Template B�for Adult Participants

							DRAFT Adult Participant Template (HIPAA) (remove this text and the instructions text below from the final
document submitted to the IRB and used for participants). (PI: This must be distributed to participants on
letterhead or copies of letterhead.)

General instructions:
   1. This authorization is to be used when Protected Health Information (PHI) is being used or disclosed
       from a unit in DePaul University that would be considered a health care provider, health care clearing
       house or healthcare plan. If the PHI will be obtained from a source outside of one of DePaul’s health
       care units, then it will generally be required to use that agencies authorization form and procedures for
       the release of the PHI. However, the DePaul consent document should include information about
       collecting the PH and the type of PHI that will be part of the research data, but it would not be required
       that the DePaul consent contain the HIPAA elements of authorization. (see the guidance document
       ‘Recommended consent language.’
   2. Remove the brackets for inserting text from the final document.
   3. Be sure to complete the title for the research. The title should match that on the application unless there
       is a specific reason for an altered title (i.e. deception will be used in the research).
   4. If the research is being conducted by a student, the last sentence of the first paragraph should identify
       them as a student, undergraduate or graduate. Additionally, the name of the faculty sponsor should be
       included, especially if they are active in the conduct or the research and will have access to the research
       data for the purposes of aiding in data analysis. Example: This study is being conducted by John Smith,
       a graduate student at DePaul University as a requirement to obtain his Masters degree. This research is
       being supervised by his faculty advisor, Jane Doe. If appropriate, include the faculty sponsors contact
       information in the consent.
   5. If you are conducting research in a foreign country or with non-English speaking participants, you
       should consider what will be the best method for a participant to contact you, especially as most research
       questions will arise during the actual conduct of the research (e.g. when you yourself are in that foreign
       location). Considerations may include presence of technology in that area of the world or the economic
       cost of making an international phone call, or what is affordable for your target population. For phone
       numbers, be sure to include the international code. Additionally, the Office of Research Protections staff
       may not be able to speak or understand the language of the participant (unless the language is Spanish).
       So, it may be appropriate to indicate that, “The person at this number and email address may not be able
       to read or understand [insert language being used] so it might be necessary for you to have someone you
       know who speaks English to help with the call or help translate your email.”
   6. If conducting research in a foreign country, you should indicate, “…DePaul University, Chicago,
       Illinois, USA.”
   7. The document submitted to the IRB should have a footer, with a version date. If the document is revised,
       it should be given a new version date. Ensure that the auto-update function for dates is turned off in the
       document so that it will not change to the current date every time you open the document.
   8. If you are requesting a waiver of documentation of consent, the signature line should be removed.
   9. If your research involves unusual procedures or design aspects and you are unsure of whether there is
       IRB required or recommended language to cover the issue, please refer to the document,
       “Recommended Consent language” for guidance.

                       CONSENT TO PARTICIPATE IN RESEARCH &
          AUTHORIZATION FOR THE RELEASE OF PROTECTED HEALTH INFORMATION

                                                [TITLE OF STUDY]

What is the purpose of this research?
We are asking you to be in a research study because we are trying to learn more about [insert a simple description
of the study’s aims and goals]. You are invited to participate in this study because you are [insert brief explanation
of why the participant was chosen, i.e. simple summary of inclusion criteria]. This study is being conducted by
[insert name of PI (if only one individual is conducting the research) or of research team] at DePaul University
[(“DePaul Research Team”)].

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How much time will this take?
This study will take about [insert specific number of minutes and/or hours for the full study] of your time. [If there
are multiple aspects of the research, indicate the time for the subparts and the research as a whole.]

What will you be asked to do if you agree to participate in this study?
If you agree to be in this study, you will be asked to [insert specific information; for example, fill out a survey,
complete an interview]. [If there are multiple aspects of the research, be sure to include a description of everything
they will be required to do for research participation, i.e. I will record your interview on audio tape and transcribe it
later to get an accurate record of what you said.] You will also be asked to allow the DePaul Research Team to use
your health information for this study.

How will my health information be used?
A federal law called the “HIPAA Privacy Rule” requires us not to use your personal medical information for
research without your permission.

If you agree to let the [PI or DePaul Research Team] use your health information, [insert names of health care units
or health care providers at DePaul University] will provide us with your health information from its/their records
and/or will let us retrieve some of your health information from its/their files. Health information that will be used
in the research study includes [insert a specific and meaningful description of information to be used]. Our purpose
for using your health information is [a description/purpose for why we are using and disclosing the participant’s
health information].

