Biobanking for ‘Omics’ in Psychiatry: Logistical and Ethical Aspects

Abstract

Biobanks are highly specialized repositories for both biospecimens and associated demographic or clinical data. They have become a crucial component of big data research in all fields of medicine, in particular as regards genomic approaches. However, biobanking faces several non-trivial logistical and ethical questions, with the majority of logistical and conceptual issues arising from the ethical challenges.

Appendix 1: Patient/Proband Information

Dear Sir/Madam,

The study of human biomaterials and the analysis of data obtained, or to be obtained, thereof have become an important tool in medical research. We therefore ask our patients/test persons, including you, whether they would be willing to provide us with certain body materials and data for research purposes. Your participation is entirely voluntary. If you decide not to participate, or if you wish to revoke your consent at a later time-point, you will incur no form of disadvantage.

In the information below, we inform you of the objectives of our study, the study procedures, and the measures applied to protect your personal data. This information is intended to enable you to form your own opinion concerning participation and reach an informed decision.

If anything is unclear, please ask your physician or clinical investigator before agreeing to provide your consent. You will also be able to contact the physician who informs you about the study at a later date should you have any questions or require any form of clarification.

13.1.1 Aims of the Study

The study involves the investigation of the biological and environmental basis of diseases of the central nervous system, e.g. major depression, manic-depressive (bipolar) disorder, schizophrenic disorders, personality disorders, anxiety disorders, posttraumatic stress disorder, pain disorders, neuropathic and somatic pain disorders, drug and alcohol dependence, and dementia.

These are all common disorders and they are responsible for a high degree of suffering in patients, in their relatives as well as in their social environment. Advances in modern medicine are continuously improving diagnostic and therapeutic methods but currently available therapies are often not effective enough and medications cause side-effects.

We now know that both genetic factors and environmental influences are important in the development of these disorders. Through the medical-genetic investigation of these factors, we attempt to gain insights into the development and course of such diseases and thereby contribute to the development of more effective treatment options and prevention strategies.

It is assumed that the development of neuropsychiatric disorders is determined by genetic factors, i.e. by individual variations in DNA (the material containing your genes).The combinations of DNA-variations that are present in a given individual can be determined through analyses of the DNA.

We aim to elucidate the means by which DNA variations as well as variations in metabolic patterns contribute to the development of neuropsychiatric disorders. We know that the development and course of psychiatric and other common disorders (e.g., hypertension, diabetes, and asthma) are not determined by one genetic variant, but that genetic information interacts through multiple pathways on the development and course of the disorders. In order to understand these complex processes we would like to investigate as many factors associated with the disease as possible. These include changes in hormone metabolism, lipid metabolism, and stress tolerance.

13.1.2 Which Types of Biomaterials and Data are Involved?

The required biomaterial is blood/tissue. The biomaterials and data will be obtained from you during your period of participation in the present study. The collected data will concern information about you personally, including medical data. Therefore, we would like to conduct a structured clinical interview concerning your psychiatric symptoms. In addition, some neuropsychological tests will be performed to evaluate your cognitive abilities. By means of various questionnaires we would also like to gather information about important life events, personality characteristics, and medical treatment history. We would therefore like to ask your permission for us to access your medical records.

Many psychiatric diseases present in an episodic form, e.g. the depressive and manic episodes seen in bipolar disorder. The transformation of genetic information into proteins (the chemicals made by genes, i.e. gene expression) alters depending on the nature of the presenting episode. We would therefore like to re-contact you if you should later present with a different episode to that seen at the baseline examination. As it is possible that you may be treated in the clinic and be unable to give consent for the taking of another blood sample for our research, we would like to ask you for your consent to this procedure in advance. You can of course withdraw your consent at any time once your psychological condition has improved, and we will bring this to your attention at that time.

13.1.3 How Will the Biomaterials and Data be Used?

The biomaterials and data provided by you will only be used for medical research purposes. However, at the present time we are unable to specify the exact research objectives. You should be aware that in consenting to participate in this study, you are granting us very wide-ranging authorization. Therefore, we request explicit consent to this wide-ranging authorization, which you can indicate by ticking the respective boxes on the informed consent document.

