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INFORMATION / CONSENT FORM

Title: The Rick Hansen Spinal Cord Injury Registry (RHSCIR)

Principal investigators :

Stefan Parent, M.D., Ph. D., FRCS, Orthopedic surgeon, Hôpital du Sacré-Cœur de Montréal, 5400 boul. Gouin, Montréal

Dany Gagnon, Ph.D., P.T., Institut de réadaptation Gingras-Lindsay-de-Montréal, Pavillon Gingras, 6300, Darlington, Montréal

Co-Investigators:

Alain Jodoin, M.D., orthopedic surgeonGilles Maurais, M.D., orthopedic surgeonPaul Khoueir, M.D., neurosurgeonJean-Marc Mac-Thiong, M.D., Ph.D., orthopedic surgeonGéraldine Jacquemin, physiatrist

Valérie Dahan, physiatrist

This project is sponsored by: Rick Hansen InstituteFoundation (RHIF)

Blusson Spinal Cord Centre6th Floor, 818 West 10th AvenueVancouver, B.C. V5Z 1M9Tel: (604) 707 210018 827 2451

Funders : Western Economic Diversification Canada

Websites: www.rickhanseninstitute.org and www.rickhansenregistry.org

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http://www.rickhansenregistry.org/

http://www.rickhanseninstitute.org/

PREAMBLE

You are being invited to participate in a study involving the Rick Hansen Spinal Cord Injury Registry (RHSCIR), referred to as the “RHSCIR Project”, because you have sustained a traumatic spinal cord injury (SCI). In this formconsent form, we refer to the registry study as the “RHSCIR study”. The information in this form consent form is intended to help you understand exactly what we are asking of you so that you can decide whether or not you want to participate in this studye RHSCIR.

The center of expertise for spinal cord injury of the West of Quebec (CE) composed of the “Hôpital du Sacré-Cœur de Montréal (HSCM)”, the “Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)” and the “Centre de réadaptation Lucie-Bruneau (CRLB)” is participating in the RHSCIR study, which is funded by Western Economics Diversification Canada. the Rick Hansen Foundation (RHF), a non-profit organization. These funds are managed and distributed on behalf of RHF by the Rick Hansen Institute (RHI), also a non-profit, organization that supports research and improvements in clinical care for people with a SCI.

Approximately 1,7500 individuals per year in Canada sustain traumatic SCI. The RHSCIR study anticipates collecting data on the majority of these individuals through its network of participating sites.

The team at RHI’s national office in Vancouver, BC, operates the RHSCIR study that contains and stores information about individuals who have sustained SCI injuries in a national database. This database is supported by a network of local site teams (e.g. medical professionals, clinical nurse specialists, physical therapists, occupational therapists, hospital administrators, clinical research coordinators and data analysts) at participating acute and rehabilitation centers across Canada. These centers are referred to as “local RHSCIR sites” and together they form the RHSCIR Network.

We are soliciting your participation in a research project. However, before accepting to participate in this project and signing the information and consent form, take the time to read, understand and carefully examine the following information. This form may contain words that you do not understand. We are inviting you to ask any question that you may have to the researcher or to other members of the team in charge of the research projectRHSCIR, and ask them to explain to you any word or information that is unclear to you. Your participation in the RHSCIR study is entirely voluntary, and a decision not to participate will not affect your patient care.

A simultaneous participation in several studies could be prejudicial to you. If you already participate in other studies, please inform the researcher about it.

WHO CAN PARTICIPATE IN THIS STUDY?

You can participate in this study if you have sustained a new, traumatic SCI, are 13 years of age or older, and have been admitted to a participating hospital.


NATURE AND OBJECTIVES OF THE RESEARCH PROJECT

Compared to other medical conditions, traumatic SCI is a rare occurrence so tThe primary objective of the RHSCIR is to collect clinical care information (a data repository) about involve all Canadians who sustain a traumatic SCI. The combined collection of clinical care information is used to:

Make clinical care and hospital administration processes across Canada better to improve health outcomes for individuals with SCI:

Answer local and national research questions; and Create collaborations in research and establish collaborations between health care and

research centres across the country to help ensure that all individuals with traumatic SCI receive the best and similar types of clinical care.

