Ethics and Research

1. Ethics and Research Chapter Four

2. Ethics and Research Chapter Four

3. What is Considered Ethical Regarding Research? • Ethics refers to the question(s) of right and wrong. • Researchers must consider if it is “right” to conduct a particular study. • The question to ask is: “Will any physical or psychological harm result from this particular research?” • By practicing ethical procedures, the researcher is doing “what is right”.

4. Statement of Ethical Principles • Ethical behavior is defined as conforming to the standards of conduct of a given profession or group (Webster’s New World Dictionary). • An agreement among researchers dictates what is considered right and wrong. • The Statement of Ethical Principles suggests three very important issues: • The protection of participants from harm • Ensuring confidentiality of the research data • The question of deceptions of subjects The Statement of Ethical Principles can be found on pp. 93-95

5. Protecting Participants from Harm • Considered the most important ethical consideration of all the principles • It is the responsibility of all researchers to ensure that participants are protected from physical or psychological harm, discomfort, or danger due to research procedures • Any study that could cause harm should not be considered • Another responsibility of the researcher is to obtain informed consent from each participant • Three important questions to ask about harm in a study are: • Could people be harmed? • If so, could the study be changed to determine the same results? • Are the results important enough to cause possible harm?

6. Ensuring Confidentiality • Once data is collected, researchers should make sure that no one else has access to the data. • Names of subjects should be removed from all data forms, if possible. • The researcher should have no knowledge of particular data linked to a subject. • All subjects should be assured that any data collected will be held in confidence, as well as that all participants have the right to withdraw from the study, if necessary.

7. Example of a Consent Form: 1 (Figure 4.1) CONSENT TO SERVE AS A SUBJECT IN RESEARCH I consent to serve as a subject in the research investigation entitled: ________________________________________________________________ ________________________________________________________________ The nature and general purpose of the research procedure and the known risks involved have been explained to me by ____________________________ The investigator is authorized to proceed on the understanding that I may terminate my service as a subject at any time I so desire. I understand the known risks are: __________________________________ ________________________________________________________________ ________________________________________________________________ I understand also that it is not possible to identify all potential risks in an experimental procedure, and I believe that reasonable safeguards have been taken to minimize both the known and the potentially unknown risks. Witness _________________________ Signed _________________________ (subject) Date __________________________ To be retained by the principal investigator

8. Should Subjects Be Deceived? • Many studies cannot be carried out unless some deception takes place. • Deception refers to intentionally misinforming the subjects to some or all aspects of the research topic. • It is often difficult to find situations where observations or obtainment of certain data can occur at certain specified times. • The possibility of harm could be created from these actions, so the following guidelines have been developed: • Whenever possible, conduct the study using methods that do not require deception • If alternative methods cannot be devised, the researcher must determine if deception is justified by the value obtained • If participants are deceived, the researcher must ensure that the participants are provided with sufficient explanation as soon as possible

9. Examples of Unethical Research Practices (Figure 4.2)

10. Research With Children • Studies using children as participants present some special issues for researchers. • The young are more vulnerable, have fewer legal rights, and may not understand the language of informed consent. • The following guidelines below need to be considered: • Informed consent of the parents or guardians is required regarding the use of minors as subjects • Researchers do not present themselves as diagnosticians or counselors in reporting results to parents, nor do they report information given by children in confidence • Children may never be coerced into participation in any study • Any form of remuneration for the child’s services does not affect the application of these ethical principles

11. Example of a Consent Form: 2 (Figure 4.3) AUTHORIZATION FOR A MINOR TO SERVE AS A SUBJECT IN RESEARCH I authorize the service of ____________________________________ as a subject in the research investigation entitled:____________________________________ __________________________________________________________________ __________________________________________________________________ The nature and general purpose of the research procedure and the known risks involved have been explained to me. I understand that __________________ (name of minor) will be given a preservice explanation of the research and that he/she may decline to serve. Further, I understand that he/she may terminate his/her service in this research at any time he/she so desires. I understand the known risks are: __________________________________ _________________________________________________________________ _________________________________________________________________ I understand also that it is not possible to identify all potential risks in an experimental procedure, and I believe that reasonable safeguards have been taken to minimize both the known and the potential but unknown risks. I agree further to indemnify and hold harmless S.F. State University and its agents and employees from any and all liability, actions, or causes of actions that may accrue to the subject minor as a result of his/her activities for which this consent is granted. Witness _________________________ Signed _________________________ (parent or guardian) Date __________________________ To be retained by the principal investigator

12. Regulation of Research • Research involving the use of human subjects is difficult to conduct. • Before any research commences, the research must be approved by the (IRB) Institutional Review Board at the institution. • The review takes place regardless of the number of researchers or who is financing the project. • The IRB is in charge of weighing the risks of subjects, checking informed consents, and the treatment of subjects. • Once the research has been approved, the researcher must obtain a group of subjects who are willing to participate in the study.

13. Department of Health and Human Services Revised Regulations for Research with Human Subjects • The revised guidelines exempt many projects from regulations by the HHS (Health and Human Services) • The list of projects now free from the control of the HHS can be found under “More About Research” in your text. Refer to p. 109 in your text