Using your biomaterials, genetic studies, i.e. investigations into the genetic material, will be carried out. Under certain circumstances, this may include the investigation of your entire genome. Your biomaterials and data will be stored and made available for medical research purposes for an indefinite period.

13.1.4 What Risks Arise from the Donation of Your Biomaterials and Data?

• (a) Health Risks

   We would like to collect 40 ml of your blood (equivalent to ca. four tablespoons).The only risk associated with the donation of your blood to the bio-bank is the low risk involved in any normal blood taking procedure. In rare cases, stronger secondary bleeding may occur from the puncture site, or in very rare cases, persistent damage to nerves or blood vessels may occur.

• (b) Other Risks

   The collection, storage, and transmission of data obtained from your biomaterials for research projects carry the risk of a breach of confidentiality (i.e., the possibility exists that you may be identified). This applies in particular to information concerning your genetic material. These risks cannot be completely ruled out, and they increase as possibilities for linking data together increase, e.g. if you yourself publish your genetic data on the Internet (i.e., for genealogical research). The personnel in the XXX assure you that they will do everything possible to protect your privacy in accordance with the latest technology, and that your samples and data will only be transferred to researchers who can demonstrate an appropriate data protection strategy (see point 8: “Who has access to your biomaterials and data?”).

13.1.5 What are the Benefits for you Personally?

You personally can expect no immediate advantage or benefit to your health from the donation of your samples and data. The results are intended solely for research purposes. We would like to point out that all investigations within the context of the study are conducted for scientific purposes only and that no comprehensive diagnostic procedure for the detection of physical or neuropsychiatric diseases is involved. In individual cases, this means that potential pathological changes may not be recognized.

Feedback can be provided if, in our view, certain information is of significant importance to your health. This is the case if the development of a (possibly life-threatening) disease can be avoided or a previously unrecognized disease can be treated. However, you may then need to disclose this information to other bodies (i.e., to an insurer). If you do not wish to be informed, please delete the re-contact option (see point 10 below).

13.1.6 Which Conditions Apply to the Use of Your Data and Biomaterials?

• (a) Your written consent is a prerequisite for the obtaining and use of your biomaterials and associated personal data for research purposes. Your consent is voluntary and may be revoked at any time (see also clause 11 “What does your right to revoke your consent mean?”).

• (b) Your biomaterials and data will be stored at the bio-bank of XXX under standardized quality and safety conditions (for an unlimited time period) and will be made available to researchers for research purposes upon request. They will be protected against unauthorized access using the latest technology.

• (c)  The review of a research project by an ethics committee is a prerequisite for the use of biomaterials and data for a specific medical research project. The ethics committee examines the ethical and legal aspects of the proposed research project.

13.1.7 Who has Access to Your Biomaterials and Data, and How are they Protected?

• (a) All of the personal data that can directly identify you (name, date of birth, address, etc.) will be replaced by a code immediately after they are obtained (i.e., rendered pseudonymous, encrypted). Afterwards, the data will be newly encoded and stored. According to current knowhow, such double coding is the best way to exclude your identification by unauthorized persons. The biomaterials and data will be provided in this form only for research purposes.

• (b) Data which identify you directly will remain at the institution at which they were collected under the responsibility of the head of the study. They will be stored separately from the biomaterials and medical data. Access to such data will only be granted in order to add further or missing medical data from your hospital records if necessary, or to contact you again if you have consented to this (please see clause 10 below). No transfer of personal data to researchers or other unauthorized third parties, such as insurance companies or employers, will occur.

• (c) Following an appropriate application, the double encrypted biomaterials and medical data can be passed on to other universities, research institutes, or research companies—if necessary abroad—under pre-established criteria for medical research. Under certain circumstances, the data may be linked with medical data sets in other databases, provided that the necessary legal requirements are met. Under certain circumstances, the data may be disclosed to research projects abroad with potentially lower standards of data protection.

• (d) Biomaterials and data which have been passed on to third parties may only be used for the proposed research purpose and will not be transferred by the recipient for other purposes.

• (e) Scientific results will be published in an anonymous form only, i.e. in a form that does not allow any conclusions to be drawn about your person.

13.1.8 Will You Obtain Any Financial Advantage from the Use of Your Biomaterials and Data?

You will receive no remuneration for the use of your biomaterials and data. If any commercial benefit is gained from the research, you will not partake in this.

