An overview on how to: An overview on how to



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An overview on how to:

  • 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).



After this presentation, you should be

  • 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.



Understand how to help protect participants’ privacy; and

  • Understand how to help protect participants’ privacy; and

  • How to help keep subjects’ study data secure (confidentiality).



Our ethical responsibility is to protect the study subjects.

  • 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.



  • 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 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).



The autonomy of the individual must be acknowledged and respected.

  • 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.


Individuals with limited autonomy must receive special protections. The limits

  • 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)


Researchers’ obligation to endeavor to “do no harm,” minimize any risks and maximize any benefits of the research.

  • 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.


  • Benefits may be

    • To individual subjects; and/or
    • To others (e.g., to basic research, to a community, or to society as a whole).
    • .


  • Treat individuals fairly.

  • Design research such that its burdens and benefits are shared equitably.



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.

  • 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.



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.

  • 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 (IC) is often misinterpreted as merely obtaining an individual’s signature on a form (or a “yes” response in a verbal consent process.

  • 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).



Study staff who recruit subjects should keep in mind that this step is also part of the IC process.

  • 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).


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.

  • 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.


For those individuals who decide to participate, the IC process continues throughout the study.

  • 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.


  • 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.





Key factors:

  • 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).


The study constitutes “research.”

  • 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.



  • 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.



  • 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.



  • 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.



Some potential subjects may be reticent about asking questions (e.g., shy, do not want to appear “dumb,” etc.)

  • 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.



If a potential subject seems stressed or anxious, it will likely be hard for him/her to assimilate the IC information.

  • 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.


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



These terms are sometimes confused.

  • These terms are sometimes confused.

  • Privacy pertains to control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.



  • 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.



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.)

  • 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.



  • Avoid scheduling interviews on sensitive topics in public places.

  • Close exam room curtains when conducting physical exams.



Share subject study data only with appropriate study team members.

  • 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.



  • 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.



The study consent documents provide an explanation of the extent to which the confidentiality of private data identifying subjects will be maintained.

  • 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.



An unintended breach of confidentiality is a risk factor for any research study.

  • 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.



  • 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.



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].

  • 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.





The Belmont Report: http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/#

  • The Belmont Report: http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/#

  • NIH Office of Extramural Research: History of human subjects protections; includes a timeline of key events: http://phrp.nihtraining.com/history/07_history.php



CPHS Data Security Guidelines & Matrix: http://cphs.berkeley.edu/datasecurity.pdf

  • CPHS Data Security Guidelines & Matrix: http://cphs.berkeley.edu/datasecurity.pdf



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