 Hi, everyone. My name is Hina and I'm the senior research data officer within the research data management team at UK Data Archive based at University of Essex, and I mainly oversee the ethical and legal compliance when it comes to data sharing. So the overall aim of this session is to show you the role of informed consent in sharing data within ethical and legal boundaries. And I aim to cover the following in this session. In the first section, I will talk you through why to seek consent. And this section will focus on introducing the use of informed consenting research and the second part of the session is about how consent can be obtained. Covering documentation methods that are used to obtain consent and finally how to manage the obtained consent forms. This is then followed by a section on when consent could be sought during the research process and some of the important aspects that needs to be considered are also discussed. And the final section. Focusing on sharing with you some of the wordings used in real consent forms by the researchers that we come across every now and then. And I'll also share the example consent form and information sheet that we ask researchers, advice researchers to use at UK Data Service. And I will finish it off by highlighting some best practice tips and resources that can be very useful for you if you are interested in data sharing. And I will respond to your questions in the end. So as I mentioned earlier, the first section is about why we seek consent. But before I begin, just a quick couple of questions to know your background on Mentimeter. If you could just go to this website or enter the number code or use this QR code over your phone, that would be helpful. I hope everyone has joined. So just quick introduction to your background. If you are post grad, early career researcher or a professional services staff. So the answers coming in professional services, PhD candidate, researchers, lecturer, project management, senior lecturer, library, someone from library staff, open research. So that's great. People with diverse background. So I hope that today's session is useful for you. So if you could let me know what type of data are you interested in or you're working with is it makes quantitative or qualitative. So majority of you with mixed some con and call. So again, a mix of people attending today's session. So I hope so that it will be useful for all of you. Thank you very much for your responses. And final question is, what do you think why we seek consent in research? I'm sure. Looking at your diverse backgrounds, you are all familiar with why we seek consent in research, but just any thoughts would be welcome. Ethical requirements, integrity and ethical conduct, HTA compliance, ethics, respect, participants, transparency. That's right. Protection from harm to inform the participants how their data will be used exactly. Research ethics to make the individuals make so that inform the participants so that they can make informed choices. That's right. Protect privacy. Yeah. Ensure interviews are happy with what shared research protocols, legal and ethical GDPR safety, paperwork, autonomy. Yes, lots of responses. Thank you very much for your responses. So, yeah, you all are very familiar with what informed consent is. And it is the process by which a researcher discloses appropriate information about the research so that a participant may make a voluntary informed choice as you have some of you have mentioned to accept or refuse to participate in the research and in the research context, consent is obtained to ensure that participants understand what they are signing up to making participation and research more effective. It also ensures that the research conducted is ethical and compliant with the data protection regulation as some of you have already highlighted that. So, in research context, if we broadly classify it, we need it for two purposes. Consent for research participation, which is considered as one of the founding principles of research ethics where it is sought before participation in any research activity and for all participants. And as you have mentioned that it usually involves providing information regarding study purpose, risk benefits, voluntary participation and so on. However, consent can also be used to comply with the data protection regulation. So if a researcher collects, manages and share personal data, then consent of the data subject can be used as a legal base to process this personal information under the UK GDPR. There are, broadly speaking, there are two legal frameworks that need to be considered when it comes to data sharing, which is duty of confidentiality and data protection legislation, which is more commonly called UK GDPR now. In the UK, there is a duty of confidentiality that is based in common law and that occurs where confidential information comes to the knowledge of a person. In circumstances where it would be unfair if it were then to be disclosed to others. And there are some exceptions when you can disclose information. For example, as I said, if participant consents to onward sharing their personal data, then sharing does not breach duty of confidentiality and sometimes public interest can also override duty of confidentiality. And occasionally there are instances when you may need to give up data such as over a court order. So in terms of the consent forms, the best practice is to avoid very specific promises in the consent forms. As researchers, we must adhere to data protection requirements when managing or sharing personal data. Personal data is any information relating to an identified or identifiable natural person. And people can be identified directly or indirectly. And examples of direct identifiers are name, address, postcode, telephone number, voice pictures, and some of the examples of indirect identifiers are occupation, geography, unique or exceptional values in the data. That is called outliers. So if the personal information about people is collected or used in research, then the GDPR applies. So a bit of background to the GDPR is necessary here. GDPR is the EU-wide data protection legislation that was introduced in 2018 and replaced UK Data Protection Act that was used until that time. However, after Brexit, it is now called the UK GDPR. Currently, UK GDPR and EU GDPR both are aligned. They place the same legal applications on researchers. But in the future, the two pieces of legislation may diverge as the UK has now left the EU. So it will therefore be important for researchers to ensure that they gain local support from their university or DPO when their research project will span across the EU. So now if the researcher based in the UK collects personal data about people anywhere in the world or a researcher outside the UK collects personal data on UK citizens, then DPA and UK GDPR both applies. However, if the researchers