Financial Management of

mailboxcuckooΔιαχείριση

10 Νοε 2013 (πριν από 4 χρόνια)

87 εμφανίσεις

1

Financial Management of
Clinical Research

Office of Research Compliance

NSLIJHS

516
-
562
-
2018

2


Overview



In 2007 over $91 million in External Funding was
received for Service Delivery and Research
projects throughout the Health System


Federal and state agencies have regulations governing
how money may be spent and when financial statements
must be filed


Sponsors often have additional reporting requirements
outlined in the Notice of Grant Award or terms of the
contract


Failure to comply with these terms can lead to reductions
in funding, disallowed costs, and disbarment from future
rounds of funding


3

Responsibilities

Who?

Principal investigators and designees (i.e. research
coordinators); institution

What?

Appropriate budget development

Cost allocation and monitoring

Operational efficiencies

When?

Before the study begins

During the conduct of the study

Study close
-
out



4

Roles and Responsibilities

Fiduciary responsibility lies with the program manager (PM) or principal investigator
(PI) of each awarded project.

As such, it is the responsibility of the PI/PM of their
designee to review at least monthly:



PeopleSoft Financial Status Reports

to monitor expenses and request changes as
necessary to ensure compliance with the terms and conditions of an award and to ensure
that costs are being captured.


Salary and Labor Monitors and Effort Certification Report Forms

to ensure that labor
and effort are appropriately allocated and are in compliance with the terms and conditions of
an award.


Grants Management staff in the Office of Sponsored Programs

(for service delivery),
Grants and Contracts

(for research),
BRANY

(for industry sponsored studies) and
Grants Financial Reporting

(for both) provide administrative and technical support to
assist PI/PMs in meeting requirements


PeopleSoft Financial Reporting

team plays a significant role and we will discuss how
to get access to reports later in this presentation


5

NS
-
LIJ Policies

Healthport:

System wide Research Policies that impact financial management for clinical
research



Time and Effort Reporting


Intellectual Property


Compensation for Research Subjects



Research Study Participant Payment Form


Research Billing Procedure for Outpatient Services, Inpatient Services and Ancillary Testing



Medicare Outpatient Payment Rates



Inpatient Research Subject Registration



Outpatient Research Subject Registration



Special Purpose Fund Account Set Up Form


Grant Close Out


Grant Applications for External Funding



Office of Sponsored Programs Grant Application Routing Form



Office of Grants & Contracts Grant Application Routing Form


Principal Investigators for Sponsored Research


Research at the North Shore
-
LIJ Health System


Research Misconduct


Office of Research Compliance


www.nslij.com/orc

Office of Grant and Contracts



www.nslij.com/ogc

6

Before

a study begins: Budget Development

Do

c
reate a project
-
specific detailed budget that includes all
protocol procedures and associated costs, even if it’s not required
by the sponsor or if the study is not yet funded. You should do this
BEFORE you agree to take on a study.


Don't

enter into final budget negotiations and execute an agreement
until you have created a final budget and are confident you have
identified all study costs.


Don't

give final approval to the budget without reviewing the final
protocol.


Do

read the contract language related to budget and payment
carefully. Consult with Grants, BRANY, or Finance if you need
clarification of terms.

7

Budget Development

How do I calculate an appropriate per patient
reimbursement?



If the sponsor has provided a detailed budget, this makes a good
starting point; however, sponsor
-
prepared budgets do not always
include all the costs associated with the study. Before beginning,
both the PI and study coordinator should review the study
protocol or schema with BRANY or OGC with the following in
mind:


Difficulty and/or complexity of study

Study preparation requirements

Patient acuity and age

Length of study

Inclusion/exclusion criteria for patient recruitment

8

Budget Development

When working with BRANY or OGC when calculating your budget you
should consider the following non
-
patient specific costs in your per
-
patient
reimbursement in addition to protocol procedures:



Study start up costs: contract negotiation and review, time spent preparing and
maintaining regulatory documents and IRB approval


Data management both while the study is active and during close out


CRF completion


Time spent with monitors


Advertising


Screening, including the costs of pre
-
screening before any subject is enrolled.


