Human Subjects Compensation Training

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Human Subjects Compensation Training

• January 18, 2005

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Presented by

• Liz Rulli, Director of Financial Affairs, Office
  of the Vice Provost for Research
• Kendra Merriman, Assistant Comptroller,
  Disbursements
• Gayle Stetler, Cash Analyst, Office of Investments

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Training Objectives

• Explain the process that results in a human
  subjects study being approved
• Discuss the role of the PI, Human Subject Office,
  Human Subjects Committee, Business Office,
  Disbursements and Investment Office in the human
  subject compensation process
• Explain the current, and new options for Human
  Subject Compensation

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Training Objectives

• Describe the processes for making and managing
  different forms of human subject payments
• Outline the expectations and responsibilities of
  the business office in human subject compensation
• Discuss some non-routine issues that arise and
  how to address them
• Provide resources to help you as you assist
  faculty with the process of compensating human
  subjects

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Compliance Requirements

• Purdue University is mandated by 45 CFR 46 to
  establish and support an Institutional Review
  Board (IRB)
• Encompasses all research involving human
  participation, both funded and not funded.
• Purdues policy is outlined in Executive
  Memorandum B-45
• Non-compliance could result in loss of federal
  funding or suspension of all federally sponsored
  research

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The IRB Committee

• Known as the Committee on the Use of Human
  Research Subjects, Institutional Review Board, or
  IRB
• Comprised of members appointed by President
  Jischke
• Membership includes faculty who are involved in
  human subjects research and community members
• IRB Office within the Office of the Vice Provost
  for Research

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Mission of the IRB Committee

• The mission of the Committee is to protect the
  privacy, safety, welfare, and rights of human
  research subjects through a thorough evaluation
  of recruitment procedures, informed consent
  processes, and analyses of the risks to the
  subjects relative to the benefits of the
  research.

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Role of the IRB

• As of July 2004, two separate IRB committees
  exist at Purdue
• Biomedical
• Social/behavioral
• The committees meet monthly to review human
  subject protocols

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Protocol vs. Proposal

• Research proposal to a funding agency
• Proposal transmittal check sheet indicates use of
  human subjects
• A human subject protocol is a separate document
  prepared by the PI
• A protocol may be associated with one or more
  research proposals, or no current external
  funding.
• A protocol may or may not include compensation.

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Compensation vs. Benefit

• A participant may receive benefit from
  participating in a research study that is not
  compensation (e.g. access to a drug that is being
  tested, or results of a study).
• Compensation may be included in a protocol to
  encourage subject participation.
• The IRB reviews the compensation to ensure that
  it is not of a coercive nature (could bias the
  research study).

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IRB Review Process

• Faculty submit protocols to the IRB Office
• The IRB staff classify as exempt, expedited or
  full review
• Expedited protocols are reviewed by IRB staff/
  IRB Committee chairs
• Those studies requiring full review go before the
  IRB Committee each month
• A protocol may be approved, denied, or revisions
  may be requested.

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Human Subject Protocols and SPS Accounts

• Review by Research Administration area within the
  Office of the Vice Provost for Research
• A new sponsored program account will not be
  established, or an existing account will be
  locked if an approved protocol does not exist or
  is expired

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Protocols that Include Compensation

• For protocols that include compensation, the IRB
  Office sends an e-mail (approx. monthly) to the
  Directors of Financial Affairs for each
  school/college
• Protocol PI Dept
  Date Appr. Compensation
• 04-612  Elicker, James G.    CDFS   
  09/02/2004        10.00  04-634  Roberts,
  Felicia COMM   09/09/2004       
  2.00   04-636  Mills, Juline 
  HTM     09/23/2004       100.00 04-639 
  Dalal, Reeshad PSYC    09/16/2004      
  gift certificate       04-640  Bendito,
  Petronio A. VPA     09/23/2004      
  40.00  04-646  Salvendy, Gavriel IE     
  10/08/2004       8.00/hr

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Business Office Expectations

• Upon receipt of the e-mail from the IRB Office,
  contact the faculty member to discuss the method
  that will be used to pay the human subjects.
• Ensure that the method, type, and amount of
  compensation planned by the PI meet the criteria
  identified in the approved human subject
  protocol.