RSHCIR is a national data repository that supports the integrated research and improvement of care and outcomes for SCI patients. With your consent, the information that you share will be used for these objectives which research. This research will hopefully play a critical role in continuing to accelerate the pace of discovery for real solutions for SCI and improving quality of life for both individuals with SCI and their families.

Permitted Purposes Data collected about you through the RHSCIR study may be used for purposes certain types of research studies that meet the goals and objectives of the RHSCIR study. Specifically, this research:

Supports and helps manage patient care: the data is used tose studies help understand the importance of how time and specialty care may improve the treatment of individuals with SCI;

Supports continued research: the datase studies supports new research into treatments and ways to evaluate an individual’s functional recovery;

Q Develops partnerships and improves quality improvement in patient care through partnerships: the data is used tose studies monitor adoption of new knowledge and advance the use of best practices across health care delivery systems (e.g. acute, rehabilitation, and community care centers);

Evaluates quality of data quality and assessment tools: the sites and the data are both reviewed to ensure thatse studies check that data collection is consistent and accurate and that tools to assess outcomes are valid and reliable methods of measurement;

Promotes business planning and future development: the data is used to se studies investigate different models of delivering healthcare and finding those that produce the best outcomes.


This consent form uses the term “permitted purposes” to refer to the permitted data uses kind of studies described above that align with the RHSCIR study’s goals and objectives.

PROCEDURES OF THE RESEARCH PROJECT

If you agree to participate in this studye RHSCIR, the quality of your care will be no different than if you do not agree to participate. You may refuse to answer any of the questions that you are not comfortable with at any time during the study.

Hospital Data Collection

After agreeing to participate in the RHSCIR study and signing the consent form, a local RHSCIR representative will perform a short interview with you to gain a complete picture of your health status. The interview will take approximately 10 – 15 minutes and includinges questions about: demographics, contact information, sociodemographics, and medical history.

Demographics - information including nationality and ethnic origin Contact information - contact information for you and your next of kin Sociodemographics - information including occupation, education, household income,

relationship status, living setting, height, and weight Medical history - information describing prior health status and current (post-injury)

health status, including non-medical drug use

The coordinator will also review your medical record for information on:

Demographics - identifying features including name and date of birth Medical History - information describing prior health status and current (post-injury)

health status, including alcohol use, drug use, other medical conditions, cause of SCI, and date and time of injury

Admission/Discharge - admission and discharge information outlining your movement through each care centre, including centre name, date of admission, admission category, date of discharge, and physician most responsible

Diagnosis - specific information describing the location of your spinal injury(ies) and any other secondary injuries or complications including diagnosis code and location

Neurology - information describing the type of SCI you have sustained, including ASIA impairment scale, motor and sensory scores, and neurological level

Procedures - details outlining any the surgical procedure(s) to stabilize your spinal column

Interventions - information detailing specific elements of care provided including skeletal traction, ventilation, bowel and bladder management, and rehabilitation therapies

Outcomes - information detailing specific measurements of physical functioning secondary to SCI, including information on your respiratory function, secondary complications, and pain management

If you continue your rehabilitation at the Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM) and/or at the Centre de réadaptation Lucie-Bruneau, the local RHSCIR research representative will perform another short interview (10 minutes) with you to collect some Version #32.1, October January 079ft 20143

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additional information including: additional contact information, sociodemographics, medical history, interventions, complications, and independence in daily activities.

Additional Contact Information, Sociodemographics, Medical History, and Interventions.

Questionnaires - including:

Penn Spasticity Scale – This questionnaire asks about muscle spasms in your arms or legs.

Pain Questionnaire – This questionnaire asks you about pain, specifically the location, intensity, how it interferes with your activities and what you are doing to manage it.

A local RHSCIR representative will combine the information collected from you and your medical record with information that has already been collected about your injury from your local hospital Trauma Registry, Discharge Abstract Database (DAD), and National Rehabilitation Reporting System (NRS). This is done in order to obtain a complete record of your injury and to avoid re-collecting information that has already been collected. This information is an important part of the RHSCIR data as it allows more complete information about your injury and care to be reviewed in order to better examine clinical standards of care, create guidelines for best practices in treatment of SCI, and illustrate the complexity of the management and treatment of SCI cases that can help define the staff resources required to manage patient care.The data collected includes:

Trauma Registryo I information detailing your medical status at the scene of the injury and on arrival

to a health care centre including assessment of your breathing and blood pressure and specialized trauma scores.

