Steps to Initiate a Study

If you are creating a new study in the BLAB, take these steps to make sure you're ready to recruit participants!

Is it IRB approved?

Check in with a lab manager to see if your study is covered by an existing IRB, or if we need to write a new one or make an amendment.

Does a protocol cover the participant population you'd like to study (age range, language exposure, specific developmental disorders, etc.)?

Does it cover the method you want to use (eyetracking looking while listening, doing studies over zoom, EEG, LENA recordings etc.)?

Does it include ALL the ancillary measures you want to collect (e.g. CDI, demographics, motor survey, language experience survey? if you create a new one, we have to submit it to the IRB as an amendment!)

Does it cover the recruitment methods you will use (including specific versions of flyers, draft emails, social media avenues, participant databases, online recruitment services?)

Does it allow us to pay participants using the right format (cash vs. gift cards) and the right funding source (e.g. the specific grant you're using?)

Are you listed as a researcher on the IRB protocol?

If you answered no to any of these, work with your lab manager to write or amend an appropriate protocol!

Filemaker Database and recruiting pipeline

Share the following relevant information about your study with a lab manager:

  • Age range of participants to recruit

    • Can be in days, months, years, or combination of days/months/years. Decimals are okay.

    • Keep in mind that this will automatically calculate which participants are eligible to be called. So, if you're running a study with eight month olds, you should decide whether 8 months means you become eligible the day you turn eight months old and become ineligible the day you turn 9 months old, or if you want 7.5-9.5 month olds.

  • If you want to either exclude or include participants based on past participation in any other BLAB study.

    • e.g. for DSC12, potential participants are excluded based on participation in DSC8 or DSC10

  • Any other eligibility criteria (premature, developmental disabilities, language exposure?

  • Ask your lab manager if the study is overlapping with other current studies-- make a plan for fairly splitting recruitment efforts for overlapping age ranges.

Surveys

For CDI, ask lab manager to create WebCDI study for you. Lab manager needs age parameters and study acronym to create the WebCDI study.

WebCDI links will be created by RAs for each individual subject that is confirmed for participation. WebCDI uses just the number part of the subject numbers for your study (i.e. "D999" turns into "999").

For other surveys to be completed by parents, they need to be approved by the IRB and then put on Qualtrics to be distributed via email. They also will need to be downloaded to the Offline App on the iPads.

Set up a participant data spreadsheet in the blab-share, in experimental_projects/[your study]. This spreadsheet should be password protected and contain the child's name, database RN, subject number for your study, parent contact info, birth date, and date of participation. Make sure there is a CONSISTENT and CLEAR subject number system.

Are there any conditions to assign participants to? If so, how and when should we distribute condition to make sure it's relatively even? Add a condition sheet to Current Studies and Condition Sheets.

Emails

Make sure you have access to bergelsonlab@fas.harvard.edu mailbox.

Check the drafts folder to see past examples of recruitment emails. You can either add your study to the list of acronyms tagged to a draft, or you can write a new recruiting email draft that describes the study--whichever choice is more appropriate for the type of study you have designed. These are the types of emails you need for your study:

  • Email to recruit for your study

    • e.g. "Hi parent! We are recruiting for a language study in the BLAB. This study is __# of visits and takes __ hours to complete..."

    • Description of what the family will do during visit

    • eligibility questions

  • Scheduling email with a link to the Acuity scheduling link for your study

  • Email to send parents immediately after they schedule an appointment to come in

    • e.g. "Hi parent! Thanks for scheduling your child for a visit. We'll call you the day before the visit to remind you..."

  • Email to send to parents the day before the visit

    • e.g. "Hi parent! This is an email to confirm your visit on date at time. You have the option to fill out the following questionnaires before your visit..."

    • Necessary attachments: consent form, surveys, driving directions to BLAB

    • For surveys (see above), either add the initials next to the other studies, if using emails we already have drafted, or create spaces for links to your surveys. See "Questionnaire 1; Questionnaire 2" in DSC draft box for examples.

Recruiting

Notify Lab Manager that study is ready for RAs to recruit participants. Specify:

  • Who should be present for lab visits (i.e. do you, the study initiator, want to be present for every visit, or can lab manager or other lab member run the study?)

  • You should recruit and run the first few participants personally, to make sure the entire pipeline is smooth

    • Do think about a backup plan. There should always be more than one person who is capable of running your study, even if you'd prefer to always be available for the visits. You might have a visit scheduled and then get suddenly injured or sick--the family is on their way and you're not around to run the visit.

    • Specify if you'll need an RA for each lab visit, and what you'd like them to do for the visits (i.e. go get participants from parking lot, complete informed consent)

BEFORE YOU EVER RUN A REAL BABY: test run your experiment, every single condition, to make sure the stimuli are appropriate and programmed correctly. This will prevent uncomfortable panic during study visits and having to throw away data because of a technical error.

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