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Business Office Expectations

• Review the guidance sheet with the faculty
  member and leave a copy with the PI for future
  reference
• Guidance sheet
• contains websites for reference
• explains the different payment types
• explains benefits and requirements surrounding
  each

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Business Office Expectations

• The appropriate source of funds for the
  compensation should be identified.
• The business office should facilitate all
  financial aspects of the process, such as
• setting up of bank accounts (if needed)
• establishing account reconciliation processes
• establishing logs
• Processing invoice vouchers, etc.
• depending on the method of payment

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Business Office Expectations

• Understand nature of study, and circumstances
  that would cause the compensation to change from
  what was included in the protocol
• For example, the participant is to receive 300
  for participating in 3 sessions, but it is
  possible an individual may only participate in
  one session, and therefore receives 100.
• When amounts requested for payment are different
  than proposed, the business office should consult
  with the PI and the IRB office as necessary.

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Role of Sponsored Program Services

• Human subject payments (made by invoice vouchers
  or request for electronic funds transfer) must be
  approved (pre-audited) by SPS.
• SPS should be consulted if there are questions
  about allowability or what is included in the
  approved budget

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Disbursements/Accounting

• Depending on the payment type, processes the
  necessary payments
• Serves as a resource to the business office to
  help with questions
• Communicates any policy or procedures changes
  that would impact human subject compensation

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Role of Investments

• Sets up university bank accounts when needed as
  part of a human subjects compensation method

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Forms of Human Subjects Compensation

• Approved methods include
• Check (Accounts Payable)
• Check (Revolving Fund)
• Cash (Advance to PI)
• Gift Certificates (NEW)
• Coupons (NEW)
• Giveaways (NEW)
• Food (NEW)

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Check(via Accounts Payable)

• Used for individual payments of 50 or more
• Invoice voucher prepared with a human subjects
  log
• Include protocol , not study title, on invoice
  voucher
• Object code 5-5613 Human Subjects Payments must
  be used
• SPS approval of the invoice voucher is required
  for funds 500-699.
• For non SPS funds, the business office must
  ensure an approved protocol exists and amounts
  are consistent with protocol

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1. Check (via Accounts Payable)

• Checks mailed or requested in advance to be
  handed out
• Checks to be handed out require seven business
  days advance processing
• Departments should hand deliver to Accounting
  Services
• Help establish reasonable expectations for
  processing
• Checks not distributed must be promptly cancelled
  by contacting disbursements

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1. Disbursements Role in Invoice Voucher
Processing

• Reviews Invoice Voucher
• Ensures necessary approvals are in place
• Addresses any tax requirements
• Generates payment

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1. Invoice Vouchers to Non-resident Aliens

• A separate invoice voucher must be prepared for
  payments to non-resident aliens
• Glacier must be completed by the participant and
  attached to the invoice voucher. 
• Taxes equal to 30 of the payment will be
  withheld (you will want to alert PIs to this)

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Check (via revolving fund)for individual
payments less than 50

• Used for projects involving a large number of
  subjects or lasting an extended period of time.
• A separate revolving fund (checking account) may
  be established.
• A log must be maintained
• The subject must sign the log

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2. Bank Account Procedures

• Investments will work with the requesting
  department to determine
• The appropriate type of bank account
• The bank where the account is to be opened
• Appropriate signatures
• How the funding of the account will be handled

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2. Investments will do the following

• Send the bank procedures manual
• Prepare resolution authorizing the designated
  custodian and signatories to operate the bank
  account
• Contact the bank to open account and obtain
  signature cards
• Arrange for monthly statements to be mailed from
  bank to the account Control
• Retain copies of signature cards and resolution

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2. The Business Office will

• Obtain signature on signature cards from
  appropriate personnel and return to Investments
• Designated Control will create a bank account
  file (Bank statement, reconciliation, all
  pertinent correspondence) to be appropriately
  secured
• Reconcile account and submit reconciliation to
  the revolving fund clerk/Accounting Services by
  the 20th of each month.

