Straight Talk from Research Coordinators: What PIs Need to Know about the

Management of Human Subjects Research

Heidi Saliba, BA

H. Robert Kolb, RN BS CCRC

Judith M. Wishin, RN BSN CCRC

Nicole Corwine, BA

Research Coordinator, Ped-I-Care & General Pediatrics, Department of Pediatrics Research Participant Advocate & Project Consultant, Clinical and Translational Science Institute Senior Clinical Research Coordinator, Department of Anesthesiology Research Programs Coordinator, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy

Presented at Southern Group on Educational Affairs’ annual meeting, Spring 2013.

Overview

Section 1: The Roles and Responsibilities of the PI Section 2: Selecting, Training, and Supervising RCs Section 3: Maintaining Success through Strong Relationships

Photo credit: Amanda Mills/CDC

Take-Home Message #1:

The Principal Investigator (PI) is ultimately responsible for all aspects of the study.

You can delegate tasks, but not full responsibility.

Section 1: The Roles and Responsibilities of the PI

• All human subjects or animal research must be IRB approved. • Clinical research calls for maintaining:

• IRB communications log; • Signed informed consent forms; • Regulatory binders; • Adverse events logs; • Billing records; • Study/data records:

• Store on encrypted database, in locked office of secure data facility • Must be securely saved for at least 7 years, then securely destroyed; and

• Numerous other records and logs.

Essentials of Research

Photo credit: James Gathany/CDC

The PI is ultimately responsible for all aspects of the study. • Study participant safety is your responsibility. • You are responsible for the conduct and execution of the study.

• All of your studies could be shut down if procedures are not followed, IRB regulations are broken, and/or files are not maintained.

• Heavy fines are one of many possible consequences of poor study management:

• Thousands of dollars for all levels and types of infractions, such as:

• Honest paperwork mistakes; • Billing errors/inaccurate reporting; and/or • Dishonesty/negligence.

What’s at Stake for PIs

The PI is ultimately responsible for all aspects of the study. • Professional and civil liability are also potential consequences of poor study management.

• Patients could sue if: • Informed consent (IC) is not properly administered; • IC is not properly documented; • Something goes wrong; • You fail to adequately supervise the research team; • There are instances of research dishonesty (real or perceived); and/or • They decide they just don’t like you or your staff.

• In some situations, your medical license could be at stake and your personal freedom could be in jeopardy.

What’s at Stake for PIs

The PI is ultimately responsible for all aspects of the study. • Criminal liability is a potential consequence of:

• Lying; • Situations which put subjects at risk; • Failure to maintain clean, well-regulated facilities; • Financial misappropriation including billing errors and Medicare/Medicaid fraud; • Failure to adequately supervise your research team; • Falsifying study findings; • Pressuring research coordinators (RCs) to break the rules/laws; and • A host of other items.

What’s at Stake for PIs

3/12/13 Washington Post article:

“Doubts about Johns Hopkins Research Have Gone Unanswered, Scientist Says”

“Last year, research published in the Proceedings of the National Academy of Sciences found that the percentage of scientific articles retracted because of

fraud had increased tenfold since 1975. The same analysis reviewed more than 2,000 retracted biomedical papers and found that 67 percent of the retractions

were attributable to misconduct, mainly fraud or suspected fraud.

‘You have a lot of people who want to do the right thing, but they get in a position where their job is on the line or their funding will get cut, and they need to get a paper published,’ said Ferric C. Fang, one of the authors of the analysis and a medical professor at the University of Washington. ‘Then they have this

tempting thought: If only the data points would line up . . .’ ”

http://www.washingtonpost.com/business/economy/doubts-about-johns-hopkins-research-have-gone-unanswered-scientist-says/2013/03/11/52822cba-7c84-11e2-82e8-61a46c2cde3d_story_1.html

The PI is ultimately responsible for all aspects of the study. • You can delegate tasks, but not full responsibility.

• Involving others does not absolve the PI of responsibility. • “Not knowing” does not absolve PI of responsibility. • Having a research coordinator does not absolve PI of responsibility.

• It is essential that you: • Understand all aspects of your protocol and how they are being carried out; and • Carefully choose, properly train, and appropriately supervise all members of your team.

Role and Responsibilities of PIs

Take-Home Message #2:

RCs must be at least as informed as the PI regarding the project, its background, and attendant requirements.

They are responsible for having the eye of an editor, the wisdom of a philosopher, the grace of a grandmother,

the protectiveness of a police officer, and the composure of a network news anchor.

Section 2: Selecting, Training, and Supervising RCs

• Job description usually mentions: • Manage IRB paperwork and communications; • Advertise for study, if advertising is IRB-approved; • Liaise communications among study participants, medical staff, PI; • Recruit and enroll study participants; and • Ensure IRB regulations and research laws are followed.

• RCs often do all the above, plus: • Liaise communications between PI and study sponsor; • Supervise staff; • Educate staff on protocol, regulations, laws; • Data entry, query response, analysis; and • Manuscript preparation, submission.

• Average RC salary: $40,000-$60,000.

Typical RC Duties & Compensation

• RCs are closest to the details and intricacies of the study. • They make ethical decisions by the minute. • They must be a liaison/negotiator between PI and the IRB. • They are usually burdened with more than PIs know:

• Every layer of research involves multiple sub-layers. • A single change in one layer could affect the larger layers and the research project as a whole.

• A knowledgeable, conscientious RC will keep your project on track, managing every detail from start to successful completion. • A sloppy, uninformed, improperly trained, and/or nefarious RC can sink the ship of your research enterprise and, ostensibly, your career – if you are not paying attention.