Archiving


Pharmacy storage and preparation costs


Shipping costs


In addition be sure that the payment schedule takes into account front loaded
screening or dose escalation visits that may be more intensive then later visits.
Failure to manage the timeline for when you are paid can often present
problems. Be careful how you request payment based on milestones.

9

Per Patient Budgets and the NIH

Increasing in popularity


Must be based on actual costs


Cost Accounting Standard (CAS) 501
requires consistency in
estimating, accumulating, and reporting costs


You cannot “profit” from NIH grants or contracts, all “credits” must be
returned at the end of the grant or contract period



If the budget states that the per patient rate was calculated based on
ancillary tests, the expectation is that the per patient amount will pay for
those ancillary tests. This does not mean you cannot roll in personnel
or other costs, but the budget will need to be clear from the start that
these costs were rolled into the per patient calculation and how the
expenses were verified.


10

Budget Development

Where can I get access to a complete list of procedures with charge
rates?



Costs for ancillary procedures

are charged to research grants based on the
Medicare fee schedule. No matter what kind of insurance or lack of insurance a
research subject has, the grant or contract will be charged the same amount that
the health system would charge Medicare.

These costs are listed in the Medicare Outpatient Prospective Payment System
(OPPS).

All services paid under OPPS are classified into groups called Ambulatory
Payment Classifications or APCs. Services in each APC are similar clinically and in
terms of the resources they require. A payment rate is established for each APC and is
hospital specific.

A spreadsheet which lists Medicare charges based on APCs effective January 1, 2009
for all health system entities has been posted on healthport under the policies tab.


Costs for inpatient stays
: are facility and discipline specific and negotiated
with the federal government by Finance. This rate is often referred to as the
“bed day rate”. If you need to know the rate for a specific facility or
discipline contact Larry Katz or Danny Halfant in Grants Financial Reporting
for more information.

11

Post Award Management

Where can I locate the amount I am being
reimbursed by sponsor for each patient or per
patient visit?



The amount the site will receive should be documented in the
clinical trial agreement (CTA) or grant budget.



Many budgets do not break out costs on a per visit basis rather
they are calculated as a per patient reimbursement.




If your study sponsor simply provides a “per
-
patient
reimbursement” you MUST develop a detailed study budget (its
required under the Clinical Trials Billing Policy)

12

Post Award Management

What is the process in obtaining fund (PeopleSoft #)?


The Office of Grants and Contracts or BRANY will initiate the start
-
up of a
fund account (called a PeopleSoft #) for research projects and programs.


This process begins with OGC or BRANY requesting a fund number from
the Department of Finance, followed by the development and dissemination
of a Fund Memorandum.


The Fund Memorandum is generated from the Grants and Contracts or
BRANY database and sent to key persons who will be involved with the
management of the grant award, including the Principal Investigator, the
Department Chair or Center head, and their respective Administrators.


If applicable, copies are sent to the Departments of Finance and Purchasing
to monitor and report out on expenses and for reference when the purchase
of materials and supplies are required for the conduct of the study.

13

What is PeopleSoft?

PeopleSoft is the health system’s financial and human resources
tracking system, it is a series of databases that help manage
operations. Two key areas are:



EPRO

PS database in which eProcurement users can order
supplies and perform the Desktop Receiving and Approving functions
for requisitions.



EPMREPORTS

PS database for

viewing PeopleSoft EPM Reports,
including all Monthly Financials, Salary Monitors, Position Control,
Monthly Goods and Services, AP Voucher Distribution reports and other
reports related to Financials and Budgeting.


If you are responsible for the administration, implementation, or
oversight of externally sponsored research protocols you will need
access to the appropriate PeopleSoft financial reports for those
projects

14

Post Award Management

How do we get access to People Soft?


New users complete and submit a PeopleSoft User
Security form and attend a PeopleSoft workshop,
offered through the Center for Learning and
Innovation.


Forms and instructions on this process may be found
at the PeopleSoft website on Health Port.


PeopleSoft Home is available under Quick Links in
the top right corner of the Health Port site.

15

Post Award Management


What is “Time and Effort”?



