The IRB reviews the recruitment process for all research protocols that require IRB approval. The IRB will evaluate the setting and purpose of the research protocol to ensure that the process for recruiting participants is appropriate and free from coercion and undue influence (45 CFR 46.111, 21 CFR 56.111). The IRB will give special attention to protocols recruiting vulnerable populations to ensure additional protections are in place to protect the participants.
The IRB also reviews recruitment materials for all research protocols. This includes phone scripts, flyers, digital advertisements and videos. Recruitment materials must contain enough information to give potential participants a sense of the study and the ability to determine whether they may be eligible to participate.
Recruitment material(s) must include:
- Must describe the study as a “Brown University research study”
- The name and Brown contact information of the investigator or a member of the research team knowledgeable about the research and research procedures
- The study protocol number
- The condition under study or the purpose of the research
- The information needed for someone to determine their interest in and possible eligibility for participation
- A brief list of participation benefits, if any (e.g., a no-cost health exam)
- The time or other commitment required of the participants
- Location of research activities
Recruitment material(s) should not include:
- A statement or imply a certainty of favorable outcome or other benefits not listed as part of the study
- A statement or imply that the procedures are equivalent or superior to practices or procedures outside of the research context
- Description of procedures as “new” or “safe” without highlighting that the procedures are investigational
- A promise of free treatment
- An emphasis on the payment or amount to be paid
- Exculpatory language
For FDA regulated studies, recruitment materials also should not include:
- Claims, either explicitly or implicitly, that the drug, biologic, or device is safe or effective for the purposes under investigation
- Claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic, or device
- Terms, such as new treatment, new medication, or new drug without explaining that the test article is investigational
- Promise a coupon good for a discount on the purchase price of the product once it has been approved for marketing
Solicitations through [email protected] for human subjects research recruitment are permitted for Brown research faculty if the study is supported by sponsored funding and has Brown IRB/HRPP approval to use this recruitment procedure.
When requesting to use this recruitment process, researchers must adhere to the approval criteria laid out in the Policy on the Recruitment of Human Subjects Research Participants. The recruitment material must include the subject line that will be used in the [email protected] posting as well as the full text to be used in the advertisement. The subject line may not feature or highlight any study compensation.
After approval by the IRB/HRPP, researchers who wish to use [email protected] must:
obtain a letter from the Brown HRPP affirming that the Brown IRB/HRPP has approved the use of [email protected] as a recruitment tool for a specific study; and
The following types of research are excluded from this opportunity:
Research under a reliance agreement (i.e., IRB Authorization Agreements [IAA]) in which Brown relinquishes IRB oversight
Crowdsourcing is frequently used to recruit for human subjects research studies. All recruitment material used for crowdsourcing must follow Brown’s Policy on the Recruitment of Subjects Research Participants.
Can I use crowdsourcing to recruit for my human subjects research studies at Brown?
Yes. However, if crowdsourcing does not allow you to provide prospective participants with recruitment material that meets the IRB’s approval requirements, you may use teaser ads. However, these teaser ads must include a link to an external landing page that contains all of the required recruitment information that volunteers will need to determine if they are interested in continuing on to the consent process.
Per Brown’s recruitment policy, teaser ads may not transfer prospective participants directly to a consent process.
If crowdsourcing does not allow the IRB/HRPP to review and approve recruitment material, it may not be used for human subjects research studies at Brown.
Can I use crowdsourcing to collect data for my human subjects research studies at Brown?
It depends. The Brown University’s Computing & Information Services (CIS) is responsible for determining which software and services are available for Brown human subjects research. At this time, CIS has approved very few crowdsourcing platforms to collect information about participants. This means that most crowdsourcing platforms have not undergone a successful vetting** of security and contract review by Brown, unless specifically requested by a PI.
We strongly encourage your crowdsourcing recruitment material to direct prospective participants to a Brown data collection platform, like Qualtrics, in order to consent participants and conduct human subjects research activities.
If it is an important part your research design to collect participant information from a crowdsourcing platform that CIS has not yet vetted, the platform will require an ancillary Data Security Review by CIS. This review will not delay IRB/HRPP review or approval of your research, but it may delay implementation of your IRB/HRPP-approved procedures.
