Transcript Document

Clinical Research Grand Rounds
Corporate Sponsors:
Working with DRDA
Elaine L. Brock, MHSA, JD
Associate Director, DRDA
May 10, 2004
Today we’ll touch on policies,
procedures, and tips dealing with:
• Nondisclosure Agreements (NDA)
• Clinical Trials
• Policies and Laws
Publication and Information
Intellectual Property
• Materials Transfer Agreements (MTA)
• Conflict of Interest
• When Things Go Wrong
Who to call in the Brock Group
Sponsors starting with:
A-B, S-T Jeff Longe (JD), jlonge, 4-9118
C-D, U-Z Krista Campeau (JD), kcampeau, 5-0672
E-K, Tom Zdeba (JD), tzdeba, 6-1292
L-R, Anna Schork (JD), meanna, 6-1356
Auto companies, various sponsor accts, Dept of Commerce, “clubs”, misc.
govt. agencies, Sharyn Sivyer, ssivyer, 6-1296
Misc., backup, whatever she wants, Elaine Brock (JD), ebrock, 3-7188
Pat Roe, patroe, 6-1289, secty. for Brock, Campeau, Longe
Sue Murphy, murwig, 7-3263, secty. for Sivyer
Jill Reed, jillreed, 4-7250, secty. for Schork, Zdeba
FAX 3-4053, 4-8510
A plea from my staff:
PLEASE provide the Project Rep with contact
information for the sponsor
AND
any correspondence, including email, that
would be helpful to understanding the project
or previous discussions between the PI and
the Sponsor.
Categorize the activity
PAF
• Conduct a project supported by $$
Research, Other Sponsored Activity, Clinical Trial
• Get information only
NDA
• Get materials only
MTA
e.g., software, prototype, biological materials
Who signs what at the University?
PI
PAF, MTF
Other forms as instructed by DRDA, IRB
Form 1572
Agreements only as instructed by DRDA
Chair, Dean
PAF, MTF
Other forms as directed by DRDA
DRDA
PAF, MTF
Proposal Applications for University
Nondisclosure Agreements
Materials Transfer Agreements
VP-Finance
Contracts
Purchase Orders, Consulting Agreements
If you need to get information from a
Sponsor, e.g., a Protocol, in order to
evaluate whether you want to conduct
a project, e.g., a clinical trial, you
may be asked to sign a Nondisclosure
Agreement or NDA.
What is a Non Disclosure* Agreement?
(*a.k.a. Confidentiality, Proprietary Information, Secrecy)
• Formal agreement signed prior to the exchange of confidential
information (nondisclosure or secrecy agreements).
• Requires receiving party to maintain the confidentiality of
designated information.
• NDAs involving University personnel acting within the scope of their
employment must be signed by an authorized University official.
NOTE: DRDA handles agreements for info. coming into UM, OTT
handles agreements for info. going from UM to a potential licensee.
Confidential Information: FOIA
Under the Michigan Freedom of Information Act (FOIA), any writing that is
prepared, used, owned, possessed or retained by the University is
subject to disclosure unless that record is specifically exempt from
inspection under FOIA.
Exemptions covered by FOIA include:
a.
.
.
.
.
f.
information of a personal nature where public disclosure would constitute a
clearly unwarranted invasion of privacy (e.g., patient records);
Trade secrets or commercial or financial information voluntarily provided to an
agency for use in developing governmental policy if: (i) The information is
submitted upon a promise of confidentiality by the public body. (ii) The promise
of confidentiality is authorized by the chief administrative officer of the public
body …[when] the promise is made. (iii) A description of the information is
recorded ….
Sponsor Confidential
Information: CRIA
The Confidential Research Information Act (CRIA) exempts from
disclosure trade secrets and commercial or financial information
voluntarily provided to the University if all the following are met:
1.
the information is covered by an authorized confidentiality
agreement entered into by the University;
2.
the information is designated as confidential before or when it is
received;
4.
a description of the information is recorded by the University
within a reasonable time after it has been received, . . .
NOTE: FOIA and CRIA are why NDAs need to go to DRDA for negotiation and
signature and why DRDA negotiates confidential information clauses in CTAs.
How do I process an NDA?
There is no University processing form for NDAs.
Send the agreement to the appropriate PR with as much lead
time, circumstances, and contact information as possible.
The PI will receive an email when DRDA assigns an SSP# to a
NDA, again when requested changes are sent to the sponsor,
and another when the NDA is fully negotiated and signed by
the University.
