The Association of Clinical Research Professionals

Professional Ethics Committee

The Professional Ethics Committee of ACRP holds the responsibility to maintain leadership and standards of professional conduct and ethics within ACRP, and periodically draft and publish Guidelines for Professional Conduct (“Guidelines”) for ACRP members. This committee meets via teleconference or face-to-face on an as-needed basis. For further information on the ACRP Professional Ethics Committee’s goals, objectives, key responsibilities, and meeting schedule, please refer to the Committee Charge below.

2020 Professional Ethics Committee Members

Patsy Ann Simon, RN, BS, CCRC, CCRA, ACRP-PM
(Chair)
Director, Regulatory and Clinical Affairs
University of Pittsburgh UPMC Center for Innovation in Restorative Medicine
Pittsburgh, PA

Robert Powers, M.Div, PhD
(Vice Chair)
Director of Research for the College of Health Sciences and Professions
University of North Georgia
Dahlonega, GA

Jill Clark, MBA, HCM
Senior Research Associate/Research Manager
Nellis AFB
Las Vegas, NV

Brittany Comunale
Clinical Coordinator
Roderick A Comunale II MD Inc
La Jolla, CA

Monica Gaidhane, MD, MPH, ACRP-CP
Associate Professor of Research
Rutgers University, Robert Wood Johnson Medical School
New Brunswick, NJ

Nadine Odo, BA, CCRC
Research Associate
Augusta University (Anesthesiology)
Augusta, GA

Natasha Phrsai, CCRC
Director, Investigator Support/Clinical Research
Northwell Health
North Shore University Hospital
Hicksville, NY

Victoria Seaman
Chief Risk Officer
Guardian Risk Management
Sioux Falls, SD

Wanda Snead, DrHSci, ACRP-CP
Research Educator
Sarah Cannon Research Institute
Nashville, TN

Peter M. Wehmeier, MD, PhD, CPI, FACRP
Psychiatrist and Psychotherapist
Associate Professor of Child and Adolescent Psychiatry
University Professional of Advanced Studies in Pharmaceutical Medicine
Vice Medical Director
Vitos Hospital for Psychiatry and Psychotherapy
Friedrichsdorf, Germany

ACRP Staff Liaison:
Kevin McCourt 
Chief Operating Officer

Committee Charge

The ACRP Professional Ethics Committee holds responsibility to maintain leadership and standards of professional conduct and ethics within ACRP.

Goals and Objectives

The Committee will review and revise, if necessary, the ACRP Code of Ethics and Professional Conduct and corresponding ACRP Discipline and Complaints Policy, and Procedural Guidance for Disciplinary Hearings, every 2 years, or sooner, if needed, to ensure it is current and relevant to ACRP members and Academy certificants.

The committee will develop and periodically publish, under authority from the ABoT, Guidelines for Professional Conduct (“Guidelines”) for ACRP members and Academy certificants. Guidelines shall be made available to members to assist them in the exercise of their professional duties, and will be of a practical nature. For example, the guidelines could take the form of FAQs on the member’s only website.

Committee members can provide guidance (e.g., mentoring) on various related professional ethical issues. Guidance shall be based on the ACRP Code of Ethics and Professional Conduct, the Guidelines, and the appropriate Good Clinical Practice (GCP).

Responsibilities for 2017

  • Address any complaints brought to the committee in accordance with the ACRP Discipline and Complaints Policy.
  • Plan for the replacement of committee members due to term completion.
  • Prepare Guidelines for Professional Conduct for ACRP members and Academy certificants.

Authority

The Professional Ethics Committee has the responsibility to maintain and enforce standards of professional conduct and ethics within ACRP and draft position statements on behalf of the Association. The committee will review and respond to cases of possible or actual misconduct by members or certificants and those seeking membership or certification.

The committee shall review and respond to cases of possible or actual misconduct by members, certified members, certificants, those seeking membership and/or others certified by or in the process of obtaining certification from ACRP. The committee has authority to take disciplinary actions for noncertified individuals as a result of a complaint investigation as deemed appropriate and in accordance with the Discipline and Complaints Policy.