DAD o Admission/Discharge - admission and discharge information, including length of stay

in Special Care Units and transfer informationo Diagnosis - diagnosis codes describing the location of your spinal injury and any

other secondary injuries or complications o Procedures - details outlining any the surgical procedure(s) used to stabilize your

spinal column, types of anesthesia used. NRS

o Functional Independence Measure (FIM) - this questionnaire asks about the amount of assistance you require with mobility tasks such as getting in and out of bed, getting dressed and using a wheelchair or walking. It is completed by your health care team as a standard part of your care.

o Rehabilitation Admission/Discharge – admission and discharge information, including information on any interruptions to your rehabilitation care

o Health Complications – diagnosis codes which describes any secondary complications

Follow-up Data CollectionAfter you have been discharged from the hospital, local RHSCIR research representatives will contact you in the community, by telephone, or mail or email link to a secure website,, asking you to complete some questionnaires related to your health and quality of life. This will be done at 1, 2, and 5 years Version #32.1, October January 079ft 20143

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from the date of your injury and then every 5 years following. Information collected at this time includes Contact Information, Sociodemographics, and Medical History, Health Care Utilization, and updated neurology information if collected as a part of your clinical care..

You will also be asked to complete the following questionnaires related to: Pain, independence in daily activities, quality of life, community and environment accessibility, heath conditions & secondary complications, and self efficacy (your perceived ability to perform task/reach goals).

Pain Questionnaire – This questionnaire asks about pain, specifically how it interferes with your activities and what you are doing to manage it.

Functional Independence Measure – This questionnaire asks about the amount of assistance you require with mobility tasks such as getting in and out of bed, getting dressed and using a wheelchair or walking.

Short Form-36 – This questionnaire asks about your general physical and mental health.

Life Satisfaction 11(LISAT-11) – This questionnaire asks about the quality of your life.

Craig Hospital Inventory of Environmental Factors – This questionnaire asks about your ability to move around your home and community and access services.

SCI - Health Questionnaire (SCI-HQ) – This questionnaire asks about other health conditions that you may have, if you are receiving treatment for them, and if they limit your activities.

If you choose not to participate…A minimal amount of information will be collected on all eligible patients, regardless of whether or not you choose to enroll in the RHSCIR.in this study. This information will include the items listed above except for interviews and follow-up data collection. This minimum information collected, describing only your injury and your movement through the hospital(s), is essential to allow accurate reporting of the frequencyincidence of SCI, and to ensure that local RHSICR staff do not approach participants who do not choose to participate in this study twice (for example, i.e. if youthey are transferred to another site). The required information will be obtained from your hospital record and local hospital Discharge Abstract Database (DAD) or NRS, and will not require any of your time. If you object to having any of your information added to the registry please inform the RHSCIR coordinator explaining this consent form to you and your wishes will be respected.

This information will be collected by local RHSCIR staff and includes information about your:

Demographics - information including name and date of birth Medical History - information describing cause of your SCI, and date and time of injury Admission/Discharge - admission and discharge information outlining your movement

through each care center, including center name, date of admission, date of discharge


Each of the Follow-up Data collection calls, mailed packaged or time spent answering theses questions via the secure email link will require approximately one hour of your time.

Neurology - information describing the type of SCI sustained, including ASIA Impairment Scale, motor and sensory scores, and neurological level

DAD o Admission/Discharge - admission and discharge information, including length of

stay in Special Care Units and transfer informationo Diagnosis - diagnosis codes which describe the location of your spinal injury

and any other secondary injuries or complications (pre-admit and post admit comorbidities)

o Procedures - details outlining the surgical procedure(s) to stabilize your spinal column, types of anesthesia used.

RISKS ASSOCIATED TO THE RESEARCH PROJECT

The questionnaires may contain questions which could provoke sadness or create anxiety for some individuals. Although every effort is made to protect your health information, there is always a minimal risk that unauthorized users may attempt to access or misuse your health information. The RHSCIR study uses the most advanced security to protect your privacy. Apart from this, there are no known risks associated with the completion of the questionnaires or assessments.

BENEFITS

There are no direct benefits from participating in the RHSCIR Project. However, this projectyour participation is important in to assisting those clinical care staff and researchersresearchers and working onclinicians improving SCI research the , quality of care, and quality of life for both persons who have a new SCI and those living in the community with a SCI.

