The initial recruitment of 500,000 participants from  assessment centres was completed in 2010. Since then, there have been two occasions when we have invited our participants to return:
- as part of a periodic re-assessment visits where we re-invite approximately 20,000 participants to repeat the baseline assessment measures (this makes the resource more useful for research purposes as it removes certain types of statistical bias http://www.ukbiobank.ac.uk/wp-content/uploads/2013/01/Regression-Dilution.pdf ;
- as part of the imaging assessment visit. This very major initiative will involve imaging over 100,000 participants in 3 centres (Stockport, Newcastle and Reading) over the course of the next 7 years. It is, by some distance, the largest imaging research project in the world
1. General principles
UK Biobank aims to recruit 500,000 people aged 40-69 from all around the UK. It is not intended to enroll people who are unable to give consent (for example, because of diminished mental capacity); those who are unable to take part in data collection (for example, because they are too ill); or those who are uncomfortable with any of the conditions of participation. Staff will be trained to judge each potential participant’s capacity to give consent and to take part in data and sample collection. Participation in UK Biobank is voluntary. All aspects of recruitment, from initial contact with potential participants through to enrolment at the baseline assessment visit, will be conducted in a way that preserves the voluntary nature of participation and respects cultural differences. In order to generate scientifically valid results, UK Biobank must also obtain agreement from participants for examination of the progress of their health, illness and incapacitation in depth and over time. UK Biobank will act in accordance with the Data Protection Act and all other relevant legislation, and seek all necessary approvals that are required for the planned invitation, assessment and followup procedures (e.g. from relevant ethics committees, the Information Commissioner, Caldicott Guardians and other relevant bodies).
2. Selection and approach
UK Biobank will seek to recruit as widely generalisable a population sample as is practicable so that the research may ultimately benefit a wide diversity of people. UK Biobank will work to reduce barriers to participation (such as those relating to age, gender, ethnicity, social class, residence, employment, and language) through, among other things, the location and opening times of assessment centres and by translation of study materials. UK Biobank will identify potential participants from contact details in NHS records (and other registers), without access to any medical information. These contact details will be processed in confidence by UK Biobank, in accordance with the Data Protection Act. Potential participants will then be sent information about the study and invited to attend a local UK Biobank Assessment Centre.
Potential participants will receive, by mail, information about UK Biobank and an invitation to attend a local study Assessment Centre. Further information will be available from UK Biobank through a free telephone service and website. During the Assessment Centre visit, UK Biobank staff will answer questions, provideclarifications and explain the consent process. If an individual decides to take part, their signed consent will then be sought and recorded before they are enrolled. Enrolment will involve completing a questionnaire about lifestyle (e.g. diet, exercise, smoking, alcohol) and other factors (such as mood, cognitive function, medical history), having baseline physical measurements (e.g. blood pressure, size, grip strength, lung function)
and giving blood and urine.
B. 1. Consent
When you were invited to join UK Biobank, we sent you information about the project. Having agreed to participate, you attended an assessment centre where you were provided with a summary of the key points again. You then completed the consent form via a touchscreen questionnaire and a copy of that form was given to you at the end of your visit.
Although we have kept the matter under close review, we have not needed to seek any further consent from you over the past 10 years, and we do not expect to do so in the future. However, if you have already or do in due course agree to participate in the imaging assessment visit then you will go through a new consent process. The only thing which has changed from the original consent is that the protocol for the feedback of incidental findings, in the context of the imaging assessment visit is rather more detailed.
B. 1. Consent
Consent will be sought to participate in UK Biobank. Participation will be presented as an opportunity to contribute to a resource that may, in the long term, help enhance other people’s health. Because it will be impossible to anticipate all future research uses, consent will be sought for research in general that is consistent with UK Biobank’s stated purpose (rather than for specific research).
Consent will be based on an explanation and understanding of, amongst other things:
- the purpose of UK Biobank, the fact that it is a longterm research resource (not a healthcare programme), and any risks and benefits of taking part
- the kinds of information and samples that will be collected at enrolment, which may include data that some participants consider especially sensitive (with options to avoid certain questions and measurements)
- the fact that there will be a link to the full record of medical and other health relevant information (past and ongoing) and the need for participants to allow such linkage for as long as possible to maximise the value of UK Biobank as a research resource
- the fact that UK Biobank will be the legal owner of the database and the sample collection, and that participants will have no property rights in the samples
- the kinds of safeguards that will be maintained, including secure storage of data and samples in reversibly anonymised form (as explained in Section I.C.2), and severe restrictions on access to data and samples that are not anonymised
- the assurance that only research uses that have been approved by both UK Biobank and a relevant ethics committee will be allowed, and that data and samples will be anonymised before being provided to research users
- the expectation that commercial entities will apply to use UK Biobank
- the possibility of being recontacted in future by UK Biobank and the purpose of such contacts
- the intention to continue to hold and allow research access to data and samples after participants lose mental capacity or die, as such data and samples are crucial for research on severe illnesses
- the right to withdraw at any time without having to give a reason and without penalty, and the meaning of different levels of withdrawal
- UK Biobank’s commitment to maintaining active engagement with participants and society in general.
The points listed above are some elements of what it means “to participate in UK Biobank”; each is discussed in more detail later in this Framework document. These elements and other customary undertakings will be addressed in information provided to participants during the consent process. UK Biobank will endeavour to make sure that participants understand what they are consenting to when they agree to take part. An evaluation has been conducted in preparation for the main phase of recruitment, which will provide further opportunities for assessment of the consent procedures. The consent to participate in UK Biobank will apply throughout the lifetime of UK Biobank unless the participant withdraws. Further consent will be sought for any proposed activities that do not fall within the existing consent.
B. 2. Collection of data from health-relevant records
You gave your permission for UK Biobank to follow your health (through your health records) over your lifetime. We have completed making links to your secondary health care records (such as hospital admissions and various registries, such as death and cancers) and we are in the process of linking to your primary health care records held at your GP surgery.
There are two instances where we have had occasion to review the scope of the phrase “health-relevant records”.
- does “health-relevant records” include information you have provided to another research resource? For example, some female UK Biobank participants are also enrolled in the Million Women Study. Our review concluded that in principle it would be reasonable to understand the phrase “health-relevant records” so as to include information about you contained in other health-related research resources. Having said that, no such linkage has yet taken place as there are other questions to be answered, specifically how such linkage should be managed so that we can ensure UK Biobank data remains under the control of UK Biobank http://www.ukbiobank.ac.uk/wp-content/uploads/2013/10/UK-Biobank-data-linkage.pdf
- does “health-relevant records” include tissue samples (for example tumour samples) that have been taken from participants during the course of clinical diagnosis or treatment? Our review concluded that it would probably be reasonable to understand the phrase “health-relevant records” so that such samples could be deemed to be included within your health relevant records. We are currently piloting a trial where UK Biobank curates some samples (tumour samples collected from UK Biobank participants in Newcastle as part of their clinical treatment) whereby the samples, or more likely the results of the analyses of the samples, may in due course be made available to researchers under the UK Biobank access procedures.
Collection of data from health relevant records
The ability to accumulate data from health relevant records will be essential for the success of UK Biobank. It must track health events, the development of disease, and the course of treatments, and so must aim to obtain such information as diagnostic codes and prescribing data. The range of different records that can be accessed will be determined by developments in health service electronic records systems. UK Biobank will collect data from NHS record systems (e.g. GP, hospital, dental and prescription records) and other relevant record systems (such as disease registries or occupational health records). In the consent process, UK Biobank will explain to participants the kinds of record systems to which it will seek access, and will keep participants informed of progress with accessing different types of records. UK Biobank will not be able to say in advance which data from these various records will be needed. Although, in general, only parts of these health relevant records will be examined, consent will cover access to the full records. This will include past records, since these will help to characterise participants and to understand later health events more completely. The full records may also be required when it is necessary to verifythe accuracy of data.
B. 3. Provision of health information
UK Biobank’s overall policy regarding the provision (feedback) of health information to participants is that we do not provide feedback of this kind to our participants. The reasons for this are set out in the original EGF and are worth repeating:
“UK Biobank will aim to ensure that participants understand that enrolment does not provide them with a health check. In principle, it would be possible to provide participants with the results of some measurements or observations at any of three stages: at the initial assessment visit (e.g. blood pressure or incidental findings), in the initial stage before samples are stored (e.g. white cell count), and much later as results arise from research studies (e.g. genetic or biochemical studies).
However, the value of such feedback is questionable because the data would be communicated outside of a clinical setting and would not have been evaluated in the context of the full medical record. As a consequence, the significance of the observations might not be clear and UK Biobank staff would not be in position to interpret their implications fully. Further, it is not likely to be constructive, and might even be harmful (including causing undue alarm and having potentially adverse effects on insurance and employment status), to provide information without prior counselling or support (which UK Biobank will not be able to provide: as explained below). For these reasons, UK Biobank will generally not provide health information to participants, and a clear explanation of this policy (and the few exceptions) will be provided in the participant information material.”
In practical terms the means that we have done the following:
- certain measurements that were taken / observed from participants during the assessment visit (and that a participant could have written down) were presented to participants on a card at the end of their visit, such as weight and BMI;
- findings or observations which are incidental to the purpose of the assessment visit (for example signs of a melanoma or domestic abuse), assessment centre staff would suggest that the participant seeks the input of an appropriate medical professional;
- certain tests were conducted on the blood samples just after they were received at the Co-ordinating Centre, but before they were frozen. The results of these assays were not returned to the participants;
- findings of risk factors, correlations, evidence of existing disease or other findings / predictions made as a result of a research project. These findings will not be returned to participants.
Since the completion of recruitment, we have regularly reviewed this approach and our conclusion is that the prevailing policy is sound for the reasons originally set out and should remain in place.
Analysis of blood samples
Since the completion of recruitment in 2010, UK Biobank has generated extensive further information on its participants, particularly by way of genotyping and analysis of blood samples.
Genotyping is a process whereby an individual’s genetic information is recorded to be used in health research. It measures whether an individual possesses certain common (and less common) genetic variants, which may have an impact on their chances of developing a particular disease. This is to be distinguished from full genome sequencing – which UK Biobank may well undertake in due course – where an individual’s entire genome (approximately 3.2 billion base pairs) is read.
UK Biobank’s genotyping measured, in each participant, approximately 800,000 common genetic variants. A further 70 million variants were imputed, meaning the statistical inference of other unobserved variants in the genetic information, using genetic algorithms. This genotyping has now been completed and the data on the first 150,000 participants was made available to researchers in mid-2015: the data on the full 500,000 participants will be made available in late 2016.
The vast majority of disease is the result of the complex interplay of a number of different genetic variants and other risk factors, such as lifestyle. The existence or not of a particular genetic sequence may effect the risk of developing a disease, but is unlikely to be the sole cause of disease. Genetic differences between us are entirely comparable to other risk factors, be they environmental, exposure-related or biochemical. As such, information that is related to genetic differences identified in studies is not fed back to participants. However, the expectation is that all participants along with the wider UK and global population will benefit from advances in genetic research.
UK Biobank is undertaking about 40 tests on the blood and urine samples from all 500,000 participants. The existence or not of certain biochemical markers are, as mentioned above, risk factors for a disease (e.g. low white blood cell count or high cholesterol LDL score).
These genotype and assay results are not incidental to the baseline assessment visit: rather they have been generated by further tests and measures from UK Biobank samples. In keeping with UK Biobank’s prevailing policy, UK Biobank does not propose to return the results of the genotyping or biomarker assays or indeed further comparable assays to participants.
However, the main area where we have had occasion to re-visit our approach has been in relation to the generation of incidental findings in the course of the imaging assessment visit.
The imaging visit
All medical research resources that recruit participants have the capacity to generate incidental findings. This is particularly the case with an imaging assessment visit, where (because of the detailed nature of imaging) there is increased opportunity to observe incidental findings. These may be of potentially greater significance and in potentially greater magnitude as compared to the original recruitment visits where imaging was not involved.
We developed our protocol for dealing with potentially serious incidental findings http://www.ukbiobank.co.uk/wp-content/uploads/2016/04/information_leaflet.pdf .
We then tested this protocol in the course of the conduct of the pilot phase. We have recently published the results [link].
Provision of health information to participants
UK Biobank will aim to ensure that participants understand that enrolment does not provide them with a health check. In principle, it would be possible to provide participants with the results of some measurements or observations at any of three stages: at the initial assessment visit (e.g. blood pressure or incidental findings), in the initial stage before samples are stored (e.g. white cell count), and much later as results arise from research studies (e.g. genetic or biochemical studies). However, the value of such feedback is questionable because the data would be communicated outside of a clinical setting and would not have been evaluated in the context of the full medical record. As a consequence, the significance of the observations might not be clear and UK Biobank staff would not be in position to interpret their implications fully. Further, it is not likely to be constructive, and might even be harmful (including causing undue alarm and having potentially adverse effects on insurance and employment status), to provide information without prior counselling or support (which UK Biobank will not be able to provide: as explained below). For these reasons, UK Biobank will generally not provide health information to participants, and a clear explanation of this policy (and the few exceptions) will be provided in the participant information material.
Specifically, provision of health information at the three stages will be covered:
- At the initial assessment visit: It would be impractical and inappropriate to conceal from participants some of the measurements taken in their enrolment visit (i.e. blood pressure, height, weight, estimated amount of fat). Consequently, a printed report will be provided at the end of their visit as a means of feeding back such
measurements. By reporting standard ranges, the participant should be provided with sufficient information to give meaning to the measurements taken, so that they may act on the results if necessary and arrange to see their general practitioner or other relevant health professional.
- The legal duty of care for staff conducting enrolment will be determined by the research context, and will apply mainly to safe and competent collection of questionnaire data, baseline measurements, and blood or other samples. They will not have the same duty of care that they would have in a clinical setting. However, even in this research context, there may be occasions when staff consider there to be a professional or ethical obligation to draw attention to abnormal measurements (such as elevated blood pressure) or incidental findings (such as possible melanoma). In such circumstances, participants will be encouraged to contact a relevant health professional.
- Before samples are stored: Prior to storage of samples, UK Biobank is planning to conduct routinely only those few investigations that cannot be done subsequently on stored samples (i.e. haematology). As is the case with other measurements that may be conducted on stored samples (see below), these baseline measurements are being conducted outside of a clinical setting without prior counselling and support.
Moreover, all such analyses will be conducted on anonymised samples without other relevant medical information about the individual. Consequently, these individual results with personal identifying details will not be provided to a participant or to anyone else. A clear explanation of this policy will be included in
the participant information material.
- Later, as a result of research studies: In normal healthcare settings, tests are conducted at the individual level immediately after sample collection; they search for specific conditions or outcomes; and, in the case of genetic tests, pre and post test counselling is provided. But, given the lack of knowledge at recruitment about
the tests that might be done in this research context (and, hence, the inability to provide specific counselling beforehand), UK Biobank will not provide participants with information (genetic or otherwise) about their own individual results derived from examination of the database or samples by research undertaken after
enrolment. Instead, the overall findings and implications of results that derive from UK Biobank will be made available to participants and the wider community so that they can influence public health strategies (including, where appropriate, the introduction of screening for newly discovered risk factors).
B. 4. Ongoing engagement with participants
Keeping UK Biobank participants informed about the resource is very important to us. We believe it is fundamental to our remit to continue to keep you updated about what we are doing. UK Biobank tries to strike a balance between providing participants with relevant information about UK Biobank without inundating you with overly-frequent updates.
UK Biobank has recently revamped its main website and updates it regularly with approved research projects and published papers. We promote this work on Twitter. UK Biobank dispatches regular newsletters and hosts regular participant meetings, whereby participants can meet face-to-face with the UK Biobank team and researchers using the resource. These events have proved to be very popular – approximately 200 or so participants turn up to each one. We are in the process of scheduling a further set of meetings around the country. UK Biobank also engages with the national and regional media to promote the findings of UK Biobank.
Ongoing engagement with participants and the public
Regular communication will be important to inform participants of general findings from research based on the resource and to encourage continued participation. UK Biobank will, therefore, look for a variety of ways for communicating with (including listening to) participants, the general public, research users and the scientific
community. A variety of media, such as websites, helplines, newsletters, and public meetings will be used to inform participants about the development and use of the resource, and of ways to contact UK Biobank (including, for example, how to withdraw). Systems will be put in place to allow participants to indicate how, and whether, they would like to receive such information. UK Biobank may also establish a participants’ panel with a clear remit that is as representative as possible of the UK Biobank population and able to express views
typical of the participants generally. UK Biobank will also maintain procedures for
responding in a timely fashion to any enquiries or complaints.
B. 5. Expectation of re-contact
Proposals for UK Biobank to re-contact participants to answer more detailed research questions are the subject of careful review. We wish to ensure that the reasons for re-contact are justified, that participants are not overburdened and that inadvertent feedback of health information is avoided. We have published a set of re-contact procedures. And these cover the various re-contact situations that could arise and set out how UK Biobank will determine whether re-contact is appropriate or not.
Recently, we have been asked by other researchers if UK Biobank is willing to contact its participants to see if they might take part in another research project or trial, where the research project or trial is run quite separately from UK Biobank.
It seems to us that, as long as the underlying aims of the re-contact study are a) plausible b) realistic and c) not in and conflict with those of UK Biobank, then we should be prepared to give our participants the opportunity to participate in other projects. However, we are monitoring the first of these research projects closely to ensure that participants do not feel that are being unnecessarily burdened.
Expectation of recontact
It will be explained to participants that they may be recontacted by UK Biobank for various reasons, including:
- To collect new information (such as questionnaire data, measures or samples) for the resource. It is anticipated that repeat assessment visits would be done every few years and would generally involve reasonably representative subsets of just a few tens of thousands of people, with different individuals selected for sequential repeat assessments. Invitations to provide additional information that do not require such visits (e.g. questionnaire data collected by mail or internet) might be sent to all participants at similar intervals during the study.
- To seek consent to proposed new uses that have passed scientific and ethics review but do not fall within the existing consent
- To ask participants whether they would be willing for researchers to contact them to discuss possible involvement in a study that requires new information or samples.
- It will be emphasised that participation in all such reassessments is entirely voluntary, and that any initial recontact will be undertaken by UK Biobank.
- Decisions on whether recontact is appropriate for particular proposals will be made by UK Biobank with advice from the Ethics and Governance Council (see Section III.A.2), and will be subject to Research Ethics Committee approval. When recontacting special subpopulations, care will be taken over the use of selection criteria (such as genetic makeup) that might inadvertently reveal information to participants about themselves of which they may not be aware.
B. Right to withdraw/ incapacipated/ expectation of personal financial gain
6. Right to withdraw
The right to withdraw is an important and continuing right of every participant. UK Biobank is an entirely voluntary project. We are pleased that very few of you have elected to use this option so far and we will continue to do everything we can to ensure that you retain your trust in UK Biobank.
7. Respect for incapacitated or deceased person’s wishes
Although there have been some changes to the general law in this area – notably the Mental Capacity Act 2005 – the provisions of this section have not changed and continue to apply to your participation in UK Biobank.
8. Expectation of personal financial gain
There is no change here, other than to say that reasonable expenses are always re-imbursed to participants, although many of you choose not to claim them (thank you as this means that there are more funds available to enhance the resource).
Right to withdraw
Participants will be advised at enrolment that they have the right to withdraw from UK Biobank at any time without having to explain why and without penalty. This is essential to preserve and demonstrate the voluntary nature of participation. Should participants become incapacitated or die, they would no longer be able to withdraw themselves (see Section 7). During enrolment, UK Biobank will provide information to participants about the options for withdrawal:
- “No further contact”: UK Biobank would no longer contact the participant directly, but would still have their permission to use information and samples provided previously and to obtain further information from their health relevant records.
- “No further access”: UK Biobank would no longer contact the participant or obtain further information from their health relevant records in the future, but would still have their permission to use the information and samples provided previously.
- “No further use”: In addition to no longer contacting the participant or obtaining further information about them, any information or samples collected previously would no longer be available to researchers. UK Biobank would destroy their samples (although it may not be possible to trace and destroy all distributed anonymised sample remnants) and would only hold their information for archival audit purposes. The participant’s signed consent and withdrawal would be kept as a record of their wishes. Such a withdrawal would prevent information about them from contributing to further analyses, but it would not be possible to remove their data from analyses that had already been done. (N.B. UK Biobank is completely committed to ensuring that participants are informed about important developments with the project. One such development to emerge during the establishment of the IT systems is that, although data from participants who choose the “No further use” withdrawal option can be made unusable, it is not possible to destroy it completely. This is due to the development of complex IT systems designed to protect the integrity and security of the data.) If, having discussed their concerns and options, a participant decides to withdraw then UK Biobank would seek written confirmation of the level of withdrawal from the participant. UK Biobank will need to retain some minimal personal data for a number of reasons, which include: ensuring that participants who have withdrawn are not recontacted; and assessing the determinants of withdrawal and any impact on research findings. Participants who withdraw will be assured that this administrative record will not be part of the main database that is available to others. Despite UK Biobank’s efforts to stay in touch with participants, it may well lose contact with some as they relocate, emigrate, or do not respond to communications. Where a participant has not actively withdrawn, UK Biobank will continue to use the samples and data and maintain linkages, although it will not be able to update some data (e.g. those collected by repeat questionnaire).