are undertaking research projects which span across the EU, then the EU GDPR will also need to be considered and adhered to. So there is a misconception that data protection laws such as GDPR prohibits data sharing. However, it does not prevent data sharing as long as you approach it in a sensible and proportionate way. In fact, GDPR is useful for research because it legalizes much of the current good practices in research such as data sharing and archiving. Under the UK GDPR, there are six possible grounds for processing personal data and one of these must be present. And you can see that these are consent, public interest, legitimate interest, protection of vital interest, legal obligation and performance of a contract. However, in the context of research, the first three ones are the most applicable grounds for the processing of personal data. Though consent is rarely used as a legal ground in the UK, but if you are using it, please make sure to fulfill certain conditions associated to it. For example, make sure that it must be freely given, it must be informed, unambiguous and it should be specific such as it is for, you need to mention if it is for audio recording, video discussion, or interview, whatever you are collecting the information. And it must be a clear affirmative action and cannot be inferred from silence, pre-tick boxes or inactivity. And make sure that the participants were given the opportunity to request to remove their personal data at any time. And this request to withdraw is for removing their data and not a withdrawal from research, which is ordinarily asked in the consent form. So these two things are different. It must be documented if you are using it as a legal base. And it could be in a recorded or written or oral form, but it should be documented. And finally, an explicit consent is also required to process special categories data, such as race, ethnic origin, political affiliation, religious, religion or genetics or health. So you need to obtain an explicit consent if you are collecting special categories data. Information commission office advised that for almost all the research conducted in the UK organizations should rely on either public tasks, for all public bodies or legitimate interest for non-public bodies. However, those holding and using health information, which is a special category of personal data in the GDPR will also require a further condition in addition to the public task. And in academia, this is usually to support scientific and historical research. And in addition, you also need to complete a data protection impact assessment for any type of processing which is likely to be high risk. So you must therefore be aware of the risk of processing the special category. As I mentioned, that explicit consent is mandatory if you process special category data under common law or duty of confidentiality. So I thought that a quick informed explicit consent is useful here if you are to obtain it. So ordinary consent can be obtained verbally or in writing. However, explicit consent, as I mentioned earlier, should always be recorded or documented. Whether you have obtained it in writing in a written form or oral form, but it should be recorded or documented. And there are certain conditions that need to be considered. Otherwise, the consent can become invalid. For example, it can become invalid if no genuine pre-choice was given or if there was a clear imbalance of power between a researcher and the individual. And if the consent request was vague or unclear or if the researcher's organization was not specifically named and if the subjects were not informed about their right to withdraw and so on. So we need to consider these things in order to make sure that your consent is explicit consent is valid. And explicit consent statement should specifically refer to the particular data set that is to be processed. The precise purpose of processing, including any automated decision making, it should identify any risks or implications that might arise for the data subject as a result of the data processing and should provide any other relevant or specific information that might influence the decision of a data subject to give or not to give their consent. So these are the things that you need to consider if you are to obtain an explicit consent. There's a couple of the following slides at the screenshots of a very nice checklist from University of Dublin in order to assess if your explicit consent form is in line with the GDPR or not. So I found it very useful. You can have a look at it later when you get the slides. And I have added a link at the bottom of this slide as well to this checklist. So apart from being good scientific practice in some countries, gaining informed consent is mandated by law. For example here, you can see that some countries have mandatory requirement to obtain consent if you collect personal data. And among this list, you can see that there is no legislative requirement for consent to be sought from participants in the UK. As I said that in the UK, it's the public interest that is being used mostly. But in the UK funders or research ethic committees and ethics guidance bodies may require it. So the next section is about how to seek consent and it includes formats to obtain consent, some information on document patient methods to obtain consent and record. Consent can be gained in written or oral form. The format of the consent depends on the kind of research. However, it is important that whatever format is being used, written or verbal, it should be documented. You need to document how it has been gained, what information has been provided to the participants and what they have agreed to. Especially if you are obtaining an explicit consent, as I mentioned earlier. Whether you obtain consent in a written form or a verbal form, both formats have pros and cons. For example, written consent has more solid legal ground. For example, participants have agreed to disclose confidential information and you have that in writing in front of you. This is the form that is usually required by ethic committees and most of all it offers more protection for researchers as they have written evidence of consent. However, it cannot be used in some instances such as in illegal activities. On the other hand, verbal consents are best if recorded, but sometimes it is hard to make all issues clear verbally and most of all it can pose greater risk for researchers in regards to adequately proving participant consent. And it may scare people from participating and have them think that they cannot withdraw their consent. So both of them, I think it depends on the individual researcher and research what is appropriate and what is not appropriate for their research. And I'm sure you all are familiar that typically written consent documentation includes an information sheet and a consent form signed by the