A process for capturing how an individual spends his/her effort over a
given time period



Reflected in percentages of total time (100%) worked in the health
system regardless of where work is performed

Total includes all
effort

(hours) spent to meet all commitments to the
health system (Total hours will vary from person to person)



Based on actual activities, but may be reasonably estimated



Reported retrospectively or “after
-
the
-
fact” every MONTH



Required by federal regulation



16


Effort is defined as the amount of time spent on a
particular activity. Individual effort is expressed as a
percentage of the total amount of time spent on work
-
related activities (clinical care, instruction, research,
administration, etc.)



% Effort = Project specific time






All time expended to meet commitments in


the Health System




How is effort calculated?

17

How does it work?

Every month key research personnel will receive an Effort
Certification Report Form (ECRF) from Research Compliance


Review the report, sign, and send back to Research Compliance


If changes need to be made they can be indicated on the form


Note if the change effects salary the appropriate position data
change form MUST be submitted to Human Resources

18

Time and Effort Reporting

NOTE a change in Process:


Processing of effort report forms is moving
from Grants Finance to Research Compliance
as of April 10, 2009.



Completed forms should be sent to Gerry
Kassoff at The Feinstein Institute for Medical
Research at 350 Community Drive,
Manhasset, NY 11030

19

20

Clinical Trial Management

If my department is providing services to a research study what will my

department be reimbursed for those services?
If my department is asking another

department to provide services what will we charged?


If your department is providing services your department will incur a cost and you will
need to seek reimbursement for that cost from a sponsor, grant, contract,
departmental fund, or operations. The entity reimbursing you is incurring the charge.



For example if a Cardiology study calls for an EKG, both the cost and the charge of the EKG
might be the responsibility of Cardiology.


However if Cardiology provides EKG services to Gastroenterology, Cardiology incurs the
cost and Gastroenterology should be charged for the cost of the EKG.


If there is external funding the Clinical Trials Billing Policy and Procedure must be followed
and the appropriate project ID (peoplesoft #) will be charged


There should be no “special deals”. All research related costs for ancillary services
are charged the same amount that the health system would charge Medicare. The
schedule is available on healthport under the policies tab.

21

Clinical Trial Management

How long does it take to get reimbursed?



Grants Financial Reporting receives a report of costs to be charged to specific
funds at the end of every month from patient accounts. If all the information is
accurate, Grants Financial Reporting will charge the appropriate peoplesoft
project ID and transfer funds to your department within 1 calendar month after
receiving notification.


How do we know if we have been reimbursed for services our
department has performed for researchers in the health system?



It will appear as a journal entry credit in your department’s PeopleSoft reports.


How do we know if we have been charged for a service provided by
another department in the health system?



It will appear as an expense in your PeopleSoft Grant Fiscal Recap or Clinical
Trial Fund Balance report.



22

Clinical Trial Management

How do we know if we have been paid by
the sponsor?



Grants Financial Reporting provides this
information.



23

Clinical Trial Management

How do I know what costs can be billed to insurance and which
ones can or should be covered by a grant or contract?
Am I
allowed to charge this cost to a third party payer?



The decision that governs clinical research costs (with the exception of
investigational devices) is called the National Coverage Decision for
Routine Costs in Clinical Trials. The decision is made by the Center for
Medicare and Medicaid Services or CMS:
http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=310.1&ncd_version=
2&basket=ncd%3A310%2E1%3A2%3ARoutine+Costs+in+Clinical+Trial
s
.



We apply this decision to all study subjects regardless of the subject’s
insurance status as a significant amount of health system
reimbursement is from CMS, most insurers follow their lead and we
have to capture and bill costs equally.

24

Clinical Trial Management

Medicare covers the routine costs of qualifying clinical trials
, as well as
reasonable and necessary items and services used to diagnose and treat
complications arising from participation in all clinical trials. (Note that there is a
separate decision for investigational devices)


Routine costs in clinical trials include
:


Items or services that are typically provided absent a clinical trial (e.g., conventional care);


Items or services required solely for the provision of the investigational item or service (e.g.,
administration of a noncovered chemotherapeutic agent), the clinically appropriate
monitoring of the effects of the item or service, or the prevention of complications; and


Items or services needed for reasonable and necessary care arising from the provision of an
investigational item or service
--
in particular, for the diagnosis or treatment of complications.