NOTE: Faculty, chairs, departmental administrators, etc. do not have the
authority to accept these agreements on behalf of the University.
What is a Clinical Trial (CT)?
A study on humans of the effects of an Investigational New Drug
(IND) or a device with an Investigational Device Exemption
(IDE) as defined by the FDA.
• Indirect cost rate is 25% of total direct cost (including patient care
costs, equipment, subcontracts, etc.).
• Access to the protocol is often preceded by a NDA.
• Often come to DRDA as a “Complete Package” = PAF, Protocol,
Budget, Contract
• IRB approval is required before p/g# will be given to PI.
Who does what to get a CT started?
1.
2.
3.
4.
Sponsor sends NDA; DRDA negotiates and signs it.
Sponsor sends protocol, budget, contract to PI.
PI negotiates Protocol, submits IRB application
Dept/PI negotiate budget prepare PAF.
-
Send PAF and Contract to DRDA as soon as PI
decides to do the study for available budget.
Draft Budget/Protocol OK to send with PAF.
5. DRDA negotiates contract, prepares Project Award
Notice (PAN)
6. Contract Admin. signs contract, sends to Fin. Ops.
Who are the Parties to these
Clinical Trial Agreements (CTAs)?
ACB, Inc. and
The Regents of the University of Michigan
• Investigators acting within the scope of their employment
are not parties.
• Investigators have responsibility to conduct the Study per
the Protocol and Clinical Trial Agreement (CTA) as
employees and as required by signature as an
Investigator on FDA Form 1572.
What are the issues in CTAs?
Issue
Basis for UM Negotiating Position
Publication of results
University policy, Dissertation research,
Federal regulations, Tax exempt status
Protection of Sponsor’s Confidential
Information
Freedom of Information Act
Confidential Research Information Act
Intellectual property/Inventions:
definition and rights
University policy, Federal regulations
Probability of IP, Use of preexisting IP
Ownership and use of data
University policy, Federal regulations
Tax exempt status
Liability/risk
Michigan Constitution, Assessment of risk
Other business terms, e.g.,
payment, reports
Project specifications, University procedures,
Sponsor requirements, Common sense
Proprietary Information,
Data, Publication
Agreements address various types
of information
• Proprietary or Confidential Information
provided by Sponsor
• Study Results, Data, and Case Report Forms
• Protected Health Information
• Intellectual Property
Confidential/Proprietary Information Different Basic Positions in CTAs
UM view:
All information can be freely
disseminated EXCEPT in limited
clearly defined cases.
UM is subject to the Michigan
Freedom of Information Act.
ABC, Inc. view:
All information is confidential
EXCEPT in limited clearly defined
cases.
Regents' Policy on Research Grants,
Contracts and Agreements
(publication policy)
1. "Standard Restrictions" (i.e., acceptable)
The following restrictions are outer limits of what has been routinely accepted in
research grants, contracts, and agreements by the University provided that the
principal investigator agreed to them. Restrictions which exceed these limits have
been accepted and may be accepted in the future, but they will require… [special
approval, i.e., PAF-R].
The University accepts with reluctance, and only with the concurrence of the
principal investigator, a sponsor's requirement to delay exercise of the
investigator's prerogative to determine the appropriate timing for the release of
research results. A delay is considered to begin…
Standard Restrictions, cont’d
a. Delay in publication or other dissemination of research results for a period of time
deemed reasonable for the specific agreement, but usually not to exceed 120 days, to
permit sponsor review for:
1. Comment (not for prior approval).
2. Protection of confidential information provided by the sponsor.
3. Possible participation in the protection of intellectual property.
Any publication delay of greater than 120 days shall be reported annually to the OVPR.
(If > 180 days requires PAF-R unless in exempt category b. or c., below.)
b. Delay in publication or other dissemination of research results… multi-center or
consortia project to conclude their studies.
c. Beta test agreements… where the results are not expected to be publishable as
research findings.
d. Agreement to refrain from disclosing the sponsor's confidential information for a
determinate time…
What publication terms
does the University prefer in CTAs?
•
The right to disseminate* results without Sponsor approval or
censorship
•
•
Time limited review and comment period for the Sponsor (<180 days)
OK to delay publication for limited, designated period to allow patent
application to be filed
OK to delay publication of data from site as part of multi-center trial
for limited, designated period
•
•
•
OK to allow Sponsor to require deletion of Sponsor’s confidential
information
No restrictions on use, disclosure to foreign nationals
*NOTE: Dissemination is broader than formal publication and includes the
right to disclose to colleagues, students, patients and others on an informal
basis.
