Use of human biological material (release review)
Use of human biological material (release review)
Approval from the TCBio via a release review is necessary prior to use of:
- human biological material from biobanks or sub-biobanks
- residual material (fresh or otherwise) from diagnostic procedures or treatment - refer also to instruction below
- human biological material left over from WMO research
- human biological material from collections not yet registered with the Central Biobank
Review uitklapper, klik om te openen
The TCBio reviews the intended use of human biological material based on the release criteria of the Biobank Regulations of UMC Utrecht (Article 10).
Always use the most recent version of the release protocol. This form has been brought in line with the Biobank Regulations.
For the compilation of a new file, for your response to questions or for amendments to approved files, please refer to the section under ‘File’.
An important part of the review relates to the study design. For advice on study design and statistical methods, please contact Julius Support for Research & Trials.
Meer informatie
File uitklapper, klik om te openen
The file for a new release review will consist of the following documents in PDF format, with the file names stated:
| Document | Explanation |
|---|---|
| (enter the requested details where it says ‘version ...’ and ‘[dd-mm-yy]’) | |
| A1 Cover letter / e-mail from applicant dated [dd-mm-yy] | A separate cover letter (paper version) with explanatory notes is optional when submitting a file. Any explanation can also be provided in the cover e-mail. |
| C3 Release protocol version ... dated [dd-mm-yy] | Link to release protocol template version 1st February 2023: C3_Release_protocol_v[x]_dd[dd-mm-jj].docx. Changes in version 1st February 2023: clarification of explanation question D4.B. Remarks on section D (Data): a) a data management plan (DMP) is not part of the TCBio file. Information may be derived from the DMP e.g. for question D7. For more information refer to the Release protocol template. b) see RNAseq statement* below. Note: In the PDF file all text in text boxes must be clearly legible. |
| E1. Biobank information letter version ... dated [dd-mm-yy] | for review based on consent already given by the donor (if applicable) |
| E2. Consent form version ... dated [dd-mm-yy] | for review based on consent already given by the donor (if applicable) |
| K3. Material Transfer Agreement or Clinical Trial Agreement of [name of company or centre] dated [dd-mm-yy] | (if applicable) Signed MTA must be received before approval can be given. |
*RNA sequencing: patient consent is necessary
RNA sequencing (RNAseq) is frequently used to generate RNA expression profiles in cells. The RNA sequence that is generated as part of this technique could be attributed to a natural person. The committee bases this statement on the following article: Nat Genet. 2012 May;44(5):603-8. doi: 10.1038/ng.2248.
Therefore, in line with the General Data Protection Regulation (GDPR), a patient's consent is needed to perform RNAseq. The opt-out rule for secondary use of residual human tissue provides insufficient ground in these cases.
A response to questions from the Committee will consist of the following documents in PDF format; also follow the submission instructions provided in the e-mail received with the Committee’s first questions:
| Document | Explanation |
|---|---|
| (enter the requested details where it says ‘[dd-mm-yy]’) | |
| A1. Response letter from applicant dated [dd-mm-yy] | = item-by-item response to the Committee’s questions |
| All documents which have changed in connection with the response to the questions | Always visualise the changes with the track changes functionality, and adjust the version number and date |
Approach for amendments to a release protocol:
| Document | Explanation |
|---|---|
| (enter the requested details where it says ‘version ...’ and ‘[dd-mm-yy]’) | |
| A1 Cover letter / e-mail from applicant dated [dd-mm-yy] | Letter with a summary of changes and a substantiation |
| C4. Release protocol amendment version ... dated [dd-mm-yy] | Visualise the changes with the track changes functionality in the approved release protocol, change the file name as stated on the left-hand side. Only the signature of the responsible investigator (G1) is needed on the amended release protocol. |
Other documents which 1) have changed in connection with the amendment and/or 2) are necessary for a new assessment of the amendment to the study (e.g. information letter) | 1) Visualise the changes with the track changes functionality and adjust the version number and date 2) Example: material will also be sent abroad as a result of the amendment > the original information letter is needed to assess whether the consent obtained is sufficient for this |
Instruction for direct use of residual material from routine care uitklapper, klik om te openen
Researchers regularly request direct use of residual material from routine care, often for a single study. In these cases there is no storage of the material before its use. Also, for technical reasons previous storage is sometimes not possible, for instance when material is no longer suitable for experiments after freezing and thawing. In some cases, there is no material left for storage for future research after the direct use in a scientific study.
For direct use of (fresh) residual human biological material from routine care in a scientific study, a simplified TCBio procedure is in place provided a set of criteria can be met. The instruction can be downloaded here:
Findings during the research uitklapper, klik om te openen
When during the research a finding not related to the research protocol is identified, the committee will be notified of the finding. The committee will formulate an advice regarding the desirability to return the result to the donor and advises on who will inform the donor.
The approach for the submission and review of findings has been laid down in a SOP:
Finishing the research uitklapper, klik om te openen
Within one year of the end date of the study as stated in the release protocol, the investigator sends the final report of the results to the TCBio. The end date of the research study is the date on which the last experiment was finished.
If the research is not finished on the end date, an extension to the duration of the study can be applied for by an amendment to the release protocol. Always include a reason why the extension is necessary in the cover letter.
Optional: review of release of data without human biological material uitklapper, klik om te openen
Sometimes an approval from an ethics committee is necessary for the use of data in a research project (e.g. for a party outside the UMC Utrecht where data is being requested). Review of release of data only (without biological material) is not yet a requirement within the UMC Utrecht. To fill this void, the committee is willing to process such requests. For review of a data-release only, please fill in the most recent release protocol template with the exception of the part regarding the biological material (section C). De committee will review all other sections according to the UMC Utrecht Biobank Regulations, the prevailing legal and regulatory requirements (such as the GDPR and the Dutch Medical Treatments Contract Act- in Dutch: Wgbo) and other UMC Utrecht policy’s.