Costs that are not covered:


The investigational item or service, itself unless otherwise covered outside of the clinical trial;


Items and services provided solely to satisfy data collection and analysis needs and that are
not used in the direct clinical management of the patient (e.g., monthly CT scans for a
condition usually requiring only a single scan); and


Items and services customarily provided by the research sponsors free of charge for any
enrollee in the trial.


25

Clinical Trial Management

If services provided in a research study are
covered by a grant or contract and/or should not
be billed to insurance, what do I do?



Follow the Health System’s Policy on Clinical Trials
Billing


The purpose of this policy is to describe the process
for capture and payment of costs associated with
outpatient services, inpatient services and ancillary
testing provided in the course of a clinical research
study.

26

Clinical Trial Billing

POLICY


It is the policy of the North Shore
-
LIJ Health System that all clinical services rendered
during the course of a research study

be billed to the appropriate PeopleSoft project
number, third party payer, or individual in compliance with applicable state and
federal regulations.



Research procedures reimbursed by a research grant or contract may not be billed to
a subject and/or their insurance carrier.


It is the research team’s responsibility to know which procedures and visits are
required and covered by the research grant or contract.




All clinical trial research studies must develop a budget and the budget must
indicate which services are billable or non
-
billable.



The correct PeopleSoft Project # must be used when billing to a research grant or
contract.



27

Clinical Trial Billing: Outpatient

Outpatient Process for hospital or office based procedures:


The investigator/study coordinator identifies that the subject is appropriate
for the study and obtains informed consent.

The investigator/study coordinator determines whether or not the
procedures are being paid for by the grant or contract by reviewing the
detailed study budget.

If the investigator/study coordinator determines the procedures/visits are
covered by the study budget they are therefore non
-
billable to the subject or
3rd party payer.

Complete requisition or prescription for services; attach the

Outpatient
Research Registration form
.

If the procedure/visit is determined to be billable and not reimbursed by the
study budget or grant


If the patient has insurance, obtain proper authorization


If the patient lacks insurance or insurance won’t cover the procedure ensure that
the consent form advises the subject that these procedures are not covered.

28

Clinical Trial Billing: Outpatient

When Patient Arrives for Visit (date of service)


Patient will be registered following normal facility procedures.

The investigator/study coordinator will provide the subject with a prescription or
requisition attaching the

Outpatient Research Registration form

Registration will record the following information to ensure research services are
correctly billed:


If the procedure/visit is covered by the research study and is being billed via
INVISION

Apply the registration to plan code
F60 for NSUH Manhasset

and enter the PeopleSoft

project number into the prior authorization AND policy number fields.


Apply the registration to plan code
GNT for LIJ, SCH, and ZHH

and enter the PeopleSoft project
number into the prior authorization AND policy number fields.



If the procedure/visit is covered by the research study and is being billed via
IDX

Apply the invoice to plan code
RES for NSUH Manhasset

and enter the PeopleSoft project
Number into the prior authorization field.


Apply the invoice to plan code
GNT for LIJ, SCH, and ZHH

and enter the PeopleSoft project
number into the prior authorization field.



If the procedure/visit is NOT covered by the research study’s grant or contract no form
needs to be completed and registration staff should apply the registration to the subject
and/or insurance

29

Clinical Trial Billing: Core Lab

Once a PeopleSoft project number has been received, the investigator/coordinator
will contact the Core Lab Billing Office to set up a protocol specific account.


Each
PeopleSoft project number must have a separate Core Lab Account #.


The investigator/coordinator will provide the Core Lab with a

Special Purpose
Fund Account Set Up Form

in order to create the account. The Core Lab will then
provide the investigative site with a pre
-
printed research requisition form specific to
the study protocol.

The investigator/study coordinator Identifies that a subject is appropriate for the
study and obtains informed consent

The investigator/study coordinator determines whether or not the procedures are
being paid for by the grant or contract by reviewing the detailed study budget.

If the investigator/study coordinator determines the procedures/visits are covered
by the study budget and are therefore non
-
billable complete Core Lab research
requisition and submit sample with research requisition to the Core Lab.

