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HCCA Compliance Institute
Hot Topics and Emerging Issues
in Research Compliance
Presented by:F. Lisa Murtha, J.D., CHC
Sonnenschein Nath & Rosenthal, LLP
(215) 801-7824
And
Holley Thames Lutz, Esq.
Sonnenschein Nath & Rosenthal, LLP
(202) 408-6836
And
Ryan D. Meade, Esq.
Meade & Roach, LLP
(773) 472-3975
INFORMED CONSENT
3
Human Subject Protections
Tuskegee study and the Nuremberg cases opened eyes to abuses in research
This led to the Belmont Report (respect, beneficence, and justice)
Led to increased monitoring of informed consent
Led to increased regulation
Oct 1, 2000-Required education in the protection of human subjects for all investigators submitting NIH applications for grants or proposals
4
The Common Rule
Compliance with federal regulations for the protection of human subjects is an obligation whenever biomedical or behavioral research is conducted or supported by any of 17 U.S. government departments or agencies, or whenever research is subject to regulation by the FDA
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Who are the regulators?
Food and Drug Administration (FDA)
The FDA published regulations for human subject protections in 1981 as a response to the National Research Act of 1974 and the 1979 Belmont Report on research ethics.
The FDA Human Subject Protection Regulations govern research on drugs, biologics, and devices regardless of study sponsorship.
6
FDA Regulations
Regulatory References for Drugs and Devices
Code of Federal Regulations: 21 Parts 312, 314, 600, 812, and 814
7
FDA Authority
FDA works with individuals, companies, and institutions to help promote compliance with rules that govern clinical research - the FDA has discretion to:
extend review of applications
send warning letters with documented concerns
disqualification / debarment of individuals
disqualification of institutions and/or IRB
other sanctions (i.e., seizures, injunctions)
8
FDA Authority
The FDA monitors research through review of required reports from investigators, sponsors, institutions, and IRBs as well as through a program of on-site inspections and audits
Investigators of FDA-regulated studies must sign Form FDA 1572 (Investigator’s Statement)
9
OHRP
45 CFR 46-Basic DHHS Regulations for the Protection of Human Research Subjects
Additional protections for vulnerable populations in subparts B-D
Govern research that is supported by several federal government agencies
10
The Belmont Report
Institutional Assurances
IRB Review
Informed Consent
11
IRBs
IRB is a medical staff committee with broad power in oversight of clinical research and the protection of human subjects
IRB determination is FINAL
Among other things, the IRB reviews the Informed Consent Documents to determine adequacy and appropriateness
IRB must remain independent
12
Informed Consent Requirements
45 CFR 46.116
50 CFR 20-27
Per the Belmont Report, consent must be:
• informed
• understood
• voluntary
Consent forms should reflect, in language that is understandable to volunteers, all relevant information about the study
13
Informed Consent Process
(Subject recruitment materials, verbal instructions, written materials, question/answer sessions, agreement documented by signature)
It contains:
• Information
• Comprehension
• Volunteerism
The “reasonable subject” standard should be used
“Comprehensiveness” is key
14
Interesting Case
Quinn v. Abiomed, Inc. et alNo. 001524, C.P. Phila. Co. Oct. Term 2002
subject received experimental artificial heart
“therapeutic misconception” theory
role of patient advocate on informed consent process
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Informed Consent Requirements-21
CFR 50.25Introduction (“This is research”)
Purpose of study
Description of study procedures (“experimental”)
Duration of subject involvement
Potential risks or discomforts of participation
Potential benefits of participation
Alternatives (treatments, other research, etc.)
Confidentiality of records statement
Compensation for injury statement (for greater- than-minimal-risk studies)
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Informed Consent Process
Contact persons
Statement of voluntary participation
Unforeseen risks
Reasons for involuntary termination of participation
Additional costs to participate
Consequences for withdrawal
New findings statement
Number of subjects
Payments (incentives, etc.)
17
Who Can Sue?
Subjects can sue
Families can sue for wrongful deaths of loved one
Parents can represent their children
The government can sue, prosecute, or take administrative action
Sponsor, institutions, and researchers can sue each other over sponsored research
18
Who Can Sue?
