Working With Research Study Participants: An Overview

Working With Research Study Participants: An Overview Office for Protection of Human Subjects / Committee for Protection of Human Subjects University of California, Berkeley ophs@Berkeley.edu / (510) 642-7461 September 2018; V.2.

Interacting with Research Subjects An overview on how to: • Share information about a research study with potential subjects who may volunteer for the study; and • Interact with subjects throughout the study (e.g., conducting the informed consent process, administering surveys, interviewing, leading focus groups).

Learning Objectives / 1 After this presentation, you should be able to: • Name and understand the three basic ethical principles described in The Belmont Report; • Implement these ethical principles when working with research subjects.

Learning Objectives / 2 Learning Objectives / 2 • Understand how to help protect participants’ privacy; and • How to help keep subjects’ study data secure (confidentiality).

The Research Team / 1 • Our ethical responsibility is to protect the study subjects. • Thorough training in how to recruit and interact with subjects, conduct the study procedures, and maintain effective communications are all key to the process.

The Research Team / 2 • Each team member should understand his/her role in the study. • All questions about the study—now or later—should be directed to [name UC Berkeley PI or designee]

The Belmont Report • The Belmont Report identifies the ethical principles upon which the federal regulations for human subject protections are based. • Reading this short document is highly recommended; see “Additional Resources” (final slide).

Belmont Ethical Principles: Respect for Persons / 1 • The autonomy of the individual must be acknowledged and respected. • Informed consent. • Voluntariness – ability to decide to participate in research and to withdraw at any time, without coercion or undue influence from others.

Belmont Ethical Principles:Respect for Persons / 2 • Individuals with limited autonomy must receive special protections. The limits • May be inherent (e.g., limited capacity to understand and process information). • May be situational (e.g., prisoners, children)

Belmont Ethical Principles: Beneficence / 1 • Researchers’ obligation to endeavor to “do no harm,” minimize any risks and maximize any benefits of the research. • Use procedures that are the least risky. • Risks – include physical, psychological, legal, social and economic harms.

Belmont Ethical Principles: Beneficence / 2 • Benefits may be • To individual subjects; and/or • To others (e.g., to basic research, to a community, or to society as a whole). .

Belmont Ethical Principles: Justice • Treat individuals fairly. • Design research such that its burdens and benefits are shared equitably.

Study Materials / 1 • Staff who recruit or work with study participants should verify with the PI/designee that only the most recent IRB-approved materials --e.g., flyers, phone recruitment scripts, interview consent documents and debriefings—are being used.

Study Materials / 2 Study Materials / 2 • Design research such that its burdens and benefits are shared equitably. Any changes to flyers, phone recruitment scripts, interview consent documents, debriefings and other study materials must be approved by the IRB via protocol amendment before being used with research participants.

Informed Consent • Informed Consent (IC) is often misinterpreted as merely obtaining an individual’s signature on a form (or a “yes” response in a verbal consent process. • Actually, IC is a process of education and decision-making that begins with the very first contact with a potential study subject (i.e., during recruitment).

IC – Begins with Recruitment / 1 Recruitment / 1 Study staff who recruit subjects should keep in mind that this step is also part of the IC process. • While initial information shared with potential subjects will be briefer than what is contained in the IC document, care should be taken during initial contacts to provide only accurate information (i.e., consistent with the IC documents/study procedures).

IC – Begins with Recruitment / 2 Regulations permit initial discussions about the study to occur in a group setting or one-on-one. A setting can be selected for reasons that are practical or based on cultural considerations. • When recruiting in group settings (e.g., informational meeting, classroom) make sure that there’s a way for subjects to raise questions/agree to participate in private (i.e., not in front of colleagues/classmates, etc.) Be sure to notify potential subjects of this option.

The IC Process • For those individuals who decide to participate, the IC process continues throughout the study. • It is an ongoing dialog that includes providing new information (e.g., changes in risk factors) that may impact the decision to continue in a study.

Goals of the IC Process To build with each potential/enrolled subject: • A trusting relationship and open dialog. • An understanding of the essence of a study so that s/he can make a truly informed, autonomous decision about whether to participate.

