GLOBAL HUMAN SUBJECT USE & COMPLEXITIES OF PAYMENTS

Joseph M. SmithManager – Research Compliance Office

Division of ResearchUniversity of Maryland College Park

Rebecca HunsakerAssistant Director – Research Administration

College of Behavioral & Social SciencesUniversity of Maryland College Park

Problems

o Current Tax Requiremento The IRS Code requires that payments to a U.S. citizen or permanent resident

for participation in a research study be reported if a subject is paid $600 or more during a year; the amount paid and the name, address, and SSN of the subject must be reported. 26 USC § 6041(a). (But note that all payments made to non-resident aliens must be reported to the IRS on a different form.)

o Collection of Names, Addresses, and SSN o Different practices/requirements to provide compensation to participants

o Any amount of compensation (including food)o Arbitrary amount such as $50 or $200o Maximum of $600

o Risk Assessmento Penalty for breaching participant confidentiality by placing them at unnecessary risk v.

penalty for not generating a 1099 for $600.

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Problems

o Risk Creationo The current policy of collecting SSNs for $100 is creating risk. Tracking participants by

their SSN across any number of studies in which they have participated, increases the potential risk of breach of confidentiality. This is especially true for participants who do not have identifiable information collected as a condition of their participation in a research project.

o Contradictoryo Investigators design their projects to minimize risk to participants. In some cases, their

risk minimization techniques include designing data collection methods that do not require identifiable participant information.

o If, when receiving compensation, these participants are then required to provide identifiable information, this contradicts the basic principal of minimizing risk to human research participants.

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Problems

o Potential for Inaccurate Resultso Current practices may lead to lower participant retention and recruitment

rates for studies leading to potentially skewed or inaccurate results . o It has been reported that participants will provide false information as they

wish to participate and receive compensation, but do not wish to provide their Name, Address and SSN.

o Potential Effect on Fundingo The current threshold and requirement also places an unnecessary administrative

burden on our investigators by requiring them to collect information they would not normally request.

o Moreover, investigators must develop additional measures to further protect confidentiality. This added burden, as well as the potential for skewed or inaccurate results, may hamper the institution’s success in acquiring and maintaining research funding.

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Problems

o It can be argued that some current practices contradict the Belmont Report: o Current participant compensation practice limits the research populations

willing to participate in research o Violates the basic ethical principal of Justice in the Belmont Report as the

risks of the research would then not be distributed evenly across eligible populations.

o Some populations would be unable to participate or receive compensation due to this policy as providing this information (Name, Address, SSN) would place them at additional risk o For example: Special Forces Units, Undercover Law Enforcement,

Transient Populations (drug users, homeless, etc.)

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Belmont Report

• 1979 Belmont Report– Identifies the basic ethical principles that should

underlie the conduct of biomedical and behavioral research involving human subjects:• Respect for Persons• Beneficence • Justice

Belmont Report

Ethical Principle #1 – Respect for Personso Treat individuals as autonomous agentso Protect persons with reduced autonomy

IRB Requirementso Investigators obtain participants voluntary consento Privacy and confidentiality are protected

Belmont Report

Ethical Principle #2 – Beneficenceo Two general rules have been formulated as complementary

expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

IRB Requirementso Risks of research are justified by potential benefits (risk : benefit)o Study is designed to minimize riskso Adequate data and safety monitoringo Conflicts of Interest are managed appropriately

Belmont Report

Ethical Principle #3 – Justiceo Distribute the risks and potential benefits of

research equally among those who may benefit from the research.

IRB Requirements o Vulnerable subjects are not targeted for convenienceo Vulnerable populations recruited are adequately protectedo Subject selection is equitableo Population exclusion is justified

How Do We Fix This?

o Regulatory Oversight o Governmental/Federal

o Institutional Review Board (IRB)o Institutional

o Informed Consento Individual/Investigator

Institutional Review Board

o Reviews amount of compensation to ensure it is not coerciveo Accounts for amount of time participatingo Pro-rated payments available for larger amounts and multiple visits. Participation is voluntary and

participants may drop out prior to completing the study

o Reviews measures in place to minimize risko Social Behavioral Research – risk of potential breach of confidentiality is common and in many cases

the only risk.o Implementing measures to minimize this risk allow for further protection of our human subjects.

o Collection of names, address, and Social Security Numbers for paymentso Many of our studies collect no identifiable information, but previous practice required collection of

name, address, and SSN no matter what amount of compensation. This included participants receiving complimentary snacks and drinks.

o Collection of this information places participants at unnecessary risk for breach of confidentiality. It requires identifiable information about participants to be sent to individuals unrelated to conducting the study.

