SAMPLE CONSENT FORM – GDS COMPLIANT

PLEASE NOTE:
1) Statements in brackets and italics are instructions or examples, and should not be
included in the actual consent form.
2) Required wording (in regular font, not italics) should be used as is (if appropriate).
3) Suggested wording (in italics) can be revised as needed to provide the simplest and
clearest description of the study.
4) Statements in grey highlight are REQUIRED for New Federally-funded and Federally-
conducted studies as of January 2019. The IRB encourages all studies to adopt this
new template.

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

CONSENT TO DONATE SPECIMENS FOR FUTURE RESEARCH

Study Title: [Insert study title here]

[Add SIMPLIFIED TITLE if needed for subjects’ comprehension]

[Important! Remove all highlighting from actual consent form]

STUDY SUMMARY

**THIS SUMMARY IS ONLY REQUIRED IF YOUR COMPLETED CONSENT FORM IS

LONGER THAN 6 PAGES**

Introduction: We are asking you to consider taking part in a research study being done by name
the study doctor/researcher at UCSF.

The first part of this consent form gives you a summary of this study. We will give you more
details about the study later in this form. The study team will also explain the study to you and
answer any questions you have.

Research studies include only people who choose to take part. It is your choice whether or not
you want to take part in this study. Please take your time to make a decision about participating.
You can discuss your decision with your family, friends and health care team.

Purpose of the study: [Limit explanation to why study is being done, explaining in lay
language in 1-3 sentences. Some examples provided directly below:]

[Example: Phase I study]

The researchers want to find a long acting drug to better control [medical condition] and
reduce the number of pills you take. This study will test the safety of [study

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 drug/intervention] at different dose levels. We want to find out what effects, good and/or
bad, it has on you and your [specify type/stage/presentation of diagnosis].

[If this is a first-in-human study, add:] This is called a “first in human” study because it
is the first time this drug/intervention will be given to humans. This means that the safety
and risk information we have is based on how animals have reacted to the
drug/intervention.

[Example: Phase II study]

The researchers want to find a long acting drug to better control medical condition and
reduce the number of pills you take. This study will find out what effects, good and/or
bad, study drug/intervention has on you and your specify type/stage/presentation of
diagnosis.

[Example: Phase III study]

The researchers want to find a long acting drug to better control medical condition and
reduce the number of pills you take. This study will compare the effects, good and/or bad,
of study drug/intervention with commonly used drug/ intervention/placebo on you and
your specify type/stage/presentation of diagnosis to find out which is better. In this study,
you will get either the study drug/intervention or the commonly used drug/
intervention/placebo. You will not get both.

Study Procedures: If you choose to be in this study, …[Limit description to 2-3 sentences. Some
examples provided directly below:]

[Example: Experimental drug study]

… you will be asked to take the study drug or a placebo (a pill that looks like the study
drug but has no drug in it) twice a day for 3 months. In addition, the main study
procedures include…

[Example: Experimental drug study]

… you will be asked to come to the clinic every six weeks to receive study drug for as
long as your rheumatism responds to the treatment. In addition, the main study
procedures include…

[Example: Experimental device study]

…we will give you the heart monitor in the clinic and tell you how to use it. You will wear
the monitor while you sleep for two weeks. In addition, the main study procedures
include...

You will be in this study about insert number of days, weeks, months or years and visit the
research site approximately insert number times.

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Possible Risks: There are risks to taking part in a research study. Some of the most likely risks
of participation in this study include: [List ~5 most common risks in bullet points.]






There are also rare but serious risks of participation, like: [List 1-3 rare but serious risks in bullet
points.]



We’ll tell you about the other risks later in this consent form.

Possible Benefits: [Use one of the two examples directly below.]

[Example: If there is a potential for benefit]

You may or may not benefit from participating in the study.

[Example: If no direct benefit to the subject is anticipated]

There will be no direct benefit to you from participating in this study.

