Informed consent form

Variable / Field Name	Section Header	Field Type	Field Label	Choices or Calculations
consent_verify		yesno	I confirm that the original consent form has been reviewed and completed correctly.	1, Yes
consent_ver		dropdown	Consent version	1, Version 2 14-Jul-20, Face-to-face
consent_v2_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 14-Jul-2020, Version 2. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_v3_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 04-Aug-2020, Version 3. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_sa2_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 01-Sep-2020, Version 4. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_sa3_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 02-Nov-2020, Version 5. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_sa4_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 24-Nov-2020, Version 6. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_nsa1_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 18-Dec-2020, Version 6.1. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_sa5_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 01-Apr-2021, Version 7.1. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_sa5_t1_q1		yesno	I have read the information sheet (or it has been read to me) for this study dated 01-Apr-2021, Version 1.1. I understand the information and have had the opportunity to ask questions for clarification. These have been answered satisfactorily. Consent item initialled?	1, Yes
consent_q2		yesno	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. Consent item initialled?	1, Yes
consent_q3		yesno	I understand that the information and samples collected up until the point I withdraw will still be used in research and 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. Consent item initialled?	1, Yes
consent_q4		yesno	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. Consent item initialled?	1, Yes
consent_q5		yesno	Use of leftover clinical test 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. Select response initialled.	1, Yes
consent_nsa1_q6		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. Select response initialled.	1, Yes
consent_q6		yesno	Additional Research Testing: I agree to undergo some or all of the additional 'Tier 2' 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. Select response initialled.	1, Yes
consent_q7		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. Select response initialled.	1, Yes
consent_q7_pt2		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. Select response initialled.	1, Yes
consent_q8		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. Select response initialled.	1, Yes
consent_q9		yesno	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. Consent item initialled?	1, Yes
consent_q10		yesno	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. Consent item initialled?	1, Yes
consent_q11		yesno	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. Consent item initialled?	1, Yes
consent_q12		yesno	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. Consent item initialled?	1, Yes
consent_q13		yesno	I understand that data that can identify me will be stored on 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"). Consent item initialled?	1, Yes
consent_q14		yesno	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. Consent item initialled?	1, Yes
consent_q15		yesno	I agree that my GP will be informed of my participation in this study. Consent item initialled?	1, Yes
consent_q16		yesno	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. Consent item initialled?	1, Yes
consent_q17		yesno	I agree to take part in the above study. Consent item initialled?	1, Yes
consultee_q1		yesno	Information about the study has been provided to me: I, [consultee_name], have been consulted about [participant_name]'s participation in this research project.  I have read the Consultee Information Sheet v2 dated 15-OCT-2020 and had the opportunity to ask questions about the study and I understand what is involved. Consent item initialled?	1, Yes
consultee_v2_q1		yesno	1. Information about the study has been provided to me: I, [consultee_name], have been consulted about [participant_name]'s participation in this research project.  I have read the Consultee Information Sheet V3 dated 02-Nov-2020 and had the opportunity to ask questions about the study and I understand what is involved. Consent item initialled?	1, Yes
consultee_v3_q1		yesno	1. Information about the study has been provided to me: I, [consultee_name], have been consulted about [participant_name]'s participation in this research project.  I have read the Consultee Information Sheet V4 dated 19-Feb-2021 and had the opportunity to ask questions about the study and I understand what is involved. Consent item initialled?	1, Yes
consultee_q2		yesno	2. In my opinion he/she would have no objection to taking part in the above study. Consent item initialled?	1, Yes
consultee_q3		yesno	3. I understand that I can request he/she is withdrawn from the study at any time, without giving any reason and without his/her care or legal rights being affected. Consent item initialled?	1, Yes
consultee_q4		yesno	4. I understand that the information and samples collected up until the point I request he/she is withdrawn will still be used in research unless I contact the study team and state otherwise. Consent item initialled?	1, Yes
consultee_q5		yesno	5. Access to his/her information: I understand that information including all assessments and interventions performed as part of his/her routine clinical care and held on national databases before, during and for up to 25 years after his/her COVID-19 hospitalisation can be shared with the study team where this is relevant to his/her 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 him/her will be passed securely to such bodies to make this possible. Consent item initialled?	1, Yes
consultee_q6		yesno	6. Use of leftover clinical test samples: I understand that "left over" samples taken as part of his/her routine care by their GP or the hospital, can be used for the research. This would only take place after the tests required for his/her care have been carried out. Consent item initialled?	1, Yes
consultee_q7		yesno	7. Use of data from other research studies he/she may be participating in:   I understand that his/her personal data may be shared with researchers running other research projects he/she is participating in. Data that he/she provides for other research studies may be collected and analysed along with the data that he/she has provided for this study. Consent item initialled?	1, Yes
consultee_q8		yesno	8. Transfer of personal data: I understand that to facilitate this research project, the study team may need to share his/her personal information with other organisations. An example of this will be passing his/her NHS number and other details to NHS Digital to allow his/her records to be located and shared with the researchers. Consent item initialled?	1, Yes
consultee_q9		yesno	9. 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 his/her taking part in this research. Consent item initialled?	1, Yes
consultee_q10		yesno	10. Sample analysis:   I understand that his/her samples, may be sent elsewhere in the world to be analysed. I also understand that his/her 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 his/her routine care and any samples left-over after tests requested by his/her doctor. His/Her samples will be stored securely and researchers that use his/her samples will not be able to identify him/her from the samples. Consent item initialled?	1, Yes
consultee_q11		yesno	11. I understand that data that can identify him/her will be stored on 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"). Consent item initialled?	1, Yes
consultee_q12		yesno	12. Use by other researchers: I understand that his/her 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. Consent item initialled?	1, Yes
consultee_q13		yesno	13. I understand that his/her GP will be informed of his/her participation in this study. Consent item initialled?	1, Yes
consultee_type		radio	Consultee Declaration Type	1, Face-to-face
consultee_signed_verified		yesno	Consultee Signature	1, Yes
consultee_signed_date		text	Consultee Signed Date
consent_signature_verified		yesno	Participant Signature	1, Yes
consent_date		text	Participant Signed Date
consent_countsign_verified		yesno	Researcher Signature	1, Yes
consent_countersign_date		text	Researcher Signed Date
consent_witness_sign		yesno	Witness/Translator Signature	1, Yes
consent_witness_date		text	Witness/Translator Signed Date
consent_data_verify		yesno	I verify that the data entered above has been transcribed completely and accurately into REDCap from the original consent form.	1, Yes