Aim

To ensure human tissue is handled in a responsible manner.

Description

A number of specific issues are important in the use of human tissue for research, for instance in respect of storing human tissue. Following the changes in legislation, COREON, a committee that reviews the regulations of the Federation of Dutch Medical Scientific Societies (FDMSS) drew up the Proper Secundary Use of Human Tissue" (not to be confused with the Good Practice Code). Proper Secundary Use of Human Tissue"Code regulates the subsequent use of human material. That is to say: Tissue collected for other purposes. The regulations for subsequent use of human tissue were drawn up on the basis of the Proper Secundary Use of Human Tissue", which has been ratified by the Executive Board of the VU University Medical Center. More information is available in the Details section, as well as in the guideline Handling privacy sensitive data, and at the following website: COREON, http://www.federa.org.
Legislation is being drawn up that will regulate the use of human tissue. Proper Secondary Use of Human Tissue" was drafted with the notion that stringent legislation will not be required if a professional group already has proper self-regulation. It is therefore in our own interests to be aware of these codes and to apply them properly. Currently, the code is under revision.

Proper Use Code and Regulations regarding Subsequent Use of Human Tissue at the VU University Medical Center

The principle for the Proper Secundary Use Code is that anonymous of coded human tissue may be used for scientific research, in so far as the individual from whom the tissue was obtained has no objection to this. The text of the code is primarily aimed at subsequent use of human tissue that has been obtained by the treatment provider during the process of treating the patient. The VUmc regulations regarding subsequent use of human tissue have been drawn up on the basis of the code Proper Secondary Use of Human Tissue. All patients at the VU University Medical Center are provided with a brochure detailing “patients’ rights and obligations”, which explains that residual material may be used for scientific research and patients are entitled to refuse to provide consent for this. Where tissue is directly identifiable, the patient providing the tissue (or their representative) will need to provide explicit consent for this to be used.

Transfer agreement
There needs to be a transfer agreement in place when human tissue is being used/collected by others outside the VU University Medical Center. The research protocol is part of this agreement. The individual providing this tissue needs to assess, on the basis of the protocol, whether the request is in conflict with patients’ control rights, that is, the informed consent derived for the original study, or the “no objection procedure”. On the basis of the agreement there should be an assumption that only human tissue will be provided if this does not conflict with the patient’s or volunteer’s control rights.

Information about study results
Patients and volunteers may ask those providing the human tissue to provide information about the results of the analysis of their tissue, which may be of direct importance to their future health. These results may only be provided in principle to those individuals who have expressed an interest. The information should only be provided to the individual responsible for the tissue (or their successor, deputy), who is able to discuss the results with the patient. The researcher should not contact the patient.

Findings
In relation to the “findings”, a distinction needs to be drawn between "new findings" and "chance findings". New findings are those that provide new scientific insights from the tissue, which at that point in time may be of importance to health of (groups of) the patients concerned or relatives. Often this will not be the case after the publication of a single study. “Chance” findings are chance (diagnostic) findings, which are only of relevance to the person donating the tissue. When you are collecting human tissue for the study yourself, you need to obtain a written answer to the question whether the individual wishes to be informed about the findings, and whether you have consent to contact their GP or doctor. If individuals indicate that they do not wish to be informed about chance findings, this may occasionally be a reason for not including them in the study. If a chance finding has been made, this should be submitted to the VU University Medical Center’s Committee for Subsequent Use of Chance Findings (Commissie Toevalsbevindingen Nader Gebruik) (the exact method for doing so is still being worked out).

Standard Operation Procedures and storage period
The human tissue needs to be treated as described in the research protocol approved by the METc. This should also include the storage period for the material. Once the study has been completed and published, the tissue should, in principle, be returned to the provider or destroyed.

The full text of the codes (Proper Secondary Use of Human Tissue Use of Data in Health Research), summaries, information, and a presentation about the principles and implementation, as well as letter templates for the agreements can be downloaded from this site: www.federa.org

Human tissue: All tissue derived from humans with the exception of foetal tissue, embryos and gametes.

V1.1  1 Jan 2010:  Translation into English and updated.

Is human tissue collected and/or used as part of this study? If so: What kind of material? What is purpose of the material? Where is the tissue going to be stored and where will it be analysed? Will the human tissue be anonymised prior to storage or analysis? Will the material be stored in a safe place and have proper emergency procedures been drawn up (e.g. regarding a power cut to the freezer)?

Has a written response been requested and obtained about whether, and if so, how research participants wish to be informed?

Have procedures been drawn up about how to deal with new and chance findings?