PUI ComplianceAssessment and Design of a

Realistic Compliance Program

Taking Stock of the Regulations

• Determine campus stakeholders

o Assess acceptance of readiness for changeo Assess operational capabilityo Cultivate champions for communication and education of different

campus groups

• Determine core compliance requirements

o What is a must for compliance?o What is needed to demonstrate compliance?o Formulate a timeline for implementation

How big is your elephant?

No matter how big, you eat it one bite at a time.

Assessing Compliance Risk – Step 1

• CONSIDERING THESE AREAS OF RISK:

Legal – Read the current periodicals and regulatory policy Safety – Watch the news and internet sources Financial – Talk internally and network with colleagues, read industry publications Reputation – Read, watch, talk and be alert to risk (social media)

• PREDICTING THE POTENTIAL IMPACT OF NON-COMPLIANCE IS NECESSARY to make an assessment

o Significant Impact – Effect is Immediate and drastico Moderate Impact – Effect is meaningfully experiencedo Low Impact – Effect is either short-lived or slow and painless

Assessing Compliance Risk – Step 2

• LIKELIHOOD OF OCCURRENCE (dynamic and endemic to campus environment of controls)

o Almost certain >50%o Moderate or probable, but not likely <50%o Low or remote <25% and NOT a Compound Effect*

• Analyzing the Compound Effect of Impact and Likelihood across multiple areas of risk is necessary to make a comprehensive assessment

Do’s and Don’ts of Compliance

DO DO NOT• Include other areas in

policy formation…Find out how information is interpreted and used by others.

• Examine the current state of non-compliance…Point out highest risk and impact areas.

• Plan, do, check…Feedback mechanisms are critical in compliance.

• Make policy in a vacuum… Realistically assess what can and will be done.

• Bury your organization’s head in the sand…Notify affected areas of compliance needs and changes (warning: your facebook “likes” will decrease).

• Set it and forget it…This method only works on an infomercial.

Responsible Conduct of Research + Rowan University: Perfect

Together

RCR BeginningsAmerica Creating Opportunities to

Meaningfully Promote Excellent in Technology, Education, and Science Act of 2007

“To invest in innovation through research and development, and to improve the

competitiveness of the United States.”

What did it mandate?

Stated RCR Agency Requirements

NSF – mandated

• Postdoc mentoring plan

• RCR training for undergrads, grads, postdocs

• Sharing of final project reports

NIH – followed suit

• Trainees, fellows, participants, scholars receiving funds through any NIH training, career development award, research education grant, dissertation grant

Stated Training Requirements

NSF

• Can be online only (left up to institution)

• Does not need to be refreshed (left up to institution)

NIH

• Must be combo of online and face-to-face discussions

• Expects RCR throughout career stages; training must be refreshed no later than every 4 years

Rowan University in Under 100 Years

• 1923: Founded in Southern New Jersey as the Glassboro Normal School to train teachers

• 1958: Name changed to Glassboro State College

• 1992: Henry Rowan gave $100M gift, largest for public college/university at that time. Name changed to Rowan College

• 1997: Granted University status. Name changed to Rowan University

• 2012: Opening of medical school

• July 1, 2013, projected: Upgraded to research university classification, absorb a second medical school

Rowan University ProfileToday:

• PUI, one doctoral program

• Primary federal sponsor is NSF, 1 active NIH grant. In FY12 $9.1M in sponsored programs

• 2011-2012: 11,816 students and 338 full-time faculty

• OSP/Research Staff of 5, 2 secretaries

Future:

• Medical school grants o Proposed: absorb portfolio of $12M from 2nd medical school

Rowan + RCR, Take One2007 Policy: University would establish a training program to educate the campus community regarding ethical/responsible

conduct of research.

Community includes: thesis/dissertation students, all faculty engaged in research. Completion is sufficient for all future grant proposals or thesis/dissertation work.

Optional community: faculty should “inform and encourage” students to complete training, including students in research-oriented classes.

No program was ever set up!

Rowan + RCR, Take Two2011 Revised Policy: NSF required the

University to update their RCR policy and procedures.

Compliance check was set for April 30, 2012.

• Hired a Compliance Specialist in February 2012 to take charge of RCR and other compliance regulations.

