SOP-M3
Recruitment and Advertising
- Number
- SOP-M3
- Category
- Module
- Edition
- Lean Edition 2.0
- Approx. pages
- 4
- Reference Edition source
- 300
[YELLOW] the site fills in. [DEFAULT: green] a value the site may keep or change.
On this page
1. Purpose
This module describes how [SITE NAME] plans recruitment, gets IRB approval for every participant-facing recruitment material, runs advertising, outreach, a research volunteer database and recruitment vendors, avoids undue influence, and reviews recruitment results.
2. Scope
Adopt this module only if [SITE NAME] recruits beyond the investigators' own patients, for example by advertising, social media, a website, letters, emails or texts, a research volunteer database, referral outreach or a recruitment vendor.
Out of scope and kept in the core: HIPAA pathways for record review, pre-screening conduct, the pre-screening log (F-300-01) and the rule on what may happen before IRB approval and before activation (SOP-05); consent (SOP-04); participant payments (SOP-10); staff compensation and conflicts of interest (SOP-02). Follow the protocol, sponsor or IRB requirement where it is stricter than this module.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Approves the study recruitment plan. Reviews site-written materials before IRB submission. Confirms methods do not coerce or unduly influence. |
| Site Director | Approves site-level advertising, website content, the volunteer database and vendor use. Reviews recruitment results across studies. |
| Regulatory Coordinator | Submits materials to the IRB, files approvals and keeps F-300-02 Recruitment Material Tracking Log. |
| Recruitment Specialist or CRC | Drafts the recruitment plan, runs outreach with approved materials only, manages the volunteer database and summarizes recruitment results. |
| Finance / Contracts Lead | Checks vendor and sponsor payment terms against 5.5 and 5.6. |
| Privacy Officer | Reviews paid recruitment communications for HIPAA marketing rules and the volunteer database agreement (SOP-12). |
| All Research Staff | Use only current IRB-approved materials. Do not offer or accept finder's fees. |
4. Definitions
| Term | Definition |
|---|---|
| Recruitment material | Anything intended to be seen or heard by potential participants to invite them into a study: ads, flyers, posters, scripts, emails, letters, texts, social media posts and paid ads, web and landing pages, videos and online questionnaires. |
| Research volunteer database | A site list of people who have agreed in writing to be contacted about future studies. |
| Finder's fee | A payment to a person, other than the site's sponsor-funded study budget, for referring or enrolling a specific individual (SOP-02, 5.8.8). Sponsor per-participant and milestone payments to the site under the clinical trial agreement are site revenue, not compensation to a person. |
| Recruitment vendor | A service provider engaged to advertise, collect leads, pre-screen or refer candidates. |
5. Procedure
5.1 Recruitment plan
5.1.1
Before activation, the Recruitment Specialist or CRC drafts a written recruitment plan for each study, and the PI approves it. The plan states:
- the sources (site patients, referring practices, volunteer database, advertising, vendors, sponsor campaigns)
- the materials needed and who produces them
- the HIPAA pathway for each records-based source, chosen under SOP-05
- the pre-screening questions and who asks them (SOP-05)
- languages needed and how non-English speakers will be consented (SOP-04)
- the access measures used for the population the protocol allows (5.7.2), or "none"
- the enrollment target and how progress is reviewed (5.8)
5.1.2
The plan is filed in the ISF or study recruitment file and updated when sources or materials change.
5.2 IRB approval of recruitment materials
5.2.1
Every recruitment material, whether written by the site, sponsor, CRO or vendor, has IRB approval before first use (21 CFR 56.111(a)(3); ICH E6(R3) Annex 1, 2.4). This includes study pages on the site's own website, social media posts and ads with their images and captions, emails, letters and texts to the site's own patients and database members, scripts and online questionnaires.
5.2.2
FDA guidance generally does not require IRB review of a basic study listing (title, purpose, summary, basic eligibility, location, contact), of communications to health care professionals only, or of news stories aimed at other audiences. The Regulatory Coordinator checks [CENTRAL IRB NAME] policy, because some IRBs require submission anyway.
