Human Subjects Considerations |
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Has the final versions of your advertising, consent forms, and research questions been approved by your institution’s Institutional Review Board? |
Yes |
No |
Do you have a written protocol for addressing risks to study participants that has been approved by your institution’s Institutional Review Board? |
Yes |
No |
Does your protocol include guidelines for logging and addressing participants’ concerns, including how this information will be communicated to your institution’s Institutional Review Board and to your funder? |
Yes |
No |
Does your protocol identify conditions and procedures for stopping data collection if there appears to be harm to participants? |
Yes |
No |
Does your protocol have guidelines for restarting a study if the issue(s) that causes data collection to stop are resolved? |
Yes |
No |
Are all databases and logs ready to be activated? |
Yes |
No |
Do you have a current referral list applicable to participants in all geographical areas from which your sample is drawn? |
Yes |
No |
Have all members of your research team completed human subjects training, per requirements of your institution’s Institutional Review Board? |
Yes |
No |
If funded by NIH, did you obtain a Certificate of Confidentiality? |
Yes |
No |
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Recruitment Considerations |
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Do you have a signed contract with the vendor(s) you will rely on to publish your recruitment banner advertisements to send out emails? |
Yes |
No |
Do you have written documentation from the vendor(s) that your recruitment plan, advertisements, and email content developed by your research team conforms to the vendor(s) marketing and advertising specifications? |
Yes |
No |
Do you and your vendor(s) have a written plan to monitor participant recruitment, as well as a written contingency recruitment plan if recruitment is slower than desired? |
Yes |
No |
Do you have adequate money in your budget to cover the costs associated with recruitment, including an estimated 50% cost overrun contingency budget if recruitment takes longer than expected? |
Yes |
No |
Do you have a written protocol for ending recruitment, including how to remove advertising, respond to inquiries from persons interested in participating in the study, block access to online instruments, and lock the database? |
Yes |
No |
Do you have a written protocol for processing participant payments? |
Yes |
No |
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Research Instrumentation Considerations |
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Have you obtained written sign-off from the Principal Investigator, Co-Investigators, and Methodologist for all instruments? |
Yes |
No |
Have you obtained written sign-off from members of your Community Advisory Board (if applicable)? |
Yes |
No |
Have online data collection instruments been tested in-house and all identified “bugs” resolved? |
Yes |
No |
Are all variables names and codes set up to facilitate easy data cleaning and analysis? |
Yes |
No |
Have you verified that online data are being correctly stored in the study database and on the designated server? |
Yes |
No |
Have you completed pilot testing? |
Yes |
No |
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Data Collection and Participant Safety Considerations |
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Do you have a written data collection protocol, including procedures for identifying and removing duplicate participants from the study? |
Yes |
No |
Have all members of the research team been trained on the data collection protocol? |
Yes |
No |
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Public Relations Considerations |
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Do you have a written public relations protocol that includes a list of key personnel allowed to interact with media, key messages, and guidelines for using online social networking media (both study-related pages and personal pages of members of the research team)? |
Yes |
No |
Have all key personnel received a copy of the emergency communication protocol? |
Yes |
No |