**Please visit the CIS Software Catalog for more information.
Can I use crowdsourcing to compensate participants for my human subjects research studies at Brown?
It depends. The Brown University’s Controller’s Office is responsible for ensuring the proper stewardship of the University’s financial resources. The IRB/HRPP relies on the Controller’s Office to determine which forms of compensation comply with federal and State laws, and University policy. Only these forms of compensation are available to you for human subjects research.
We strongly encourage you to design your study using one of the compensation methods approved by the Controller’s Office. If you intend to use a method of compensation that is not approved, you will need to contact Accounts Payable ([email protected] or (401) 863-2716) for consultation and approval for its use before including the compensation in your IRB/HRPP Application.
**Please visit the HRPP Compensation page for more information.
Yes, there may be, and these concerns can vary depending on the type of crowdsourcing and/or research you conduct. This is why CIS has approved so few crowdsourcing platforms for data collection.
Do I need to add special confidentiality language to my consent document when I use crowdsourcing to collect data?
Yes. Required consent language specific to IRB/HRPP-approved crowdsourcing is available in the Additional Consent Language Guidance documents on the HRPP website.
This language should be added to the confidentiality section of your consent document.
- Standard Consent Template: “7. How will my information be protected?”
- Bulleted Consent Template: “Confidentiality”
What are some examples of crowdsourcing platforms approved by CIS?
MTurk, is a virtual crowdsourcing marketplace owned by Amazon that enables various entities, or Requesters, to outsource tasks and procedures, or HITs, to distributed Workers who seek out and virtually complete the HITs via the MTurk website.
An overview of MTurk is available on Amazon through an Introduction to Amazon Mechanical Turk. Here you can also learn the glossary of terms and Concepts used in MTurk (i.e. Requester, HIT, and Worker).
More information about MTurk can be found in the Amazon Mechanical Turk Getting Started Guide and MTurk’s FAQs. You can also find helpful tips using the Customizable Templates for MTurk Requester Projects.
At this time:
- CIS has approved MTurk for Risk Level 1 studies for recruitment and data collection.
- Controller’s Office has not approved MTurk for compensation.
Centiment is a research platform to build advanced surveys and reach targeted audiences. Centiment allows its platform to be used for recruitment, data collection purposes, and/or participant payment purposes.
At this time:
- CIS has approved Centiment for Risk Level 2 studies for recruitment only.
- Controller’s Office has not approved Centiment for compensation.
CloudResearch is a recruitment platform intended to gather participants from the MTurk population based on your IRB/HRPP-approved eligibility criteria. Centiment allows its platform to be used for recruitment, data collection purposes, and/or participant payment purposes.
At this time:
- CIS has approved CloudResearch for Risk Level 1 studies for recruitment only.
- Controller’s Office has not approved CloudResearch for compensation.
Prolific is a British-based company registered in England and Wales. This platform will pre-screen prospective participants based on your study’s IRB/HRPP-approved eligibility criteria. Prolific allows its platform to be used for recruitment, data collection purposes, and/or participant payment purposes.
At this time:
- CIS has approved Prolific for Risk Level 1 studies for recruitment only.
- Controller’s Office has not approved Prolific for compensation.
For additional information regarding Brown’s recruitment requirements, please review our “Policy on the Recruitment of Subjects Research Participants.”
What is a Research Subject Pool?
By joining a “subject pool,” a person identifies themself as being willing to participate in research. Joining the subject pool does not mean they have consented to participate in a research study, since they have not yet been provided with sufficient information concerning the exact study in which they might participate. Until they go through a consent process (unless that process is not appropriate for the study or waived according to federal regulations), a member of a subject pool is not a participant in a research study. All subject pool members are free to decline participation in any research study at any time without penalty.
Does Brown have a subject pool?
Yes. Many Brown departments and labs have chosen to set up subject pools.
Do human subjects research studies using the subject pool need HRPP/IRB review?
Yes. All human subjects research studies must have HRPP/IRB approval to use the subject pool for recruitment.
