COVID-19 Vaccination Decision-Making: Perspectives from Equity-Seeking Groups (Individuals)

Letter of Information and Consent to Participate in a Research Study

 

Principal Investigator:                                              Co-Investigator

Janet Parsons                                                               Clara Juando-Prats

Applied Health Research Centre                                  Applied Health Research Centre

Li Ka Shing Knowledge Institute                                Li Ka Shing Knowledge Institute

St. Michael’s Hospital, Unity Health Toronto              St. Michael’s Hospital, Unity Health Toronto

30 Bond St., Toronto, ON, M5B 1W8                         30 Bond St., Toronto, ON, M5B 1W8

Telephone: 416-864-6060 ext. 7111                            Telephone: 416-360-4000 ext. 47850

Email: janet.parsons@unityhealth.to                           Email: clara.juando-prats@unityhealth.to

 

Janet McLaughlin                                                         Notisha Massaquoi

Associate Professor, Community Health                      Assistant Professor,

Research Associate,                                                     Department of Health and Society

International Migration Research Centre                     University of Toronto Scarborough

Wilfrid Laurier University                                            E-mail: notisha.massaquoi@utoronto.ca

E-mail: jmclaughlin@wlu.ca

 

Community Partners:

College Montrose Place: Corina John, Mark Osler and Emilia Rodrigues

Occupational Health Clinics for Ontario Workers: Eduardo Huesca and Michelle Tew

Women’s Health in Women’s Hands Community Health Centre: Muna Aden

 

Research Coordinator:

Jannah Wigle

Applied Health Research Centre,

St. Michael’s Hospital, Unity Health Toronto

30 Bond St., Toronto, ON M5B 1W8

Phone: 416-360-4000 ext. 47834

E-mail: jannah.wigle@unityhealth.to

 

Granting Agencies: The Vaccine Readiness Grant: Social Sciences and Humanities Project provided by the Canadian Institutes of Health Research, through the Canadian Immunization Research Network.

 

Conflicts of Interest:

There are no known conflicts of interest on the part of the investigators and/or study institutions. This study is paid for with money from the Canadian Institutes of Health Research and the Canadian Immunization Research Network. This includes pay for study staff.

 

Invitation:

You are being asked to consider participating in this research study  to share your perspectives, experiences and concerns regarding COVID-19 vaccination. This information sheet explains the purpose of our study, the risks and benefits, and what you will be asked to do. You can contact the Research Coordinator (Jannah Wigle, jannah.wigle@unityhealth.to or 416-360-4000 ext. 47384) if you have any questions.

Taking part in this study is your choice. You decide whether or not you do an interview. You can also change your mind later and quit the study if you like.

 

Why is this study being done?

A better understanding of the perspectives, experiences, and concerns of equity-seeking groups (including international agricultural workers, members of African, Black, Caribbean or Latinx communities, and newcomers in Ontario) regarding the COVID-19 vaccination and rollout is needed, as these individuals often experience worse outcomes from COVID-19 infections.

 

Vaccination against COVID-19 is recommended for all individuals over 12 years of age (for Pfizer-BioNTech) and over 18 years (for Moderna and AstraZeneca vaccines). We hope this study will help to inform the development of vaccination strategies for a wide range of Ontarians.  Our research team will conduct six focus groups (with 6-10 individuals each) and up to 21 interviews. We want to understand:

  • What are your perspectives, experiences and concerns about COVID-19 vaccination and its rollout?
  • What informationdo you need to inform your COVID-19 vaccination decisions?
  • What barriers have you experienced in relation to your race, gender, and other aspects of your social identity?

 

We will learn about these things by:

  • Working with community-based organizations, researchers, healthcare providers and service providers who are members of and/or working closely with African, Black, Caribbean and Latinx Ontarians, international agricultural workers, and persons who immigrated within the last five years to Ontario;
  • Facilitating discussions about COVID-19 vaccination with equity-seeking groups; and
  • Speaking with diverse individuals about their experiences related to COVID-19 vaccines.

 

What is the purpose of this interview?

These interviews will help our team understand the diverse perspectives, experiences and concerns of equity-seeking groups related to COVID-19 vaccination in Ontario.

 

You are being asked to participate in an interview. This will:

  • Be held on the phone or Zoom
  • Take up to 60 minutes
  • Involve you and an interviewer from our team
  • Be scheduled at a time you find convenient

You will be asked questions about:

  • Your perspectives, experiences and concerns about COVID-19 vaccinations.
  • Information you value and/or need as you make your vaccination decision.
  • Challenges you may have encountered due to your race, gender, immigration status, or other intersecting social categories.
  • Demographic information, such as your age, ethnicity and employment.

 

Individual interviews are anticipated to last up to 60 minutes and will be conducted by team members with expertise leading/analyzing this type of research. Interviews are audio recorded so that we do not lose any details of the conversation, but this is optional. If you agree to the recording, it will later be listened to and typed out. If you do not agree to the recording, the person conducting the interview will instead take notes. If you do not agree to the notes or the recording, we will not be able to go ahead with the interview. During the interview, some of the questions may seem personal and may make you feel uncomfortable or may upset you. You can skip questions that you do not want to answer. If you have any questions or concerns while answering these questions, please mention them to the interviewer. After the interview, we will ask some demographic questions, such as age, gender identity, ethnicity, and employment status. Any information will be used strictly to contact you for study purposes and to collect demographic information about study participants.