• A five-part revised policy was created by the Office for Research in December 2011 and approved by the University Senate and became effective Jan. 1, 2012.

Rowan + RCR, Take Two1. OSP would host the CITI training program.

2. All named researchers (faculty, staff, students, even consultants) on all new proposals must take RCR prior to Associate Provost for Research signing off internally. These are identified via our internal paperwork process. Extension requests are granted by AVP only in extenuating circumstances and a log is kept to follow-up that training is completed. If the faculty is still non-compliant when an award is received, no account will be created.

3. All students have to take RCR prior to appointment. Student employment paperwork is now routed to our Compliance Specialist, who sends the PI an e-mail, prior to going to HR.

4. All new faculty will be informed of RCR at new faculty orientation.

5. Faculty and students currently supported on research grants are required to take training by April 30, 2012 or expenditures would be disallowed. A list of all actively-paid researchers was pulled after April 30 and cross-checked to RCR training.

Rowan + RCR, Take TwoIs the policy compliant with NSF/NIH policy?

YES!

NIH requires face-to-face training meetings for RCR. We have no NIH training grants, however, our NIH-funded researchers still take CITI training. In addition, our Compliance Officer began offering workshops on research ethics and compliance issues starting Spring 2012.

Progress report was submitted to NSF on June 1, 2012 and the report was accepted by NSF as

satisfactory.

Rowan + RCR, Take ThreeUniversity community took issue with the wide umbrella of individuals who need to take RCR.

*Concerned with “non-research” employees. Rowan created a broad definition to place creative and scholarly activity in the same category as research.

Therefore, the following Amendment to the RCR policy was passed in June 2012:

Rowan + RCR, Take ThreeSponsored project activities where the intent, purpose and responsibilities are clearly and explicitly understood to be not research and not scholarly or creative activity are exempt from the RCR training policy requirements.

The activities listed below fit the aforementioned criteria, and are exempt from RCR training policy requirements.

• Tutoring• Professional Development Workshops• Academic Advising• Routine Administrative/Office Support (e.g. photocopying, filing,

mailing etc.)

All exemptions must be requested via the RCR Training Exemption Request Form, which will be reviewed and approved/denied by the Associate Provost for Research.

An Excel log is kept: tracks all extensions and exemptions on a per-project basis.

Embry-Riddle Aeronautical University

• PUI – emerging research institution

• Limited amount of IRBs

• Went from approx 50 in FY 2011 to close to 100 in FY 2012 – majority are exempt

• Types of Research we do that require full review:

o Upset Recovery (How to recover a plane from flying upside down)

o Use of the Normobaric Lab to study Hypoxia (Oxygen deprivation)

o Airplane (cockpit) noise studies

o Motion sickness Studies

o Stress & Arousal in Freefall

Fast Facts on ERAU• International Institution with campuses all across the world

o Two residential campuses; one in Daytona Beach, FL and one in Prescott, AZo Our World Wide campus provides instruction to > 150 locations in the US,

Europe, Canada & the Middle East

• Offer 5 Associate Degrees

• 38 Bachelor Degree programs

• 24 Master’s Degree programs

• 2 PhD programs with another one coming

• Combined annual enrollment all campuses of > 33K

• Conduct approx $15 million a year in Applied Research

• Best Aviation and Aerospace Technology University in the World

HHS – Office for Human Research Protections

(OHRP)• Workshop in Miami Summer of 2010• Reviewed IRB

– Written Policies and Procedures– Membership Requirements– Records and Meeting Minutes

• Title 45 Code of Federal Regulations 46 (45 CFR 46)

• OHRP education website – http://www.hhs.gov/ohrp/education

“Magnificent 7” • Required elements and operational

procedures necessary to meet HHS requirements

– §46.103(b)(4-5) Procedures IRB will follow for:

1. Conducting initial review of research

• Method of Review – expedited or full• Reviewer System – primary or other?• Documentation – protocol, informed consent, other materials

“Magnificent 7” • Procedures IRB will follow for:

2. Conducting continuing review of research

• Protocol summary and/or full protocol• Current informed consent document• Status report

3. Reporting findings and actions to the investigator and the institution

• Written communication• Request for modification or clarifications• Which institutional official(s) notified and how accomplished

