- What assumptions guide the P.I. Program?
- What is the goal of the P.I. Program?
- Why would an institution refer someone to the P.I. Program rather than terminate employment/training?
- How common is serious wrongdoing at US research institutions?
- When do you recommend referring someone to the P.I. Program?
- Is the P.I. Program suitable for all investigators who have made bad decisions?
- Is the P.I. Program appropriate for researchers in diverse fields?
- Is it appropriate to refer a graduate student to the P.I. Program?
- Is the P.I. Program seminar actually suitable for very specific kinds of wrongdoing, e.g., improper care of animals?
- How do researchers get referred to the P.I. Program?
- Can an institution refer a researcher to the P.I. Program without officially finding the researcher "guilty" of violating a policy or regulation?
- Is the P.I. Program evidence-based?
- How was the P.I. Program developed?
- Is participation in P.I. Programs confidential?
- How can a participant demonstrate program completion? Is any information shared with institutions?
- What information is collected about participants from institutions?
- Is an onsite group workshop really necessary?
- Why is the workshop 3 days?
- Who should pay course fees?
- How does an individual sign up for a P.I. Program course?
- Are Continuing Medical Education credits available?
What assumptions guide the P.I. Program? (Back to Top)
- Everyone referred to the program has some behaviors that must change
- The causes of wrongdoing or unprofessional behavior are typically complex, involving an interaction of the individual with the research environment
- Without intervention the risk of recidivism or repeating problematic behaviors is high
- Researchers can change
We also assume:
- Effective education on professionalism should avoid blaming or judging participants and focus on developing new habits—habits of thinking, solving problems, and managing stress and work responsibilities.
What is the goal of the P.I. Program? (Back to Top)
- We want to foster professionalism in research and reduce rates of recidivism.
Why would an institution refer someone to the P.I. Program rather than terminate employment/training? (Back to Top)
the P.I. Program is designed to retain productive and talented investigators in whom the institution and others have invested while …
- Preventing recidivism–at your institution and others
- Restoring trust
- Managing risk by having a reasonable response plan in place
How common is serious wrongdoing at US research institutions? (Back to Top)
In January 2012, we contacted one research integrity officer (RIO) and one Institutional Review Board (IRB) Chair at all MD and comprehensive doctoral degree institutions in US (N=194). Responses were obtained from 161 individuals (44%) at 129 institutions (66%).
- 84% of individuals reported the investigation of a credible case of wrongdoing over past 2 years. With responses from both RIO's and IRB chairs, 96% of institutions had investigated a case
- The most common number of cases that individuals reported was 3 – 5; however, respondents used the full range from 0 cases to 16 or more cases. Seven percent reported investigating 16 or more cases over the past 2 years
- RIOs most frequently reported cases of research misconduct (falsification, fabrication, and plagiarism) (53%); procedural violations (53%); consent failures (34%); oversight failures (29%); and animal care violations (28%)
- IRB chairs most frequently reported cases of procedural violations (81%); consent failures (66%); oversight failures (41%); privacy violations (36%); and recruitment violations (15%)
When do you recommend referring someone to the P.I. Program? (Back to Top)
The P.I. Program was designed for researchers who have engaged in research wrongdoing or have repeatedly failed to comply with policies and procedures and who might benefit from an intensive professional development program that engages cognitive biases, promotes effective ethical problem-solving strategies, and develops personalized management plans to implement following the program. We provide individualized assessment and follow up.
Is the P.I. Program suitable for all investigators who have made bad decisions? (Back to Top)
No. We recommend against referring investigators at two extremes—those who might benefit from a less intensive intervention, and those whose needs are greater than our intervention can meet:
- For first-time errors in judgment that arise from a lack of knowledge (say of institutional policies) a simple instructional program and review of policies might suffice.
- Those who have untreated serious mental health or substance abuse disorders are unlikely to benefit from the P.I. Program. We recommend appropriate professional treatment.
Additionally, at present, the P.I. Program is only available in English. Participants should have an adequate level of English oral proficiency to engage in group discussion.
Is the P.I. Program appropriate for researchers in diverse fields? (Back to Top)
Yes. Although the National Institutes of Health funded the development of the P.I. Program curriculum, it is appropriate for all kinds of investigators including those in the STEM fields (science, technology, engineering, and mathematics). We do not, however, consider it appropriate for humanities scholars.
Is it appropriate to refer a graduate student to the P.I. Program? (Back to Top)
The P.I. Program is appropriate for researchers. If a graduate student is funded on a pre-doctoral fellowship and actively engaged in research, then it may be appropriate to treat the student as a researcher. Feel free to call our office to discuss individual cases.
