Letter of Information / Informed Consent Form

Secondary Use of Existing Research Data

[Template for AU Research]

The Letter of Information / Informed Consent form should be:

Written in plain, clear language avoiding the use of jargon and acronyms.

Tailored to the reading level of the participants so they can understand what is required of them and make an informed decision about their participation.

Presented on this template.

Participants should be given a copy of the letter of information / signed consent form or advised to retain a copy for their own records.

Researcher(s) should retain a copy of the signed consent form in their records.

This template demonstrates the minimum information that should be included in the consent form. Additional information may be required depending on the nature and complexity of the project.

The template begins on the next page.

Do not include this instruction page with your form.

Directions for what to include in each section are written in italicized red text.

All italicized red text should be replaced with information specific to your project.

LETTER OF INFORMATION / INFORMED CONSENT FORM

Secondary Use of Existing Research Data

[Title of Research Project]

[Date]

Principal Investigator (Researcher):	Supervisor (if applicable):

[insert name and contact info]	[insert name and contact info]

You are invited to take part in a research project entitled ‘your project title here’.

This form is part of the process of informed consent. The information presented should give you the basic idea of what this research is about and what your participation will involve, should you choose to participate. It also describes your right to withdraw from the project. In order to decide whether you wish to participate in this research project, you should understand enough about its risks, benefits and what it requires of you to be able to make an informed decision. This is the informed consent process. Take time to read this carefully as it is important that you understand the information given to you. Please contact the principal investigator, your name here if you have any questions about the project or would like more information before you consent to participate.

It is entirely up to you whether or not you take part in this research. If you choose not to take part, or if you decide to withdraw from the research once it has started, there will be no negative consequences for you now, or in the future.

Introduction

My name is your name here and I am a insert degree program student at Athabasca University. As a requirement to complete my degree, I am conducting a research project about briefly describe the project in lay terms 1 – 2 sentences. I am conducting this project under the supervision of your supervisor’s name here. If NOT a student, input appropriate description.

It is key to explain why you need consent. The people being approached in this instance consented to participate in previous data collection. Generally, you would be analyzing those data to address a new question, or possibly comparing their data with data collected in a different project. In essence they need to know what they consented to the first time, and what you propose to do now that is new and different. Make very clear what research question their data is being used to address.

What is the purpose of this research project?

Describe the purpose of the research, including what the project hopes to answer.

Who Will be Included in the Research Study

The study you were in originally included Explain what characteristics people needed to have to be in the initial study, and if only some are being selected to be part of the new proposed analyses how those will be selected. The language should be simple and direct.

Example: “The study you were originally in included all seniors from this community between the ages of 65 and 85 who lived in their own homes. For the current analysis, we will only include those between the ages of 70 and 80, so the data are directly comparable with the data from the [name] study that was conducted in [place].”

How will data be used?

Describe here what you will do with people’s data that they did not previously consent to—new analyses, new comparisons, new questions addressed. People allowed their information to be collected originally for specific purposes, they have a right to say no to its use for this new purpose.

What are the risks and benefits?

Identify any benefits to the participant, for the development of knowledge, or for a change in practice. State explicitly if there are no direct benefits to the participant.

Risks generally concern breach of privacy, which should be discussed. Where there is a possibility of repercussions to any individual or group, these should be described. In some instances, risks may exist for communities associated with the study (stigmatization, community discord). The steps that will be taken by the researcher to minimize risks should be stated.

Example: “In conducting these new comparisons between your data and similar data that has been conducted in [place and place] we may find that people here are _________ compared with the other two groups. This may [have repercussions].”

Do you have to take part in this project?

As stated earlier in this letter, involvement in this project is entirely voluntary. Describe how participants can stop and/or end their participation during the data collection.

How will your privacy and confidentiality be protected?

The ethical duty of confidentiality includes safeguarding participants’ identities, personal information, and data from unauthorized access, use or disclosure.

Include a statement about how participants’ privacy and confidentiality will be maintained. If confidentiality cannot be guaranteed (e.g. participants may be identifiable due to specific characteristics in the sample population), specify the limits to confidentiality.

Describe any other limitations to confidentiality that may be applicable [if there is a likelihood that reportable information may arise during the research project (e.g. protected populations, revelation of illegal or heinous act), include a specific statement to address this. “All information will be held confidential, except when legislation or a professional code of conduct requires that it be reported.”

How will my anonymity be protected?

Anonymity refers to protecting participants’ identifying characteristics, such as name or description of physical appearance.

Limits to anonymity of participation and/or data, should be explained.

If anonymity is desired, researchers should assure participants that Every reasonable effort will be made to ensure your anonymity; you will not be identified in publications without your explicit permission.

How will the data collected be stored?

Indicate how data will be stored, whether it will be disposed of and if so, how and when.