CONFIDENTIALITY

Your confidentiality will be respected. Protecting your privacy is of primary importance to RHI and the RHSCIR study. Unless required or authorized by law, no information that might directly or indirectly reveal your identity will be released or published without your specific consent. Any reports or publications resulting from the RHSCIRis research study will be use de-identified and/or aggregated data and will not identify you specifically.

Research records (health, data collected or other source records) and health or other source records identifying you may be inspected in the presence of the Investigator or his or her designate by representatives of the Rick Hansen InstituteHI, the Research Ethics Board of the Hôpital du Sacré-Coeur de Montréal (HSCM) and the Research Ethics Board of the CRIR Institutions (IRGLM and CRLB) for the purpose of monitoring the research and ensuring accuracy of the data collected. All of these people have a professional responsibility to protect your privacy.


Your data will be shared electronically with the national RHSCIR group, which receives data from all of the participating RHSCIR sites across the country. Only a limited number of authorized staff at the national RHSCIR office will have access to your identified data for the purpose of database system administration. These individuals must comply with very strict privacy and security regulations under RHI’s privacy and security framework (if you wish, this can be explained to you).

In every other instance (when the collected data is used) you will only be identified in this study by a unique Registry ID Number instead of your name. All your records will be identified with this unique Registry ID Number, both locally and nationally, to protect the confidentiality of your personal health information and to respect your privacy.

Locally, only the Principal Investigator and authorized RHSCIR research staff affiliated with the RHSCIR sites which you are treated at will have access to your identified data. This means that if you are transferred to other participating RHSCIR sites, your RHSCIR data will be shared with that site’s local RHSCIR team. This enables your research team to have the most complete record of your progress through your acute and rehabilitation care. All RHSCIR staff that may review your medical records have signed cConfidentiality aAgreements and have received training on their obligations to protect your privacy. Your local site team will collect and store identifying patient information about you in accordance with local provincial privacy laws, which provides privacy rules for how health care providers must protect your health information.

Furthermore, local participating sites adhere to their own local privacy policies and procedures and in accordance with the Canadian Institutes for Health Research (CIHR) best practices to prevent against unauthorized or unintentional use, disclosure, modification, retention or destruction of your information. Your rights to privacy are also protected by all applicable provincial and federal legislation at the national level. The Privacy Officer for the RHSCIR study is responsible for overseeing and protecting the data that is managed by the National RHSCIR team. Further details about the privacy program for the RHSCIR are available upon request or through www.rickhanseninstitute.org.

Data Records will initially be collected on paper and stored in a secure area such as a locked filing cabinet at HSCM and at IRGLM under the responsibility of the local RHSCIResearch Coordinator and Principal Investigator. The data will then be entered into a secure information management system. All data entered into this system will be stored in a secure facility in Canada. The privacy and security of your information is managed using a set of administrative, technical and physical safeguards. All participants have the right to access and review their own data research files in order to verify and validate the information and make corrections. Requests for access to your data will be managed by Dr. Stefan Parent and Dr. Dany Gagnon. This right is limited by certain legal exceptions.

All SCI information collected will be stored by the local site for a minimum of 25 years (to satisfy Health Canada guidelines) and by the national site in electronic form for as long as necessary to fulfill the purposes of the RHSCIR study and will be destroyed in a confidential and secure manner in accordance with RHI’s Data Retention and Destruction Policy. If required, the duration of storage may be reviewed periodically by the REB for the data provided by its local site teams.

The linkages with other databases described above (under the Procedures - Hospital Data Collection section) comply with the privacy and confidentiality rules mandated at local RHSCIR Version #32.1, October January 079ft 20143

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sites. For example, dData sSharing aAgreements and cConfidentiality aAgreements are completed by local RHSCIR sites in advance of any sharing of data with the national RHSCIR team.

Requests for access to national RHSCIR data are reviewed and approved by two levels of governance in accordance with RHSCIR’s Data Use and Disclosure Policy. Any use of local site data needs approval of the Principal Investigator who is part of the Data Access Committee.

