Split Tier Consent - isaric4c/wiki GitHub Wiki
| Variable / Field Name | Section Header | Field Type | Field Label | Choices or Calculations |
|---|---|---|---|---|
| split_consent_verify | checkbox | I confirm that the original consent form has been reviewed and completed correctly. | 1, Yes (Tier 1 consent form) | |
| split_tier_ver | dropdown | Consent version | 1, Version 1.1 18-Dec-20, Face-to-face | |
| split_tier1_q1 | yesno | 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 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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_q7pt2 | 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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_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 | |
| split_tier1_q13 | yesno | I understand that data that can identify me will be stored on local site, onward referral site and 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 | |
| split_tier1_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 | |
| split_tier1_q15 | yesno | I agree that my GP will be informed of my participation in this study. Consent item initialled? |
1, Yes | |
| split_tier1_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 | |
| split_tier1_q17 | yesno | I would like to be considered to take part in additional research tests and samples as described in the participant information sheet (Tier 2). I agree to be contacted by the study team for consideration in Tier 2. I understand that by saying 'yes' does not mean I have to take part and that I can decide not to take part at a later date. Select response initialled. |
1, Yes | |
| split_tier1_q18 | yesno | I agree to take part in the above study, participating in Tier 1. Consent item initialled? |
1, Yes | |
| split_tier1_parti_sign | yesno | Participant Signature | 1, Yes | |
| split_tier1_parti_date | text | Participant Signed Date | ||
| split_tier1_research_sign | yesno | Researcher Signature | 1, Yes | |
| split_tier1_research_date | text | Researcher Signed Date | ||
| split_tier1_witness_sign | yesno | Witness/Translator Signature | 1, Yes | |
| split_tier1_witness_date | text | Witness/Translator Signed Date | ||
| split_tier2_q1 | yesno | Information about the study has been provided to me: I have had the opportunity to read again 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 | |
| split_tier2_sa5_q1 | yesno | I have had the opportunity to read again 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 | |
| split_tier2_q2 | yesno | I understand that my consent above for the study remains valid, and that I am hereby only consenting to take part in additional research visits and testing. Consent item initialled? |
1, Yes | |
| split_tier2_q3 | yesno | i) Connective tissue disease | 1, Yes | |
| split_tier2_q4 | yesno | I continue to agree to take part in the above study, now participating in both Tier 1 and Tier 2. Consent item initialled? |
1, Yes | |
| split_tier2_parti_sign | yesno | Participant Signature | 1, Yes | |
| split_tier2_parti_date | text | Participant Signed Date | ||
| split_tier2_research_sign | yesno | Researcher Signature | 1, Yes | |
| split_tier2_research_date | text | Researcher Signed Date | ||
| split_tier2_witness_sign | yesno | Witness/Translator Signature | 1, Yes | |
| split_tier2_witness_date | text | Witness/Translator Signed Date | ||
| split_consent_data_verify | checkbox | I verify that the data entered above has been transcribed completely and accurately into REDCap from the original consent form. | 1, Yes (Tier 1 consent form) |