 

What are the burdens, harms, and potential harms?

There are no known risks to taking part in this interview. It is possible that you may not like some of the questions and find some of them hard to answer. You can always skip questions, take a break, or stop participating any time. If at any point you feel uncomfortable answering a question, you can choose not to answer it.  If you feel upset because of this interview, we will refer you to services that can provide you with more information and support.

 

What are the possible benefits?

Participating in this study will have no direct benefits to you. The findings of our study may help inform the development of more appropriate strategies for COVID-19 vaccination in Ontario.

 

Can I withdraw from the study?
Your participation in this study is voluntary. If you choose not to participate, there will be no impact to the medical care received at, employment at, or other relationship with Unity Health Toronto now or in the future for you or your family.  You can withdraw from the study at any time during the interview. If you decide to withdraw we will take your information out of the study. If you choose to withdraw before your data is analyzed, we will delete the files and not include your data in the study. If your data has already been analyzed, we will not be able to exclude it, but we will endeavour not to include quotes from you in the analysis.

Dr. Janet Parsons is the lead researcher on this study. She may decide to stop inviting people for interviews, or to cancel the study. Our funders, or the Research Ethics Boards at Unity Health Toronto could also cancel the study.

 

Will the study cost me anything and, if so, how will I be reimbursed?

Your participation in this interview will not involve any additional costs to you.  If you complete an interview, you will be offered a $50 gift card to thank you for your time and participation.

 

How will I be informed of study results?

You have the right to be informed of the results once the entire study is complete. If you are interested in obtaining the results of the study, you can contact the investigators or research team. We estimate that the study results will be available in 2022.

How will my privacy be protected?

The study team will make every effort to keep your personally identifying information private and confidential in accordance with all applicable privacy legislation, including the Personal Health Information Protection Act (PHIPA) of Ontario.  Protecting your privacy is an important part of this study but there are limits to what we can protect. This means we can’t guarantee complete privacy. Other than the individuals or groups described in this section, no persons will have access to your identifiable information without your consent, unless required by law. The researchers are required by law to disclose any information that threatens the health, life and safety of you or others. Additionally, it is important to understand that despite the protection measures described in the list below, there continues to be the risk of an unintentional release of information. The risk of unintentional is low.

 

We do take steps to keep your information confidential:

  • The research team only collects information needed for the study. The interview questions will not ask about your personally identifying information.
  • The researchers and study staff will keep your information confidential. This will be done following the steps described in this information sheet, and to the extent allowed by applicable laws.
  • Study information will be stored in secure databases on the St. Michael’s Hospital server. This information will only be accessible on password-protected computers. Only trained study staff and researchers will have access to this information. This information includes:
    • Recordings of the interview
    • Notes taken by the interviewer
    • Transcripts made from the recording
  • Study data may also be transferred outside of Unity Health Toronto and shared with others for purposes related to the conduct of this study.
  • Information like your name, phone number or email address will only be shared with the St. Michael’s Hospital research team.
  • Representatives of the granting agencies or the Unity Health Research Ethics Board may inspect study records. This information could identify you. Dr. Parsons or another team member will take part in this inspection if it happens.
  • We will transcribe your interview word-for-word except for identifying information that will not be transcribed. Your name will be removed from the transcript of your interview. Other information that could identify you will also be removed.
  • If you choose, you can review your transcript after your interview.
  • Your interview transcript will be de-identified by using a unique study identification number instead of any of your personal identifiers. The principal investigator at Unity Health site, Dr. Janet Parsons, is in control of the key that links your study number to you personally.
  • Our team will keep study files for five years after the study is finished, with the exception of audio recordings which will be deleted six months after the publication of results.
  • We may use quotes from your interview in reports or presentations but there will be no way to identify you personally.

 

What are my Research Rights?

You have the right to all information that could help you decide if you want to do an interview or not. You have the right to ask questions about this study. You can ask questions before you decide to do an interview, during the interview and after. You have the right to have these questions answered before deciding if you want to participate.

 

Completing an interview indicates that you have agreed to take part in this research and for your responses to be used.  In no way does this waive your legal rights nor release the investigator(s), sponsors, or involved institution(s) from their legal and professional responsibilities. If you have any questions at any time during or after the study about research in general or your rights as a participant you may contact the Chair of the Research Ethics Board, Unity Health Toronto at 416-864-6060 ext. 2557.

 

How do I get involved?

If you would like to participate or if you have any questions, please contact the Research Coordinator Jannah Wigle (jannah.wigle@unityhealth.to or 416-360-4000 ext. 47384). Verbal consent to participate will be obtained before the interview.

 

Please note that email is not secure. Emails can be intercepted, viewed, changed or saved by others. Only send information to this address that you do not feel is sensitive.

 

Thank you for considering participation in this study!

Title: COVID-19 Vaccination Decision-Making: Perspectives of Equity-Seeking Groups

Version: 2

Date:  16 November 2021