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Research Ethics Training Curriculum
Second Edition

Introduction to the Second Edition

The Research Ethics Training Curriculum (RETC) developed by FHI was first published in the spring of 2001. Since that time there has been an evolution of thinking about research ethics, not only within FHI but also within the global research community. Also, experience gained through trainings using the RETC, the review of research by the FHI Protection of Human Subjects Committee, and FHI’s experience in implementing a global research portfolio compelled us to undertake the writing of a second edition.

Since 2001, some basic research ethics concepts have been expanded. This includes the vision of the three basic research ethics principles—respect, beneficence, and justice—going beyond the individual research participant to include entire communities where the research will be conducted. Of particular importance is the recognition that communities should be involved in the design and conduct of such research. Also, the concept of informed consent as an empowerment process continuing throughout the duration of the research is now firmly established. These and other new concepts are included in this second edition.

In the years since the publication of the first edition of the curriculum, FHI has conducted numerous trainings throughout the world using the RETC. We have learned a great deal and received many useful recommendations and suggestions, many of which have been included in this edition. We are very grateful to all who provided us with their invaluable advice.

One aspect that has not changed in this edition is our assertion that the fundamental ethical principles must continue to guide the design and implementation of research involving human participants. We further assert that these principles must be considered universal, transcending geographic, cultural, economic, legal and political boundaries. We acknowledge that the availability of resources needed to maintain these principles is not optimal. These limitations are more profound in developing countries, where the resources available for the operation of local Research Ethics Committees are often insufficient, potentially affecting the level of protection of research participants. We have also learned the importance of translating these principles into national or local guidelines that describe the processes that must be followed to actually protect the research participants.

This RETC has been developed for an international audience of researchers and Research Ethics Committee members who:

  • Design or implement research that includes human participants
  • Conduct reviews of the ethical aspects of research

The RETC provides a basic and accessible level of training appropriate for individuals from different professional backgrounds and world regions. It provides:

  • An overview of the main ethical principles to be considered in the development and conduct of research involving human participants
  • Guidance to assist researchers in designing studies that are respectful of local cultures, regulations, and expectations
  • Case studies for considering real-world examples of ethical issues
  • Ancillary reference documents on modern perspectives that shape the research ethics field

The promulgation of the principles of research ethics and the creation of national and international regulations and guidelines are the result of abuses in the past and in the present. Today, a great amount of attention is directed to improving the level of protections provided to research participants. Internationally accepted standards for research ethics help ensure that research conducted at the local level meets international expectations. Adhering to international norms validates the goodwill and trust invested by the participants.

It is essential that researchers familiarize themselves with the subject matter in this curriculum. Understanding current attitudes about research ethics and the events that shaped them will help each researcher move toward the goal symbolized by the lotus flower—purity and perfection in each research study.

The Lotus Flower
Another element retained from the original Research Ethics Training Curriculum is the lotus flower, which we use to symbolize the fundamental ethical elements. In many cultures, the image of the lotus flower represents purity and perfection. Through this curriculum, we challenge the research community to aspire to a pure and perfect research design—the foundation on which ethical research is developed and implemented.

We acknowledge that each research design, like each lotus flower, will be unique in that it will be:

  • Specific to the study’s design and research objectives
  • Relevant to the local research environment
  • Respectful of local culture

How to Use This Curriculum
This Research Ethics Training Curriculum is designed to engage the learner. Adult learning and retention improves with active participation by the learner. The RETC can be used as either an interactive, self-study program or as a participatory, group training experience. Individual learners can expect to spend a minimum of four hours completing the curriculum. Due to the number of suggested activities and case studies, it will generally take longer to complete the curriculum in a group setting; however, it can typically be covered in an eight-hour day. We recommend using the curriculum flexibly, without strict time limits. Sections such as the principles of research ethics, informed consent, and the responsibilities of Research Ethics Committees may generate much discussion by participants and may require longer periods of time.

The curriculum is divided into four sections:

  • Contents
  • Case Studies
  • Evaluations
  • Additional Resources

The Contents section is composed of illustrative slides and narrative text. Learner/
Facilitator Notes contain interactive questions or activities designed to stimulate further discussion of topics. Take the time to think about or to even write down your ideas about these questions or activities. If you are facilitating group training, ask the group to call out or write on flip charts the answers prompted by the Learner/Facilitator Notes.

The Case Studies section highlights issues in international research ethics and presents thought-provoking questions. In the original curriculum, the case studies focused on ethical issues in reproductive health research and were based on actual situations encountered by researchers at FHI. In the second edition, we have expanded the selection to include studies in other research areas and conducted by various organizations.

Several of these case studies are incorporated into the Contents section of the curriculum in order to emphasize key ideas. The additional case studies are included in the Case Studies section and may be interchanged according to local interests or to make the curriculum more interesting over repeated trainings.

The Evaluations section includes a post-test and a curriculum evaluation form. If you are interested in receiving a certificate of completion from FHI, you will need to return the curriculum evaluation form to FHI, as noted below.

The Additional Resources  sectionunder Basic Research Ethics Documents  contains websites that will provide direct access to the full text of the following documents: The Belmont Report, the 2008 Declaration of Helsinki, the 2001 CIOMS International Guidelines for Biomedical Research Involving Human Subjects, the WHO Operational Guidelines for Ethics Committees that Review Biomedical Research and the U.S. Code of Federal Regulations. This section also provides a list of useful internet sites, and a suggested bibliography.

Getting Started
After reading this introduction, continue to the Contents section. First-time users should follow the sections sequentially. Do not rush; take time to consider the supplementary activities and case studies.

Once you complete the RETC, you will be prompted to complete the post-test. When you have finished all sections of the curriculum and the post-test, complete the curriculum evaluation found in the Evaluations section.

Certificate of Completion

Everyone that successfully completes the RETC is elegible to receive a certificate of completion from FHI's Office of International Research Ethics (OIRE).

Individuals completing the training online will have to: 1) take the post-test, 2) obtain at least an 80% grade, 3) submit the curriculum evaluation form, and 4) receive the certificate. FHI will issue immediately an electronic copy of the certificate that needs to be completed by the trainee who adds his full name and date of completion.

In group trainings, facilitators have the option of providing a certificate issued by the local institution sponsoring the training. Facilitators also have the option of requesting an electronic version of the certificiate to be printed and completed locally. Facilitators should provide printed evaluation forms for group training that are to be completed by trainees and sent to FHI.

Completed curriculum evaluations are submitted electronically to RETC@fhi360.org. Paper submissions should be sent to:

Office of International Research Ethics
FHI 360
359 Blackwell St, Ste 200
Durham, NC 27701
USA

Paper submission must include complete contact information, including e-mail address, so that FHI can send your certificate of completion. Be sure that your mailing address is complete—include the name of your country!

Contact Information
You may contact FHI at the mailing address above, visit our Web site at www.fhi360.org, or e-mail us at RETC@fhi360.org.

We look forward to hearing from you!

Note: Adobe Flash Player and Adobe Acrobat are required for this curriculum. You may be required to download or update your versions of these application and/or plugins to access all parts of this curriculum.

 
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