Types of Data:
Case Report Forms (CRFs)
UM and Company agree that Company can own
the CRFs.
UM distinguishes ownership of the CRFs from
ownership of the information contained in them.
Health Insurance Portability and Accountability
Act (HIPAA) considerations apply.
*HIPAA in Clinical Trials



Under HIPAA, Covered Entities are required to restrict access to
and disclosure of individually identifiable health information
(protected health information - PHI) for research purposes –
therefore, if a project is not HIPAA compliant, access to
necessary data may be blocked.
Patient permission or “authorization” is usually needed to use or
share PHI for research.
Conduct of research generally is governed under federal
regulations for the protection of human subjects (the “Common
Rule”); and use or sharing of PHI for research is governed by
HIPAA.
What is Protected Health
Information (PHI)?
PHI includes all of the following:
Names
License
Numbers
 Geographic
Vehicle
Identification Numbers
All
Account
information smaller than state
(3-digit zip usually ok)
dates
Telephone
& Fax Numbers
Biometric
E-mail
Addresses
Device
Social
Security Numbers
Full
Medical
Health
Record Numbers
Numbers
Identifiers
Identifiers
Face Photos
 Any
Other Unique Identifying Number,
Characteristic or Code
Plan Numbers
NOTE: Information does not need to include diagnosis or treatment
information to be considered PHI.
Some PHI Authorization Requirements
are of particular concern to CT sponsors
Required Elements of Authorization:
What information will be used or disclosed
Who can use or disclose
Who can receive the information
Purpose of disclosures
Right to revoke authorization
Notification of any consequences of refusing to sign the authorization
(e.g., no participation in the research project)
Warning: once authorized information is disclosed, it may no longer
be protected under HIPAA
Expiration date or event (may be “at the end of the project” or
“none”)
Signature, date, and (if applicable), authority of representative to
sign
Intellectual Property (IP):
The Basics
IP Summary
Protection
Protectable Material, e.g.
Patent
Patent issued by: USPTO (after
determination that invention is New,
Useful, Non-obvious.)
Useful process, machine,
algorithm composition of
matter, ornamental design,
business process
Trade Secret
Recognition of value and utility in a
contract between parties who know
the secret.
Know-how and formulae
Copyright
Attaches to an original work once
reduced to fixed tangible medium.
Filing with US Copyright office is
optional.
Book, manuscript, music,
software
Intellectual Property Policy/Law
University policy assigns ownership of employee
developed IP to UM



Section 3.10 of the Regents By-laws
UM IP Policy (1996)
3.10 Certification signed by employees
Federal government regulation and policy controls
ownership and rights to intellectual property made using
government funds



Bayh-Dole Act
Veterans Administration acts
Agency policies


Per RFPs
Per regulations, e.g., NIST Advanced Technology Program
What Intellectual Property (IP) terms
does the University prefer in industrysponsored agreement?
•
Ownership of IP developed by University employees
•
Joint ownership if University and Company employees both invent
•
Option period for Company to decide to acquire exclusive commercial
rights
•
Resulting license will be royalty - bearing based on value of University
contribution
•
Defer decision on royalty-rate until after IP is identified
•
Retained use of the IP by University
•
Reservation of rights in the IP for the government prime sponsor
Practical Concessions Regarding IP
in Sponsor initiated CTAs:
If the Sponsor writes the Protocol to cover the Study of
a Drug that they have patent rights on and the
Investigator conducts the Study according to the
Protocol the probability of IP being developed by the
Investigator is low.
Why do we need an IP clause at all and why does it
become an issue to be discussed?
IP: ABC, Inc., Viewpoint
Companies usually recognize the low probability of inventions
not covered under the Company’s patent rights but need
freedom to practice just in case there are any inventions made
in performance of the study, particularly those that cover a
new use.
Patent law favors the inventor, i.e, the University, so absent
contractual provisions the sponsor would acquire no rights in
the University’s inventions.
Costs, Budgets, Payment
Clinical trial budget considerations:
•
•
•
•
•
•
•
What is the likelihood of completing a subject?
Can expenses be prorated by visit, procedure?
What about screen failures, dropouts?
How long will it take to “complete” a subject?
Fees - IRB, pharmacy
Upfront - advertising, pre-enrollment, recruiting
Fixed Price rule
Payment Terms in CTAs should reflect
the budget considerations in order to
maximize likelihood of covering costs.