participant. Because this division allows the background information to be as tilt as necessary while keeping the signature form short and concise. And an information sheet should cover the following. You can see the list, purpose of the research, what is involved in participating, benefits and risk of participating. Procedures for withdrawal, future usage of data, which is very important if you plan to share data, you should inform the participants about the future uses of data such as storage, publishing and archiving. It should also mention the details of the research such as funding source, sponsoring institution, name of the project, contact details for researchers and how to file a complaint. And researchers need to make sure that consent form used, they are designing or they are using, should use simple language and should allow the participants to clearly respond to points such as they have read and understood information about the project. They have been given the opportunity to ask questions and they voluntarily agrees to participate in the project. They understand what they are signing up to. And as I said, future uses of the data should be mentioned there if you are planning or you are required by your funders to share that data for future reuse. You should pay particular attention to this section of your consent form informing the participants about what you are going to do with the information you have collected. And it should also have signatures and dates of signing from the participant and the researcher. And especially if personal information is collected, best practice is to provide information about how personal information will be processed and stored and for how long. And what procedures you are going to use for maintaining confidentiality, whether real names will be used or not. If data will be anonymized, how you are going to anonymize it, it should also state procedures for ensuring ethical use of the data, especially in the context of archiving and reuse. And finally, if the GDPR applies, remember that GDPR applies if you are not able to anonymize the data and there is a personal information in there. So if the GDPR applies, then further information needs to be provided in the consent form, such as the contact details of the data controller. Data controller is the entity that determines the reason for processing personal data. It could be our data protection officer, REO at your organization or a researcher himself or herself. Consent form should also state who will receive or have access to the personal data and it should also have a clear statement on the rights of the participants because participants can request to access their data. They may ask for corrections or even ask for removal of their personal data. So these things need to be communicated to the participants. However, you may use some information in the information sheet and some in the consent form. And I have added a link to the UKDS model consent form where you can see these sections that are addressed separately. I will be going through that later in the presentation. So different methods can be used to obtain consent and ICO has recommended the following. And you can go through the, this is a long list, signing a consent form statement on a paper form is acceptable, taking an opt-in box on paper or even electronically and clicking an opt-in button or link online, selecting from equally prominent, yes, no options, choosing technical settings. Responding to an email is also considered. If somebody respond to your email and consent to the information you have provided, it is also considered. Okay, by the ICO and answering yes to a clear oral statement request. And you can see that all of the methods fulfill the conditions that are required for the consent, which is there should be a clear affirmative action and it should not be inferred from silence, pre-text boxes or inactivity. I mentioned earlier that researchers should be able to keep record of the consent, whether they have obtained it verbally or in writing. So it is essential that researchers are able to demonstrate that data subjects have consented for their personal data to be processed. So records must be kept in use as an evidence, if and when required. So good record keeping should include the following. As you can see that you, it should mention who consented, when they consented, what they were told at a time, how they were consented and if the consent have been withdrawn and if it has had, if it has been withdrawn, when it was withdrawn, so all the information should be documented. So consent can become invalid if there are doubts over whether someone has consented. If a person doesn't realize they have consented, there are no clear records to demonstrate participants have consented, no genuine free choice was given or if there was a clear imbalance of power between a researcher and the individual, then the consent becomes invalid. So researchers need to pay particular attention to how they are dealing with the consent forms. It also becomes invalid if the consent request was vague or unclear, as I already mentioned. If pre-ticked opt-in boxes or other methods of default consent was used and even if the researchers organization was not specifically named, subjects were not informed about their right to withdraw and subjects cannot easily withdraw consent or the research purposes or activities have evolved since the original consent. So just pay particular attention and you can see that how important these things are. If you are using consent as a legal base, even ethically speaking, you need to pay particular attention to these. If you are not using it as a legal base, even ethically, these are the important things to consider. So just for a break, because it's a lot of content to take in, if you can go to Mentimeter and ask few questions, you can use this code. So if you have used the consent for your research, which format have you used? Paper, written, some majority, electronic form, tick box, click through, explicit written consent, mix of paper and digital, verbal, so video file, that's great. So a variety of different forms have been used by you. That's fantastic. Thank you very much. And have you given the opportunity, if you remember, because most of the time, as far as I remember when I was doing the PhD, I just used the standard consent form that was, I think, available at that time from the research ethics committee. So I don't remember at all whether what was in the consent form just, I just used that standard form. And I think most of the time is the case with all the researchers. So that's great. If most of you have remembered that you have given the opportunity to ask questions. Some of you are not sure, like me, I did not remember at all. It was around three or four years ago when I completed my PhD. I don't remember what I have written in the consent form because I just used the standard consent form available in my university. So did your consent form inform the participants about future uses of data such as publications, data archiving. Most of the time the collections we receive from researchers to deposit their data. They do mentioned about the future uses of data such as publications and research outputs and conference presentations, but the problem arises when there is no mention of data archiving. It's not really required, but ethically speaking need to inform your participants about data archiving in your consent form. So majority of you have informed the participants, which is good. And some of you are unsure. Yeah, definitely in the information sheet may be not specifically in the consent form. As I said that you can provide the detailed information in the information sheet and you can use just this consent form as a short signature form only. It's just to provide information, whether you provide it in the consent form or you provided it with the information sheet it doesn't matter. So I think it's the last question. Are you collecting personal information? If so, have you informed the participants how it will be processed stored and for how long this someone said no and some are not sure which is understandable. And I can relate to that as I mentioned my own experience and majority of you have informed the participants, which is very good. That's fantastic. I think that that's that was the last question. Thank you very much for your responses. It was just to reflect on and to see how you're getting with your consent for more information sheet. Thank you. So this section focuses on when to seek consent, obtaining consent for participation in research or future uses such as publication or for sharing and reuse of data can be a one of occurrence or an ongoing process. Both approaches have advantages and disadvantages. For example, one of consent is used for taking part in the research project only once as the name implies. So it is simple and the least hassle to participants as well as researchers. But there are disadvantages such as sometimes research outputs are not known in advance and the participants will not know about the information they will be contributing to. So that's the disadvantage on the other hand process consent is requested continuously throughout the research project. It ensures active consent, but it may not get all the consent needed before losing contact that it can be repetitive or participants may get annoyed. So both of the methods they have their pros and cons and they'll always depend on the specific research what is ideal for any given project. There are situations where special considerations are needed when seeking consent, but it is beyond the scope of this session to go through all of these. But I have signed posted these here. You can find detailed information on all of these situations on our website that there is a link on the bottom of the slide where you can go and have a look at the later. And sometimes researchers are faced I'm sure you are aware that when researchers are faced with the challenges, especially when it comes to data sharing or archiving. And if the data contains personal information and cannot be anonymized, but that's the biggest challenge and at that time of data collection they do not consider obtaining consent for future users of data specifically archiving and sharing. So in that case, they may consider retrospective and we always advise researchers go back to the participants and request a retrospective consent. However, if participants cannot be traced depositing the data in our repository will need to be assessed on a case by case basis to identify whether it is appropriate to share it or possibly presented to the ethics board for review and decision. And in that case, the assessment is made based on the risk benefits, this close if nature of the data. So, in addition, sometimes researchers are faced with the challenges when participant asked to withdraw from their research. That's another challenge. This is challenging, especially if the data has been collected or archived already. And again, this needs to be considered on a case by case basis but it is best if researchers consider this in advance and provide information about this in the information sheet or consent form. Sometimes there may not be a problem as the personal data is not shared or it may be anonymized but sometimes in qualitative studies where there are very less participants it could be very damaging to the data. It could lose its quality. So, researchers can consider for dealing with participants wishing to withdraw. They could seek a meeting to explain to the participant the cost of this to the project or they could discuss whether some of the data could be kept or used or if some of the data can be completely anonymized. So, it again depends on case to case basis. There are circumstances where no form of consent can be obtained and these situations are exceptional and will need case by case review again and clear arguments to satisfy the requirement of ethics review boards. And there can be varied reasons why consent is not possible. For example, limited capacity may prevent a person from being fully informed. Data may have already been collected for another purpose that did not require consent such as government administrative data and consent may not be technically feasible in some very large scale projects. So, you can get detailed information regarding this on our website. And in addition to these participants perception or of the sample comprises of children and vulnerable people, patients poor awareness of their rights failure to provide adequate information and absence of consideration of participants educational level and more importantly cultural background time constrained unclear language in the consent form. These are some of the challenges that that researchers face. In terms of data sharing if not communicated clearly participants are skeptical of confidentiality issues as well so always try to think and plan carefully and always open to discussion. Now I will show you some real examples from the consent forms that depositors have used to deposit their data with us. But before that, you can see that the information in the consent form or information sheet, mainly I will focus on consent form you can break down the information into three key details. Information related to participation in the research, how the information collected will be used by the researcher and information about future uses by the researcher or by other researchers if data would be shared. So these are the three areas that you can break down the information broadly speaking. So this is an extract of the UK data service model consent form and this section is about taking part in the study. So we have break down the information into three sections and this is the