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2. Check (via revolving fund) for individual
payments less than 50

• At no time may the account be overdrawn
• Voided checks must be retained and returned to
  the business office
• SPS approval is obtained on the Form 52A (request
  for electronic funds transfer) that reimburses
  the revolving fund for check disbursed.
• For non SPS funds, the business office must
  ensure an approved protocol exists and amounts
  are consistent with protocol
• Object code 5-5613 Human Subjects Payments must
  be used

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2. Revolving Fund Change Fund Procedures can
be found at

• http//www.purdue.edu/account/Reference/Revolving_
  Funds/procedures-i.htm
• This site includes detailed guidance for
• Establishment
• Managing interest
• Cash versus checking accounts
• Creating of checking accounts
• Handling of bank charges

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2. Revolving Funds (contd)

• Managing expenditures
• Replenishment of revolving funds
• Reporting requirements
• Closing the fund and checking account

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3. Cash (via cash advance) for payments less
than 50

• An invoice voucher (Form 56) is prepared in the
  name of the PI, business manager, or business
  assistant
• Object code 5-5613 Human Subjects Payments must
  be used
• SPS approval of the invoice voucher is required
  for funds 500-699.
• For non SPS funds, the business office must
  ensure an approved protocol exists and amounts
  are consistent with protocol

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3. Cash (via cash advance) for payments less
than 50

• A cash-handling plan must be completed for
  locations disbursing cash
• The request for funds should be made close to the
  time funds will be disbursed
• Checks made payable to the project director or
  other appropriate staff member must be cashed

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3. Cash (via cash advance) for payments less
than 50

• Funds cannot be deposited into personal accounts
  nor can separate accounts be established to hold
  these funds
• Cash must be appropriately secured
• Unused funds must be promptly returned to the
  Business Office

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3. Cash (via cash advance) for payments less
than 50

• A log must be maintained
• The business office reconciles the original
  disbursement, participant payments, and excess
  cash
• The business office prepares a Cash Receipts
  Voucher (CRV) to deposit unused funds. CRVs are
  taken to the Bursars Office for deposit

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3. Cash (via cash advance) for payments less
than 50

• A Cash Advance Reconciliation Statement of
  Condition must be returned to the Tax group
  monthly with the human subjects recipient log
• When the project is complete, or human subject
  compensation activity has ended, a final
  reconciliation statement should be submitted

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4. Gift Certificates

• Gift certificates (not gift cards) may be issued
  in lieu of cash or check
• The face value of the certificate must be less
  than 50
• A log must be maintained
• The subject must sign the log
• The log must be provided to the business office
  monthly

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4. Gift Certificates

• Certificates must be secured as if they were cash
  
• The IRS considers gift certificates to be cash
  equivalent thus the same tax rules apply to
  these as with more traditional payment methods

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4. Gift Certificates

• Gift certificates may be purchased using a
  departmental purchasing card
• Gift certificates for lottery tickets, alcoholic
  beverages, or tobacco products are not allowable
  under any circumstances
• Object code 5-5636 Cash Eq Human Subjects Pmts
  must be used.
• The business office must ensure an approved
  protocol exists and amounts are consistent with
  protocol for all funds (exercising
  SPS/Comptroller delegation)
• Cash handling plan is required

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4. Unused Gift Certificates

• Unused certificates must be returned to the
  business office
• The business office reconciles the log to the
  original purchase and unused certificates
• Unused certificates may be used
• For another study
• For future use in the same study
• For another appropriate use in the department

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4. Unused Gift Certificates

• Costs must be moved to appropriate account
• Be aware of potential for certificate expiration
  or loss of value
• It is not allowable to give unused certificates
  to faculty or staff as a recognition or award

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4. Gift Certificates of Nominal Value

• Certificates of nominal value mailed to
  respondents of a survey
• Nominal value would be amounts of less than 15
  that are not recurring
• PI must keep a record of certificates but subject
  signature is not required

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4. Why not Gift Cards?

• The University cannot verify and validate the
  stored value of a gift card
• Some gift cards charge fees, or may expire or
  lose value
• It would be embarrassing for a participant to
  attempt to use a gift card and learn it did not
  have the value expected

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5. Coupons

• Received free of charge from various vendors as a
  marketing tool (i.e. free pizza)
• Are of nominal value
• Logs are not required
• SPS approval is not required, as there is no
  expenditure reflected on the SPS account
• Coupons for lottery tickets, alcoholic beverages,
  or tobacco products are not allowable under any
  circumstances
• Unused coupons may be handled similarly to unused
  gift certificates

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6. Giveaways

• Items of a nominal value may be given to each
  participant
• Giveaway items must have prior sponsor approval
  before expenditure can occur
• Contact SPS for assistance if these were not
  originally budgeted
• The business office must ensure an approved
  protocol exists and amounts are consistent with
  protocol for all funds (exercising
  SPS/Comptroller delegation)

