1. Human Studies Program Office of Research Compliance Vice Chancellor for Research and Graduate Education Denise Lin-DeShetler, M.P.H., M.A. Director, Human Studies Program CTE Dissertation Series - IRB Series 2 October 27, 2014

2. Human Studies Program Office of Research Compliance 1. What is informed consent and why is it important? 1. Informed Consent Process: ◦ Who will obtain consent? ◦ Where will consent be obtained? ◦ When will consent be obtained? ◦ How will consent be obtained? 2. Types of “Informed Consent” and what is appropriate

3. Human Studies Program Office of Research Compliance  Based on the Belmont principle of “Respect for Persons,” informed consent involves 3 requirements: 1.INFORMATION  Disclosing to potential participants information needed to make an informed decision; 2.UNDERSTANDING  Facilitating the understanding of what has been disclosed; and 3.VOLUNTARY AGREEMENT  Promoting the voluntariness of the decision about whether or not to participate in the research  Informed consent must be legally effective (e.g., signed by participant) and prospectively obtained.

4. Human Studies Program Office of Research Compliance  Informed consent is an active PROCESS of sharing information between investigator and participant: ◦ Starts with initial outreach (i.e., recruitment) and continues until completion of the research study ◦ Means:  Recruitment materials  Informed Consent  Q&A  Updated information on risks  Informed consent is very IMPORTANT because it is commonly the ONLY mean of how participants get information about the research

5. Human Studies Program Office of Research Compliance Coercion: overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence: an offer of an excessive or inappropriate reward or other overture in order to obtain compliance  Hierarchical relationship between researcher and participant ◦ Teacher-researcher to student ◦ Physician-researcher to student ◦ Employer-researcher to employee

6. Human Studies Program Office of Research Compliance Suggestions:  Have research assistants collect consent forms and do not disclose who consented until after power relationship between investigator and participant has ceased.  Provide alternatives to participation  In consent, state explicitly that consent or refusal to participate will not affect relationship (e.g., service to patient, grades of student, etc.)

7. Human Studies Program Office of Research Compliance  Privacy is essential to the consent process ◦ Should be conducted in a private setting where no one else can overhear the discussion.  Settings can heavily impact one’s decision to participate (i.e., peer pressure in classroom setting). ◦ Who is around? ◦ Does the setting provide adequate time for potential participants to ask questions or read through the consent to fully understand the study?  Even if research is presented in a group setting, it is important to give each participant individual attention when consenting so that they are given full opportunity to ask questions (i.e., intimidation factor).

8. Human Studies Program Office of Research Compliance  Consent MUST ALWAYS be obtained PRIOR to conducting any research activity (except when to remove a immediate threat or harm to participant) in the approved consent method.  Active participants should be re-consented with the most currently approved informed consent, such as: ◦ New findings of risks to participants, ◦ Contact information for participants, ◦ Conflict of Interest of a new PI for the study

9. Human Studies Program Office of Research Compliance  Directly (face-to-face) vs. Indirectly (electronically)  Type of Consent ◦ Written vs. waiver or alteration of informed consent  Tools to enhance understanding ◦ Pre-screening for mental capability ◦ Length and readability level of consent form ◦ For complex studies, use of flowchart, brochures and other aids ◦ Having participant re-iterate consent back to researcher  Documentation of Informed Consent Process

10. Human Studies Program Office of Research Compliance  Written “long form” consent  Study Information Sheet  Short Form  Translated informed consent  Oral consent  Parental Consent  Child Assent What type of informed consent you use for your research depends on the appropriateness of your study population in order to meet the three requirements: (1) Disclosure of information, (2) Understandable, and (3) Promotes Voluntariness

11. Human Studies Program Office of Research Compliance 1. Purpose 2. Research Activities ◦ What part is experimental ◦ Duration of involvement 3. Potential Benefits and Risks ◦ To participant, group, and/or society 4. Privacy and Confidentiality 5. Alternatives to Participation 6. Voluntary 7. Contact Information

12. Introduction of researcher and purpose of study Extent of subject participation

13. Describe potential risks and benefits; don’t be pretentious about benefits Privacy and Confidentiality should include how data will be kept secure

14. Compensation for time and effort in participating should go under this section

15. Human Studies Program Office of Research Compliance Waiver of a signed informed consent can be requested, and if granted, would include the language on the right in lieu of the left

16. Human Studies Program Office of Research Compliance  Audio Recording  Video Recording  Use of real names instead of pseudonyms  Permission to contact for future studies

17. Human Studies Program Office of Research Compliance  Age or mental capacity ◦ Minors ◦ Diminished mental capacity  Vulnerable Population ◦ Prisoners ◦ Children ◦ Homeless  Setting ◦ Institutionalized ◦ Prison Facility ◦ Schools  Primary language

