Research ethics
Table of contents
Prerequisites
- Log in to the Splash Page - MacREM Applications with your MacID. This will automatically activate your account in the system.
- After you log in, Dr. Xiao will create an application form under our ethics protocol. And you will receive an email from MREB informing you as the member of this research project.
- Use the templates and examples in the Research ethics documents to prepare your application.
Instructions for ethics application
Filling out the individual study form
- Section 1.3 Add your study name. You can also add an abbreviation of the name which can be used in the documents upload (see 2.b. for further explanation)
- Section 1.6 Students should be selecting option 1 in section 1.6 after they receive feedback about their MREB application submission. This way they will be able to upload a summary of the changes they have made to their application before re-submitting for approval.
- Section 2.8 Add your name if you are in the original program of research ethic application, otherwise, you can choose Yes in Section 2.9 and add your own information.
- Section 3.1 Please answer the following questions to complete this section. It is important to provide a detailed procedure in this part (e.g., trials, duration). You should change the part that unique to your own project. Leave the Recruitment plan and Confidentiality/Data storage/ Consent in other session.
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Number and description of participants for this chapter project (e.g. children & parents)
Fill in based on study-specific information.
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Specific recruitment plan (children & parents)
Template: Participants will generally be recruited using the PNB developmental participant database (separate ethics protocol #3693, PI: Xiao, approved). This database stores the contact information of families who previously expressed an interest in having their children participate in our studies. Authorized research staff and students will contact caregivers with children in the age range and with the relevant criteria for a study. At that time, we will first call or email the family (depending on their listed preference) to let them know that they are eligible to participate in the experiment and invite them to schedule an appointment. Qualified children whose parents respond positively to this contact will be scheduled for a study appointment.
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Methodology
Describe how you are collecting data (e.g. questionnaire), where (e.g. Zoom, telephone), how long the interview/experiment will take, audio/video recordings, transcription (children & parents)
Fill in based on study-specific information.
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Confidentiality and data storage
Are you collecting identifying info, where and how long will you keep identifiable data (contact info, recordings), where and how long will you keep the de-identified research data/transcripts?
Template for Online Studies with Children and Infants:
Participants or their legal guardians’ names, signatures, and email addresses will be collected for informed consent purposes. The personal/contact information will also be used to prevent participants from being recruited for studies they already participated in. We will also collect participants’ or their legal guardians’ names and signatures on a signup sheet to indicate that they received the participation incentives (compensation). Only authorized personnel on the ethics protocol will have access to the information.
We will use a Family Code plus Child Code to identify child and infant participants. The Family Code is a randomly generated 4-digit number and the Child Code is an alphabetical letter. For example, the first child will be coded as Family Code + a, and the second child will be coded as Family Code + b.
Video recordings of participants are required for the study. Participant’s names or any identifiable information will never be used with the recordings (e.g. using identifiable information to name video files). The primary use of these recordings is internal with all videos viewed only by approved research personnel and all files kept on password-protected computers and MacDrive. However, participants may additionally consent to allow their images to be used for research and educational purposes outside the lab (e.g. in publications, research presentations, & lectures). This use of the images is entirely optional and clear consent for this use is given by participants on the consent form. In all cases, participants will have provided voluntary consent for the use of their identifying information in this way.
Research data will be temporarily stored on data collection computers. These computers will connect to the internet and are protected by passwords. When an experiment finishes, we will upload all related research data to the lab’s MacDrive and remove them on the data collection computers. Research data will be retained on the lab’s MacDrive indefinitely. Only authorized researchers can access the videos associated with their research program.
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Consent process
When will participants receive the letter of information, how and when will consent be documented, and how can participants withdraw during and/or after the interview?
Template for Online Studies with Infants and Children:
Individuals younger than 16 years of age will require consent from their legal guardians as substitute decision-makers. For online studies, parents or legal guardians will read the Letter of Information and consent form presented to them on an online platform (Zoom) at the time of the study appointment. They can click a button on the screen to indicate their consent to participate in the study. To withdraw from a study, the participants (or their parents) just need to inform the researchers via email, phone call, or in-person conversation, and we will immediately terminate the ongoing study. Participants can also request to withdraw their data from the study after their data has been submitted/collected. However, withdrawal from the study is not possible after the study is published. Withdrawal will not affect the incentive or reimbursement they are supposed to receive after participation.
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Please make sure to go over the template and remove those parts which don’t apply to your study.
For example, for an online study, you need to delete or revise references to signatures, sign-up sheets any other statements that do not apply to this individual study. (e.g., in the Confidential and Data storage section, it is not necessary to include ‘Participants or their legal guardian’s names, signatures, and email addresses will be collected for informed consent purposes’. ‘We will also collect participants’ or their legal guardians’ names and signatures on a signup sheet to indicate that they received the participation incentives (compensation)’ )
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**Please also include a section to indicate certain requirements for the study. **
For example, for an online study, you need to mention that a computer with a camera to allow for video recording is required.
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- Section 3.7 Confidentiality/Data storage/Consent will be uploaded as a Letter of Information (Template). When you change the template, make sure to highlight the parts that are unique to your project.
- Section 3.8 Upload Recruitment Plan (Template). Make sure to highlight the parts that are unique to your project. Recruitment documents and scripts should not be combined. For instance, the phone script and email script should be in separate documents. All documents need to be submitted in PDF format.
- Please check if you need to make changes based on your study.
- The full study title should also be reflected in the document (e.g., in the 1st paragraph).
- Include information about specific requirements needed to participate in the study (e.g., a computer with a camera)
- You can also reiterate your targeted age groups in the email and phone script.
- PLEASE upload the recruitment email and reminder email as separate PDFs and rename each more specifically.
Upload documents
- Convert LoI and Recruitment scripts to pdf and highlight the parts that are specific to your study (different from the template)
- Make sure all the information (e.g., title, duration) is consistent across all documents and the individual form.
- Every document should have the name of the study on the first page, and in the footer of every page.
- Document files should be named according to the version number, date approved, and the study name. The file name should also include a short form of the study name (e.g. abbreviation) so that each document is more easily identified. The format should be [Document Type]_[Abbreviation of Study Title]_Date_VersionNumber.pdf
- An example file name for an approved Letter of Information: LoI_IPFFM_21Sep2021_v2.pdf
- An example file name for a pending Recruitment Document: Recruitment_CLDPF_29Aug2021_v1.pdf
Ethics revision
- Check My revised program of research form in response to ethics review comments from the MREB Chair (option 1) at 1.6 and upload your responses to the comments as a pdf file.
- Remove old documents at sections 3.7, 3.8.1, and 3.10.1, if applicable.
- In any newly uploaded documents, you need to highlight the changes you made to make the review process easier for the ethics board.