If the procedure/visit is determined to be billable and not reimbursed by the study
budget or grant submit sample with clinical requisition to the Core Lab:


If the patient has insurance, obtain proper authorization.


If the patient lacks insurance or insurance won’t cover the procedure ensure that the
consent form advises the subject that these procedures are not covered.

30

Clinical Trial Billing: Inpatient

Process for
Category A
subjects (those hospitalized specifically for

research):

The investigator/study coordinator identifies that the subject is appropriate for the
study and obtains informed consent.


The investigator/study coordinator determines whether or not the hospitalization is
being paid for by the grant or contract by reviewing the detailed study budget.


If the investigator/study coordinator determines the hospitalization is required by
protocol and covered by the study budget and are therefore non
-
billable
notify
Admitting either prior to hospitalization or if already hospitalized at the time the
subject becomes a research subject

(day they sign consent); provide admitting
with the Inpatient Research Subject Registration form.


If the hospitalization is determined to be billable and not reimbursed by the study
budget or grant:


If the patient has insurance, obtain proper authorization.


If the patient lacks insurance or insurance won’t cover the procedure ensure that the consent
form advises the subject that these procedures are not covered.


31

Clinical Trial Billing: Inpatient

Process for
Category B
subjects (those hospitalized for medical

necessity):


The investigator/study coordinator identifies that the subject is appropriate
for the study and obtains informed consent.


The investigator/study coordinator determines whether or not
hospitalization is required by the protocol, or whether services are being
paid for by the grant or contract by reviewing the detailed study budget.


If the investigator/study coordinator determines that hospitalization is not
required but that ancillary services are covered by the study budget and
are billable
notify Patient Accounts

the day the subject is enrolled, (day
they sign consent); provide patient accounts with the Inpatient Research
Subject Registration form.


If procedures are determined to be billable and not reimbursed by the
study budget or grant.


If the patient has insurance, obtain proper authorization.


If the patient lacks insurance or insurance won’t cover the procedure ensure that
the consent form advises the subject that these procedures are not covered.

32

Clinical Trial Billing: Inpatient

Admitting Procedure


Patient will be registered following normal hospital procedures. If this is a planned
admission, Investigators must contact bed management and admitting prior to the day
of admission


The investigator/study coordinator will provide admitting with the Inpatient Research
Subject Registration form (Attachment A).


Admitting will record the following information to ensure research services are correctly
billed:


If the procedure/visit is covered by the research study:


Apply the registration to plan code F10 for NSUH Manhasset and enter the PeopleSoft
Project number into the prior authorization AND policy number fields


Apply the registration to plan code GNT for LIJ, SCH, and ZHH and enter the
PeopleSoft project number into the prior authorization AND policy number fields.


If the procedure/visit is
NOT

covered by the research study’s grant or contract
and proper authorizations have been obtained no form needs to be completed
and staff should apply the registration to the subject and/or insurance

33

Clinical Trial Management

Should the front desk make a regular chart for the
research patient if this patient is only seen by research?
How does this impact their account?



Yes if the study involves a clinical intervention. Note that FDA
and Good Clinical Practice guidelines require that sites be able
to provide original source documents for everyone who
participates in a clinical research study. This includes subjects
who are seen as normal controls. You need to be able to verify
against the chart for auditing and legal purposes.



It should not impact on the subject’s “account” adversely if the
appropriate process is followed for clinical trial billing. If there is
no funding for the study the visit need not be billed, there are
codes in IDX that can be used to keep a bill from being
generated.

34

Pharmacy Services for Clinical Trials

You should always consult with the appropriate Pharmacy service when evaluating whether to

accept a new study that involves a pharmaceutical agent. Facility Pharmacy Contacts:


NSUH Manhasset


Leonard Langino, RPh



Phone: (516) 562
-
1588 Fax: (516) 562
-
1697 Email:
llangino@nshs.edu


LIJ


James Abberton, RPh or Zina Faynblatt, RPh


Phone 1: (718) 470
-
7423 Phone 2: (718) 470
-
7430 Fax: (718) 343
-
824 Email:
zfaynbl@lij.edu


SCHNEIDER

Richard L. Goldstein, RPh Phone 1: (718) 470
-
3420 Phone 2: (718) 470
-
7430


Fax: (718) 343
-
8244 Email:
rgoldste@lij.edu


ZUCKER
-
HILLSIDE

Ken Sokol, RPh Phone: (718) 470
-
8321 Fax: (718) 831
-
2605 Email:
ksokol@lij.edu


Note: If the study will involve other Health System pharmacies, the PI must contact the
pharmacy administration of each facility.