18. Human Studies Program Office of Research Compliance A research may qualify for a waiver or alteration of consent if some or all of the following conditions are met: 1. The research involves no more than minimal risk to the participants; 2. The waiver or alteration will not adversely affect the rights and welfare of the participants; 3. The research could not practicably be carried out without the waiver or alteration; and 4. Whenever appropriate, the participants will be provided with additional pertinent information after participation Examples:  Anonymous online survey on brand preferences of jogging shoes  Interview of domestic violence victims on the availability and accessibility of counseling services in their community  Looking at prevalence of racial stereotyping among college students of different culture

19. Case Example Type of Alteration or Waiver  Anonymous online survey on brand preferences of jogging shoes  Interview of domestic violence victims on the availability and accessibility of counseling services in their community  Looking at prevalence of racial stereotyping among college students of different culture  Study Information Sheet: written consent form given, but no signature collected  Oral consent: written consent form read to participant, consent usually recorded  Debriefing Form: consent form disclosing deception and reason why it was necessary, asks participants if data can be used

20. Human Studies Program Office of Research Compliance  In most cases, research in which participants are minors parental consent and assent must be obtained before participation. ◦ Includes exempt normal educational curriculum studies – permission to use data; UH IRB follows HIDOE regulations  What is considered consent: ◦ Even if parent consents, child does not participate unless he or she assents ◦ If child assents and parent does not consent, child cannot participate  Waiver of parental informed consent: ◦ Abused minors ◦ Runaway minors

21. Human Studies Program Office of Research Compliance  Translated informed consents should be provided to participants whose primary language is not English  Translated Materials: ◦ Use professional translation services = $$$$ ◦ Forward and backward translation by two different individuals fluent in English and the other language  Certification of translation/ back translation ** Translated materials should be provided to the IRB for review and approval before use

22. Human Studies Program Office of Research Compliance  Use of an INTERPRETER is appropriate and encouraged during the informed consent process to facilitate any Q&A, if investigator cannot speak the same language  Use of “short form consent” is used to document consent between investigator and participant with assistance of interpreter ** Good Practice: Researcher should speak to and make contact with participant, not interpreter. The interpreter should be placed between researcher and participant

23. Human Studies Program Office of Research Compliance  For individuals who may have diminished capacity to consent, an assessment of their capacity must be made prior to enrolling the participant in the study.  Depending on institutional policies (i.e., hospital regulations), state and local laws, there are specific requirements for consenting adults with limited capacity: ◦ Assent: potential participants object or are not capable of objecting are not enrolled in the research ◦ Legally Authorized Representative (LAR): an individual or court-appointed body authorized under applicable law to consent on behalf of the the potential participant  If there is an expectation that the mental capacity of subjects may become diminished during the course of their participation, a monitoring plan should be included in the protocol/ research proposal on how the investigator would test for diminished capacity.

24. Human Studies Program Office of Research Compliance Per Belmont Report, such types of research is only justifiable if: 1. Incomplete disclosure is truly necessary to accomplish the goals of the research, 2. There are no undisclosed risks to participants that are more than minimal, and 3. There is an adequate plan for debriefing the participants, when appropriate

25. Human Studies Program Office of Research Compliance  Used for studies involving deception  Violates Belmont principle #1 – full understanding of research – but if research cannot be practically done without deception, then IRB may grant this alteration  Debriefing Form is given immediately after completion of participation  Discloses true purpose of study  “Re-consents” participants asking permission from participant on whether or not data collected can be used.

26. Human Studies Program Office of Research Compliance  Introduce yourself and why you are doing this research project  Include your inclusion criteria (e.g., “you are asked to participate because you are….. And 18 years of age”)  Make sure you know the difference: Anonymous vs. confidential  Storage and destruction of data ◦ Where are you keeping the data? ◦ How long are you going to keep the identifiable data?  Compensation is not a benefit  Optional section with a “yes” and “no” to initial ◦ Audio recording ◦ Contact for future study ◦ Use of real names in publication

27. Human Studies Program Office of Research Compliance  An Informed consent has three basic requirements: ◦ (1) Informative, ◦ (2) Understandable, ◦ (3) Voluntary Agreement  There are many forms of informed consent documentation, and appropriate form should suit the research’s level of risk, study population, and research setting  Informed Consent is not just a paper, it is a process!

28. Human Studies Program Office of Research Compliance Templates of consents can be found at https://manoa.hawaii.edu/researchcompliance/templates https://manoa.hawaii.edu/researchcompliance/templates Contact Us: Human Studies Program Office of Research Compliance UH Manoa Biomedical Building B-104 (808) 956-5007 uhirb@hawaii.edu Website: https://manoa.hawaii.edu/researchcompliance/human- studieshttps://manoa.hawaii.edu/researchcompliance/human- studies