All recruitment material must meet the requirements for approval as described in the HRPP Policy on the Recruitment of Research Participants, and include:
- protocol number
- first name (at a minimum) of the PI or a member of the research team
- “(PAID)” OR “(CREDIT)” after the study title – REQUIRED ONLY for CLPS studies using the Research Participation System (“Sona System”)
Can any human subjects research study use a subject pool?
No. Research under an IRB Authorization Agreement (IAA) in which Brown relinquishes IRB oversight cannot use subject pools for recruitment.
Can I use [email protected] to recruit people for my study conducted through one of Brown’s subject pools?
Yes. Use of [email protected] is allowed for Brown research faculty if the study is supported by sponsored funding (including Brown internal sponsored funding, e.g., Office of the Vice President for Research Seed and Salomon awards) and has Brown IRB/HRPP approval to use this recruitment procedure.
Brown’s subject pool administrators should work with University Communications to advertise for volunteers. As long as the administrators are seeking volunteers to join the subject pool and not prospective participants for research studies, they do not need IRB/HRPP approval to use [email protected].
What type of compensation can I provide using a subject pool?
Compensation for study participation in the subject pool may be in the form of cash, gift cards, or Brown course credit.
Although you can use a variety of payment options through a subject pool, you may not combine them. You must decide whether compensation will be monetary or course credit, and this must be clearly reflected in your recruitment material.
Can professors require that students participate in research as part of their class or for a grade?
No. By federal law, research participation can only be voluntary. Federal regulations require that all human subjects research minimize the possibility of coercion and undue influence. Whenever research participation is a course requirement, or when extra credit or course credits are offered for participation, students must be informed of non-research alternatives involving comparable time and effort to fulfill the course requirements or obtain the credit in order for the possibility of undue influence to be minimized. Students cannot be penalized for refusing to participate in research.
Can extra credit and course credit constitute undue influence?
Yes, in certain circumstances. Non-monetary incentives can create undue influence on a person’s decision to enroll in research.
Researchers should ensure that non-financial incentives are not so great that they reduce a person’s voluntariness to consent to participation or their ability to appreciate the potential risks involved.
To avoid undue influence over students, when faculty offer extra credit or course credit through research, another non-research opportunity to earn that credit must be provided concurrently. Research participation may not be the only avenue for students to earn that credit in a course. So to, the non-research alternative must be comparable to the time and effort expected in the research study. It must be clear that choosing not to participate in research will not in any way adversely affect a student’s relationship with Brown, their professors, teaching assistants, or peers.
What options do professors have as an alternative to research participation for students to earn credit?
Faculty are encouraged to work directly with subject pool administrators to ensure that their non-research alternative options and research studies are equitable.
Examples of non-research alternatives that might take roughly the same amount of time and effort as research participation:
- reading journal articles or empirical papers and answering questions
- writing a 1-2 page paper about comparable research
- attending colloquia
What should I do if a participant withdraws or if I need to terminate the session without completing the study procedures?
Enrolling in a research study is voluntary. Every participant is allowed to withdraw from a study at any time during the research. So too, you might need to terminate a study session for reasons that have nothing to do with the research or if the participant is not following the terms of the study.
If a participant withdraws during a study procedure or if you terminate the study session, you must provide the participant with the full compensation (monetary or course credit) for that session, as listed in the compensation section of the consent document.
If the participant withdraws (i.e., cancels appointment or does not appear for the appointment), you do not need to compensate the participant for that session.
Can I use a subject pool if my human subjects research involves deception?
Yes, but you are encouraged to use a debriefing process if appropriate for your study design. This debriefing process should occur within a reasonable amount of time after the participant has completed the study procedures or when the study is over. During this process, participants must be told about the nature of the deception and, if the data is identifiable, you should ask permission for continued used of the data.
At this time, the following recruitment methods or services are not allowed for human subjects research studies, as determined by the IRB:
Lucid survey sampling service – As part of their service, Lucid creates marketing material. However, the company does not share their material with the customer (the PI and Brown University) for review or approval before use with prospective participants. Since the IRB must review and approve all recruitment materials prior to their use, Lucid may not be used for recruitment of prospective participants in human subjects research studies at Brown.
For additional information regarding Brown’s recruitment requirements, please visit our IRB Guidance & Policies page and review our “Policy on the Recruitment of Research Participants.”