Prospective projectsresearch studies that do not meet the RHSCIR Permitted Purposes will require review by the Research Ethics Board of the Hôpital du Sacré-Coeur de Montréal (HSCM) and of the Research Ethics Board of the CRIR Institutions (IRGLM and CRLB). This is to ensure that the proposals have both scientific merit and meet ethical practices. The local RHSCIR staff may then contact you to discuss your interest in future participation in approved projectsresearch studies.

VOLUNTARY PARTICIPATION

Participation in the RHSCIR study is entirely voluntary. It is up to you to decide whether or not to take part in the RHSCIR. If you wish to participate, you will be asked to sign this form. By signing this consent form, you are not waiving any of your legal rights.

If you decide to take part in the RHSCIR study, you may withdraw at any time and without giving any reasons for your decision. If you decide not to participate you will not lose the benefit of any medical care to which you are entitled or are presently receiving. You will need to inform your local RHSCIR staff member or the Principal Investigator of the RHSCIR study to ensure that you are not contacted in the future. All data collected up to the point of your withdrawal will be retained in the database for analysis, but no further data will be collected or entered.

Please take the time to read the following information carefully and to discuss it with your family, friends and doctor before you decide.

COMPENSATION

There will be no monetary compensation for participating.

IDENTIFICATION OF CONTACT PERSONS

If you have any concerns or questions about the RHSCIR study, you may call: Dr Stefan Parent at (514) 338-2222 extension 2060 Mr. Dany Gagnon, Ph.D. at 514-340-2111 extension 2260.

You can also communicate with the project coordinators of the Rick Hansen Registry:

Ms Katia Drouin at Hôpital Sacré-Cœur, phone number 514-338-2222 extension 3696, Ms Louisane Dupré at Hôpital Sacré-Cœur, phone number 514-338-2222 extension 3696 Ms Marie-Thérèse Laramée at the IRGLM, phone number 514-340-2111 extension 4214,


Ms Isabelle Robidoux at the IRGLM, phone number 514-340-2111 extension 3158, M Simon Laliberté at the CRLB, phone number 514-527-4527 extension 2608, Ms Michèle Bleau at the CRLB, phone number 514-527-4527 extension 2347.

If you want to ask a professional or a researcher, who is not involved in this registryresearch project, you can communicate with Dr. Michel Malo at (514) 338-2222 extension 2060.

For any question concerning your rights and/or your experiences while as a research subject participating in thise RHSCIR projectregistry or if you have comments or wish to file complaint, you can communicate with the Direction générale, Hôpital du Sacré-Coeur de Montréal at the following number: (514) 338-2222, extension 3581. You can also communicate with Me Anik Nolet, Coordinator of the Ethic Board of the CRIR establishments at (514) 527-4527 extension 2649 or by email: [email protected]

NEW INFORMATION/COMMUNICATION OF RESULTS

All new findings developed during the course of the RHSCIRis research, which may influence your desire to continue your participation in the RHSCIR study, will be posted on the RHSCIR website when the information becomes available. If you would like to read more about the RHSCIR, please check the website at www.rickhansenregistry.org or www.rickhanseninstitute.org.

CONTROL OF ETHICAL ASPECTS OF THE RESEARCH PROJECT

The Research Ethics Board of the Hôpital du Sacré-Coeur de Montréal and the Research Ethics Board of the members institutions of CRIR approved the RHSCIR project and are responsible for ensuring its monitoring. Any change or amendment made to the information/consent form or the study protocol must first be approved by the Research Ethics Boards.


http://www.rickhanseninstitute.org/

http://www.rickhansenregistry.org/

mailto:[email protected]

SUBJECT PARTICIPANT CONSENTTitle: The Rick Hansen Spinal Cord Injury Registry (RHSCIR)

I have read, or have been read, and understood the information provided in this subject information and consent form and all of my questions have been answered to my satisfaction. I have had sufficient time to consider whether to participate in the RHSCIR study. I understand that my participation in the RHSCIR study is entirely voluntary, that I may withdraw from theis RHSCIR study at any time, without explanation, and that my level of care will not be affected by my decision to decline or withdraw participation.

I voluntarily consent to participate in the RHSCIR study. I agree to allow clinical personnel and researchers to access my health records to collect information relevant to my SCI and to ask questions regarding my medical history and& sociodemographic status which will be used and disclosed for the purposes of the RHSCIR study, as described to me in this consent form. This will also include follow up questions reviews that are conducted by RHSCIR staff or online at 1, 2 ,5 years and then at 5 year intervals thereafter to complete questionnaires related to my health status. I agree to have this information shared between all RHSCIR sites that I receive treatment during my acute and rehabilitation care.

