Obtaining consent for personally identifiable and/or sensitive data

Transcription

1 Obtaining consent for personally identifiable and/or sensitive data If the linkage you are requesting contains personally identifiable and/or sensitive data and you do not have Section 251 approval you will need to get consent from the individuals to whom the data relates. What is personally identifiable and sensitive data? Personally identifiable data includes: NHS Number Name Address Postcode Date of Birth Date of Death Sensitive data includes: Racial/ethnic origin Political opinions Religious (or similar) beliefs Physical or mental health conditions Sexual life Criminal records Why is consent needed? The purpose of consent is to provide sufficient information for an individual to make an informed choice about the re-use of their personal data. What can consent involve? a consent form information literature face to face interaction What should I include in a consent form? We recommend using the following statement in your consent form: I understand that the information held and maintained by The Health and Social Care Information Centre and other central UK NHS bodies may be used to help contact me or provide information about my health status. What should I include in the information literature? This can include posters, letters, leaflets, web pages and patient groups and should clearly explain the purpose and process for using their data.

2 You should also provide the individuals with information about the involvement of The Health and Social Care Information Centre and the data confidentiality and security arrangements, including your compliance with the Data Protection Act. We strongly recommend that you do not give assurances that their data will not leave your organisation. Consent and the Data Linkage application process You will need to provide us with a copy of the consent form and all associated information literature as part your Data Linkage application. See our examples of good practices in this document -

3 Example of consent form Participant Consent Form Title of Project: Participant Identification Number for this trial: Name of Researcher: Initial each numbered point 1. I confirm that I have read and understand the information sheet dated XXXXXX (Version X) for the above research study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. 2. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected. 3. I understand that data collected during the study will be kept confidential. 4. I understand that relevant sections of data collected during the study, may be looked at by individuals from University XXXXXXXXXX from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records. 5. I understand that information held and managed by The Health and Social Care Information Centre and other central UK NHS bodies may be used in order to provide information about my health status. To do this, I understand that my name, postcode and date of birth will be shared with the NHS Health and Social Care Information Centre. 6. I understand that audio recordings may be made during telephone conversations and will be used in the research process and for monitoring and training purposes. 7. I agree to my GP being informed of my participation in the study.

4 8. I agree to take part in the above study. Name of Participant Signature Signature When completed, 1 copy for participant; 1 copy for researcher site file. Name of GP GP Surgery Participant Identification Number for this trial:

5 Example of patient information sheet Participant Information Sheet Research Title: Invitation We would like to invite you to take part in this research study. Before you decide if you would like to be involved, we would like to explain why the research is being done and how you might be involved. Please take time to read the following information carefully. The researcher will read through this information again with you during their visit. Please ask if there is anything that is not clear or if you would like more information. Please take time to decide whether or not you wish to take part. What is the purpose of the project? We want to find out XYZ. The XXX Institute has funded the XXX University and XXX Charity to find out. Why have I been invited? You are aged XX or over and have told us that you are interested in hearing more about the study before deciding whether or not to take part. Do I have to take part? It is up to you to decide whether or not you take part. If you think that you would like to be involved a member of the research team will read through this leaflet with you and then you will be asked to sign a consent form. Even if you do sign up you are still free to pull out at any time without giving a reason. Your future care and the services you receive will not be affected if you decide not to take part and you will not be contacted again by our research office. What will happen if I agree to take part? If you agree to take part in the study we will arrange for one of our researchers to meet with you, answer any questions you may have and complete a brief assessment. The researcher will ask you some questions and check the study is appropriate for you. What will happen next? XYZ Are there any expenses or payments involved? XYZ

6 What will I have to do after I have agreed to be involved? After you have consented to be involved and been accepted into the study, a researcher will visit you again. Whether you are in group 1 or group 2 the researcher will ask you some questions about yourself, your health and wellbeing and what services you use. We will ask you the same questions again a further six months later and finally a further six months after that. We are most likely to ask you these questions over the telephone. However a researcher will arrange to visit you at home to complete the questionnaires with you should you need it. What is the intervention that is being evaluated? The intervention that is being tested XYZ Will my taking part in the study be kept confidential? All information about you will be kept confidential in locked filing cabinets at the university. Whether you are in group 1 or group 2, we will, with your agreement, contact your GP to let them know that you are taking part in the study. With your consent, we will share your name, postcode and date of birth with the Health and Social Care Information Centre. The information we share will be used by The Health and Social Care Information Centre and other central UK NHS bodies in order to provide us with information about your health status. The information we collect from you will be retained for 5 years after the study has finished in a secure archive. After then, the information will be destroyed. Why do you want to tell my GP that I am taking part in the study? If you take part in any clinical trial then the research team is required to inform your GP. This will also make sure your GP is aware of anything you might do in the study that could potentially influence your medical care. However your GP will not be given any of the information we collect from you. What will happen if I don t want to carry on with the study? You can decide to withdraw from the study at any time and, if necessary, let us know if you no longer want to be contacted. If you do wish to drop out, you do not have to give a reason. What if there is a problem? If you have any cause to complain about any aspect of the way you have been approached or treated during the course of this study, National Health Service complaints mechanisms are available to you. This will not affect the services you receive in any way. If you have any complaints or concerns, please contact the study manager, What are the possible risks and benefits of taking part in this research? XYZ

7 What if I am distressed? If you are distressed by taking part we will discuss this with you but there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for legal action, but you may have to pay for it. What will happen to the results of the research study? This research will take place over about three years, after which the results will be presented at academic conferences and published as academic reports in scientific journals. You will not be identified in any presentation, report or publication. You will be able to access the results of the study on the XXX University website. The results will also be made available to charitable organisations like XYZ. Who is organising and funding the research? The research is organised by the XXX University in collaboration with XXX Charity, XXX City Council and NHS XXX. It is funded by the XXX Institute. Who has reviewed the study? All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has been reviewed and given a favourable opinion by XXX Research Ethics Committee. Contact for further information: This information sheet is for you to keep. Thank you for your time and help.