Do I need to report iPSCs that are immortalized but have lost pluripotency?
    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 that should be reported.
22. Q: Should I report bacteria or viruses isolated from human biospecimens to include but not limited to, tissues, blood, serum, plasma, urine, CSF, and other body fluids?
    A: No. Although the bacteria or virus come from a human sample they are not 'human' material and do not need to be reported.