May I have your permission please?

1. May I have your permission please? The consent process: What, Where, When, Who and Why Valerie Smith OHRP IRB Program Manager 327-2370/valeries@unr.edu

2. The Farside, by Gary Larson

3. Why?

4. The Belmont ReportEthical Principles and Guidelines for the protection of human subjects of research (1979) Basic Ethical Principle Respect for Persons. -- Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

5. Application of the basic principle Informed Consent. -- Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. What does this mean for the researcher-subject relationship? It means we need to: Provide information Assess comprehension Assure and assess voluntariness

6. What?

7. 45 CFR 46General requirements for informed consent Researchers must obtain consent from all subjects Researchers must provide subjects with adequate time and opportunity without potential undue influence to give consent Researchers must provide study information in language understandable to subjects (8th grade or lower, translation, no jargon or scientific terms unless defined) Researchers must not include any language through which subjects rights might be or appear to be waived

8. 45 CFR 46Eight Basic Elements of Consent A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; A description of any reasonably foreseeable risks or discomforts to the subject; A description of any benefits to the subject or to others which may reasonably be expected from the research; A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

9. 45 CFR 46Eight Basic Elements of Consent A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

10. 45 CFR 46Eight Basic Elements of Consent An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

11. 45 CFR 46Documentation of Informed Consent …informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

12. 45 CFR 46Exceptions to Documentation of Consent An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:  (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or  (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

13. Some Exceptions to Obtaining Consent Large-scale retrospective data studies in which there is no information available to contact subjects to provide consent Cases in which the study design necessitates that the subjects not be aware that research is being conducted (ethnographic observational studies, studies with deception or incomplete disclosure) In these instances, researchers must justify to the IRB why they want to waive consent. Waiving consent may not be requested or justified simply because it makes the research easier to conduct.

14. 45 CFR 46Justification to Waive Consent An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:  (1) The research involves no more than minimal risk to the subjects;  (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;  (3) The research could not practicably be carried out without the waiver or alteration; and  (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

15. Who, Where, When?

16. Who, Where, When? Laboratory (social behavioral) research Online survey research Clinical research Education research

17. Concerns in Obtaining ConsentWhat should researchers be aware of? Emphasis on obtaining consent as a process rather than one-time event Providing information in an accessible manner Assessing comprehension of subjects Assessing voluntariness and assuring no undue pressure in the environment or conduct of the consent process Providing for privacy of subjects during consent process as well as during study conduct

18. Resources for more information and templateshttp://www.unr.edu/ohrp/index.html Social Behavioral Research Valerie Smith, CIP(775) 327-2370valeries@unr.edu Gwenn Snow, MS, RD, CIP (775) 784-3506gwenns@unr.edu Biomedical Research / Exemptions Nancy Moody, JD, MA, Director(775) 327-2367NMoody@unr.edu Valerie Smith, CIP(775) 327-2370valeries@unr.edu

19. Q & A THANK YOU! Valerie Smith OHRP IRB Program Manager 327-2370/valeries@unr.edu