• Progress Payments: Usually based on number of participants, events
• Pre-Payment: Upfront costs, e.g., advertising, pre-enrollment, IRB
fee, pharmacy fees
• Termination costs:
- actual cost recovery
- costs of withdrawing participants from the protocol
•Adverse Event cost:
- not covered by insurer
- addressed in informed consent
Payment of costs of related to Adverse Events
General Rule: the sponsor should cover the cost of medical care
required due to an adverse event.
Cost of study devices or drugs
General Rule: the sponsor should provide the study drug or device to
the University at no cost to the University or the subject.
To bill a subject/insurer/government/3rd party:
• IRB must approve
• the informed consent must disclose the billing to the subject
• the CTA must described the University’s obligations and be consistent
with the IRB approval and informed consent
• the administrator must know about billing procedures.
DRDA can help
If you tell DRDA about upfront costs, unusual
considerations, etc., we can try to put terms in the
CTA to protect against unrecoverable expenses.
Sponsors are not likely to propose these protective
terms unless we ask for them.
Materials Transfer
Agreements
What is a Materials Transfer
Agreement (MTA)? (Biological Materials,
Software, Prototypes, Data)
Essentially these are sponsored projects but without
funding from the sponsor. The sponsor provides the
material but someone else, often UM or NIH, pays for the
research.
A Materials Transfer Agreement* describes the conditions
under which another organization will provide requested
material to UM.
A Materials Transfer Approval Form must be completed.
*NOTE: Faculty, departmental administrators, etc., do not have the
authority to accept MTAs on behalf of the University.
What is a Materials Transfer Form (MTF)
and why do I need one?
A Materials Transfer Form informs the Chair, Dean and
DRDA of the materials to be received and the project in
which they will be used. DRDA uses answers on the MTF
to insure that the proposed use will be consistent with
UM policies, sponsor conditions, informed consent, and
overlapping agreements or licenses.
How do I process an MTA?
The PI requests the material from a Provider. (DRDA is not usually
involved in the initial request to the Provider.)
The Provider sends an agreement.
Administrator completes an MTF and has it signed by PI, Chair, Dean.
The signed MTF is sent to the appropriate PR with the agreement and
the request. (Provide as much lead time, circumstances, and contact
information as possible.)
The PI will get a an email when DRDA assigns an SSP# and PR to a
MTA, and another when it is completed and signed by the University
after the PR has negotiated any changes.
Clarification
When the transfer of material or the exchange of
confidential information occurs in a project
financially sponsored by the provider of the
material or information these issues will be
addressed in the sponsored research agreement
and approvals covered by a PAF.
Conflict of Interest
Conflict of Interest Management
Underlying Premise
“You do not have to do anything
improper to have a conflict of interest;
it is strictly situational”
Paul J. Friedman
Financial Disclosures
• FDA Financial Disclosure Rule
1. Title 21 Code of Federal Regulations Part 54
2. Effective February 2, 1999
• Sponsor Financial Disclosure Form
• University Financial Disclosure/Conflict of
Interest Disclosure
Disclosures to Sponsors (e.g., NSF, NIH)
(Keeping Jim, Elaine and Marvin out of jail)
The submission of the proposal is Certification by Authorized
Institutional Representative that the institution has implemented
and is enforcing a written policy on conflicts of interest consistent
with the provisions of Grant Policy Manual Section 310; that, to the
best of his/her knowledge, all financial disclosures required by the
conflict of interest policy were made; and that actual or potential
conflicts of interests, if any, were, or prior to funding the award,
will be satisfactorily managed, reduced or eliminated in accordance
with the institution's conflict of interest policy or disclosed to NSF.
Disclosure by Clinical Trial
Sponsor to FDA
“As the Sponsor of the submitted studies I certify that I have
not entered into any financial arrangement with the listed
clinical investigators (CI) whereby the value of compensation to
the investigator could be affected by the outcome of the study. I
also certify that each CI required to disclose to the sponsor
whether the investigator had a proprietary interest in this
product or significant equity in the sponsor did not disclose any
such interests. I further certify that no CI was the recipient of
significant payment of the sort defined in 21CFR 54.2*
(Form 3454, 3455)”
University-wide Policy and Procedures for Dealing
with Financial Conflicts of Interest in Sponsored
Projects and Technology Transfer
(1) The University of Michigan will exercise care in accepting or entering
into sponsored agreements in which the faculty investigators or
professional staff involved (or, to their knowledge, their spouses or
dependents) have interests that create conflicts. Such agreements will
not be accepted if the conflict:
(a) can be expected with reasonable certainty to compromise the
integrity of those investigations or undermine the employee's
obligations to the University, to the sponsor, or to students; and
(b) cannot be satisfactorily managed with appropriate administrative
oversight
It all starts with disclosure.