5.2.3
Before submission, the PI reviews each site-written or site-modified material and confirms that it:
- does not state or imply the product is safe, effective, or equivalent or superior to other treatment
- does not call the product a "new treatment" or "new drug" without saying it is investigational
- does not promise "free medical treatment" (it may say study-related care is at no cost)
- states payment only as the IRB approved and does not emphasize it with larger or bold type
- promises no benefit beyond the protocol and consent form, and is accurate and readable for the audience
5.2.4
The Regulatory Coordinator submits each material in its exact final form (layout, images, audio or video; for digital ads each variant, caption and where it will run). A change to text, images or placement that changes the message is resubmitted before use. Formatting-only changes follow IRB policy.
5.2.5
The Regulatory Coordinator logs each material on F-300-02 with version, IRB approval date, where it is used and retirement date, and files the approved version in the ISF. Only materials on F-300-02 with a current approval are used.
5.2.6
When a study closes to enrollment, the Recruitment Specialist or CRC takes down its materials (web pages, ads, posters) within [DEFAULT: 5 business days] and records the retirement date on F-300-02.
5.3 Advertising and social media
5.3.1
Posts and ads run only from site-controlled accounts, with access limited to staff named by the Site Director.
5.3.2
The Recruitment Specialist disables public comments where the platform allows. Where it does not, the Recruitment Specialist checks comments [DEFAULT: each business day] while an ad runs and removes any comment that discloses a person's health information.
5.3.3
Staff answer comments and messages only with IRB-approved text or a general invitation to contact the site privately. Staff never give medical advice or discuss a person's eligibility in public.
5.3.4
Staff never post photos, names or stories of participants without the participant's written authorization and IRB approval.
5.3.5
If a sponsor or vendor pays the site to send recruitment communications to the site's own patients, the Privacy Officer reviews the communication before use, because HIPAA marketing rules may require patient authorization (45 CFR 164.501 and 164.508(a)(3)).
5.4 Outreach and the research volunteer database
5.4.1
Staff contact people identified from records only by the IRB-approved method (letter, call or message from the treating provider or the study team). Where the IRB requires the treating provider to make first contact, the study team waits until the provider has done so or the patient asks to be contacted.
5.4.2
The Recruitment Specialist adds a person to the volunteer database only with the person's written or electronic agreement to be contacted, which states what is kept, how it is used and how to be removed, and records the agreement date.
5.4.3
Staff search the database only for studies with an approved recruitment plan and contact members only with IRB-approved materials.
5.4.4
Staff remove a person who opts out within [DEFAULT: 5 business days] and record the removal.
5.4.5
Before an automated call or text campaign to mobile numbers, the Site Director confirms the site's consent language and any vendor's compliance with the Telephone Consumer Protection Act (47 U.S.C. 227). Outreach follows each person's stated contact preferences.
5.4.6
When the site uses an external registry or referral platform, staff follow its terms and the recruitment plan and record the source on F-300-01 (SOP-05).
5.5 Incentives and undue influence
5.5.1
Finder's fees, staff incentives and performance pay follow SOP-02, 5.8.8. Recruitment materials, vendor contracts and referral arrangements must not create such a payment.
5.5.2
Participants are not offered payments or gifts for referring others unless the IRB approved the specific incentive in advance.
5.5.3
Sponsor-funded recruitment bonuses or enrollment milestone payments to the site are reviewed under SOP-M2 (or by the Site Director where SOP-M2 is not adopted) and disclosed to the IRB where IRB policy requires.
5.6 Recruitment vendors
5.6.1
The site engages a recruitment vendor only after qualification and a written agreement under SOP-M1, recorded on F-105-01. The agreement covers HIPAA status (a business associate agreement where the vendor handles PHI for a covered entity), data security, return or destruction of data, and use of IRB-approved materials only.
