1. Research Ethics The Protection of Human Subjects

2. Presented by Carolyn Strong, CIM Research Coordinator Office of Sponsored Programs Administration JMAC Bldg 6, Suite 26 Phone: (540) 568-2318 Email: strongcd@jmu.edu

3. IRB Mission To oversee and review all research projects that involve research with human subjects. It is important to note that the IRB reviews all projects, not just externally supported activities. These reviews include faculty/ student research and classroom activities as well. See IRB Policy for more details: http://www.jmu.edu/JMUpolicy/1104.shtml

4. IRB Membership At least 5 members At least 1 scientist At least 1 non-scientist At least 1 person not affiliated with the institution Members with varying backgrounds Diverse membership (gender, race, cultural background)

5. IRB Responsibilities SAFEGUARD THE RIGHTS AND WELFARE OF HUMAN SUBJECTS

6. Authority of the IRB The IRB’s decision to deny approval of a protocol (or to deny permission to recruit subjects on-campus) cannot be overridden by the president, any member of the administration, or the Board of Trustees of the institution. **THE IRB’S DECISION IS FINAL!

7. Definitions Research “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

8. Definitions Human subjects “living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

9. Brief History 1947 – (26) Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics)

10. Brief History 1940s – A series of research abuses starts in Tuskegee, Alabama. In one study on the natural history of untreated syphilis, poor, black males are uninformed of their disease and denied treatment even after a treatment is found in 1947. The abuses were revealed in 1972.

11. Brief History 1960s: Milgram Studies of Obedience to Authority  Basic purpose – to understand why people follow the directions of authority figures even when they are told to do things that are cruel or unethical.  Experiment – subjects deceived into thinking they were helping with a study to evaluate the role of negative reinforcement on learning. Subject was instructed to deliver an electric shock when a person who was playing the role of the “learner” answered a question incorrectly.  Results – many of the subjects experienced extreme psychological distress after understanding the level of cruelty of their actions.

12. What Research Must Be Reviewed? All research at James Madison University that involves humans, human tissue, or records gathered on human subjects requires IRB review. This is true regardless of its funding source or area of research.

13. Basic Principles Autonomy Each person should be given the respect, time, and opportunity necessary to make his or her own decisions. Participants must be given the information they need to decide to enter a study or not to participate. There should be NO pressure to participate.

14. Basic Principles Beneficence Obligates the researcher to secure the well-being of all study participants. It is your responsibility to protect participants from harm, as well as ensure that they experience the possible benefits of involvement. **Maximize possible benefits and minimize possible harms.

15. Basic Principles Justice Distribute the risks and potential benefits of the research equally among those who may benefit from the research Selection of subjects not based on convenience, subject availability, compromised position of subjects, subject manipulability, or language barrier.

16. IRB Review Criteria The IRB uses the following criteria to review your research: 1.Risks to subjects are minimized. 2.Risks to subjects are reasonable in relation to anticipated benefits. 3.Selection of subjects is equitable.

17. IRB Review Criteria 4.Informed consent is: a.Sought from each prospective participant or his or her legally authorized representative, and b.Properly documented. 5.Adequate preparation is taken to protect the privacy and confidentiality of subjects. 6.Adequate provisions are made for the ongoing monitoring of subjects’ welfare.

18. Categories of Review Exempt Review Research activities in which the only involvement of human subjects will be in one or more of the listed categories found at the following URL: http://www.jmu.edu/sponsprog/irb/irbProtocolExemptionGuide.doc

19. Categories of Review Category 1 - Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods. Category 2 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation. (Note: Exemption for survey and interview procedures does not apply to research involving children. Exemption for observation of public behavior does not apply to research involving children except when the investigator does not participate in the activities being observed.)

20. Categories of Review Category 3 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2 above if: (a) the human participants are elected or appointed public officials or candidates for public office; or (b) federal statute requires without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Category 4 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.

21. Categories of Review Category 5 - Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to these programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs. Category 6 - Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consumed; or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

22. Categories of Review Full Board Review Research activities conducted outside the classroom and/or departmental research participant pool if they involve:  minors (i.e., persons under the age of 18),  external funding involved  a targeted population of adults whose ability to freely give informed consent may be compromised (i.e., persons who are socio-economically, educationally, or linguistically disadvantaged, cognitively impaired, elderly, terminally ill, or incarcerated),  pregnant women and/or fetuses who may be put at risk of physical harm,  a topic of a sensitive or personal nature, the examination or reporting of which may place the research participant at more than minimal risk, or  any type of activity that places research participants at more than minimal risk.

23. Categories of Review The schedule for full board submission deadlines and convened meetings can be found at the following URL: http://www.jmu.edu/sponsprog/irb/irbMtg-SubmDates.html

24. Categories of Review Expedited Review All other research that does not qualify for Exempt or require Full Board review (e.g., no more than minimal risks & participants at least 18 years of age or older)

25. Researcher’s Responsibilities Educate the participants about risks and benefits Obtain consent before involving participants in the research Keep participants informed

26. IRB Online Certification Training Since October 1, 2000, federal guidelines mandate all investigators and key personnel directly responsible for the design and conduct of the human subjects part of a project be trained prior to working with human subjects. To assist in preparing a protocol that is consistent with IRB procedures and reviewer criteria, follow the steps to complete the four training modules located on the Office of Sponsored Programs’ web site: http://www.jmu.edu/sponsprog/irb/irbtraining.html. IRB training for students is valid for up to 1 year.

27. IRB Forms IRB Forms can be found at the following URL: http://www.jmu.edu/sponsprog/irb/irbforms.html

28. Contact for IRB Assistance CAROLYN STRONG, CIM Research Coordinator JMAC Bldg 6, Suite 26 Phone: (540) 568-2318 Email: strongcd@jmu.edu