Waiver of Informed Consent&/Or

Institutional Review Board

(734) 712-5470

Waiver of Informed Consent&/or

Waiver of HIPAA Authorization

Consent and/or HIPAA Authorization may be waived for part or all of a study.

AnInformed consentfrom an adult participant who is to be in a non-exempt research study is always required by federal regulations, unless an IRB grants a waiver of this required consent.

HIPAA authorization (permission) is always required by federal regulations when a researcher wishes to access a participant's medical recordor in the use anddisclosure of protected health information (PHI) to conduct research, unless an IRB/Privacy Board grants awaiverof this required authorization.

This form is the methodto request one or both of these actions (p. 1 waiver of consent, p. 3 waiver of HIPAA authorization). Federal regulations stipulate criteria that must be met in order for an IRB to grant a waiver.

Use the Waiver of Assent form for children who are participants.

Need help? Call(734) 712-5470

Waiver of Informed Consent No consent will be obtained for

part or all of the research

Adult Participants

Title of Research Project:

Indicate thestudy components that you are requesting a waiver of informed consent for:

Screening for eligibility criteria in the medical record for an FDA-regulated study(safety and effectiveness of FDA regulated products; drug, device or biologic)—STOP, the FDA does not consider this to beresearch, so you do notneed to request a waiver for this step of your research; however, the HIPAA regulations may still apply. Note: Screening in the medical record for other reasons and screening tests/proceduresthat are performed solely to determine eligibility are considered research and an informed consent is required.

Screening for eligibility criteria in the medical record for an OHRP (non-FDA)regulated study

(OHRPdoesconsider screening to be research; 45 CFR 46.116applies. HIPAA regs may also apply)

A part of the study:

The entire study

Parental permission for an OHRP-regulated study

Planned emergency research (under 21 CFR 50.24)- contact the Research Compliance Dept for a different form.

Note: For FDA-regulated drugs, devices, or biologics, consent may only be waivedin limited circumstances-- foremergency use of atest article (21 CFR 50.23) or for planned emergency research (21 CFR 50.24). In planned emergency research, a waiver cannot be granted for pregnant women or those people meeting the regulatory definition of a prisoner.

A waiver of consent cannot be granted for research that includes participants who meet the regulatory definition of a prisoner. Will your research involve the participation of prisoners?

Prisoner status will not be known

Noprisoners will participate (status will be known)

Yes – STOP, a waiver can only be granted for those participants in the study that are not prisoners.

If yes, describe how you will differentiate between participants that are prisoners and those that are not, so that prisoners may be consented:

Are you requesting a waiver of consent to look at mental health, substance abuse, social services records or to look at HIV or AIDs or AIDS-Related Complex status?

No

Yes - please be aware of the following:

• Under Michigan law, HIV status may not be accessed or used for research purposes without the individual's written permission for a specific research use. You must consent each participant, therefore you may not use this form to request a waiver of consent or HIPAA.
• Substance abuse laws allow you to waive consent if the identifiable information will not be released to anyone outside of SJMHS or re-disclosed to anyone. Researchers must maintain and destroy patient identifying information in accordance with federal substance abuse laws.There are criteria that will need to be met during the review of your study submission.
• Information in the record of a recipient, and other information acquired in the course of providing mental health services to a recipient: The individual who is the subject of the information shall not be identified in the disclosed information unless the identification is essential in order to achieve the purpose for which the information is sought or if preventing the identification would clearly be impractical, but not if the subject of the information is likely to be harmed by the identification.Psychotherapy notes may not be accessed unless prior consent is provided by the subject.

Please refer to applicable policy or contact the Research Compliance Dept. for further assistance: .

Choose one of the following two optionsin order to request a waiver of informed consent

for OHRP-regulated research(see 45 CFR46.116):

1st Option:(a-d must be answered in order for a waiver to be granted)

a)Explain whythe research involves no more than minimal risk* to the participants:

Retrospective chart review where all of the data already exists at this time

Other- please describe:

*Minimal risk means that the probabilityand magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

b) Explain why the waiver will not adversely affect the rights and welfare of the participants:

(i.e., describethe plan to protect the confidentiality of the information to be collected; explain why the infobeing sought is important enough to justify invasion of privacy without the participants' consent to do so; etc.)

c) Why is it not possible or practical to obtain the required informed consent?

d)If appropriate, will the participants be provided with additional pertinent information after participation?

