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
- 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: C3_Release_protocol_v[x]_dd[dd-mm-jj].docx. Most prominent changes version 2nd May 2022: clarification section D, supplementary explanations and addition of a glossary (Definition of Terms). For 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 biobank protocol, change the file name as stated on the left-hand side, and have it signed again for approval of the changes |
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 |
Findings during the research
The approach for the submission and review of findings has been laid down in a SOP: