Do you have consent to use the data?

Why does consent matter?

SHIP is concerned with the appropriate sharing and use of health data for research purposes. Where data are ‘personal data’ (i.e., relating to an identifiable individual) they enjoy the full protection of the law. This does not mean that such data cannot be used for research purposes but strict requirements apply, for example, the consent of the person should be obtained.

The concept of autonomy is the ethical concept which underpins the need to obtain consent. The concept essentially invokes the integrity and dignity of the human person, and in the context of research involving the secondary use of patient data, it prescribes that individuals should be able to decide what is to be done with his or her personal data. Respecting autonomy in this context therefore means that before use is made of a patient’s personal data, specific consent for the proposed use should be obtained.

In the context of medical research involving the secondary use of data, the notion of consent can be can be narrowed down to the right of an individual to determine what his or her personal identifiable information is used for. The function of consent is therefore that it enables researchers to use patient information in a way that would otherwise violate the autonomy of the individual’s concerned.

For more information on consent, place see the guidance page on ‘autonomy and consent’.

Do existing consent conditions apply to your proposed data use?

It may be that existing consent conditions apply to your proposed data use, meaning that it will not be necessary to obtain any further consent.

In order for consent to be legally valid it must be made by a competent individual, it must be voluntary and it must be informed. It is likely that the final hurdle of informed consent will require further investigation in order to be satisfied. Essentially the notion of informed consent means that the individual should be fully information as to what they are consenting to, i.e. as to what their personal information will be used for. According to guidance given by the British Medical Association in their ‘Consent Toolkit’ patients should therefore be given information about the nature, purpose and scope of the proposed research project and information about confidentiality. Patients should also be made aware that they can withdraw their information from the research project at any time. This means that it is unlikely that general uninformed consent to any secondary data use will suffice. Consent will need to be informed and specific in order to be legally valid.

It should however be noted that the standards for information disclosure about the proposed data use will vary according to the sensitivity of the data. The more sensitive the data, the more information will need to be given to the patient to ensure that consent is fully informed.

Therefore, when you are assessing whether existing consent conditions apply to your proposed data use, you should look at the information the individual was given about the potential uses of their data at the time that consent was given. If the information given covered data use for research projects such as yours then it is likely that the existing consent conditions will be sufficient. If not you may need to take additional steps to obtain consent, or alternatively you may need to anonymise the data and/or seek the relevant authorisation for data use.

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