“Magnificent 7” • Procedures IRB will follow for:

4. Determining which projects require review more often than annually

• Specific criteria used to make these determinations• Document approval period

5. Determining which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review

• Specific criteria • Complexity of projects, history or concerns

“Magnificent 7” • Procedures IRB will follow for:

6. Ensuring prompt reporting to the IRB of proposed changes in a research activity and ensuring that such changes in approved research may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject

• Steps to ensure compliance• Exception – eliminate apparent immediate hazards to subjects

“Magnificent 7” • Procedures IRB will follow for:

7. Ensuring prompt reporting to the IRB, appropriate institutional officials, the Department or Agency head, and OHRP of any:

• Unanticipated problems involving risks to subjects or others• Any serious or continuing noncompliance• Any suspension or termination of IRB approval

IRB Training• Additional IRB training and information can be found

at the links below:

• http://phrp.nihtraining.com/users/login.php

• http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

• http://www.hhs.gov/ohrp/faq.html

Financial Conflicts of Interest in PHS Funded

Research42 C.F.R. Part 50, Subpart F

Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible

Prospective Contractors

• Changes in PHS Financial Conflicts of Interest Requirements as of August 24, 2012

o Mandate to define institutional policy on FCOI and require timely disclosure of SFI.

o Covers design, conduct or reporting of PHS funded research.

o Explicit requirements to• Educate• Monitor (including subrecipients)• Timely Report and • Take Action on non-compliance

Comparison Old vs. New FCOI Regulations

Prior to August 24th, 2012 New Regulations

1. SFI Threshold of $10,000

2. SFI investigator deems relevant to research

3. Travel is not mentioned

4. Reporting requirements are less clearly defined

5. Subrecipient assurance of policy is required

6. No requirement for publicly accessible policy

7. No FCOI training requirement

8. No requirement for retrospective review

1. SFI Threshold of $5,000

2. All SFI related to institutional responsibility

3. Travel is explicitly mentioned

4. Reporting requirements are more clearly defined

5. Subrecipient disclosure of SFI is required

6. Publicly accessible policy is required

7. FCOI training is mandatory

8. There are monitoring and mitigation requirements of retrospective review

Dotting I’s and Crossing T’s

• The effective date of the new regulations may affect:

o Current proposals submitted August 24th and forward. PI’s need to disclose information relevant under the new regulations, not the old. New competitive awards will issue under the new regulations, but will not clearly state this information in the funding announcement or notice of award.

o Renewing subrecipient agreements. Most agreements are vague as to whether the new regulations actually apply, leaving it up to the institution to apply their understanding of the circumstances. Better safe than sorry, you may want to be conservative and use the new regulations.

Case in Point…• Facts given for an NIH R type award pass-through

to a subrecipient:

o Date of issuance of the amendment is 8/1/2012.

o The purpose of the amendment is to authorize a 12 month no cost extension to the period of performance.

o Period of performance is amended to 8/3/2011-7/31/2013.

o No additional funding is provided.

Yet, note the wording…

• Subrecipient certifies that it has implemented and is enforcing a written administrative process to identify and manage COI consistent with the provision of 42 CFR Part Part 50, Subpart F & 45 CFR Subtitle A, Part 94 [effective date of regulatory change is 8/25/2011*] and “at this time” there is no COI as defined by these regulations…Subrecipient will report to the Prime Recipient…the existence of the conflict…and the specific method the subrecipient adopts for addressing the conflict (managing, reducing or eliminating it).

In Summary…• Plan A: Cast the net wide. Just do it for all active

work in place as of the effective date of the regulation or your policy implementation, which ever comes first, and no later than 8/24/2012.

• Plan B: If if it doesn’t specifically apply and you really don’t want to change your standard procedures—a choice is to refine the language of particular incoming and outgoing agreements that fall under the old regulation. This may be an option for PUI’s, but it is difficult to manage.

Checklist for FCOI Policy Development (Handout**)

When in doubt, use a checklist. NIH has outlined the requirements of a compliant FCOI policy and program at

http://grants.nih.gov/grants/policy/coi/checklist_policy_dev_20120412.pdf

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