Indicate whether data will be deposited into some form of data repository and if so, what the access to that data will be. Also describe to what degree the data will be anonymized before deposit and whether or not data will be openly available in the repository.

Identify all individuals/agencies who will have access to data from the research project, or the report, now or in the future (e.g. supervisor(s); organization(s); whether the data be deposited into a data repository of some type).

Describe the procedures/methods that will be employed to protect confidential data in all its forms (e.g. password protections and encryption on electronic data; use of pseudonyms (false names) or data codes; locked filing cabinets for hard copy data)

If you intend to use/store/deposit the data for future research purposes, adapt one of the following statements as applicable:

The identifiable / anonymized data collected in this research project may be [used by members of the research team in subsequent research studies exploring similar lines of inquiry] OR [deposited in a research repository (name the repository if known) for use by researchers doing similar research], with your consent. Such projects will undergo ethics review and any secondary use of identifiable / anonymized data will be treated with the same degree of confidentiality and anonymity as in the original research project.

Who will receive the results of the research project?

Describe how and where results of the research project will be disseminated and whether or how they will be made available to interested participants.

If you are an AU graduate program student and the research is a final research project or thesis, include the following statement: The existence of the research will be listed in an abstract posted online at the Athabasca University Library’s Digital Thesis and Project Room and the final research paper will be publicly available.

Be sure to comment on whether direct quotations or personally identifying information (with permission only) will be reported; or whether reporting is only in aggregate or summarized form.

Be sure to highlight whether audio/video recordings will be used in dissemination of the research.

State what information or feedback on the research project will be available or provided to participants after the project is complete (e.g. report, executive summary, poster presentation). Indicate how/if participants can access the project results without having to contact the principal investigator (e.g. available on researcher’s website).

Who can you contact for more information or to indicate your interest in participating in the research project?

Thank you for considering this invitation. If you have any questions or would like more information, please contact me, (the principal investigator) by e-mail insert e-mail address or insert any other means of contact you wish to use or my supervisor by insert e-mail address or phone number. If you are ready to participate in this project, please complete and sign the attached Consent Form and return it by [provide directions on who, where, how and by when] .

Thank you.

[nsert researcher name]

This project has been reviewed by the Athabasca University Research Ethics Board. Should you have any comments or concerns about your treatment as a participant, the research, or ethical review processes, please contact the Research Ethics Officer by e-mail at rebsec@athabascau.ca.

If written consent is being obtained, the signature page should be signed and dated by the research participant or by the person authorized to sign on behalf of the research participant (e.g., a parent or care giver). In the latter instance, the participant’s name must also be clearly indicated.

Informed Consent:

Your signature on this form means that:

You have read the information about the research project.

You have been able to ask questions about this project.

You are satisfied with the answers to any questions you may have had.

You understand what the research project is about and what you will be asked to do.

You understand that you are free to withdraw your participation in the research project without having to give a reason, and that doing so will not affect you now, or in the future.

Only include the points from the following that are applicable to your project.

You understand that if you choose to end your participation during data collection, any data collected from you up to that point will be Choose one of the following to complete the bullet point, as applicable:

destroyed.

retained by the researcher, unless you indicate otherwise.

You understand that if you choose to withdraw after data collection has ended, your data can be removed from the project at your request, up to insert cut-off date here.

You understand that the data included in this study have been de-identified, and therefore cannot be removed.

Include these checkboxes if they are relevant to your project:

YES	NO
I allow de-identified data collected from me to be archived/deposited in insert name/description of archive/repository here	⃝	⃝
I allow identifiable data collected from me to be archived/deposited in insert name/description of archive/repository here	⃝	⃝
I allow de-identified data collected from me to be retained by the members of the research team for use in future research exploring similar lines of inquiry.	⃝	⃝
I allow identifiable data collected from me to be retained by the members of the research team for use in future research exploring similar lines of inquiry.	⃝	⃝

Your signature confirms:

You have read what this research project is about and understood the risks and benefits. You have had time to think about participating in the project and had the opportunity to ask questions and have those questions answered to your satisfaction.

You understand that participating in the project is entirely voluntary and that you may end your participation at any time without any penalty or negative consequences.

You have been given a copy of this Informed Consent form for your records; and

You agree to the inclusion of your previously collected data in this new research project.

____________________________	__________________________

Signature of Participant	Date

If a summary of results is being offered to participants, this option can be provided on the consent form.

Example: “Please provide an email address below if you would like to be sent a summary of the study results.

Email address: _________________”

Principal Investigator’s Signature:

I have explained this project to the best of my ability. I invited questions and responded to any that were asked. I believe that the participant fully understands what is involved in participating in the research project, any potential risks and that they have freely chosen to participate.

_____________________________	____________________________

Signature of Principal Investigator	Date