the institutional perspective

Mary Childs, Legal Counsel University of Guelph, November 2013

The Institutional Perspective

Tri-Agency Framework:

Responsible Conduct of Research – Building

an Environment of Research Integrity


If we knew what it was we were doing, it would not be called research, would it?

Albert Einstein


The need for policies…….. Piltdown Man 1912

– “missing link” between apes and man found in Sussex, England….the “missing link” had the skull of a modern man and the jaw of an orangutan. The teeth had been filed and the bones chemically aged.

Obviously, the researchers were “missing” something as well.

Precedents


1950-1970 – Project MKUltra CIA supported experiments which

included a number of illegal activities including the surreptitous administration of LSD and chemicals to unsuspecting test subjects

research undertaken at 80 institutions, including 44 colleges and universities including McGill

Became associated with the widespread destruction of most records, lack of informed consent for thousands of participants, the uncontrolled nature of the experiments, and the lack of follow-up data.

Results included incontinence, amnesia, paranoia and several deaths.

Precedents

Painting by numbers 1974 William Summerlin, researcher at

Memorial Sloan-Kettering Cancer Center in NYC

claimed to have shown success with skin transplants between genetically unrelated animals by transplanting fur of black mouse to white mouse

It was discovered that a black marker had more to do with black patches than transplantation

Precedents


1998 Andrew Wakefield – conflict of interest Medical researcher famous for his study

linking the Measles/ Mumps/Rubella (MMR) vaccine to the onset of autism

In addition to the findings of fabrication and falsification, it was also revealed that Wakefield planned to launch a financial venture to provide new medical tests associated with the study results.

Precedents


Hwang Woo-Suk, South Korean veterinarian and research Published two papers in Science (2004 and

2005)reporting his ability to produce human stem cell lines using cloned embryos from patients suffering from spinal-cord injury

Data was fabricated or falsified. Human eggs for the research were provided by two of his research assistants

2009 – after a three year trial, he was found guilty of embezzling research funds and illegally purchasing human eggs. He received a two-year suspended jail sentence and later moved to Libya.

Precedents



January 22, 2013 on-line article in The Scientist, reporting on a study published in mBio by Joan Bennett et al of Rutgers University

Study of 228 individuals found guilty of research misconduct by the Office or Research Integrity (ORI) between 1994-2012

88% of fraud committed by faculty in the life sciences were by male faculty and 60% of the misconduct was conducted by senior research personnel compared to students and postdocs.

One on-line comment to the article indicated that women were just more covert and manipulative

Research on Research

Misconduct


The Framework


Good people do not need laws to tell them to act responsibly, while bad people will find a way around the laws.

Plato

Introduction/Scope/Objectives Ensure funding decisions are based on

accurate and reliable information Ensure funds are used responsibly Promote and protect the quality,

accuracy and reliability of funded research

Promote fairness in the conduct of research

Body of the Agreement Responsibilities of the Researchers –

section 2 Responsibilities of the Institution – section

4 Responsibilities of the Agencies – section

6

Parts of the Contract


1. Promoting Research Integrity (positive obligation)

High level of rigour Complete and accurate

records Referencing and obtaining

permission for use Authorship Acknowledging

contributions Managing conflict of

interest

Responsibilities of the

Researcher – 5 categories


2. Applying for and Holding Funding Provide true and complete

info on application Certify not otherwise

ineligible Ensure others listed have

agreed to be included3. Management of awards/funding MOU on Roles and

Responsibilities in the Mgmt of Federal Grants and Awards

Individual funding agreements


Researcher….


4. Compliance with other policies

Include but not limited to 8 other policies or guidelines…Ethical Conduct of Research Involving Humans, CCAC Policies and Guidelines, Cdn Environment Assessment Act, Laboratory Biosafety guidelines…..

5. Rectifying a breach Obligation to be

proactive in rectifying it


Researcher……


1. Including but not limited to ….. Fabrication Falsification Destruction of research

records Plagiarism Redundant publications Invalid authorship Inadequate

acknowledgment Mismanagement of Conflict

of interest

Breaches by Researchers –

4 categories


2. Misrepresentation in an application or related document3. Mismanagement of funds4. Breaches of other policies for certain types of research

Role of Individs. re allegations “Responsible

allegations….should be sent….”

Breaches by Researchers…


Definition includes actual, perceived and potential

No absolute ban Identify, report and decide

Activity to cease Activity to continue with

parameters Activity to continue with no

parameters Institutional definitions

Conflict of Interest


Abide by MOU on Roles and Responsibilities in Mgmt of Federal Grants and awards (“MOU”)*

Promotion of responsible conduct

Obligation to develop and administer policies to address allegations of breach

Reporting of allegations to Agencies

Promoting awareness and education

Breaches by the institution Addressed under MOU

Responsibilities of Institutions


Communicating, promoting, reviewing…

Process for Addressing allegations Receiving allegations Review of Institutional

Reports Recourse Request correction of

research record, refuse future applications, terminate present installments, seek refund, other recourse under law

Accountability and Reporting Includes public disclosure

in cases of serious breach


Agencies



Click icon to add pictureR. Lee Emery

I firmly believe that you live and learn,

and if you don't learn from past mistakes,

then you need to be drug out and shot.

the institutional perspective

Documents

research assistants

research boundaries

human eggs

human subjects4painting

black patches

black marker

missing link

albert einstein mary