No, the research team will not interact with the participants (i.e., retrospective chart)

Other- please describe:

OR

2nd Option:

a) A demonstration project or research that is designed to study, evaluate, or otherwise examine(these may be identified as a demonstration project meeting 45 CFR 46.116(C)(1) by the sponsoring federal department or agency):

Public benefit or service programs;

Procedures for obtaining benefits or services under those programs;

Possible changes in or alternatives to those programs or procedures; OR

Possible changes in methods or levels of payment for benefits or services under those programs;

b) The demonstration project or research will be conducted by or subject to the approval of state or local government officials[see 45 CFR 46.116(C)(1)]. Please describe how your study meets this definition and provide evidence that it meets the definition:

c) Describe why the research or demonstration project could not practically be carried out without the waiver of consent:

NOTE: If you intend on accessing the medical record, you will need to request a waiver of HIPAA Authorization

The Waiver of HIPAA Authorization form follows, below. The PI's signature is not required for a waiver of informed consent.

Please return this completed form via e-mail to:

Waiver of HIPAA Authorization You plan to access the medical record

no written authorization will be obtained

The HIPAA regulations should not be confused with the FDA or OHRP regulations regarding waiving informed consent. The HIPAA regulations (45 CFR 164.512, 164.508, 160) are separate from the FDA and OHRP regulations.

You may need a Waiver of HIPAA even if: youalso have a Waiver of Consent,a Waiver of Consent is not needed, or your study is exempt from review by an IRB for 45 CFR 46.

A partial waiver or alteration of the HIPAA authorization may be requested in cases where thegranting of a full waiver of authorization is not warranted. This allows the IRB to alter or eliminate one or more of the regulatory elements normally required in the HIPAA authorization.

Title of Research Project:

Will you be accessing medical records or individually identifiable health information (PHI)?

Yes

No—STOP—HIPAA may not apply. Contact the Research Compliance Dept for clarification.

Are you requesting full waiver, partial waiver, or alteration of HIPAA authorization?

Alteration

Of which elements?

Partial Waiver:

Screening in the medical recordfor eligibility criteria orresearch recruitment purposes

For follow-up contactinformation only

Chart review of data that already exists; chart review is onlypart of the study

Other:

Full Waiver:

Chart review of data that already exists, where chart review isthe entire study

For entire study

Are you requesting a waiver of HIPAA to look at mental health, substance abuse treatment, or social services records or to look at HIV or AIDs or AIDS-Related Complex status?

No

Yes - please be aware of the following:

• Under Michigan law, HIV status may not be accessed or used for research purposes without the individual's written permission for a specific research use. You must consent each participant, therefore you may not use this form to request a waiver of consent or HIPAA.
• Substance abuse laws allow you to waive consent if the identifiable information will not be released to anyone outside of SJMHS or re-disclosed to anyone. Researchers must maintain and destroy patient identifying information in accordance with federal substance abuse laws.There are criteria that will need to be met during the review of your study submission.
• Information in the record of a recipient, and other information acquired in the course of providing mental health services to a recipient: The individual who is the subject of the information shall not be identified in the disclosed information unless the identification is essential in order to achieve the purpose for which the information is sought or if preventing the identification would clearly be impractical, but not if the subject of the information is likely to be harmed by the identification.Psychotherapy notes may not be accessed unless prior consent is provided by the subject.

Please refer to applicable policy or contact the Research Compliance Dept. for further assistance: .

Has another IRB or Privacy Board reviewed this request for a waiver or alteration of HIPAA authorization?

Yes—state the name and please attach documentation:

No

All of the following criteria must be satisfied in order for a waiver or alteration of the required HIPAA authorization to be granted:

1)Explain why theresearch could not be practically conducted without the waiver or alteration of the required participantHIPAA authorization; that is-- why is it not practical for you to gain their permission?

2)Explain why the research could not practically be conducted without access to and use of the Protected Health Information (PHI); that is-- why do you have to have PHI in order to conduct your study?

3)The use or disclosure of Protected Health Information must involve no more than a minimal risk to the privacyof individuals. Per HIPAA Regulations each question below must be answered in order to document that the use of a waiver meets the definition of minimal risk to privacy.

a)Please provide an adequate plan to protect the identifiers from improper use and disclosure:

b)Please provide an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or that such retention is otherwise required by law:

c)Please provide adequate assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law for authorized oversight of the research project, or for any other research for which the use or disclosure of protected health information would be permitted:

4)The waiver will permit the researcher to access, use, or discloseonlythe specific individually identifiable health information for which access, use, or disclosure is being requested. Indicate below what specific sourcesand from whom this information will be accessed, obtainedor disclosed from the medical record:

Who owns the data?
Check all that apply
What sources of data will you access,use or disclose? Check all that apply / SJMHS / My Private Practice / Trinity Health / Other:
Electronic medical records: name of system(s):
Paper records:name of records:
Verbal
Images:
Other:
Other:
Other:

a)If you are accessing or using data/images/records from the health record that is owned by SJMHS or Trinity Health, who will extract the data?Check all that apply