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6. Giveaways

• Giveaways items should be secured to prevent
  theft or loss
• Non-promotional giveaway items of nominal value
  (e.g. small toys)
• Must be less than 15
• Gift certificates may be purchased using a
  departmental purchasing card
• NEW Object code 5-5637 Non-cash Human Subjects
  Payments must be used
• Business Office maintains supporting
  documentation

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6. Purdue Promotional Giveaways

• Items of nominal value used for Purdue
  promotional or marketing purposes (e.g. pens,
  coffee mugs)
• Contain a university school or departmental logo
• Should be administered according to the
  guidelines for promotional giveaways

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Food/Meals asHuman Subject Compensation

• Meals for focus groups, etc. may be included as
  human subject compensation
• Must have prior sponsor approval before
  expenditure can occur
• Contact SPS for assistance if these were not
  originally budgeted
• The business office must ensure an approved
  protocol exists and amounts are consistent with
  protocol for all funds (exercising
  SPS/Comptroller delegation)

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7. Food/Meals as Human Subject Compensation

• P-card that allows food purchases should be used
• NEW Object code 5-5637 Non-cash Human Subjects
  Payments must be used
• Do not use any other food, hospitality or
  entertainment object codes
• Business office maintains support documentation

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Drawings and Raffles

• There has been past practice of entering
  participants names in a drawing for a prize as
  part of human subjects compensation
• We have received a legal opinion that these types
  of drawings must be open to anyone (not just the
  research participants) or they could constitute
  an illegal lottery.
• Difficult to show benefit to a sponsored program,
  and reduce incentive to research participants
• Drawings and raffles may not be used as human
  subject compensation
• A university-wide policy regarding this issue is
  being developed.

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Protocols that Contain Unallowable forms of
Compensation

• If during the protocol review process IRB staff
  identify forms of compensation that are not
  allowable under Purdue policies, they will work
  with the staff of the OVPR Office and PIs
  business office to bring these situations to the
  attention of the PI.

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Deviations and Exceptions

• Deviations from the amount and method of payment
  approved by the IRB must be reviewed by the IRB
• The Comptroller must approve any exception to
  these payment methods.

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Items of Special Interest

• PI Personal Funds
• A PI may use personal funds for human subjects
  payments and not request reimbursement. This is
  still an issue for the IRB, but there is no
  business/cash management issue.

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Items of Special Interest

• Dollar bills in mailings
• A PI may include a 1 bill in a survey
  instrument. This may be an exempt activity, and
  therefore, have no IRB issue, but have a
  business/cash management issue. A log of survey
  recipients/mailings should be maintained.

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Items of Special Interest

• Invoice Vouchers under 50
• A payment may be anticipated to exceed 50, but
  be prorated resulting in a less than 50 payment.
  An invoice voucher could still be prepared with
  the circumstance noted.

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Items of Special Interest

• Key/Code system
• As with all financial and personnel data the
  business office handles, appropriate care should
  be used regarding confidentiality of participant
  information.
• In some sensitive studies, the PI may chose to
  use a key/code system. The business office would
  have a log indicating that Person A received
  10. The PI would retain a key Person A John
  Smith
• The key/code system is not appropriate for
  invoice voucher payments.

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Contacts

• Kendra Merriman km_at_purdue.edu
• Liz Rulli lrulli_at_purdue.edu
• Gayle Stetler gstetler_at_purdue.edu
• The IRB Office irb_at_purdue.edu
• Robin Bhaerman, IRB Administrator
  rdillner_at_purdue.edu
• Peter Dunn, Associate VPR pedunn_at_purdue.edu
• Becky White, Assistant Dir., SPS
  rlwhite_at_purdue.edu
• Kathy Vanderwall, Endowment and Investment
  Accountant, kvanderwall_at_purdue.edu

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Forms and Resources

• IRB website http//www.irb.purdue.edu/
• Business Procedures Manual http//www.purdue.edu/t
  axes/Consultant_Payments/humansubjectpymts.htm
• Detailed Procedures
• Logs and forms
• Guidance sheet
• This presentation Human Subject Compensation
  Training http//www.purdue.edu/taxes/Human_Subjec
  ts/

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Questions