Upon donation of your biomaterials, they become the property of the XXX. Furthermore, in providing your consent, you are authorizing the use of your data by the XXX. You have the right to amend wrongly stored or processed data at any time.

13.1.9 Will We Contact you Again?

It may be useful to contact you again at a later date to request additional information, such as additional historical data, and/or biomaterials. In addition, when re-contacting you we may request your consent, for example, to compare your data with those in other databases or to provide you/your physician/medical investigator/GP with feedback on results of relevance to your health (please see clause 5 above), or results of relevance to the study. Contact will be made by the head of the study—or by a person delegated by the head of the study—via telephone, letter, or e-mail.

If you do not wish to be contacted again, please tick the appropriate box on the consent form.

13.1.10 What Does Your Right to Withdraw Your Consent Mean?

You may withdraw your consent to the use of your biomaterials and data at any time without stating any reason and without incurring any adverse personal consequences. If you revoke your consent, you will be asked to decide whether your biomaterials should be destroyed and the associated data deleted, or whether they may be used in an anonymous form for further research projects. However, once all reference between you personally and the biomaterials and the remaining data have been deleted, their destruction is no longer possible. In addition, data from previously performed analyses can no longer be removed. Despite revocation, a later attribution of the genetic material to you personally via other sources can never be excluded.

To revoke your consent, please contact: XXX

13.1.11 Insurance Cover

For harm arising as part of the investigation, which may be caused by the principal investigator or other personnel at the XXX during the course of their professional duties, we have arranged appropriate insurance cover through our public liability insurance policy with the company XXX.

For any damage occurring en route to a study investigation, an accident insurance policy is also available.

Thank you very much for your interest in our research!

Declaration of consent

Patient/test person: _________________

(Name, first name)

Date of birth: ______________________

I agree to donate my biomaterials and data, as described in the information document, to the XXX, and to their use for medical research purposes. Under certain circumstances, this also applies to their transfer for the purposes of research projects abroad where potentially lower levels of data protection are in place. I transfer the ownership of my biomaterials to the XXX.

I have read the information sheet and have had the opportunity to ask questions.

I am aware that my participation is voluntary and that I can withdraw my consent at any time and for any reason, and that such withdrawal will have no disadvantageous consequences for me.

I agree that I may be contacted again at a later date (if you do not wish to be contacted again, please tick “no” as appropriate):

• For the purpose of obtaining further information/biomaterials;® no

• For the purpose of obtaining consent for comparisons with other databases;® no

• For the purpose of feedback regarding results of possible relevance to my health ® no

• For the purpose of feedback concerning results of relevance for the study® no

• For the purpose of feedback concerning secondary findings of relevance to my health as follows:

  • (a)  I agree that I will be informed about medically-significant findings not related to the aim of the present study for which a targeted therapy or preventive strategy is currently available. ® no

  • (b)  I agree that I will be informed about medically-significant findings not related to the aim of the present study for which there is no treatment or preventive strategy currently available, but they may be important for my life planning. ® no

This feedback should be provided by the establishment, in which my biomaterials/data were obtained, or by the following specialist (please specify if applicable)

...............................................................................

Name and address of the responsible study leader:

XXX

Privacy statement:

I hereby agree that the XXX—as described in the information documentation

• May collect and store my personal data;

• May gather further details about my health from my medical records;

• May pseudoanonymize (i.e., encrypt) my data and biomaterials

The biomaterials and data may be used for an unlimited time period for medical research projects.

They may be provided in a pseudonymized form to universities, research institutes, and research companies—if necessary abroad—for the purpose of medical research.

I have been informed that I may revoke the consent I have given to the XXX at any time and for any reason. In the event that I revoke my consent, the remaining biomaterials and the data collected from me will be destroyed, erased, or made anonymous if I so request. Data from already completed analyses cannot be removed.

I have received a copy of both the consent form and the patient/test person information. The original will remain at the XXX.

____________________________________________________

Patient’s/test person’s name in capital letters

____________________________________________________

Place, date (to be completed by patient/test person), patient’s/test person’s signature

I have conducted the informed consent briefing and obtained the patient’s/test person’s consent.

____________________________________________________

Name of specialist in capital letters

____________________________________________________

Place, date, signature of specialist