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Human Subjects - Human Research Participant Compensation Training.ppt

VIEWS: 35 PAGES: 60

									Human Subjects
Compensation
Training
January 18, 2005
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
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
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
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.
   Purdue‟s policy is outlined in Executive
    Memorandum B-45
   Non-compliance could result in loss of federal
    funding or suspension of all federally sponsored
    research
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
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.
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
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.
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).
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.
    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
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
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.
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
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
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.
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
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
Role of Investments
   Sets up university bank accounts when
    needed as part of a human subjects
    compensation method
Forms of Human Subjects
Compensation
    Approved methods include:
    1.   Check (Accounts Payable)
    2.   Check (Revolving Fund)
    3.   Cash (Advance to PI)
    4.   Gift Certificates (NEW)
    5.   Coupons (NEW)
    6.   Giveaways (NEW)
    7.   Food (NEW)
1. 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
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
1. Disbursement‟s Role in Invoice
Voucher Processing
 Reviews Invoice Voucher
 Ensures necessary approvals are in place
 Addresses any tax requirements
 Generates payment
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 PI‟s to this)
2. 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
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
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
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.
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
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
2. Revolving Funds (cont‟d)
  Managing  expenditures
  Replenishment of revolving funds
  Reporting requirements
  Closing the fund and checking account
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
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
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
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. CRV‟s are taken to the
  Bursar‟s Office for deposit
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
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
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
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
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
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
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
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
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
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)
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
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
7. Food/Meals as
    Human 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)
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
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.
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 PI‟s business office to bring
    these situations to the attention of the PI.
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.
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.
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.
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.
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.
Contacts
   Kendra Merriman km@purdue.edu
   Liz Rulli lrulli@purdue.edu
   Gayle Stetler gstetler@purdue.edu
   The IRB Office irb@purdue.edu
   Robin Bhaerman, IRB Administrator
    rdillner@purdue.edu
   Peter Dunn, Associate VPR pedunn@purdue.edu
   Becky White, Assistant Dir., SPS rlwhite@purdue.edu
   Kathy Vanderwall, Endowment and Investment
    Accountant, kvanderwall@purdue.edu
Forms and Resources
   IRB website http://www.irb.purdue.edu/
   Business Procedures Manual
    http://www.purdue.edu/taxes/Consultant_Payme
    nts/humansubjectpymts.htm
     DetailedProcedures
     Logs and forms
     Guidance sheet

   This presentation „Human Subject
    Compensation Training‟
    http://www.purdue.edu/taxes/Human_Subjects/
Questions…

								
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