PAF Instructions; CONFLICT OF INTEREST
Conflict of Interest -- Certain financial or management interests held by key
investigators or their families in sponsors of research or entities directly
related to the sponsored project requires disclosure and review. More
information* about conflict of interest and Procedures for disclosing and
managing conflict*
The Principal Investigator is responsible for ensuring that every key
investigator of the proposed research has either (a) certified that he or she
does not have a significant financial interest or (b) has disclosed such
interest(s) on an official disclosure form*.
*http://www.research.umich.edu/policies/um/conflict_of_interest.html
Medical School Disclosure
Faculty members are to prospectively disclose outside activities to
their Department Chair, who will approve based upon adherence to
Medical School policy. Faculty members are to indicate if a
potential Conflict of Interest exists. It is the responsibility of the
faculty member to read and understand the Conflict of Interest
Policies of the Medical School.
The guidelines are available online at:
http://www.med.umich.edu/med school/orgs/Research Policies
Some Conflicts of Interest have to be
approved by a two-thirds vote of the Board
of Regents.*
Those involving contracts, including license agreements,
research agreements, purchase orders, leases, between the
University and any entity, non-profit or for-profit, in which a
University employee, directly or indirectly, is an owner,
officer, director, partner, or member.
*NOTE: Since the Regents meet only 8 times per year this may mean a
delay in getting a sponsored activity or license signed by the
University.
Conflicts of Interest in sponsored research can
arise from Roles of Investigators relative to the
the Sponsor, Trainees, other Participants
Consultant to Licensee, Sponsor



Product development
Scientific Advisory Board member
Review of other technologies, research areas
Management of Company that is a Sponsor, Licensee

Director, Officer
Investigator on Research Contract from Licensee
Leave of Absence/Sabbatical/Split Appointment - Employee
at Company
Supervisor and Mentor of employees/students of University
and Company
Avoiding Overlap is Critical
Consulting A
Licensed IP
Research Project 2
Scope of UM
employment
Research Project 1
Consulting C
Licensed IP
Consulting B
Management plans protect basic values of the
University against risks posed by entrepreneurial
activity. Basic values of the University include:
• Objectivity of research
• Open and timely publication of research results
• Appropriate use of sponsor and University funds
• Fulfillment of obligations to colleagues
• Fulfillment of obligations to trainees/students
• Fulfillment of administrative duties
• Integrity of academic decision-making
• Appropriate transfer of intellectual property
• Full informed consent of human participants
When things go wrong.
No $$$$ from Sponsor
• Watch your accounts!
• Check cash balance and payment status before
asking for nctx (no cost time extension).
• Watch for Past due Notices from Fin OPs
• Check with DRDA - maybe we can help mediate.
• Department is responsible for bad debt.
• Turning project over to a collection agency could
cost 30% - department absorbs loss.
Breach of Contract by UM
Consequences of UM’s failure to perform:
- Termination and loss of funds
- Injunction forcing performance or some activity, e.g.,
disclosure of results
- Willful breach could be misconduct by PI, others
DRDA can build some protections into exceptional
contracts that need them:
-
Extra insurance (included in project budget?)
Unemployment compensation (escrow)
Nonrefundable payments if terminated without cause
Costs of withdrawing subjects from protocol
Proliferation of laws and regulations
affecting University/Industry
relationships, e.g.:
• NIH, NSF Conflict of interest policies (effective July 1995), NSF
http://www.nsf.gov:80/bfa/cpo/gpm95/ch5.htm#ch5-6
• FDA Financial Disclosure Rule (effective February 2, 1999) 21CFR 54,
http://www.fda.gov/oc/guidance/financialdis.html
• Generic Drug Enforcement Act of 1992 (use of debarred or convicted individuals)
21USC 335b,
http://www.fda.gov/opacom/laws/lawtoc.htm
• Stem Cell Research regulations (various)
http://www.nih.gov/news/stemcell/index.htm
• Health Insurance Portability and Accountability Act (HIPPA), (effective 4/14/03) 45
CFR 160, 164
• FDA Human Cell and Tissue Products, (effective 1/31/03) 21 C.F.R. § 1270 et seq
http://www.fda.gov/cber/tissue/issue.htm
• Export Controls, Use of Foreign Nationals, Control of Dangerous Substances - flurry
of activity since 9/11, See Council on Governmental Relations site for summary
http://www.cogr.edu/restricted/index.htm (Note: umich.edu domain access only)
What can you do to move CTAs faster
and make them run more smoothly?