Groups of subjects can commence a Class Action:
380 women sued Tampa General Hospital for performing medical experiments on them including multiple amnios when they were pregnant, allegedly without their consent
Claim was for violation of right to be treated with dignity and to be free of unwanted treatment
Diaz v. Hillsborough County Hospital Auth.,
M.D. Fla. August 7, 2000 (Settlement)
19
Who Can Be Sued?
Robertson v. McGee (N.D. Okla. 2002)
Plaintiffs in melanoma study alleged lack of consent because defendants failed to follow federal human subject regulations and failed to notify plaintiffs of lack of compliance.
Defendants included Oklahoma University School of Medicine at Tulsa, University administration, as well as individual IRB members
Partial settlement includes IRB members
20
How Much Should Be Disclosed?
Gelsinger v. University of Pennsylvania
(C.P. Phila. Co., 2000)18 year old with OTC, a rare metabolic disorder, entered a gene transfer clinical trial as a volunteer
Principal investigator at Penn’s Institute for Human Gene Therapy was also founder of Genovo, Inc., which had a business arrangement with Penn
Information given during consent process did not mention:
• monkey deaths
• previous adverse events
• relationship between principal investigator, University of Pennsylvania, and Genovo, Inc.
After injection of adenovirus vector, subject died
Confidential settlement reached
21
Are Expectations Different for Non-
Therapeutic Research?
Death of healthy volunteer at Johns Hopkins (2001)
volunteer was employee
incomplete research by investigator alleged
no lawsuit filed, but OHRP acted
led to state legislation on IRB activities
22
Criminal Implications of Fraudulent
ResearchUnited States v. Paul H. Kornak (Criminal Action No. 03-CR-436 (FJS))
Defendant was investigated and prosecuted criminally for various false statements and related frauds resulting in the death of a research participant involved in cancer cooperative research conducted at a VA Hospital in NY
The false statements included untrue facts resulting in inclusion of participants who did NOT meet the study inclusion criteria
The Defendant’s activities resulted in losses to the sponsors of the studies involved in excess of $500,000
Penalties include jail time and reimbursement
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Preventing Litigation Through
OversightRelationship with Subject
recruitment
consent process
continuing communication throughout the study
Relationship with IRB
accreditation of institution’s human subject protection program
use of external IRBs?
24
Preventing Litigation Through
Oversight
Relationship with Subjectsponsored research agreement
financial relationships
reporting responsibilities
investigator-initiated research
Research Integrity and
Scientific Misconduct
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Risk Areas In Scientific Misconduct
Collaboration
Intellectual Property
Data Acquisition and Management
Falsifying Data on CRFs
Suppression of Data
Falsification, fabrication and plagiarism
Students As Investigators
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Conflicts of Interest
28
Why Are Conflicts A Problem for
Organizations Conducting Research?May endanger human subjects’ safety
May jeopardize public’s faith in findings and/or lead them to question whether the investigator is acting in their best interest or merely using them as a vehicle for conducting research
May reduce the public’s willingness to participate in studies
May inhibit future discoveries if less support for research
OIG 2005 Work Plan identifies “financial conflicts of interest” as a focus area
29
Definition of Conflicts of InterestA Conflict of Interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.
Conflicts of Interest always involve the use of a person’s authority for personal and/or financial gain.
Conflicts may involve both individuals and institutions
30
Public Health Service RegulationsAffects PHS governed agencies, such as the National Institutes of Health (NIH)
Regulations are found in: 42 CFR Part 50, Subpart F
Under the regulations, an investigator must disclose:
Any “significant financial interest” in entities whose financial interests might be affected by the research, and require the institution to designate an “institutional official(s)” to solicit and review the financial disclosure statements made by investigators
31
PHS Definition
PHS regulations define a significant financial interest as:
Income (salary, royalties and other payments) which when aggregated for the investigator, an investigator’s spouse or dependent children exceeds $10,000 over twelve months OR
An equity interest (including spouse and dependent children) in excess of $10,000 or 5% ownership in a single entity
32
Management of COIs
The Institution, not PHS, selects the method for gathering information from investigators, determining if a COI exists, and if any COI that exists is properly managed
If an institution determines that an investigator has a conflict, it must report that conflict to the “PHS awarding component and explain whether the conflict has been managed, reduced or eliminated.”