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Solution

o Set $600 (at once or total) as the new threshold o Create Consent Form language and Individual Receipt

Form for all studies participant payments. o Allow participants to self-report in Consent Form

o Do you expect to earn $600 or more from participating in research studies over the course of this year?

o Response triggers which Receipt Form to use.o Participants can also choose to participate and

not be compensated

Solution

o $600 and Overo To manage/mitigate potential risk, a limit of $600 is

proposed. In the unlikely event that a participant will earn over $600 in a calendar year participating in studies, the following will be implemented:

o If earning over $600 in one study, they must be told up front that name, address and SSN will be collected in order to participate and receive compensation.

o Participants can participate without receiving payment if they do not wish to provide identifying information.

Solution

Any amount of compensation:

o Consent Form Language - Monetary or other compensation: A statement describing the amount and types of compensation and clearly specifying the requirements to earn them.

o Example: “You will be responsible for any taxes assessed on the compensation. If you expect to earn over $600 as a research participant in UMCP studies in this calendar year you must provide your name, address and SSN to receive compensation for your participation. If you do not expect to earn over $600 as a research participant in UMCP studies in this calendar year, this information will not be collected.”

o Consistency: Individual Receipt Forms for Under $600 as well as $600 and Over have been developed to allow investigators to collect this information when required.

Benefits

o Researcherso Raising the reporting threshold will likely result in a participant recruitment pool that is more

representative (typical) of the general population and increases the likelihood of achieving target enrollment numbers for gender and ethnicity.

o The increased participant and recruitment rate will likely increase the dissemination of the research findings through peer-reviewed publications and national and international research conferences.

o The process of obtaining Informed Consent will be simplified. Research assistants can focus on the risk/benefits of the protocol and not on how confidential information will be released for the purpose of payment and tax reporting.

o The administrative burden on the PI and the research team to document exceptions or deviations to the policy when SSN is not available will be eliminated.

o Institution – Central Office Organizationso Eliminates the need for UMD employees not directly involved in the research from having to sign

confidentiality statements and receive responsible conduct of research training.o Minimizes the secure file storage space needed for records retention

On the Horizon

o Improve research capabilities by identifying alternatives to cash paymentso Suggestions?o Success stories?

o Minimize administrative burden/potential for theft without increasing risk to participants.o Raffleso Gift Cards (physical or online)o Amazon Mechanical Turko PayPal (or similar online payment)

o Allows for ease of compensating international participants

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Other Practiceso University of Texas at Austin

o Do not require investigators to obtain the SSN of participants who receive compensation for participating in a research study, unless earning $450 or more.

o Language is included in the consent form that explains the reporting requirements: “[If monetary gifts or gift cards are used include the statement “You will be responsible for any taxes assessed on the compensation.”]”

o Ohio State Universityo For all U.S. citizens and residents, SSN is not collected for any research study under $500 of total compensation.o For any nonresident aliens, address and/or SSN is collected for all research with a compensation amount of $100

and above.o An exception to these requirements may be granted if the study is of a highly sensitive nature and a Certificate of

Confidentiality has been secured from the Department of Health and Human Services. If the exception results in any IRS tax liabilities, these amounts will be charged to the PI’s college.

o University of Michigano Collects SSNs for some research participants based on what “tier” level the project is given. A “tier” is determined

by the risk of the study and the compensation amount.o Michigan has an official audit system in place- if amount hits or exceeds $600.00, participants are automatically sent

a Form 1099-MISC. o All personal identifiers collected for payment are stored in a central secure location. Investigators are told not to

keep this information in their location due to its sensitive nature.

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Other Practices

o University of Delawareo Matters of compensation are processed on a case by case basis in compliance with the different

funding sources, the IRS, and UD’s institutional policies. o In general, UD does not recommend the collection of private information unless needed to comply

with such requirements and regulations. o In many cases, a signed receipt by the participant is requested at the time of payment

o University of North Carolinao Collects SSNs for all participants for payments over $200 in a calendar year and for all participants

who receive payments in check form regardless of amount.o If the SSN is required solely for tax identification, the subject must be informed that (s)he has the

right to renounce any research payment and consequently would not be required to disclose the SSN in order to participate in the research study.

o For participants who have been paid more than $200.00 within a calendar year, the investigator should forward the name, address, and SNN of recipients, with the dollar amount paid, to Material & Disbursement Services (M&DS) at the end of that calendar year. No study-related information is required by M&DS.

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Investigator Responsibilities

o Protection of human subjectso Informed consento Appropriate expertiseo Confidentialityo Minimize risk

o Uphold ethical principles o Autonomy/Beneficence/Justice

o Research design/Scientific validity/Quality of study conduct

o Compliance with federal, state, institutional requirements

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