35

Pharmacy Services for Clinical Trials

How do you reimburse the hospital or satellite pharmacies for services provided in

support of clinical research?



If the study has a funding for Pharmacy, monies are transferred via a memo from the PI or
Study Coordinator to Finance to transfer the funds from your study specific peoplesoft # to
the appropriate Pharmacy Clinical Research Account.


The correct Account # can be obtained by calling Pharmacy Service.


If we have a study that covers the cost of a marketed drug that is not provided by the

sponsor, can we buy a supply of the drug through the hospital pharmacy department

from study funds and then dispense it to the subject as we would for any other study?

How would this work?



For marketed drugs the hospital pharmacy can purchase the drug for your study. They can
also obtained placebos and other types of pharmaceutical study related items.


Pharmacy will provide you with a quote on cost, they will purchase the medication or supplies
and let you know when they have been received. A memo from the PI or Study Coordinator
to Finance to transfer the funds from your study specific peoplesoft # to the appropriate
Pharmacy Clinical Research Account is all that is required to pay your “bill”.


Medication may need to be stored on site at the pharmacy.


DO NOT ASSUME THIS IS AUTOMATIC: Pharmacy Service may need to negotiate a
contract with procurement or allocate space and resources, you must call Pharmacy before
the study begins, ideally when the contract with sponsor is being negotiated.



36

Clinical Trial Management

Managing Per
-
Diems, Pick
-
up Hours, and off shift work:

CALL Research Compliance before you

consider entering into any of the following. It might be possible but special procedures and in some

cases legal contracts need to be put into place.



How

do

you

reimburse

another

business

unit

or

department

within

the

health

system

for

provision

of

personnel

services

as

back
-
up

coordinators?

What

would

be

the

process

involved

in

reimbursing

one

department

for

the

staff

services

they

have

rendered

for

another

department’s

patient

visit?





I

work

part

time

at

1

health

system

facility

and

pick

up

additional

hours

by

working

at

another,

part

or

all

of

my

salary

is

funded

by

federal

grants,

what

do

I

need

to

do?



We

have

a

study

coordinator

working

on

collaborative

studies

where

she

is

actually

paid

full

time

by

our

collaborating

site

but

will

be

spending

20
%

of

her

time

at

NSLIJ,

how

do

I

reimburse

the

collaborating

site

for

the

portion

of

her

salary

spent

working

on

NSLIJ

activities?



I

need

a

nurse

“on

call”

for

a

research

study

that

involves

after

hours

enrollment
.

I’d

like

to

use

a

nurse

from

a

different

clinical

department

who

already

works

full

time

as

she

understands

the

disease

and

has

agreed

to

work

overtime

when

needed
.

This

is

a

federally

funded

project,

how

do

I

budget

this,

how

does

her

salary

get

split,

and

how

to

I

capture

effort?




37

Compensation to Research Subjects


POLICY


Must be reasonable for the tasks completed, conform to any limitations or exclusions
set forth in federal regulations, and not be unduly coercive to study participants.

Protocol specific justifications for compensation should be applied consistently across
all study cohorts.

Credit for payment should accrue as the study progresses and not be contingent
upon the participant completing an entire study.

Participants should be paid in proportion to their time and inconvenience as a result
of participation in a research study.

Unless it creates undue inconvenience or a coercive practice, payment to participants
who withdraw from a study may be paid at the time they would have completed the
study (or completed a phase of the study) had they not withdrawn.

Information concerning payment, including the amount and schedule should be
described in the informed consent document.

38

Compensation to Research Subjects


PROCESS


The amount and schedule of all payments should be
presented to the IRB at the time of initial review.

The IRB should review both the amount of payment and
the proposed method and timing of disbursement to
assure that neither are coercive nor present undue
influence.