In agreeing to the above data collection, I also agree to allow local RHSCIR representatives to link this data, and understand that my data will be used and disclosed only for the permitted purposes of the RHSCIR study, as described to me in this consent form.

I confirm that I have discussed with my next of kin and that he/she has agreed to allow local RHSCIR staff to collect researchers to collect information about my next of kin and be contacted for the purposes of releasing my contact information so I can continue participating in follow up reviews.

I understand that I am not waiving any of my legal rights as a result of signing this consent form.

I agree to have my name added to the RHI mailing list so that they may keep me up to date on what is happening within their organization and to receive information regarding other SCI research opportunities.

Any additional contact will be handled through local RHSCIR staff at HSCM and IRGLM who may contact me about new studies or future initiatives.

I will receive a signed copy of this consent form for my own records.

Printed name of subjectparticipant Signature Date (dd-mm-yyyy)


Subject Participant is unable to give written consent and has given verbal consent to participate in the RHSCIR study. Witness signature to subject’s participant’s verbal consent:

I, the undersigned (e) agree that _____________________ (name of subjectparticipant) participates in the Rick Hansen Spinal Cord Injury Registry.

_________________________________ _________________________ _______________Printed name of the witness Signature Date (dd-mm-yyyy)

Subject Participant is unable to give written OR verbal consent OR assent to participate in the RHSCIR study. Subject’s Participant’s representative has consent on their behalf:

I voluntarily consent that _____________________ (name of subjectparticipant) participate in the Rick Hansen Spinal Cord Injury Registry.

_________________________________ _________________________ _______________Printed name of the representative Signature Date (dd-mm-yyyy)

Relationship of representative to subject participant : ___________________________________________

Reason why subject participant is unable to provide informed consent : ____________________________

Subject Participant is unable to understand information and consent form in English or French and has the translated for them:

_________________________________ _________________________ _______________Printed name of the translator Signature Date (dd-mm-yyyy)

Language translated : ___________________________

Individual obtaining consent

I have explained all the relevant aspect of the research to the subject participant and/or participantsubject’s legal representative and answered their questions. I have pointed out that participation in the research studyRHSCIR is completly voluntary and that they may stop their participation at any time.

_________________________________ _________________________ _______________Printed name of the individual Signature Date (dd-mm-yyyy)


obtaining the consent

SUBJECT’S PARTICIPANT’S ASSENT TO PARTICIPATE IN THE RHSCIRRESEARCHThis section to be used when subject is a legal minor or is unable to give fully informed consent (e.g., has sustained a traumatic brain injury and is able to only partially understand the RHSCIRresearch study)

I have had the opportunity to read this consent form, to ask questions about my participation in this RHSCIRresearch, and to discuss my participation with my parent(s)/guardian(s)/substitute decision-maker. All my questions have been answered. I understand that I may withdraw from this RHSCIRresearch study at any time, and that this will not interfere with the availability to me of other health care. I understand that my consent will be sought once I am able to consent for myself. I have received a copy of this consent form. I assent to participate in the RHSCIR study.

Printed name of subjectparticipant Signature Date (dd-mm-yyyy)

RepresentativeAs the parent/guardian/substitute decision-maker (authorized representative) I am satisfied that the information contained in this consent form was explained to the child/participantsubject to the extent that he/she is able to understand it, that all questions have been answered, and that the child/subject assents to participating in the researchRHSCIR.

I voluntarily consent that _______ _______________ (name of subjectparticipant) participate in the Rick Hansen Spinal Cord Injury Registry.

Relationship of Representative to subjectthe participant:______________________________________________

Reason why subject the participant is unable to provide informed consent:_____________________________________

Individual Obtaining Subject Participant Assent and Consent of Representative

I have explained all the relevant aspects of the research to the Subject participant and/or to the Subject’s participant parent(s)/guardian(s) and answered their questions. I have pointed out that participation in the research studyRHSICR is completely voluntary and that they may stop their participation at any time.


_________________________________ _________________________ _______________ Printed name of the individual Signature Date (dd-mm-yyyy)who obtained assent/consent


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