33
FDA COI Policy
Regulations are found in 21 CFR Part 54
Form FDA 3455 is the form used to make disclosures
FDA form is only for the clinical investigators
Form asks for:
Payments coupled to results
Compensation in the form of equipment, retainer for ongoing research or honoraria
Any proprietary interest in the product tested
Any significant equity interest held by the clinical investigator in the sponsor of the study.
34
PHS and NIH Regulations
Both the PHS and FDA regulations demand reporting of financial interests only.
They do not require any recusal by the researchers with a conflict of interest
There is no requirement for notification to research subjects
35
IRBs and Conflict of Interest
IRB conflict of interest issues are regulated under:
45 CFR 46.107(e)
21 CFR 56.107(e)
Under these regulations, “No IRB member may participate in initial or continuing research in which they have a conflicting interest except to provide information requested by the IRB.”
If a conflict is found, an IRB member must recuse him or herself.
36
Regulation Compliance
If an institution has an IRB, conducts research that is FDA regulated, and receives PHS funding, it must follow all three sets of regulations.
37
Most Recent Guidance
Department of Health and Human Services (DHHS) – “Financial Relationships in Research Involving Human Subjects: Guidance for Human Subject Protection” (Federal Register May 12, 2004)
Available at:
http://ohrp.osophs.dhhs.gov/references/fr03-7691.pdf
38
DHHS Guidance RecommendationsThe Guidance asks: Would the rights and welfare of human subjects be better protected by any or a combination of the following:
Reduction of the financial interest
Disclosure of the financial interest to prospective subjects
Separation of responsibilities for financial decisions and research decisions
Additional oversight or monitoring of the research
An independent data and safety monitoring committee or similar monitoring body
Modification of role(s) of particular research staff or changes in location for certain research activities, e.g., a change of the person who seeks consent, or a change of investigator
Elimination of the financial interest
39
How Should An Institution Respond to the Problem of COIs?
Objective:
The goal of an institution’s conflict of interest/conflict of commitment policy should be to:
• Protect the institution
• Protect those who volunteer to participate in the research
though management of financial, relationships that create the potential for conflicts of interest
40
Where is the Issue of Conflict of
Interest Going From Here?
Greater focus on the issue from Congress
Increased regulation and guidance from PHS, FDA, OHRP, and other federal agencies
Universities will need more precise policies and procedures which lay out not only a definition of conflict of interest, but also policies and procedures for identifying, disclosing, and handling conflicts of interest
41
The Penalty for Failure
Several recent civil lawsuits have linked failure to manage potential conflicts of interest to human subject harm.
Defendants have included: investigators, administrators, IRB members, sponsors, patient advocates.
Who is next???
42
Effort Reporting
43
Effort Reporting Old Issues – New Focus4 cases: 2 civil, 2 criminal$5.5 million settlement - Northwestern University
qui tam lawsuit, False Claims Actreview of 1995-2001 faculty effort“knowingly or recklessly overstated salary rates for faculty”faculty did not devote committed effortUniversity lacked system to reconcile proposed effort and actual effortUniversity knowingly made false statements
$2.6 million settlement – Johns Hopkins University
faculty did not devote committed effortovercharging for fringe benefit cost
Investigation - Harvard Medical Schoolinternal review reported to NIH resulted in DOJ investigation
44
Effort Reporting Requirements
48 CFR Part 31 (For Profits)
OMB Circular A-21 (Universities-every “term” reporting)
OMB Circular A-122 (Non-Profits)
45 CFR Part 74, Appendix E (Hospitals-every month reporting)
45
Defining Effort Reporting
What is effort reporting?
A means of verifying that:
–The % effort expended by research personnel on various activities is commensurate with the % of salaries and wages charged to those accounts
–Cost sharing commitments were met
–Total effort commitments were met
–Appropriate treatment of costs in indirect cost rate
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Defining Effort Reporting (contd.)
Why have effort reporting?–Federal requirement for all recipients of federal funds
–Labor related charges generally comprise the majority of direct research costs
Labor charges typically represent about one-half to two-thirds of direct charges on sponsored projects.
