Human Subject Compensation Training

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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
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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
04-612 Elicker, James G. CDFS
04-634 Roberts, Felicia
COMM
04-636 Mills, Juline
HTM
04-639 Dalal, Reeshad
PSYC
04-640 Bendito, Petronio A. VPA
04-646 Salvendy, Gavriel
IE
Date Appr.
09/02/2004
09/09/2004
09/23/2004
09/16/2004
09/23/2004
10/08/2004
Compensation
10.00
2.00
100.00
gift certificate
40.00
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
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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
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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 (preaudited) 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.
2.
3.
4.
5.
6.
7.
Check (Accounts Payable)
Check (Revolving Fund)
Cash (Advance to PI)
Gift Certificates (NEW)
Coupons (NEW)
Giveaways (NEW)
Food (NEW)
1. Check
(via Accounts Payable)
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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)
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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 Nonresident 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
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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
2. Investments will do the
following:
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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:
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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
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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
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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
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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. CRV’s are taken to the
Bursar’s 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
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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
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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
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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
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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
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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
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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
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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)
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7. Food/Meals as Human Subject
Compensation
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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
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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
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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
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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
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IRB website http://www.irb.purdue.edu/
Business Procedures Manual
http://www.purdue.edu/taxes/Consultant_Payme
nts/humansubjectpymts.htm
 Detailed
Procedures
 Logs and forms
 Guidance sheet

This presentation ‘Human Subject
Compensation Training’
http://www.purdue.edu/taxes/Human_Subjects/
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