This tutorial explains the rationale for the protection of human participants in biomedical and behavioral research and the procedures to which researchers must adhered to safeguard the safety of human participants. Major topics covered include the historical context leading to federal mandates for protection, procedures to insure the informed consent of participants, and the review process of the Internal Review Board.
The following are the instructional objectives listed on the website.Upon completion of this course, the learner will be able to: (1) Identify key historical events and current issues in research that impact guidelines and legislation on human participant protection in research. (2) Identify the ethical principles that guide the conduct of research with human participants. (3) Demonstrate the ability to use the guidelines and federal regulations to protect human participants throughout the research process. (4) Describe guidelines for the protection of special populations in research. (5) Define informed consent and the components necessary for a valid consent. (6) Describe the role and responsibilities of the IRB in the protection of human participants. (7) Recognize the roles, responsibilities, and interactions of federal agencies, institutions, and researchers in conducting research with human participants.
Target Student Population:
Any undergraduate or graduate student who needs to understand the legal and ethical issues involved in conducting research with human subjects.
Prerequisite Knowledge or Skills:
Basic understanding of the purposes of conducting empirical research.
Type of Material:
Very useful for any student or faculty who needs to understand the legal and ethical issues around the protection of humans participating in research studies. Especially helpful to people in the fields of sciences,
health, or medicine because of the examples used in the tutorial. However, the information is applicable to all kinds of research in all fields. Successful completion of the tutorial could be required as a step in the development of the student?s research proposal before submitting it to the local IRB.
No special requirements.
Evaluation and Observation
This tutorial includes essential information divided into five chapters about the history of research on human subjects, basic terms used in federal guidelines, current practices regarding informed consent, IRB review procedures, and additional information regarding the ongoing protection of human participants in research. This information is essential knowledge for anyone conducting research on humans or participating in such research. Links to related official government policies are provided for those who want or need more in-depth information. A glossary of important terms is included. All content is accurate and up-to-date. The site appears to be updated and upgraded, as it has more links than the first time it was reviewed about a year ago. Very good explanation of informed consent. The discussion covers preparing the informed consent document and includes a table detailing what should be included in such a document. Another section provides advice on soliciting volunteers for research and the information that should be provided to potential participants by the researcher to insure the validity of the informed consent process. Good explanation of the role of the IRB in approving research and the criteria that they use. Criteria are presented in a table form that students could print and use as a checklist to prepare for defense of their research before an IRB. The meaning of minimal risk to the participant is explained and its role in the approval of research by the IRB is examined.
The tutorial is slanted towards biomedical research in that all examples and case studies in the tutorial use biomedical research. Instructors may want to supplement these with cases of educational and psychological research that have posed risks to participants (e.g.,
the classic studies of conformity by Asch) and studies that use deception to hide the real purpose of the research from the participants.
Potential Effectiveness as a Teaching Tool
Assigning this site for students to complete on their own either before or after a lecture and discussion of the legal and ethical issues around conducting research with humans subjects in class would be very useful. College students, both undergraduates and graduates, would benefit from hearing this information more than once and in more than one format. This tutorial would be a very worthwhile use of students? time in a research methods class or an educational psychology class. It would probably take most students several hours to go through the site thoroughly, take all the end-of-chapter quizzes, and print out the certificate of completion as proof of finishing this assignment. It might be best to have students complete this tutorial before the related class so that they would have a chance to develop questions and also attain adequate prior knowledge for an in-depth discussion of the importance of protecting humans participating in research. An evaluation of the tutorial is solicited at the end of the five chapters but before the user receives a certificate of completion. The evaluation and the certificate are both nice features, and the latter cannot be attained until the user has completed all five quizzes. The tutorial has specific measurable objectives with matching items so can provide effective feedback regarding comprehension to both student and instructor. The tutorial is relatively brief and written at a level that both undergraduate and graduate students writing a research proposal can benefit from its use. Its use is somewhat flexible and it could be used as the basis of discussion of the ethical uses of humans in research to how to protect humans during research to the more practical matter of preparing a research proposal for the IRB review.
Some users may have difficulty relating to the examples which all come from the sciences, health, or medicine. The instructor would need to provide additional examples related to the course topic. Not completely flexibility in how this site can be used. It is too long for a faculty member to go through it screen by screen during a class period.
Ease of Use for Both Students and Faculty
The format of this tutorial is easy to follow. Navigational system is consistent from one section to another. Each screen is easy to read. Users are required to register and login, so by using the bookmark provided in the tutorial users can return to where they left off last. Although an ideal sequence is suggested, users do not have to proceed in any particular order through the tutorial. Supplementary screens provide additional information, if users chooses to view them. The quizzes at the end of each chapter are simple to use and feedback is provided for each answer. Users receive a score.
The button to return to the main menu from a subsection is a graphic without any labeling and if users do not discover this button they may have difficulty navigating around the site. Some of the links to external resources have expired and apparently have not been updated.