Global Human Subject use & Complexities of payments

Global Human Subject use & Complexities of payments Joseph M. Smith Manager – Research Compliance Office Division of Research University of Maryland College Park Rebecca Hunsaker Assistant Director – Research Administration College of Behavioral & Social Sciences University of Maryland College Park

Problems • Current Tax Requirement • 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.) • Collection of Names, Addresses, and SSN • Different practices/requirements to provide compensation to participants • Any amount of compensation (including food) • Arbitrary amount such as $50 or $200 • Maximum of $600 • Risk Assessment • Penalty for breaching participant confidentiality by placing them at unnecessary risk v. penalty for not generating a 1099 for $600. 2

Problems • Risk Creation • 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. • Contradictory • 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. • 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. 3

Problems • Potential for Inaccurate Results • Current practices may lead to lower participant retention and recruitment rates for studies leading to potentially skewed or inaccurate results . • 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. • Potential Effect on Funding • 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. • 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. 4

Problems • It can be argued that some current practices contradict the Belmont Report: • Current participant compensation practice limits the research populations willing to participate in research • 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. • 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 • For example: Special Forces Units, Undercover Law Enforcement, Transient Populations (drug users, homeless, etc.) 5

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 Persons • Treat individuals as autonomous agents • Protect persons with reduced autonomy IRB Requirements • Investigators obtain participants voluntary consent • Privacy and confidentiality are protected

Belmont Report Ethical Principle #2 – Beneficence • 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 Requirements • Risks of research are justified by potential benefits (risk : benefit) • Study is designed to minimize risks • Adequate data and safety monitoring • Conflicts of Interest are managed appropriately

Belmont Report Ethical Principle #3 – Justice • Distribute the risks and potential benefits of research equally among those who may benefit from the research. IRB Requirements • Vulnerable subjects are not targeted for convenience • Vulnerable populations recruited are adequately protected • Subject selection is equitable • Population exclusion is justified

How Do We Fix This? • Regulatory Oversight • Governmental/Federal • Institutional Review Board (IRB) • Institutional • Informed Consent • Individual/Investigator

Institutional Review Board • Reviews amount of compensation to ensure it is not coercive • Accounts for amount of time participating • Pro-rated payments available for larger amounts and multiple visits. Participation is voluntary and participants may drop out prior to completing the study • Reviews measures in place to minimize risk • Social Behavioral Research – risk of potential breach of confidentiality is common and in many cases the only risk. • Implementing measures to minimize this risk allow for further protection of our human subjects. • Collection of names, address, and Social Security Numbers for payments • 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. • 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. 11

Solution • Set $600 (at once or total) as the new threshold • Create Consent Form language and Individual Receipt Form for all studies participant payments. • Allow participants to self-report in Consent Form • Do you expect to earn $600 or more from participating in research studies over the course of this year? • Response triggers which Receipt Form to use. • Participants can also choose to participate and not be compensated

Solution • $600 and Over • 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: • 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. • Participants can participate without receiving payment if they do not wish to provide identifying information.

Solution Anyamount of compensation: • Consent Form Language- Monetary or other compensation: A statement describing the amount and types of compensation and clearly specifying the requirements to earn them. • 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.” • 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 • Researchers • 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. • 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. • 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. • 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. • Institution – Central Office Organizations • 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. • Minimizes the secure file storage space needed for records retention

On the Horizon • Improve research capabilities by identifying alternatives to cash payments • Suggestions? • Success stories? • Minimize administrative burden/potential for theft without increasing risk to participants. • Raffles • Gift Cards (physical or online) • Amazon Mechanical Turk • PayPal (or similar online payment) • Allows for ease of compensating international participants 16

Other Practices • University of Texas at Austin • Do not require investigators to obtain the SSN of participants who receive compensation for participating in a research study, unless earning $450 or more. • 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.”]” • Ohio State University • For all U.S. citizens and residents, SSN is not collected for any research study under $500 of total compensation. • For any nonresident aliens, address and/or SSN is collected for all research with a compensation amount of $100 and above. • 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. • University of Michigan • 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. • Michigan has an official audit system in place- if amount hits or exceeds $600.00, participants are automatically sent a Form 1099-MISC. • 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. 17

Other Practices • University of Delaware • 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. • In general, UD does not recommend the collection of private information unless needed to comply with such requirements and regulations. • In many cases, a signed receipt by the participant is requested at the time of payment • University of North Carolina • 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. • 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. • 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. 18

Investigator Responsibilities • Protection of human subjects • Informed consent • Appropriate expertise • Confidentiality • Minimize risk • Uphold ethical principles • Autonomy/Beneficence/Justice • Research design/Scientific validity/Quality of study conduct • Compliance with federal, state, institutional requirements 19

Global Human Subject use & Complexities of payments