ࡱ> O Jbjbj 8wewe<14 #T$%$%$%$8]$!%T%$lju%:%%%%&&&lllllll$prP,l&&&'i(P,l%%4Al.,,,(R%%l,&l,,N0ch%`M )Ld0kol<lesW)s`h@Hhsg"Vh&&,&&&&&,l,l'*&&&l&&&&s&&&&&&&&& : How to draft and Informed Consent Form INFORMED CONSENT FORM Full title of the research SMU REB File Number (The REB application receipt will provide.) Principal Investigator and Faculty Supervisor names Department Saint Marys University, 923 Robie Street, Halifax, NS B3H 3C3 Phone #; Fax #; Email address Researchers: This is a sample INFORMED CONSENT FORM. Feel free to modify it to suit your purposes; remove text as needed, leave or make new headings, add information, etc. This is your agreement with your participants your promise to participants. You are the subject matter experts and best positioned to know your population and know your consent form in a way that will be meaningful to them. Research team introduction and invitation into a voluntary research: Begin with a statement describing your role in the research. (For example, As part of my masters/honours/Ph.D. thesis, I am conducting research under the supervision of Dr._______....) Add an invitation to take part in your study, stating that it is research, and that it is voluntary. (For example: We invite you to take part in a study that examines how people use technology.) What the researchers are trying to learn from this research study: Describe the purpose and aim of your study in lay terms. (For example, imagine you are telling your neighbour or a high school student about your research.) Usually about 1 paragraph is included. Common mistakes include using jargon and technical language that is not easily comprehensible to readers. Who researchers are looking for to join this research: Specify the population of interest in the research and the eligibility criteria. (For example: we are inviting people who have recently moved to Halifax because were interested in.) Include exclusion criteria, if applicable. (For example: if you have lived in Halifax for more than 2 years, we thank you for your interest but the question of this study does not apply to those circumstances). What participants will be invited to do: Describe what participants are being invited to share in the research. (For example: if you choose to participate, well ask you some questions about , the research involves and open-ended interview, or a focus group session, or 3 surveys include 1 demographic survey and 2 online survey questionnaires consisting of 30 questions in total, or 4 visits to the lab for 30 minutes each during the period of 2 months.) Indicate where and when the study would take place and for how long. (For example: we can conduct the interview over the telephone or in a location we both determine is appropriate. We will be conducting the research between January and March of this year and we expect that most interviews will last about 20 minutes. If you agree, we may invite you to take part in the second and third phase of this research or this is an online study, the link to the study is found at the end of this document.) It is accommodating potential research participants to include several examples of the questions that would be asked, timetables, images, etc., so they can easily understand what the research is about. Possible benefits that could arise from taking part in this research: Discuss any foreseeable benefits of the study (direct or indirect). Consider the potential benefits to participants (for example, participants will learn about a new stress-management device application), benefits to science (for example: the scientific community should have a better understanding of how people use technology to manage their stress), benefits to society (for example: we dont know yet what the benefits to society are). Note that benefits are unknown, so it is better to frame expected benefits as tentative (for example: we hope to understandclients may gain a better appreciation forthe scientific literature might be enriched) Possible risks that could occur from taking part in this research: Discuss any foreseeable risks that may emerge from participating in this research. Risk and different levels of risk is common just tell the participant what it is, what is foreseeable. For example, participants may feel upset after sharing the story of their childs illness. If there are no foreseeable risks, say so. For example, we do not foresee any risks in this study at this time If there is a known way to mitigate foreseeable risks, explain how you will mitigate them. Explain the resources are available to manage risks. Tell participants they have options if they choose not to share certain information. For example, that they can skip parts of the research (e.g., specific questions) or chose to withdraw. Of course, they can decline to participate as well. For example: If you feel that the research topic may induce symptoms of anxiety, this study might not be suitable for you at this time. Information gathered Explicitly state what type of information you will be collecting: For example, we will gather your location information from the GPS application that we will install on your device of choice. We will also gather blood pressure, weight and height. Finally, we will measure how often you use recreational facilities, public transportation, and health services. Indicate who will have access to the participants information collected: Indicate whether others outside the research team will know the identity of the participant and what information will be kept private or made public. Indicate whether it will be possible to link participants information with their identity. Indicate whether you plan to share your data with other scholars (de-identified or otherwise). Indicate whether you plan to share your data with journal editors, for example. Indicate how long you plan to keep the data (note that destroying data is often neither planned, promised nor required). Keep in mind that researchers are responsible for the secure storage of their data. Think about succession planning when making this agreement with participants. Storage of data: Include how data will be organized, maintained and stored during and after the research. Include what steps will be taken to protect the identity of participants, if this was promised.  