eConsent Tier 2 - isaric4c/wiki GitHub Wiki

Variable / Field Name Section Header Field Type Field Label Choices or Calculations
econ_q1_resp radio Information about the study has been provided to me:I have read the information sheet (or it has been read to me) for this study dated 19-Feb-21, Version 7. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. 1, I agree
econ_q2_resp radio Voluntary participation:I understand that my participation is voluntary and that I am free to withdraw from the study at any time. I do not need to give a reason and my medical care or rights will be unaffected. 1, I agree
econ_q3_resp radio I understand that the information and samples collected up until the point I withdraw will still be used in research. Information will continue to be collected about my health from central NHS records, hospital and my GP, unless I contact the study team and state otherwise. 1, I agree
econ_q4_resp radio Access to my information:I agree that information including all assessments and interventions performed as part of my routine clinical care and held on national databases before, during and for up to 25 years after my COVID-19 hospitalisation can be shared with the study team where this is relevant to my participation in the PHOSP-COVID study. The medical information may be located in local or national health and research organisations. I understand that information that identifies me will be passed securely to such bodies to make this possible. I understand I can opt out of this at any time by writing to the study team. 1, I agree
econ_q5_resp yesno Use of leftover clinical samples:I agree that "left over" samples taken as part of my routine care by my GP or the hospital, can be used for the research. This would only take place after the tests required for my care have been carried out.This statement is optional, you may choose "Yes" or "No". 1, Yes
econ_q6_resp yesno Electronic questionnaires (True Colours):I agree to my email address being used to send me a link to complete electronic questionnaires about my symptoms during the first year after my discharge from hospital.This statement is optional, you may choose "Yes" or "No". 1, Yes
econ_q7_resp yesno Additional research visits and testing:I agree to undergo some or all of the additional research tests and investigations as described in the participant information sheet. The nature of the tests and investigations and any possible risks have been explained to me. I understand that if I tick 'No' and choose not to take part in these additional research investigations then the study will still be collecting information, imaging, data and 'left over' samples from my normal clinical care for use in research.This statement is optional, you may choose "Yes" or "No". If you choose "No" to this statement you will not be invited to attend a research visit, if you choose "Yes" you can still choose not to attend or undergo any specific test if you are invited at a later date. 1, Yes
econ_q8_resp yesno Sample and DNA testing:I agree that any samples that I provide will be analysed to determine factors related to my COVID-19 susceptibility, severity, recovery and longer term health effects, and that I will not be provided with the results of these analyses.This statement is optional, you may choose "Yes" or "No". 1, Yes
econ_q8_pt2_resp yesno Sample and DNA testing (Part 2):I agree that my DNA (genetic variation) will be analysed for this study and that I will not be provided with the results of the DNA analysis.This statement is optional, you may choose "Yes" or "No". 1, Yes
econ_q9_resp yesno Re-contact for future studies:I agree to be contacted directly about future ethically approved studies based either on the results of sample analyses (including DNA), on my health status, or on other personal characteristics (for example, age, ethnicity, biological sex). I will not be obliged to take part in any such study once contacted.This statement is optional, you may choose "Yes" or "No". 1, Yes
econ_q10_resp radio Use of data from other research studies I may be participating in:I understand that my personal data may be shared with researchers running other research projects I participate in. Data that I provide for other research studies may be collected and analysed along with the data that I have provided for this study. I understand and agree. 1, I agree
econ_q11_resp radio Transfer of personal data:I understand and agree that to facilitate this research project, the study team may need to share my personal information with other organisations. An example of this will be passing my NHS number and other details to NHS Digital to allow my records to be located and shared with the researchers. 1, I agree
econ_q12_resp radio Data regulation:I understand that data collected during the study, or obtained from samples, may be looked at by regulatory authorities, authorised individuals from the University of Leicester, this hospital, NHS Trust, funding bodies, regulatory authorities or public health agencies, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records. 1, I agree
econ_q13_resp radio Sample analysis:I agree that my samples, may be sent elsewhere in the world to be analysed. I also agree that my samples may be used in additional ethically approved research in the future, including after the end of this study,  if necessary in different parts of the world.  These samples include those already taken as part of my routine care and any samples left-over after tests requested by my doctor. My samples will be stored securely and researchers that use my samples will not be able to identify me from my samples. 1, I agree
econ_q14_resp radio I understand that data that can identify me will be stored on [econsent_site], any other NHS Trust I may attend for this research, University  of Leicester and University of Leicester Hospitals NHS Trust Hospitals sites separately and securely, and that to enable approved researchers to undertake  research projects securely a copy of the data will be kept in a Trusted  Research Environment ("Data Safe Haven"). 1, I agree
econ_q15_resp radio Use by other researchers:I agree that my research data and samples from the study may be made available to other approved researchers and academic partners for future ethically approved research. This could include researchers in other countries and in commercial companies. I understand that such researchers will not be able to identify me from my data or samples. 1, I agree
econ_q16_resp radio I agree that my GP will be informed of my participation in this study. 1, I agree
econ_q17_resp radio I understand that healthcare professionals will be made aware of any abnormal test or assessment results where this is relevant to my ongoing clinical care. 1, I agree
econ_q18_resp radio I agree to take part in the above study. 1, I agree
econ_verify_resp radio Participant declaration 1, I agree
econsent_date text eConsent Completion Date
econsent_researcher_date text eConsent Review Date
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