N/A—not using data owned by SJMHS or Trinity Health

SJMHS Quality Institute

Research teammember who is:

anemployee or member of the SJMHS or Trinity Healthworkforce

("employees, volunteers, trainees, and other persons whose conduct, in the performance of work for a covered entity or business associate, is under the direct control of such covered entity or business associate, whether or not they are paid by the covered entity or business associate" 45 CFR 160.103).

not an employeeor member of the SJMHS or Trinity Health workforce–

answer below:

If not an employee or member of SJMHS or Trinity Health workforce, does the person have the required Business Associate Agreement with SJMHS or Trinity Health that allows him or her to extract this data?

No--contact the HIPAA Privacy Officer or legal dept for forms approval

Yes-- please attach.

SJMHS or Trinity Health employee who is not a research team member (required for de-identified or limited data set data extractions)

Name:

Department:

Other (not listed above):

If not an employee or member of SJMHS or Trinity Health workforce, you must have the required Business Associate Agreement with SJMHS or Trinity Health

b) Dates of records to be accessed: from // through //

or N/A if screening, etc. (dates of the records, not dates that you will physically be reviewing them)

c)Indicate below the specific Protected Health Information for which use or access is necessary and for which you are requesting access to:

Name (including Initials)
Address

Street address

City, state, county, precinct, zip code
Elements of dates (Birth Date, Admission Date,

Date of Service, Date of Death, etc.)

Age for people over 89 years old. You must collapse age into a single category for

participants over 89 in order to be granted a waiver:

I/we will

Telephone number
Fax number
E-Mail address
Social Security Number
Medical Record Number
Health Beneficiary number
Account numbers (credit card, etc.)
Certificate/License numbers
Vehicle Identification/serial numbers
Device Identification/serial numbers
Website URLs
Internet protocol (IP) Addresses
Biometric identifiers (voice, fingerprints, etc.)
Full face images
Any other unique identifying numbers, characteristic or code (linked study

identification numbers, etc.):

Other:

d)Is this the minimum necessary PHI that is needed in order to conduct this study?

No—please revise your list to only include the absolute minimum necessary PHI

Yes

e)Will the PHI be shared with anyone who is not an employee of SJMHS?

No

Yes—answer below

If yes:

1) Who? Include affiliation:

2) How will it be shared (VPN between SJMHS and recipient,encrypted e-mail, etc.)?

3) Is the required Data Use Agreement and/or Business Associate Agreement in place?

No--Contact the HIPAA Privacy Officer or legal dept for forms approval

Yes—please attach.

For waiver or alteration of HIPAA authorizationONLY:

INVESTIGATOR ATTESTATION and SIGNATURE

• I declare that the information provided on this form accurately reflects my research intentions and all of the PHI that will be accessed, used or disclosed.
• If my intentions change, I acknowledge that I am required to resubmit this form to the IRB for review and determination.
• I declare that the requested information constitutes the minimum necessary data to accomplish the goals of the research.
• I agree to seek permission from the IRB before reusing participant medical record information for a different purpose or disclosing it to any other person or entity, except as required by law.
• I will not re-use this information for other research for which the use or disclosure of protected health information is requested without first gaining permission from the IRB.

Printed Name of Principal Investigator

______

Signature of Principal InvestigatorDate

A waiver of HIPAA authorization cannot be granted without the Investigator's signature.

Please return this completed form and the page below, via e-mail to:

A copy of the waiver of HIPAA authorization form will be return to youfor

retention in your records for 6 years

Title of Research Project:
IRB USE ONLY:
St Joseph Mercy Health SystemIRB HIPAA Determination
Per Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a member of the SJMHS IRB (acting as the Privacy Board) reviewed thisrequest for an alteration or waiver of the required HIPAA authorization for the use and disclosure of Protected Health Information in the above entitled study with the above described PHI. The SJMHS IRB determined that the alteration or waiver(in whole or in part)of the HIPAA authorization:
satisfies all the required criteria listed above
does not satisfyall of the required criteria
This request was reviewed and approved under full convened board procedures at 45 CFR 46.108(b) or expedited review procedures at 45 CFR 46.110.
SJMHS IRB member'ssignature: ______Date:___
Return a copy of the HIPAAwaiver form to the PI for mandatory retention in their records for 6 years(from the date the waiver or alteration was obtained or the date when it was last in effect, whichever is later; per 45 CFR 164.152).

SJMHS Research Compliance 10-24-16e Page 1 of 8