Dissemination of research results: Insert the plans for research results dissemination. For example, once all the data are collected and analyzed for this study, I plan on sharing the information with (as appropriate: the research community through seminars, conferences, presentations, journal articles, etc., insert locations if known). If applicable, specify how/whether the information will be available in the public domain. If you will be utilizing a feedback form, remember to include all known information in the consent form at the time participants make an informed decision about their welfare. A common mistake is researchers include additional information in the feedback form that is not listed in the informed consent form and then may need to adjust so the different forms provided to participants match. Dissemination of research results to participant: Provide information on how and in what form participants can find out about the results to which they contributed data. Note that it is better if researchers provide a brief summary of the findings in a way that does not require participants to identify themselves to the research team. For example, if appropriate for your population, you could make the results available on a website and provide that link to participants (for example: a summary of the results will be available on June 1 next summer on this website:  HYPERLINK "https://smu.ca/academics/summaries-of-completed-research.html" https://smu.ca/academics/summaries-of-completed-research.html). Note: SMU provides this link to all SMU researchers, should they need it. Compensation: If there is no compensation available, just say so. If applicable, include information about a) any partial and full payments, bonus points, etc., and relating details, b) incentives, c) reimbursement for participation-related expenses (parking, taxi, bus fare, equipment, out of pocket, etc.) and d) compensation for research related injury if applicable. Attempt to estimate the odds of winning raffles. For example: You have a 1 in 50 change of winning the draw. Provide information about the source of funding, if someone is paying for the research. It is good practice to discuss compensation details once a potential participant has already been presented information about purpose, involvement and the possible benefits and risks of the research. Options if you change your mind taking part in the research: State that participants are free to withdraw from the research study at any time without penalty. Tell participants how to withdraw. For example, tell the interviewer, exit the browser, as needed. Describe what will happen to the data collected if one withdraws from the study. For example, sometimes when a participant withdraws from a study, the researcher cannot remove the participants data because it is not identifiable. That is ok! Just tell the participant. If it is possible to remove the participants data when they announce their wish to withdraw, then tell the participant. If there is a best before date to withdrawal (for example, if participants want to withdraw and remove their data, it is best that they announce their wish before you present or publish the findings. Therefore, provide a best before date for withdrawal + removal of data. Options for asking more information about the research at any time from members of the research team when choosing whether the research is the right research study for you: Researchers should include their scholarly contact information for themselves; if it is student research, contact information for faculty supervisor must be provided. Provide contact regarding ethical matters (Research Ethics Officer:  HYPERLINK "mailto:ethics@smu.ca" ethics@smu.ca or 902-420-5728) Provide clear direction that participants can discuss the study with you at any time and that the research team will answer questions and be available during the course of the study participants may wish to clarify or if they feel something has not yet been provided as it relates to their circumstance. Additional information: If your research is funded, then indicate where the funding is coming from. If you have a conflict of interest (or others may perceive a conflict of interest), then declare this. Include this standard language at the end of the Informed Consent Form: Research participant rights and protection: The Saint Marys University Research Ethics Board has reviewed this research with the guidance of the TCPS 2 based on three core principles: Respect for Persons, Concern for Welfare and Justice. If you have any questions or concerns at any time about ethical matters or would like to discuss your rights as a research participant, please contact  HYPERLINK "mailto:ethics@smu.ca" ethics@smu.ca or 902-420-5728. Signature of Agreement (if appropriate - it is good practice for researchers to document that they have obtained consent from participants, but a signature may not always be appropriate or feasible: I understand what this study is about, appreciate the risks and benefits, and that by consenting I agree to take part in this research study and do not waive any rights to legal recourse in the event of research-related harm. I understand that my participation is voluntary and that I can end my participation at any time without penalty. I have had adequate time to think about the research study and have had the opportunity to ask questions.  