first section on taking part in the study. I will let you read it quickly. So you can see that it has captured several aspects such as participants have read and understand the information about voluntary participation about withdrawal. And it also explains what they have to do how information is being collected or if there are any potential risks. So this is the second section on the form which is about the uses of information that is being collected. It also addresses the confidentiality aspect by asking what can or cannot be shared. So this is the third section which is the most important section in terms of our experience and if there is such a plan to share their data. This section is all about informing the participants about future use and reuse of the information. And it can wait to the participants that all the information where the data will be deposited which form whether it is anonymized or if available under restrictions or not so. So these are the three important areas where you can break down the information you can put it in the information sheet or consent form. It's up to you but these are the three areas that need to be considered. These are some of the example extracts that have been used in real researches. I'll let you read this first. So the first extract focuses on two things, future uses of data and also all forms of data such as audio recordings, transcripts and photographs. They are mentioned separately addressing the condition of granularity. So that's a very nice example that if you are using different forms of data, collecting it in different formats, then it's best to mention it separately in the consent form. And in the second examples, participants are being informed about the future uses such as report content of a website, archiving and reuse by other researchers. You can see that they have also been told that they may be contacted again if their personal data or a quote or photograph will be used which shows an active consent or process consent which is again very nice. But I understand that it's not always possible to keep it active. So here again, you can see that providing information regarding archiving who will have access to the data and on what conditions and the reuse purposes are also mentioned here. These are some of the extracts that are very ideal, but most of the time we do not get the records or collect data collections that have these sort of ideal consent forms. So again, another two extracts to show how confidentiality can be maintained, how personal data will be stored, who can have access to it and on what conditions and where it will be stored. So these are some of the nice wordings that have been used in the consent forms by some depositors. However, most of the time as I said that it's not ideal, but most of the time we encounter the collections that have these statements. So I'm sure by now you have an understanding that though not legally but ethically we need to inform the participants about the future uses of the data we are collecting and unfortunately most of the time we receive collections that have problematic statements such as these ones. For example, statements like any information that I give will be used for research only and will not be used for any other purpose. Or I understand that only the research team will have access to the information I provide such statements precludes data sharing and it becomes very problematic for us to deposit that data. So, yeah, always try to avoid such statements. They are usually advised to obtain retrospective consent, which is not an ideal situation and most of the time it's not feasible as well. And another problematic statement is data will be destroyed after so and so years on when research is published or grant ends and such statements also preclude data sharing. Here, researchers need to specify which data do they mean data which will be contained in the research data set they are going to deposit. And then what about the funder requirement to deposit and share data here again it is about providing clarity to participants around which data will be deleted specifically and which will be archive. Most of the time they wanted to indicate something about around personal data but missed this term in their consent forms. And destroying personal data depends on individual organization policies and but as a general rule, you should not keep data longer than it is needed. So always try to avoid such statements. Here is an example from the Health Research Authority and I found it a very nice example. It is about a blood donation study and I'm not sure how many of you are health researchers but this may give you an idea how to present information to the participants. Here they have combined information sheet and consent form in one document. And on the title page they have added consent statements addressing most of the conditions we have gone through. So you can see that this first section it focuses on why is the study needed. What does taking part in the study involve why have I been invited and am I eligible do I have to take part what should I do if I want to take part. What happens during my next visit what will happen all the information about the process that is involved in this study and what happens immediately after I enroll what happens next, all the information about withdrawing from the study, then use of information that is being collected, then whether they are able to know the results. Who is organizing and funding the study, who has approved the study, what will happen if an invention is made using my sample and what happens if something goes wrong and all the contact details. So a very comprehensive information that is being communicated by combining the information consent forms. So the takeaway message from today's session is do not collect personal data if it is not essential. And it's always nice to clearly indicate in consent form where the participant is being asked for processing their personal data and where they are being asked to take part in the research. And you should always keep your consent forms under constant review and always indicate the future uses of data especially the archiving if you are planning to share your data or you are required by your funder to share the data. So here I have added some resources that could be useful for you. It's a model consent form that I have just gone through example information sheet on our website and then this visit is quite nice. It just asked you to fill in your information and it prepared a consent form for you. So that's a very nice visit I find. And then the HRA example consent form I have just shown you went in the book which has lots of useful information. So thank you very much for listening to me and any questions you ask so you can always email me after the session and I can go through your questions on any specific project related queries if you have.