Human Subject Incentive Program SSN Policy FAQs

Policy link: HSIP SSN collection Policy

1. What is changing?
   • Previous policy mandated collecting SSNs from participants if their potential total payment from a single-study could exceed $100 in a calendar year. The updated policy makes two changes to this rule: 1) increases the dollar amount threshold to $400 in a calendar year; and 2) requires gathering SSNs based on a participant's annual total earnings from all studies, not just one study. 
   • In addition, the current tier structure is going away. Studies will now fall into two tiers: payments up to $400, and payments over $400. For studies potentially paying over $400 in a calendar year, SSNs must be collected before the initial payment.
2. Why is this change happening?
   • The policy change is happening to streamline the process for collecting study participant information, ensuring better tracking and compliance with federal IRS payment reporting requirements.  This shift aims to standardize the SSN collection process when participant compensation reaches or exceeds a certain threshold ($401 or more) regardless of individual study payments. 
   • This change will also create more flexibility in participant recruitment and remove the administrative burden of collecting and storing SSNs for many studies.
3. How will this affect new studies?
   • After June 1, 2024 New studies will be expected to follow the new tier system. This should cause minimal to no disruption as prior requirements of collecting a payee's name and address remain the same.
   • All new studies will need to include language in the informed consent document informing participants of the requirement around providing their SSN.
4. How will this affect existing studies?
   • After June 1, 2024 existing studies will be migrated to the new tier system over the next 12 months when appropriate. This is expected to have minimal disruption and will relax the data collection requirements for many studies, removing the need to collect SSN from all payees and only collecting when an individual has been compensated more than $400 or the study is designated as Tier B.
   • Existing studies may need to re-consent participants informing them of the requirement to provide a SSN if they are compensated more then $400
   • Existing studies with Tier 2 designation or exemptions from collecting certain information will need to reach out to the HSIP office to revisit their exemptions to determine if the exemptions are still appropriate.
5. How will new and existing studies be supported in transitioning to this new policy, and what resources are available to assist with compliance?
   • The HSIP team will be available to answer questions and provide guidance. HSIP will contact studies teams if they identify a payment that pushes a participant over the $400 threshold. HSIP can be contacted at [email protected].
   • The IRB will adjust all current studies to the new tier system and facilitate  amendments to informed consent docs via standard methods.
6. What steps should a study team take if a participant is approaching the $401 threshold?
   • The study for which the participant is currently seeking to receive payment when reaching this threshold is responsible for collecting the SSN to enable any payment that places the participant’s total payment during a calendar year at $401 or more.
   • When a participant's yearly earnings from studies hit $300, HSIP will alert the Principal Investigator and Payment Requestor of the last study paid. This notice informs the team that exceeding $400 in annual compensation requires the participant's SSN. The notice can prompt early SSN collection by the study team, which is highly recommended before payments reach $400.
7. What should a study team do if they become aware of non-compliance with this policy?
   • Study teams are strongly encouraged to track participant payments when study teams are disbursing multiple payments directly to participants and they have received a notification from HSIP that a study participant is close to the $400 limit to ensure compliance and inform participants about SSN submission requirements for future paid research participation.
   • If a study team becomes aware of non-compliance with one of its participants, then they should inform HSIP office and inform the the research participants they can either:
     • Provide their SSN to continue to receive payments
     • Or decline to provide their SSN and forego any future payments for the calendar year. 
   • Non-adherence to these guidelines may result in the HSIP Office notifying the Director of the Human Research Protection Program.
   • If a participant withdraws consent due to unwillingness to provide their SSN for payment, the study team should file an ORIO report with the IRB.
   • HSIP monitors and  conducts weekly audits of participant payments and will notify research teams of any issues it identifies.
8. What is considered non-compliance with this policy?
   • Non compliance exists when a study team fails to collect required information for payments that are distributed. For Tier A Studies this is name, address, payment amount and payment date. For Tier B studies this is name, address, SSN, payment amount and payment date.
     • If a participant refuses to provide information i.e. name and address a study team can document that refusal to demonstrate efforts to comply with the policy.
     • When a participant has been compensated more than $400 in a calendar year regardless of study Tier assignment, all information is mandatory for that participant and study teams are expected to collect this information before distributing compensation to avoid non-compliance.
   • Non-compliance is evaluated holistically, with a focus on patterns or systemic issues in following payment policies rather than isolated incidents.
9. In case of policy non-compliance, how can a study team regain the ability to distribute payments directly to participants?
   • Study teams must show they can adhere to the policy effectively. If participants refuse to share specific information, documenting attempts by study groups to gather the required information will be considered compliant and can result in reinstating the ability to distribute payments directly to participants. 
10. How should a study team handle participant consent and payment if the participant does not have an SSN?
    • If a participant does not have a SSN to provide and is residing in the United States, they should be paid through payroll and not through HSIP. If there are questions please contact [email protected] for help in determining what is appropriate.
11. Are there any special considerations or alternative procedures for sensitive studies that involve vulnerable populations?
    • Requests for exceptions to this policy should be submitted in advance of payment distribution to the HSIP Office. Decisions regarding exceptions for sensitive studies will be made in collaboration between the HSIP Office, the IRB, Tax Office and the Human Research Protection Program, ensuring compliance with federal regulations in both domains.
12. Do I need to update the informed consent document?
    • Informed consent documents must clearly state that participants must provide the University their TIN or SSN for payment if they earn $401 or more within a calendar year from research participation. If participants have received $400 from the University in one year for research participation but refuse to provide their TIN or SSN, they can still join studies but won't be paid for any participation for the rest of that year. 
13. What are the implications for a participant if they choose not to provide their SSN after reaching the $401 threshold?
    • If the participant fails to provide their SSN to receive payment, the participant can (1) decline to give their SSN and not be paid or; (2) decline to give the SSN and be paid only up to the $400 threshold in the calendar year.
14. Can a participant retract their SSN after they have provided it, and what would be the consequences?
    • HSIP is unable to remove SSNs from UM systems once they have been submitted. 
15. Can I delete SSN once I’ve submitted it to the HSIP system?
    • Study teams should store the payment information collected until they receive an email notification their HSIP request has been completed. Once study teams receive this notification HSIP has received payment information, they can delete payment information which may include a SSN.
16. What is the role of the Principal Investigator in ensuring compliance with the new policy?
    • SPG 501.07 states financial management is in the hands of the PI’s and with their study teams. The PI should understand the financial authority and obligations related to Human Subject Payments.
17. What are the potential consequences for the University if IRS penalties are applied due to non-compliance with this policy?
    • When the University does not issue a 1099 to participants paid $600 or more in a calendar year, IRS penalties could be applied to the University and the research participant.  Further, when a study team fails to collect a SSN when required by IRS regulations and the research is federally funded, the study is in breach of terms requiring adherence to applicable laws and requirements (2 CFR Part 200.300­ & 2 CFR 200.303). The study team has a responsibility as stewards of University and federal funds to minimize the possibility that the University is subjected to any IRS penalties and adhere to contractual terms of federal grants.