5.6.2
The Finance / Contracts Lead confirms the vendor's fee is for services (flat fee or fee per activity) and is not a payment per referred or enrolled individual.
5.6.3
Vendor materials, landing pages and questionnaires go through 5.2 before use. Vendor referrals are logged on F-300-01 with the vendor as the source.
5.6.4
Sponsor-contracted vendors are overseen by the sponsor. The site still confirms that the materials the candidate saw are IRB-approved for the site and records the referral source.
5.6.5
The Recruitment Specialist or CRC reviews vendor referrals and complaints at each recruitment review (5.8.1) and reports problems to the Site Director. Vendor issues are logged on F-105-01 (SOP-M1).
5.7 Reaching the intended population
5.7.1
Candidates are not excluded for language, literacy or disability unless the protocol requires it (SOP-05).
5.7.2
The recruitment plan records the access measures the site will use where feasible, for example outreach through practices and community organizations serving the affected population, IRB-approved translated materials, visit hours, transport and reimbursement (SOP-10), remote options the protocol allows (SOP-M4), and plain-language materials.
5.7.3
Staff collect demographic information before consent only if the IRB-approved questionnaire includes it, and report it to sponsors only in aggregate unless the IRB approved otherwise.
5.8 Reviewing recruitment results
5.8.1
For each enrolling study, the Recruitment Specialist or CRC summarizes F-300-01 for each PI oversight note (SOP-02, 5.6.3) and when the PI or Site Director asks: candidates by source, referred for consent, screened, enrolled and main reasons for not proceeding.
5.8.2
The PI and Site Director review the summary against the plan and decide on changes (new materials, new sources, closing a source). New or changed materials go through 5.2.
5.8.3
Sponsor requests for recruitment data are answered with aggregate counts from the summary. The log itself is released only under SOP-05.
5.8.4
Complaints about recruitment conduct (for example unwanted contact or a misleading ad) are recorded and sent to the Quality Lead the same business day, who decides whether a deviation or CAPA (SOP-08) or a privacy incident (SOP-12, F-400-01) is needed. Reportable events go to the IRB per its policy.
6. Related Forms and SOPs
- F-300-02 Recruitment Material Tracking Log
- F-300-01 Pre-Screening Log
- F-105-01 Service Provider Qualification and Oversight Record
- F-400-01 Privacy Incident Report
- SOP-02 Roles, PI Oversight, Delegation and Conflicts of Interest
- SOP-04 Informed Consent
- SOP-05 Pre-Screening, Screening, Eligibility, Randomization and Blinding
- SOP-08 Protocol Deviations and CAPA
- SOP-10 Participant Retention, Withdrawal and Payments
- SOP-12 Privacy, Electronic Systems and Record Retention
- SOP-M1 Service Providers and Vendors
- SOP-M2 Feasibility, Contracts, Budgets and Research Billing
- SOP-M4 Decentralized Trial Elements
7. References
| Reference | Title |
|---|---|
| 21 CFR 50 | Protection of Human Subjects |
| 21 CFR 56.111(a)(3) | IRB approval criteria: equitable selection of subjects |
| ICH E6(R3) Annex 1, 2.4 | Communication with IRB/IEC (approval of recruitment procedures) |
| ICH E6(R3) Appendix C | Essential records (advertisements for participant recruitment) |
| 45 CFR 164.501 and 164.508 | HIPAA marketing; uses and disclosures requiring authorization |
| 47 U.S.C. 227 | Telephone Consumer Protection Act |
| FDA Guidance (1998) | Recruiting Study Subjects: Guidance for Institutional Review Boards and Clinical Investigators |
| FDA Guidance (Jan 2018) | Payment and Reimbursement to Research Subjects |
Independent Site SOP Library. Licensed CC BY-NC 4.0 by the American Institute for Medical Research (AIMR), with added permission for any site's internal use (license terms). Not legal advice: each adopting site confirms state law, IRB and sponsor requirements with its own counsel and owns every step it approves.