Any alterations in research participant payment must be
submitted as a modification to the IRB for approval prior
to implementation.

Subjects may be paid through use of petty cash, check
requests or gift cards.

39

Subject Compensation and the IRS

Reporting Payments to the IRS

The Internal Revenue Service (IRS) requires that
institutions report payments to an individual in
excess of $600 per calendar year on Form 1099
-
Misc.


As a result, Finance will require that the name and
social security number of participants

be collected
on a check request form and released to the Office
of Procurement/Accounts Payable for processing,
unless a specific request is made not to capture this
information due to confidentiality or other study
concerns.


The collection and release of this information must
be addressed thoroughly in the informed consent
document so that it is clear to participants that their
identity will be released for the purpose of payment
and reporting.


If the study involves sensitive information and/or the
amount of compensation provided will not exceed
$600 in aggregate during the calendar year,
investigators must submit a signed

Research Study
Participant Payment Form

in addition to the
Check
Request Form


Name of Study Participant:


Was the study participant’s social security number

obtained?

Y

The study participant’s Social Security number

is:

-

-

.

N

The above named person is participating/has

participated in a research study in which subjects

have been assured that their confidentiality will be

preserved; where they have not consented to the

release of their social security number; and/or

where compensation for participation in research in

aggregate for the calendar year will not exceed

$600.

40

Questions about Compensation

How long should it take for the subject to receive their check?



Accounts Payable's standard turn around time on check request
processing is 10 business days FROM the time it is

received

in
Accounts Payable.


Those submitting the request should be cognizant
of the time it takes for the appropriate approver to approve the check
request and also the time in transit from your building to ours (which
unfortunately can take two business days.)


If alerted, AP does it's best
to expedite requests of an urgent matter.





Note Research is authorized to use American Express Gift checks to
pay for research study subjects.


Controls similar to the way petty cash
is handled such as independent accounting, logs and sign offs have to
be put in place; however in general it is allowable.


41

Questions about Compensation

Who can we call to check on the status of a check
request for subject compensation?



There are queries available in PeopleSoft that most departments
use to track the completion of their check requests (AP would be
happy to show you), end users can always call the main AP line
at 516
-
396
-
6430.





The receptionist will connect the inquiring party to the proper
person.


However before doing so, AP respectfully requests that
the end user (requestor) factor in the turn around timeline
mentioned above.


Inquires prior to considering that only serve to
slow down the process overall.

42

Questions about Compensation

If a study subject is also an employee, how
do they get paid for doing the study
-

what is
the process? Is it true that the check request
process is not used for employees?





The process for compensating employees and non
-
employees for research participation is the same


The issue is that IRS rules will definitely be triggered
and employee subjects should expect to receive a
1099 for misc. compensation

43

Grant Close Out

PeopleSoft Project IDs will be
automatically “turned off” 90 days after a
grant or contract period has ended and
there is no possibility of renewal

After this 90 day period costs will no
longer be allowed to be incurred against a
specific project without the review and
approval of Grants Financial Reporting


44

Costs Incurred After Close
-
out

The PI/PM’s Business Unit (ex. LIJ, MANH,
FIMR) retains responsibility for costs and
liabilities incurred after PeopleSoft Project ID
close out.

Charges incurred against an PeopleSoft Project
ID after close out will be evaluated by Grants
Financial Reporting and will be allocated to the
appropriate Business Unit’s operating budget.

Grants Financial Reporting will notify Site
Finance when charges are allocated.


45

Process for Special Extension

There may be times when it is appropriate to maintain a PeopleSoft
Project ID even though a grant period has ended, for example when
an awarded contract for continuation or no cost extension approval
is pending or when the award does not have a set expiration date.



A written request to maintain a PeopleSoft Project ID, including project
specific justification, must be submitted to OGC or OSP at least 60 days
prior to the end of a grant.



OGC or OSP will evaluate each request on a project specific basis in
consultation with Grants Financial Reporting.



Grants Financial reporting will notify the PI/PM and Site Finance
Director of their decision prior to grant close out.


46

For questions or further information, contact

Cyndi Hahn

Administrator, Research Compliance

516
-
562
-
2018