Breadth & Depth of RCs’ Power

• Be extremely careful in hiring: • Know what you need; • Conduct a thorough background check; • Conduct one or more interviews;

• Involve a seasoned RC to conduct the follow-up interviews; and

• Think and reflect before making a decision. • Consider and commit to the type, level, intensity, and frequency of training that will be necessary for the person you choose. • Commit to the work of developing a warm, collegial relationship with your RC and the team they will lead.

Selecting the Right RCs

• Character-based essentials: • Trustworthy and trainable • Good judgment, common sense

• Technical and professional skills: • Excellent verbal communicators • Eye for detail in written communication • Insightful understanding; troubleshooting abilities • Able to think on their feet • Highly professional and approachable

• Carefully consider their cover letter, resume/CV, interview behavior, and background check.

Selecting the Right RCs

Photo credit: Amanda Mills/CDC

• Provide thorough, appropriate training: • HIPAA for researchers • Collaborative Institutional Training Initiative (CITI) training: citiprogram.org • Institutionally-required training

• At UF, Research & Administration Compliance

• Cultural & linguistic competence • The National Center for Cultural Competence at Georgetown University is a good place to start: http://nccc.georgetown.edu/.

Training Your Assistants

Photo credit: James Gathany; content provider CDC/James Gathany

• Research ethics • Recommended: “ORI Introduction to the Responsible Conduct of Research,” by Nicholas H. Steneck.

• Available at: http://ori.hhs.gov/documents/rcrintro.pdf.

• Position-specific training: • Informed consent procedures • Billing & fraud prevention • Local IRB training • Leadership & supervisory training

• Protocol training

Training Your Assistants

“It’s ironic…most companies spend 50% to 70% of their money on people’s salaries. And yet they spend less than 1% of their budget to train their people. Most companies, in fact, spend more time and money on

maintaining their buildings and equipment than they do on maintaining and developing people.”

– The One-Minute Manager

Take-Home Message #3:

The extent to which PIs have developed and applied their own leadership equates to the quality, integrity,

and outcomes of their research and other work.

In the words of John Maxwell, you must do the work to connect with your people.

Section 3: Maintaining Success

Through Strong Relationships

“The stronger the relationship and connection between individuals, the more likely the

follower will want to help the leader.”

– John Maxwell

• Create a warm rapport with your RC so they feel comfortable in coming to you with ideas, suggestions, problems, and mistakes. • Thank them for keeping you out of trouble. • Do not fight them on the IRB regulations or ask them to “get creative” with the rules – their job is to ensure the rules are followed to the letter.

Leadership & Supervision

Photo credit: Cade Martin; content provider CDC/Dawn Arlotta

• Do not micromanage. • By the time you get done micromanaging, you could have just done the job yourself. • Micromanagement negatively affects productivity and damages morale. • If RCs are carefully chosen, thoroughly trained, and appropriately supported, micromanagement becomes unnecessary. True leadership becomes the order of the day.

Leadership & Supervision

“A good supervisor is a catalyst, not a drill sergeant. He creates an atmosphere where intelligent people

are willing to follow him. He doesn’t command; he convinces.”

– Whitley Davis

• Include RCs as authors in the research, since their role is integral to the project’s success or failure. • If RCs are supervising a team of assistants, make sure they have proper leadership training and skills, and are fully versed in human resources requirements and employment law. • Ensure that RCs are given appropriate autonomy and authority in decision making; it is pointless to ask them to supervise if a PI overrides their decisions.

Leadership & Supervision

• Pay for RCs’ membership in professional societies such as the Association of Clinical Research Professionals (ACRP). • Support their professional development through funding for conference travel, time allowances for educational events, and encouragement of their participation in networking and outreach activities.

Leadership & Supervision

Photo credit: Cade Martin; content provider CDC/Dawn Arlotta

“The point I would stress to other managers is that you can never overemphasize the importance of the little things like treating staff fairly, having kind words to say, and being your staff’s biggest

fan…and remembering that not only are the patients your customers, but so are their families,

your physicians, and other employees.”

– A letter to the Studer Group, from Hardwiring Excellence

References Photos from the Public Health Image Library by the Centers for Disease Control. Available at http://phil.cdc.gov/phil/details.asp. Saliba H. “Principal Investigators’ Responsibilities In the Informed Consent Process: Teaching, Training, and Supervising Assistants.” University of Florida Human Resources training module, 2013. Whoriskey P. “Doubts about Johns Hopkins Research Have Gone Unanswered, Scientist Says.” The Washington Post, March 11, 2013. Available at http://www.washingtonpost.com/business/economy/doubts-about-johns-hopkins-research-have-gone-unanswered-scientist-says/2013/03/11/52822cba-7c84-11e2-82e8-61a46c2cde3d_story_1.html. Steneck NH. “ORI Introduction to the Responsible Conduct of Research.” Available at http://ori.hhs.gov/documents/rcrintro.pdf. Blanchard K and Johnson S. The One-Minute Manager. William Morrow and Company, Inc. 1982. Studer Q. Hardwiring Excellence: Purpose, Worthwhile Work, Making a Difference. Studer Group, LLC 2003. Maxwell JC. The 21 Irrefutable Laws of Leadership. Thomas Nelson 2007. Saliba H. “Developing Your Leadership Legacy: The Interpersonal, Communicative, & Attitudinal Aspects of Success.” Training workshop, the University of Florida, 2011. Witherspoon P. Communicating Leadership: An Organizational Perspective. Allyn & Bacon 1997.