Information for the Public

Key considerations & concepts

Risk vs. Benefit Analysis (HRPP Operations Manual, Part 3, section III, C.6.b&c)

The IRB reviews the proposed study to verify if the risk to the subjects and/or to society as a whole outweighs the potential benefits. Risks are potential harms, usually physical or psychological.  These risks may affect you, your family, or groups in society at large. 

• For a PI, the risk/benefit analysis determines what protections will be required for participants if the study is approved
• For the IRB, the risk/benefit analysis determines whether the risks involved are minimized and justified
• For you, the risk/benefit analysis helps you determine whether you want to participate in the study

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Informed Consent (HRPP Operations Manual Part 3, section III, C.6.e)

(Adapted from Informed Consent: The Consumer’s Guide To The Risks And Benefits Of Volunteering For Clinical Trials, Kenneth Getz and Deborah Borfitz)

Informed consent refers to the communication process that allows individuals to make a knowledgeable choice to voluntarily participate in the research study, decline to participate, or to withdraw at any time for any reason after the study has started without penalty.  As a potential participant, you must be provided with complete information about the study; understand this information; and feel free to decide whether or not to voluntarily participate.  

In general, you should be given written information (verbal or other format is acceptable only if approved by the IRB) explaining that the study involves research, the purpose of that research, and including the following details to help you decide whether or not to participate:

• The risks, side effects or discomforts that you might reasonably expect
• The benefits you and others might reasonably expect
• The study’s duration and what will happen in the study
• Whether any procedures, drugs or devices will be used that are different from those used in standard medical treatment
• Appropriate alternative treatments that might be advantageous to you
• Available treatments or compensation, if complications occur during the study
• Whether your health information will be used in the research, with an expiration date for your authorized use this information, and information how to revoke authorization
• The risks to the your privacy and confidentiality
• Contact information for the IRB, if you have any concerns

You are allowed to ask any questions about the study before giving consent and at any time during the course of the study. You must be allowed ample time, without pressure, to decide whether to consent (agree) to participate or not in the study.  You should receive a signed and dated copy of the informed consent form.

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Privacy & Confidentiality (HRPP Operations Manual, Part 3, section III, C.6.g)

Privacy and confidentiality of the subjects is to be maintained throughout the research process.  Research involving particularly sensitive information requires additional privacy protections for subjects.  Each project needs to develop and enforce a mechanism for safeguarding the privacy and confidentiality of its subjects that all members of the study team (PI, students, staff, visiting scholars, etc.) are responsible for applying.  In general, study team members: 

• DO NOT reveal a participant’s name, address, telephone number, or other identifying information (or that of a family member, employer, or other person connected to a subject) to any person other than a member of the research team/staff directly connected to the study or an authorized official involved in oversight.
• DO NOT reveal the contents and substance of the information gathered in the study regarding any identifiable subject (or family member, employer, or other person connected to a subject) to any person other than a member of the research team/staff directly connected to the study, except as authorized by a PI or their designate, or authorized officials involved in oversight.
• DO NOT contact any subject (or family member, employer, or other person connected to a subject) except as authorized by the approved protocol.
• DO NOT release a data set (including for unrestricted public use or for other, unrestricted, uses) except in accordance with approved and established policies and procedures.

All persons not part of the research team/staff who have access to subjects’ data (other than unrestricted public release data sets) adhere to the same standards in protecting subjects’ privacy, anonymity, and confidentiality.

(Adapted from Informed Consent: The Consumer’s Guide To The Risks And Benefits Of Volunteering For Clinical Trials, Kenneth Getz and Deborah Borfitz)