47
Effort Report ScopeEffort reports must reflect all compensated activities, including those efforts not federally funded such as instruction, governance, and academic advising.
Activities within the scope of the employment relationship are considered compensated.
OMB Cir A-21 J8a notes that “compensation for personal services covers all amounts paid currently or accrued by the institution for services of employees rendered during the period of performance under sponsored agreements.”
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Reporting Basis
Effort reports should be prepared on a percentage basis so as to assure consistency with award terms and utilize flexibility by regulation.
OMB Circular A-21 J8c(2)(b) states: “These reports will reflect an after the fact reporting of the percentage distribution of activity of employees.”
OMB Circular A-21 J8b(l)(c) states: “…it is recognized that research, service, and administration are often inextricably intermingled. A precise assessment of factors that contribute to costs is not always feasible, nor is it expected.”
49
Certification
Effort reports must be certified by an individual with full knowledge of all aspects of the employee’s effort. Reports should be certified by the employee whenever possible, but may be approved by the PI or Chair in the employee’s absence.
Assessments of payroll and effort consistency should occur by reporting period, permitting variations between effort and payroll by pay period.
50
Cost Sharing
Effort reports serve a critical role in documenting cost sharing commitments. Only the cost sharing that has been committed to the sponsor need be reported in the effort reports. University/hospital guidance should address the types of cost sharing and institutional reporting policy.
51
External Activities
OMB Circular A-21 J8a states that “Charges to sponsored agreements may include reasonable amounts for activities contributing and intimately related to work under the agreements, such as delivering special lectures about specific aspects of the ongoing activity, writing reports and articles, participating in appropriate seminars, consulting with colleagues and graduate students, and attending meetings and conferences.”
52
Summary
The method for verifying effort must:
Reasonably reflect the activity for which an individual is paid by the University
Reflect all of these activities performed by the individual (except…)
Include after the fact confirmation to ensure that charges reasonably approximate estimates of effort
Be performed by a responsible individual who can verify that the work was performed
53
Effort Reporting: A Typical Effort Report
NIH Grant ANIH Grant B
Organized Research
CTA – BigPhara Inc.
Other Sponsored Activity
10%10%
20%
Charged % Actual Effort %
Total Effort 100%
By signing this statement, I certify that the effort distribution reflected above is reasonable relative to the work performed …
Signature Date
Teaching 20%
Departmental Administration 10%
Patient Care 20%
Research Admin 10%
54
Recent Changes and Updates in Clinical
Research Billing
55
Why is this an issue?Medicare “double billing” has been the subject of numerous OIG/DOJ investigations/settlements
OIG 2004-2009 Work Plans include Clinical Trial Billing in its top “compliance” initiatives
OIG 2005-2009 Work Plans include numerous other initiatives, including Time and Effort Reporting, and Privacy Compliance.
From a research and business perspective, it is important to track clinical care/standard of care vs. “research only”
56
Challenges in clinical trial billing
Most billing systems were not constructed with research in mind
Research organizations are typically separate from clinical billing departments, thus requiring a strong systems link or strong communication
Research is decentralized and Investigators/Coordinators often find “workarounds”
57
Financial Management
Considerations
ComplianceResidual Billing—Could be viewed as a kickback
Finders fees or other incentives—is this an inducement to investigators to cram subjects into studies?
Double Dip—payments from grants/trials and insurers
58
Clinical Trial Billing
Clinical Trial Billing should be viewed as a business cycle—including all financial and administrative aspects of the process…….
59
Critical Areas of the Process:
Budget Preparation
Protocol Approval
Consenting Subjects/Informed Consent
Registration of Subjects
Billing Requirements
Treatment of Residuals
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Key Members of the ProcessInvestigators
Contracting Office/Tech Transfer
Research Finance/Billing
CTCs
Registrars
IS Staff
HIM Dept.
Pharmacy and Lab Support
61
Consider ContingenciesWho is responsible for the cost of services resulting from adverse events?
Will the sponsor pay for additional tests and procedures if they are requested during the course of the trial?
Indemnification language appropriate?
How much is provided for trial start up—e.g. screening costs
Under what conditions are additional payments made? (Expectations for timely payment or penalties for non-compliance?)