Cultural Considerations / 1

Cultural Considerations / 2 • Key factors: • Trying to remain aware of our own biases. • Educating ourselves and asking for help. • Being sensitive to and curious about cultural differences (i.e., asking, not assuming).

From the Outset, Potential/Enrolled Subjects Need to Know: • The study constitutes “research.” • It is entirely up to them whether they participate or not. • They are free to skip questions (e.g., during an interview), or stop participating in the study at any time without having to share their reason(s) for doing so.

The Informed Consent (IC)Process / 1 • People approach volunteering for a study with preconceived ideas and life issues that may impede true informed consent. It is the research team’s responsibility to identify and address these issues as part of the IC process.

The IC Process / 2 • Some potential subjects may adopt a “Give me the form, I’ll just sign it” approach. However, the key points about a study should always be reviewed as part of the process.

Tips for the IC Process / 1 • IC discussions should take place in a quiet, private location. If IC occurs via phone, check to see if it’s a good time for the person to talk, and if s/he is in an appropriate location.

Tips for the IC Process / 2 • Some potential subjects may be reticent about asking questions (e.g., shy, do not want to appear “dumb,” etc.) • Avoid passive acceptance when a potential subject states s/he has no questions. To facilitate understanding, encourage a subject to repeat—in his/her own words—the key points about a study.

Tips for the IC Process / 3 • If a potential subject seems stressed or anxious, it will likely be hard for him/her to assimilate the IC information. • Consider offering to reschedule the discussion. • If the individual wishes to go ahead, slow things down by going point-by-point, encouraging his/her input, and/or summarizing the responses.

Tips for the IC Process / 4 • In general, encourage potential subjects to take their time (e.g., ask questions, take the form home, talk to friends/family, etc.)

Privacy and Confidentiality / 1 These terms are sometimes confused. • Privacy pertains to control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Privacy and Confidentiality / 2 • Confidentiality pertains to the treatment of information that an individual discloses in a relationship of trust. It involves the expectation that information will not be divulged to others-- without permission--in ways that are inconsistent with the understanding of the original disclosure.

Protecting Subjects’ Privacy: Examples / 1 • When an individual other than the subject answers the phone, ask for subject by name but withhold the context (e.g., do not share that the call is about a research study; do not name study, etc.) • Be sensitive to privacy issues when leaving voice mail messages. Check with the subject to see if it is okay to leave messages.

Protecting Subjects’ Privacy: Examples / 2 • Avoid scheduling interviews on sensitive topics in public places. • Close exam room curtains when conducting physical exams.

Protecting Confidentiality: Examples / 1 • Share subject study data only with appropriate study team members. • Keep signed consent forms and other documents containing identifiable data in a secured location. • Encrypt and password-protect all identifiable data files – including all audio and/or video recordings.

Protecting Confidentiality: Examples / 2 • Keep memory sticks, laptops and other removable media secured when not in use. • Keep participant names/study identification codes in a separate, secure location from all other study data.

Informed Consent, Privacy and Confidentiality / 1 • The study consent documents provide an explanation of the extent to which the confidentiality of private data identifying subjects will be maintained. • Familiarize yourself with the study consent documents and our study team data security plan. Apply these standards in your day-to-day work.

Informed Consent, Privacy andConfidentiality / 2 • An unintended breach of confidentiality is a risk factor for any research study. • Since complete confidentiality of research data cannot be guaranteed, avoid any wording that implies such assurance.

Unanticipated Problems and Adverse Events / 1 • Despite a study team’s best efforts, unanticipated problems (e.g., a confidentiality breach; using an outdated version of a study questionnaire; person faints during a blood draw) do happen.

Unanticipated Problems and Adverse Events / 2 • It is very important that study team members report any unanticipated problem or adverse event as soon as possible to [name UC Berkeley PI or designee]. • The PI assumes overall responsibility for the study.

Thank you for your attention! Questions? June 2016

Additional Resources • The Belmont Report: http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/# • CPHS Data Security Guidelines & Matrix: http://cphs.berkeley.edu/datasecurity.pdf

Working With Research Study Participants: An Overview