Note: In cases of complaints of misconduct made against Academy certificants, the Professional Ethics Committee will perform investigation and adjudication and will forward the decision to the Academy of Clinical Research Professionals’ Board of Trustees for final action.

Function

Meeting Schedule

Meetings are Ad Hoc with a minimum of two required meetings per year, one at the start and one at the end of each year. In the event of ethics complaints received, members of the Professional Ethics Committee will be required to make themselves available for meetings to review and conduct investigations and hearings. Meetings will typically be conducted telephonically and hearings will likely be in-person, at the ACRP office. Committee members may need to travel accordingly.

Committee Representation

  • Consists of a minimum of five volunteer members who are active members in good standing with ACRP.
  • Will have international representation (at least one member from outside of the United States) and reflect the characteristics of the general ACRP membership and the nature of the activities undertaken by the committee.
  • At least one half of the sitting members, less the chair, shall be currently certified by the Academy of Clinical Research Professionals. If there are an odd number of committee members, the number of certified members will be greater than the number of non-certified members.
  • Leadership will entail a committee Chair and a Vice Chair, who are appointed by the ACRP Board.
  • When reviewing and assessing complaints reported to the Committee, the Committee may obtain expert advice as necessary, including but not limited to representatives of the following disciplines: Law, Statistics, and others as deemed appropriate.
  • Committee members must sign a confidentiality agreement when they join the committee.

Role of Chair

The Professional Ethics Committee Chair is responsible for leadership and facilitating the work of the committee.

Role of Vice Chair

In the absence of the Chair, the Professional Ethics Committee Vice Chair is responsible for leadership and facilitating the work of the committee. While it is the intent to have succession planning within committees through mentoring of all committee members including the Vice Chair, it should be understood that based on the needs of the committee, the Vice Chair may not automatically ascend to the Chair position at the completion of his or her term as Vice Chair.

Role of Chair or Vice-Chair Designee

In the event that the Chair or Vice Chair cannot participate in an ethics complaint investigation and/or hearing, a member of the committee may be appointed by the Chair to serve as the designate. If it is the Chair who cannot participate, the Vice-Chair will be appointed as the Chair designate. If the ViceChair cannot participate, another committee member in good standing will be appointed to serve this role for a particular investigation and/or hearing.

Role of the Committee Staff Liaison

The Committee Staff Liaison provides all necessary support to the Chair, Vice Chair, and all the committee members to facilitate the work of the committee, including setting up meetings and helping to prepare the materials.

Staff Liaison: Director, Membership and Executive Director

Term Length

  • Committee members will serve a two-year term and based on availability, contribution, and performance may serve one sequential term of two years.
  • Previous members may return to serving on the committee, per the needs of the committee, after a one year break in service.
  • A member’s term starts in the year he/she joins the committee.
  • If an individual has served two two-year terms, he/she may be appointed as Chair for an additional one-year term. Those who have not completed two two-year terms may also be appointed Chair at any time during their service on the committee.

Skills and Expertise

  • Skills and expertise preferred for Professional Ethics Committee members will be determined annually by the committee as a whole, with guidance from the Committee Chair, ABoT Liaison, and staff liaisons.
  • Desired skills include: o Experience dealing with difficult situations of sensitive nature o Ability to perform unbiased review based on facts o Tactful, direct communication
  • Expertise may include:
    • Clinical Research Process knowledge and experience
    • Communication skills
    • Leadership Skills
    • Regulatory Compliance – FDA and ICH expertise
    • Depending on the nature of the complaint received by the committee, Committee members may seek additional expert advice in reviewing specific cases

Related Working Groups: Appeals Panel as needed for disciplinary complaints per the ACRP Discipline and Complaints Policy.

Accountability

  • Notify the ABoT of complaints and action taken on an ongoing basis
  • Submit an annual report to the ABoT.
  • Keep the committee’s work aligned with the ACRP Strategic Plan.
  • The staff liaison is responsible for providing the orientation to all committee members.