Is the P.I. Program seminar actually suitable for very specific kinds of wrongdoing, e.g., improper care of animals? (Back to Top)
Yes—for two reasons. First, we will customize the parts of the program (knowledge-building and management plans) that are relevant to specific kinds of research endeavors. Using the example of animal researchers:
- Participants will be assessed for knowledge of animal care and use; if they do not do well on the knowledge test, they will complete specially selected CITI online modules addressing their knowledge deficits. (We don't actually anticipate that most animal care failures are due to knowledge deficits)
- Each participant will develop an individualized management/follow up plan pertinent to their work. They will identify a mentor/peer support who does their kind of research; they will identify management weaknesses and a strategy for addressing them; they will identify relevant institutional policies and become familiar with them.
- In class, we will explore their specific problem situations to help them identify more adaptive ways of doing their work.
Second, many needs of participants are quite general and are relevant to all domains of research. Thus, all participants will receive education aimed at fostering constructive mental models for research and good ethical decision-making. These aims serve researchers well regardless of the kind of wrongdoing involved in their referral.
How do researchers get referred to the P.I. Program? (Back to Top)
We expect researchers to register themselves for the program. However, they are ordinarily referred to the program by their institution, department chairs, or oversight bodies.
Can an institution refer a researcher to the P.I. Program without officially finding the researcher "guilty" of violating a policy or regulation? (Back to Top)
Yes, as long as the institution believes that some research behavior should change. Consider the example of suspected data fabrication. Even if the institution cannot prove intent to fabricate data, the act of publishing inaccurate data may be considered sufficiently problematic to warrant professional development education.
Is the P.I. Program evidence-based? (Back to Top)
Yes. We expect the P.I. Program to be effective in reducing rates of recidivism because the P.I. Program curriculum is based on best available evidence, including:
- Research studies conduct by development team members and others on the predictors of ethical and unprofessional behaviors in research
- Successful physician remediation training programs
- Needs assessment data from 129 research intensive institutions
- Ongoing quality improvement data from the P.I. Program
How was the P.I. Program developed? (Back to Top)
The P.I. Program was developed by a team of experts in cognitive and industrial-organizational psychology, research ethics, law, remediation training, and research oversight. Development of the program has been funded by the National Institutes of Health (administrative supplement award to the Washington University CTSA grant UL1 RR024992).
Is participation in P.I. Programs confidential? (Back to Top)
Yes. To the fullest extent of law, the P.I. Program will protect participant data. We will:
- Require workshop participants to sign a confidentiality agreement
- Use first names only during courses
- Hold education sessions in a discrete location
- Send no information to third parties without participant consent (as permitted by law), with the exception of a certificate of completion.
How can a participant demonstrate program completion? Is any information shared with institutions? (Back to Top)
We will provide all participants who complete the entire program, including assessments and follow up, with a certificate of completion. We will send referring institutions a copy of the certificate of completion. Participants may also provide us with a list of individuals to whom they would like us to send an official copy of the certificate.
Participants will also be provided with a copy of their personalized management plans and their post-test scores. They may choose to share these with their institutions.
What information is collected about participants from institutions? (Back to Top)
We request that institutions provide us with information on why participants are referred to the P.I. Program and complete a satisfaction survey after a participant completes the course.
Is an onsite group workshop really necessary? (Back to Top)
Yes. We are unfamiliar with any remediation education programs with demonstrated efficacy that do not include face-to-face discussion with others who are similarly situated. All core program activities depend upon inter-personal discussion and relationship building.
Why is the workshop 3 days? (Back to Top)
Each day is dedicated to a different fundamental aim: Promoting thinking patterns that support ethical research; fostering ethical decision-making skills; developing personalized management plans to support professionalism after leaving the P.I. Program; and assessment. We could not achieve these aims in less time. This timeframe is fairly typical of professional remediation programs.
Who should pay course fees? (Back to Top)
We expect that different institutions will cover course fees in different ways, for example, using faculty travel funds, indirect cost (F&A) funds, or departmental funds. Some institutions may require participants to cover their own costs as their policies allow.
How does an individual sign up for a P.I. Program course? (Back to Top)
Are Continuing Medical Education credits available? (Back to Top)
Yes, CME credits are available.
ACCREDITATION: Saint Louis University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
AMERICAN MEDICAL ASSOCIATION: Saint Louis University School of Medicine designates this live activity for a maximum of 17.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.