Ethics

DESCRIPTION

As part of our core commitment to the profession, RAPS maintains an Ethics Committee that supports and maintains the Code of Ethics for Regulatory Affairs professionals to integrate our educational mission and promote ethics within the profession. RAPS and the Ethics Committee have developed this general primer, “Ethics – Essential Tools for Regulatory Affairs Professionals.” This course is designed to identify and analyze ethical issues as they relate to regulatory affairs professionals.

This course is intended to:

Give a general introduction to complex concepts, principles, and theories including bioethics and legal principles.
Provide an overview and highlight ethical issues in areas of:
- Product Development
- Industry Compliance
- Clinical Testing
Provide insights into Institutional Training & Educational Activities

LEARNING OBJECTIVES
Upon completion, participants will be able to:

Identify and describe several historical events that influenced current ethical guidelines and federal regulations.
Identify various fundamental ethical principles that can impact the decision making of regulatory professionals.
Understand the purpose of the RAPS Code of Ethics and how it was developed.
Understand the Eight Core Values central to the RAPS Code of Ethics.
Define the necessary elements for obtaining valid and meaningful informed consent.
Describe conditions that may affect a person's capacity to consent and the responsibilities of the researcher in seeking consent from research participants.
Define IRB, IRB membership requirements, and IRB scope.
List study criteria to be met in order to be approved by an IRB.
Identify ongoing protections ensured by the IRB throughout the conduct of a study.
Explain how IRBs are regulated.
Summarize at least three FDA findings identified in IRB Warning Letters.
Identify several organizations or individuals protecting human participants.
Gain knowledge of what compliance is and why it is important for both individuals and corporations.
Become familiar with state and federal regulatory agencies and the laws they enforce.
Become familiar with common compliance and ethical issues presented in the market place.
Gain knowledge of special ethics and compliance concerns for publicly traded companies.
Gain knowledge of what companies are doing to promote ethical training in the workforce and assess best practices.

TARGET AUDIENCE

This course is applicable to a variety of professionals, regulatory employees, and support staff including:

Regulatory Affairs Professionals
Medical Personnel (Physicians, Nurses)
Clinical Investigators
Research Personnel
Quality Systems (Compliance) Managers
Legal Professionals
Statisticians
Corporate Management

Cost: Member $175; Nonmember $250

Type: Web-based Class

RAC Points: Participants receive 2.5 RAC points.

Frequently Asked Questions

What is the time period of the course and when is the end date?

You will have 60 days to complete the course from the time of your purchase. The end date is calculated from your purchase date. You can complete the course work at any time, day or night, that fits into your schedule. There is no pre-assigned time that you need to be online. It is a completely self-paced online course.

How many hours will it take to take the course?

It will take approximately 2-3 hours online to complete the course. This includes time for the final exam.

Is there any home work?

No, all the information you need to complete the course is included in the online course materials.

Is there any special computer requirements for access or software that must be downloaded?

RAPS Online University works best with an up-to-date version of IE explorer or Firefox. A current version of Flash is a common plug-in used in our courses. For your convenience, the URL to download this plug-in can be found at www.macromedia.com.

Is the purchase of any additional text required?

No, all the information needed to complete the course is included in the online course. However, RAPS does offer books on Ethics that you may find of interest as supplemental reading to the course, but they are not required texts and you may complete the course without them.