Respect for incapacitated or deceased participants’ wishes
UK Biobank will not enrol potential participants who express the view that they would want to be withdrawn should they lose mental capacity or die because this would reduce the value of the resource for research. But, if a participant decides some time after enrolment that he or she would wish to be withdrawn in the event of mental incapacity or death then this request would be honoured. In such circumstances, the options for withdrawal would be discussed with the participant (see Section 6) and written confirmation of their preferred option sought to confirm their modified consent. UK Biobank would then withdraw that participant in accordance with their preferred option for withdrawal on becoming aware that he or she had lost capacity or died (e.g. through routine follow up systems or by being notified by a family member or someone else able to act on behalf of the participant). Otherwise, participants will not be withdrawn if they lose mental capacity or die. In all events, UK Biobank will continue to safeguard the confidentiality and security of all participants’ data and samples as long as it holds them, including after a person’s mental incapacity or death.
Expectation of personal financial gain
Participants will not be offered any material financial or other inducement to contribute to UK Biobank, irrespective of whether the use of data or samples might ultimately lead to profit. Reasonable expenses incurred through participation (such as travel and parking) will be reimbursed as required by the participant. As is explained in Section II.A “Stewardship of data and samples”, participants will be told that their involvement will not create or confer any property rights in samples.
Our commitment to maintaining the confidentiality of your data is of paramount importance to us. We regularly conduct security audits and internal and external tests of all our IT systems.
Information about UK Biobank participants, including contact details, continues to be held securely. Data about you including your health records is only released to scientists (for research) in a way that does not identify you (in what is known as a reverse-anonymised or pseudo-anonymised manner). For further information on this please refer to our data de-identification protocol .
Access to the key code to identify UK Biobank participants is restricted to a very limited number of UK Biobank staff. To date the number of instances where a participant has been inadvertently identified is (as far as we are aware) zero. This remains our objective. We remain very vigilant in this area, particularly given the growing number of publicly available databases, which contain potentially identifiable information (such as genealogy databases which contain family names, family history and some genetic information).
We remain wholly committed to maintaining the security of your samples and data. Our systems are regularly reviewed, audited and updated to address changes in technology.
UK Biobank is committed to protecting the confidentiality of data and samples. Systems will be in place for secure data flow and for protecting confidentiality, (reversibly) anonymising data and samples, and enforcing security. These measures will be explained to participants during the consent process. Some principles and comments on these matters follow in this section.
1. Commitment to maintaining confidentiality
UK Biobank will maintain strict measures to protect confidentiality, and will ensure that data and samples are (reversibly) anonymised, linked and stored to very high standards of security. The same protection will be extended under contract for any handling or analysis of data or samples by third parties engaged to provide services necessary for developing the resource. Research users will only be given access to anonymised data and samples.
During enrolment, the assessment centre will need to hold identifying information (such as name, address, birth date, NHS number) together with information collected from the participant during the assessment visit, and this information will be encrypted for security. Following the assessment visit, these data will be transferred to the UK Biobank central system and removed from the assessment centre system. On arrival at the UK Biobank coordinating centre, all personal identifying information will be separated from participants’ data and samples and only linked using a code that has no external meaning (e.g. not the NHS number). All identifying information will be held centrally by UK Biobank in a restricted access database that is controlled by senior UK Biobank staff. Only a few people within UK Biobank will have access to the “key” to the code for relinking the participants’identifying information with their data and samples (i.e. “reversible anonymisation”). It is necessary to retain this link with identifying information to allow follow up of participants’ health; to eliminate redundant data (e.g. duplicate cases); to verify correctness and completeness of data against original records; to establish correct linkages among databases; and to find specific data or samples if participants withdraw.
Access to the key code will be restricted to only those UK Biobank staff who need it to allow proper linkage of followup data and for other necessary procedures. All UK Biobank staff will be required to sign confidentiality agreements as part of their contracts. Researchers will not be able to identify individual participants from the anonymised data or samples that are provided to them.
A wide variety of measures will be taken to ensure the security of data, samples, the database and the information technology system in general. These include staff training and confidentiality pledges, physical and electronic controls on access to data, cybersecurity, and physical security. This should prevent identifiable information from being used – inadvertently or deliberately – for any purpose other than approved research (see Section II.B.1 below).
Page last updated 07/06/2016