A trained staff member should do the health pre screening, by phone, and the text should only handle logistics from a fixed script that the IRB has approved. A survey in GoHighLevel can ask non clinical questions, filter out people who obviously do not qualify, and book a screening visit, and it should not use a free form AI bot. The bottom line: recruitment messages count as part of the consent process, so who says what, and in what words, is regulated.
What regulators and IRBs say
An FDA information sheet on recruiting study subjects says FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process, that advertisements should be reviewed and approved by the IRB, and that no claims should be made that the product is safe or effective for the purpose under investigation. A University of California San Diego procedure says recruitment materials, including telephone scripts, must be approved by the IRB before use, that recruitment and pre screening may not begin until IRB approval, and that verbal or written informed consent must be obtained before any screening test done solely to decide eligibility. Castle IRB's guidance says materials should say the study is research, not treatment, list age limits or other qualifications, the time commitment, any compensation without overemphasis, and the investigator or site, and that the person answering calls should know the study, not be a general operator.
Institutions differ on texting. The University of Pennsylvania's IRB guidance says Penn Medicine does not allow texting for recruitment of patients because it is not HIPAA secure, and that exceptions need a rationale. Check your sponsor's, your IRB's, and any institution's rules before you build.
Who does what
| Task | Who |
|---|---|
| Non clinical questions: age range, ZIP code, best time to call | IRB approved text and survey |
| Health eligibility questions | Trained coordinator, by phone, using the approved script |
| Explaining the study and consent | Site staff at the screening visit |
| Answering medical questions | Investigator or qualified clinician |
| Booking the screening visit | Calendar link in an approved message |
GoHighLevel's support portal says accounts are not HIPAA compliant by default and that HIPAA is an optional US$297 per month add on with a business associate agreement. Ask your sponsor and counsel whether it is needed.
Build it in GoHighLevel
- Get the recruitment text and survey wording approved by your IRB first.
- Build a survey or form with fixed questions only: age range, ZIP code, and permission for a coordinator to call. Do not use a free form AI bot.
- Use Conditional Logic with a Disqualify rule for answers outside the approved range, and a Message rule that thanks them and points to the site's study list. GoHighLevel's help page lists Redirect, Message, Disqualify, and Show/Hide as the actions.
- Build a workflow with the form submitted trigger that creates a task for the coordinator to call within one business day.
- After the phone pre screen, send the calendar link for the screening visit from the workflow, using the approved wording.
- Add reminders 2 days and 1 day before the screening visit, and a note on what to bring.
- Turn on Stop on Response and set a Time Window.
A third party setup guide notes that forms fire one workflow trigger and surveys fire a separate one, and that a trigger with no form selected fires for every form, so select the exact form.
What the workload looks like
For example, if 100 people respond to a recruitment text and a coordinator needs about 10 minutes per call, that is about 17 hours of calls (100 times 10 divided by 60 is 16.7). If the survey removes the 30 percent who are outside the age range or ZIP area, that is 70 calls, about 12 hours, and the coordinator's time goes to people who might qualify.
Mistakes to avoid
- Texting before IRB approval. Pre screening may not begin until approval.
- Letting a bot answer health questions. Use trained staff.
- Calling a trial a treatment. Materials should say research.
- Overemphasizing payment. Castle IRB advises against it.
How this was handled before
Research sites recruited through referring physicians, flyers, and phone screening lines staffed by coordinators. The phone line kept clinical judgment with trained people. Text and web forms add reach and speed, and they add the same regulatory review, so the tool has to stay inside what the IRB approved.
Check before you switch it on
US text messages sent from a standard 10 digit number need A2P 10DLC registration. The HighLevel support portal says registration is required for texts to US recipients from 10 digit long code numbers and that toll free numbers do not require it. HighLevel's opt in guidelines also say a person cannot be forced to agree to text messages in order to submit a form, so keep the consent box optional. One compliance guide separates informational texts, which need documented consent, from marketing texts, which need prior express written consent. Ask your attorney which category your reminders fall into. Prospective volunteers may not have agreed to texts, so use the consent language your IRB approved. This is general information, not legal advice.
Questions people ask
Can a text pre screen volunteers?
It can handle non clinical logistics from an IRB approved script. Health pre screening belongs with a trained coordinator.
Does recruitment need IRB approval?
FDA says direct advertising is the start of consent and selection, and IRBs review and approve recruitment materials, including telephone scripts, before use.
Is GoHighLevel HIPAA compliant?
Not by default. Its support portal describes an optional US$297 per month HIPAA add on.
Ready to try it yourself? Start a GoHighLevel account here.
You can also see this in action in our GoHighLevel capabilities demo.