62
Prepare a Billing Plan
Knowing the costs of the study is not enough—Need to know who will pay which costs and have a plan to promote timely and appropriate billing of trial costs
Develop a billing plan that clearly differentiates between costs borne by sponsor and costs borne by other parties
63
National Coverage Decision
NCD (9/19/00) Defines requirements and procedures for submitting “routine costs” associated with “qualifying”clinical trials
Available at http://www.cms.gov/quality/8d2.htm
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Compliance Issues with Clinical Trial
Residual Balances
Unrelated Business Income Tax (UBIT)
Private Inurement
Conflict of Interest
Anti-kickback consequences
65
Changing Your Clinical Trial Billing
Process
Develop your workgroup
Hire some technical resources if necessary
Develop process work flows and roles/responsibilities
Pilot the new process
In-service staff
Roll-out
66
Clinical Research Billing
In response to a June 7, 2000 Executive Memorandum, issued by President Clinton, requiring Medicare to pay for routine carecosts in clinical trials, the Health Care Financing Administration (HCFA)* implemented a Clinical Trial NCD on September 9, 2000. On July 10, 2006, CMS began the first reconsideration of the Clinical Trial Policy NCD. On December 13, 2006, CMS organized a Medicare Coverage Advisory Committee (MCAC)** public meeting at their head office in Baltimore, Maryland to re-evaluate the current Clinical Trial Policy. On April 10, 2007, CMS released their proposed revisions to the Clinical Trial Policy NCD with a 30-day public comment period.On July 9, 2007, CMS released their final decision memorandum on the Clinical Trial Policy NCD.
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Clinical Research Billing
Within the July 9th decision memo, CMS indicated opening of a second reconsideration process for the clinical trial NCD to provide the public with additional opportunity to respond to theproposed changes. Ten days after the release of the decision memo, on July 19, 2007, CMS released their proposed decision memorandum for second reconsideration of the clinical trial policy with a 30-day public comment period.To facilitate discussions among the public, the stakeholders andthe CMS on the proposed CRP NCD, CMS held a special open door forum (ODF) on August 7, 2007.The final decision memo for the second reconsideration process was issued on October 17, 2007.
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Clinical Research Billing-The CTP
The coverage remains the same.
“Effective for items and services furnished on or after July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply.”
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The CTP
What are the Key Tests to Determine if the Costs of a Trial are Coverable?
Is it a qualifying clinical trial?
Are the items and services routine costs?
Are the routine costs reasonable and necessary? (i.e., does Medicare generally cover the services outside a clinical trial?)
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CTP
Any clinical trial receiving Medicare coverage of routine costs must meet the following four requirements:
1. The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
1. The trial must have therapeutic intent. It cannot be designed to test toxicity or disease pathophysiology, exclusively. (Note: we discuss this in a greater detail later in the presentation…)
2. Trials of therapeutic interventions must enroll patients with diagnosed disease. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.
3. The clinical trial must be “deemed”.
71
The CTP
A trial is “deemed” to automatically meet the seven desirable characteristics if it is:
funded by NIH, CDC, AHRQ, CMS, DOD, or the VA;
supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD or the VA;
conducted under an investigational new drug application (IND) reviewed by the FDA; or
a drug trial that is exempt from having an IND under 21 CFR 312.2(b)(1).
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The CTP
The four types of deemed trials are “deemed” to have the following seven desirable characteristics (self-certification was not adopted):1. The principal purpose of the trial is to test whether the intervention
potentially improves the participants' health outcomes; 2. The trial is well-supported by available scientific and medical
information or it is intended to clarify or establish the healthoutcomes of interventions already in common clinical use;
3. The trial does not unjustifiably duplicate existing studies; 4. The trial design is appropriate to answer the research question
being asked in the trial; 5. The trial is sponsored by a credible organization or individual
capable of executing the proposed trial successfully; 6. The trial is in compliance with Federal regulations relating to the
protection of human subjects; and 7. All aspects of the trial are conducted according to the appropriate
standards of scientific integrity.
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The CTP
Alternative: CMS will cover the routine costs of clinical trials that are subject to the CED process:
The CED process can add additional requirements.