•
Get things to DRDA promptly after you get them.
•
Stay in touch with your project rep.
•
Read the Protocol, Informed Consent, and Contract!
•
Talk to DRDA before making commitments to the Sponsor.
•
Identify Sponsor clearly (Provide contact information!).
•
Answer PAF or MTF questions as fully as possible.
•
Secure IRB, IACUC, BioSafety Level approvals promptly.
Moving CTAs faster, cont’d
•
Read the PAN and the Agreement as soon as you get
it. Report errors to DRDA.
•
Identify related IP that will be involved at the
proposal stage.
•
Identify conflicts of interest at the proposal stage.
•
Tell PR what your timing needs are.
•
Clarify/Understand your role and obligations relative
to those of DRDA and FinOps.
HIPAA Questions
Contact [email protected] if you have any questions about
the Privacy Rule or applicable UMHS policies or procedures; or if you
would like to make a complaint.
Contact the Health System Legal Office at 734-764-2178 if you have
any legal questions.
Contact IRBMED at 734-763-4768 if you have any questions about
IRBMED forms or procedures. Visit IRBMED’s HIPAA website often for
HIPAA research updates at:
http://www.med.umich.edu/irbmed/NewIRBMEDHIPAA.htm
For more information about the Privacy Rule, visit
www.dhhs.gov/ocr/hipaa.
Websites of Interest:
More about NDAs:
http://www.research.umich.edu/policies/um/nondisclosure.html
More about MTAs:
http://www.research.umich.edu/projects/transfers/materials_transfer.html
More about UM Tech Transfer, IP policy:
http://www.techtransfer.umich.edu
More about UM Copyright policy:
http://www.copyright.umich.edu.copyright.umich.edu
More about Publication and Exceptions to policy:
http://www.research.umich.edu/policies/um/Regents_policy.html
More about COI - University policy:
http://www.research.umich.edu/research/policies/um/conflict_of_interest.
html
Audience Comment
I just want you to reemphasize, we’re
seeing a lot of PI’s interacting with us
saying that there assume that you’re also
negotiating the financial contract, meaning
the budget. Your office doesn’t do that,
that’s up to the PI to do that and there are a
lot of misconceptions about that.
Audience Question
“So do we have to decide on a final budget
number before sending in the packet?”
Audience Question
“We had a new one that came up last week that I
actually bounced over the Office of Research and
Graduate Studies… a number of other major
academic medical centers are charging for
document storage space, because you have to
retain documents for a certain period of time and
its costly to do so. And the information I got back
sort of informally is that that should already be
covered in our indirect cost and I was wondering
what your read on that was?”
Audience Question
“Non disclosure agreements… a lot of times we
might have different roles with industry and we
might start out and we might start out by being a
consultant with them where we don’t necessarily
need DRDA or the university to sign the non
disclosure agreement but then that morphs them to
where there might be sponsored research that
occurs at the institution. If that occurs … do we
then have to take a new NDA and get that signed?
And until there’s a sponsored research agreement
with the university there isn’t a requirement?”
Audience Question
“I just want to clarify… you don’t have to have a
written IRB approval before you work on
something?
That’s been drilled into my head since I’ve been
here and I honestly have gotten a little tired of
doing IRB stuff and waiting for IRB renewals
when I don’t even have a contract signed.”
Audience Question
“Is there a claim eventually for your office to
be hooked in with the M Prime system so
that there would be some sort of automatic
notification or parallel processing or is that
going to be incumbent on the investigators
to do that?”
Audience Question
“The topic of incentive payment has come up
again recently and I can’t find policy on the
web anywhere to refer someone to incentive
payments for equipment to spur
improvement..”
Audience Question
“It seems like they are still offering quite a bit
of trips and other things.
Is there going to be something written down
that we can point people to or is it just
going to stay in a form?”
Audience Question
“If you go anywhere else you won’t find
anything as good as the DRDA.
What’s the current status of the PEERS self
education and certification process related
to writing checks?”
Audience Comment
“If you are getting NIH money you have to at
least do the human subjects and conflicts of
interests modules.”