How will my privacy and the confidentiality of the research records be protected?
Only the DePaul Research Team will be authorized to use (add: “and disclose” if you will disclose data to another
party) your health information. Both your health information and other study records will be stored securely, and
only the DePaul Research Team will have access to the records. In any report we might publish, we will not
include any information that will identify you by name. Some people might review our records in order to make
sure we are doing what we are supposed to. For example, the DePaul University Institutional review Board, the
funding agency for the research [insert funding agency or delete if not externally funded], and/or the Data and
Safety Monitoring Board [Insert if you create one or delete if not needed.] may review your information. If they
look at our records, they will keep your information confidential. [If there are exceptions to the maintenance of
confidentiality (such as transcribers having access to make transcriptions of the recordings), include them. If the
research sessions will be recorded (audio or video), indicate how long the tapes or files will be kept before
destroying them and how they will be destroyed.]

[If you will disclose protected health information to a 3rd party, such as a collaborator or sponsor, you must include
this paragraph:

    “Information used may be subject to disclosure by us to [insert to whom information may be disclosed to and
    why we are disclosing that information to that person/entity]. Once the information has been disclosed to the
    [people/entities] above, they may further disclose the information to others and it may no longer be protected
    by privacy laws. However, any mental health, substance abuse, genetic testing or HIV/Aids information
    disclosed pursuant to this authorization may not be further disclosed without your authorization. Except as
    permitted above, the DePaul Research Team shall not disclose your health information to third parties unless
    required by law or permitted under HIPPA.”

Authorized use of your health information [add: “for the purpose of use and disclosure” if you will disclose data to
another party] will expire [insert expiration date or an expiration event that relates to the individual. The statement
“end of the research study” or similar language is sufficient. However, you must include some type of language
that states an expiration date.].

What are the risks involved in participating in this study?


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Being in this study does not involve any risks other than what you would encounter in daily life. [Delete this
statement if it is not true, for example the research involves greater than minimal risk.] [Insert specific information,
even if the risks are minimal. E.g., “For example, you may feel uncomfortable or embarrassed about answering
certain questions. Although it unlikely/has never happened before on any of my/our projects, it is also possible that
others could find out what you said.” The second statement should not be used, if you have not conducted enough
research to justify it. The most common risks are breach of confidentiality, if data are identifiable, and feeling
uncomfortable, if questions are sensitive. You may need to list other risks, depending on the nature of your study.]

What are the benefits of your participation in this study?
You will not personally benefit from being in this study. However, we hope that what we learn will help [sub-
group, population, or society targeted by the inquiry]. [If your study is an intervention & has potential benefits,
please describe.]

[Please note that material inducements are not considered benefits. If you will provide an inducement, you should
create another section entitled “Will I receive any kind of payment for being in this study?”]

Can I decide not to participate? If so, are there other options?
Yes, you can choose not to participate and not to allow the use and sharing of your health information. [choose
which option applies to your research, a) However, because your health information is required for research
participation in this study, if you decide not to allow the use and sharing of your health information, it will
only mean you cannot take part in this research. If you do not allow us to use [and share] your health
information, it will not affect your non-research related treatment, payment or enrollment in any health
plans or your eligibility for other medical benefits at DePaul University. b) The portion of the research
that uses health information is optional and you may still participate in the research without providing
your authorization for the use [and sharing] of your health information. If you do not allow us to use [and
share] your health information, it will not affect your non-research related treatment, payment or
enrollment in any health plans or your eligibility for other medical benefits at DePaul University.

Even if you agree to be in the study now, you can change your mind later and leave the study. You may do so by
writing to [insert your name and contact information]. If you take back your authorization, we may continue to use
[add: “or disclose” if you will disclose data to another party] information that was obtained prior to the time you
revoked your authorization. If our study integrity is reliant on your information, for example you had a bad
reaction to the research and we want to ensure that we have all required information about the event and the event is
resolved, we may continue to use and disclose new information after we receive your request to take back your
authorization. [If there are alternatives (e.g., leaving class early, working on a different activity), please describe.]

Whom can I contact for more information?
If you ever have questions about this study, you may contact [insert your name and contact information].

If you have concerns about your privacy rights, please contact the DePaul University Chief Privacy Compliance
Official at 312-362-8458.

If you have questions about your rights as a research participant, you may contact Susan Loess-Perez, DePaul
University’s Director of Research Protections at 312-362-7593 or by email at sloesspe@depaul.edu.

You will be given a copy of this form to keep for your records.

Statement of Consent:

I have read the above information. I have all my questions answered. (Check one:)

 I agree to the use [and sharing] of my health information and I consent to be in this study.


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 I DO NOT agree to the use [and sharing] of my health information, but DO consent to participate in the rest of
the study. [Delete if this is not an option for your research]

 I DO NOT agree to the use [and sharing] of my health information, and I DO NOT consent to be in this study.


Signature:_______________________________________________              Date: _________________

Printed Name:___________________________________________


Signature of Person Obtaining Consent:__________________________________ Date: __________________

Printed Name:___________________________________________




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