A special NCD will be issued for CED trials.
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The CTP
Routine costs in clinical trials include items and services:
For which there exists a benefit category;
That are coverable by Medicare outside of a clinical trial;
That are typically provided absent a clinical trial (e.g., conventional care);
Required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
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.
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The CTP
Routine costs in clinical trials exclude items and services:
That are investigational, unless otherwise covered outside of the clinical trial;
That are statutorily excluded;
For which there is a national non-coverage decision;
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
Provided by the research sponsors free of charge for any enrollee in the trial.
As mentioned earlier, the italicized text is the new language added to the July 9, 2007 CTP.
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The CTP
Additional items of note:
Complications: Medicare will cover treatment of complications (even in a non-qualifying clinical trial) as long as the treatment of items and services are generally covered by Medicare.
Non-covered items and services: if an item or service is not covered by virtue of a national non-coverage policy and is the focus of a qualifying clinical trial, the routine costs of the clinical trial (as defined above) will be covered by Medicare but the non-covered item or service, itself, will not.
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The CTP
How to determine what is reasonable and necessary?
Whether an item or service is reasonable and necessary is the basis of most NCDs and LCDs.
NCDs and LCDs determine whether an item or service is reasonable and necessary.
If there is not an NCD or LCD addressing the item or service and the item or service is not statutorily excluded, then determining whether an item or service is reasonable and necessary is a question of clinical judgment and the physician should document in the medical record that the item or service is medically necessary
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The CTP
CTP remains vague on the coverage for medical devices.
The CTP says the following about devices:
“This policy does not withdraw Medicare coverage for items and services that may be covered according to local medical review policies (LMRPs) or the regulations on category B investigational device exemptions (IDE) found in 42 C.F.R. §405.201-405.215 and §411.15 and §411.406.”
IDE devices should continue to follow the device trial regulations
79
The CTP
On October 17, 2007, in addition to the decision memo, CMS posted seven frequently asked questions and answers. Within this document, CMS has encouraged providers to seek clarification from their local Medicare contractors (i.e., Medicare Carriers and Fiscal Intermediaries) for trials that do are meet CTP’squalifying criteria. In addition, CMS said that it will revise its policy through formal “rulemaking,” which means through a formal regulations process (e.g. Code of Federal Regulations (CFR)) instead of the NCD process.
However, no timeline was provided by CMS.
80
Therapeutic Intent
Approach 1: Apply the primary objective test and consider a study a QCT only when one of the primary objectives is to measure therapeutic benefit
Do not bill Medicare for items and services required by a non-QCT
Negotiate sponsor to cover all costs of Phase I non-QCTs
Approach 2: A provider should ask its local Medicare medical director what test should apply in the region
If CMS is not going to issue any more clarifications, then with full disclosure of CMS statements, providers can make argument to medical director that therapeutic intent can be met by any objective
After the issuance of the October 2007 CTP, if a provider does not adopt Approach 1, the prudent approach is to consult the provider’s local Medicare medical director
81
New Research Modifiers
On January 18, 2008 CMS issued transmittals eliminating the QV, QA and QR modifier – retroactive to January 1, 2008.
New modifiers:
Q0: “investigational clinical service”Q1: “routine clinical service”
What should providers do?
1. Every study must sort the protocol required services to determine which are the “investigational clinical services” and which are the “routine clinical services”2. Institute a process to appropriately place modifiers on claims3. Consult Medicare contractor to determine if the contractor can accept the modifiers yet
82
Clinical Trial Number
Encourages providers to place clinical trial number on claim –this is voluntary for providers
Requires Medicare contractors to accommodate receiving clinical trial number
Requires contractor to “generate one monthly report…to CMS data center” that identifies:
use of the clinical trial numbersuse of the new modifiersnumber of clinical trial claimsnumber of patients
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Other Hot Topics
84
Other Hot Topics
Subject Related Injury, MSP and Related Research Billing Issues
OHRP Guidance on Research Involving Coded Private Info. or biological specimens (See OHRP website)
Investigator Initiated Research
Innovative Care vs. Research
FDA final guidance on clinical holds for Investigator Misconduct
85
Questions/Discussion