Research pending, you may wish to include checkboxes, etc. or other creative ways, that present associated options for participants so they can elect or specify their preferences. For example, Yes/No, to indicate their preferences involving options in your research. It may involve options involving audio or video recording, I give permission to be audio recorded Research Participant Signature: ___________________________ Name (Printed): ______________________________ Date: __________________ (Day/Month/Year) Principal Investigator Signature: ___________________________ Name (Printed): ______________________________ Date: __________________ (Day/Month/Year) Please keep one copy of this form for your own records.     (Page # of #, Version number, Date) Tailor the consent form to your type of research and double check that information listed in the Informed Consent Form matches what has been provided in the application form, (Form 1 or 1C). Researchers receive their SMU REB number on their email receipt that acknowledges the receipt of the application at the time of submission, and then later update their Informed Consent Form and any other relating research materials to include the assigned SMU REB number. Specify that the research, i.e.: seeks employees in mid-sized organizations in Atlantic Canada, jury-eligible citizens, SMU students, faculty, staff, etc. Exclude incentives, financial compensation and bonus points here. It is best to use language that the study may or might or should result in certain predicted benefits versus that it will when listing the potential benefits because it is not known whether the outcome of the research will be useful. Types of information include: directly identifying, indirectly identifying, coded, anonymized and anonymous. Researchers understand what type of information they are collecting and are able to communicate and explain relating details to their research participants as well as understand methods of de-identification, if applicable. Investigate and verify that the steps taken to protect the data that you are promising to keep secure match the current way IT servers on campus, a system or device currently function by familiarizing yourself with the systems up-to-date terms of use and service, when applicable. Provide participants with some sense for when dissemination of the research results will be as appropriate. I.e., May, 2020. Include how participants will be provided the results of the research, i.e. whether they will be emailed the results of the research, or whether they can locate the results on a link you are providing, etc. Preferably it is best to not ask participants to email the researchers rather providing a link where the results will be posted and indicating when the results are expected to be available as this route protects the research participants identity because it does not need to be revealed. Attempt to estimate the odds of winning raffles. (I.e., You have 1 in 50 chance of winning the draw.) Discuss whether withdrawal of study participation includes withdrawal of personal data collected up until that point, or whether data collected up until that point will be included in the study analyses as well as any options to participants to consider. I.e., participants may walk out of a study at any time, but if participation is anonymous and participants wish to withdraw after they have provided their data, it will be impossible to remove the data from consideration. The scientific or scholarly contact are the research study investigators. (I.e., the faculty or student Principal Investigator, Co-Investigators, Student Investigators.) This means that the scientific or scholarly contact is not the REB. The contact regarding ethical matters is the REB. This means that the ethical contact is not the research investigators. I figure readers don't know what that means without some sort of second part of the sentence. Jason/Veronica- do we we want to say anything, or no? Use this Certification standard wording paragraph word for word and simply paste it into the Informed Consent Form. This paragraph tells the readers that the research study has had ethical oversight. Research pending, you may wish to include that personal preferences that relate to the protection of identities, data dissemination, obtaining of research results, audio or video recording, etc. can be discussed and specified with the research team; or as a common practice, you may apply the use of check boxes for such preferences here. I.e., I give permission to be audio recorded. Yes/No, etc. ( ( ( Signed Informed Consent Forms arent always appropriate. Oral consent may be the only way to conduct research in some contexts or populations. If consent was sought in a language other than English, researchers add signature lines for translators and indicate the language in which consent was sought. If consent was sought through an Authorized Legal Representative, researchers add a signature line as applicable. 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