Your Other Options: You do not have to participate in this study. Your other choices may
include:
 Getting treatment or care for your condition without being in a study.
 Taking part in another study.
 Getting no treatment or receiving comfort care to relieve your symptoms and discomfort.
[If comfort care is not an option, delete “or receiving comfort care to relieve your
symptoms and discomfort.”
 If there are specific alternative treatments or procedures, add them to this list.]

Please talk to your doctor about your choices before agreeing to participate in this study.

Following is a more complete description of this study. Please read this description carefully.
You can ask any questions you want to help you decide whether to join the study. If you join this
study, we will give you a signed copy of this form to keep for future reference.

DETAILED STUDY INFORMATION

This part of the consent form gives you more detailed information about what the study involves.

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Medical research includes only people who choose to take part. Take your time to make your
decision about participating. You may discuss your decision with your family and friends and
with your health care team. If you have any questions, you may ask the researchers.

You are being asked to take part in this study because you are/have [specify prospective subjects’
medical condition or other reason for recruitment to study, such as being about to have specific
tissue removed, some of which will not be needed for clinical care].

Why is this research being done?

The purpose of this study is to…[Limit explanation to why study is being done, explaining in one
or two sentences. See examples for drug/intervention trials directly below.

[Address sponsorship and financial interests here:

 The IRB requires that all consent forms disclose which agencies or institutions (e.g.,
National Institutes of Health, Department of Defense, Center for Disease Control, State
agencies), cooperative groups (CALGB, COG, ACTG), foundations or industry sponsors are
funding the research or providing study drugs or equipment for the study. If the study is not
being funded by an external agency, then the internal funding source, i.e., Department funds,
personal funds, should be identified.

 Investigators must also disclose the nature of any financial or proprietary interests, though
this disclosure can be in general terms. For suggested wording, see Conflicts of Interest in
Research.

How many people will take part in this research?

About [state total accrual goal here] people will be asked to donate specimens for this research.
[For multi-center studies, it is good to give figures both for the whole study and for local
enrollment at UCSF.]

What will happen if I agree to donate my specimens?

If you agree to let researchers collect and store your specimens for future research, the following
will happen:
 After all routine tests required for your care are finished, instead of discarding your leftover
specimens we will save them in what is called a “tissue bank” for possible future research..
We also will collect and save information from your medical record, including things like
[List all types of information to be recorded for study purposes, including results of physical
examinations, diagnostic tests, medical questionnaires and histories, diagnoses, treatments,
etc. Be complete; this listing is required by HIPAA regulations.] We do not know for sure if

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 your specimens or medical record will be used, but they might be used in research about [List
the types of conditions that the specimens may be used for research on, e.g. cancer, heart
disease, diabetes, or other diseases.] Genetic information taken from the specimens (also
known as genotype data) and the medical record data (also known as phenotype data) may
be shared broadly in coded form.

 [If any additional tissue (including blood) will be taken for research purposes, describe the
procedures, including how the sample will be taken and how much will be taken. For
example: We will also collect a sliver of normal muscle or skin (the size of a grain of rice)
from the same place we make a cut for your surgery. We will draw extra blood (2
tablespoons) through tubes already in place for your surgery. We will not collect the extra
muscle and blood if we think it will cause any additional risk, discomfort, or pain beyond
what we normally expect from your surgery.]

 [If the researchers will continue to gather additional information from medical records or
other sources over a period of time, the collection activities and amount of time they will
continue should be described here.]

 We may give your specimens and certain medical information about you (for example,
diagnosis, blood pressure, age if less than 85) to other scientists or companies not at UCSF [if
applicable, add “or SFVAHCS”], including to a an unrestricted or controlled access
government health research database, but we will not give them your name, address, phone
number, or any other information that would identify you. We cannot guarantee that no one
will ever be able to use this information to identify you. Research results from these studies
will not be returned to you [describe any rare instances that this may occur].Sometimes
specimens are used for genetic research (about diseases that are passed on in families). Even
if we use the specimen for genetic research, we will not put the results in your medical
record. The research will not change the care you receive. Your specimen and any
information about you will be kept until it is used up or destroyed. It may be used to develop
new drugs, tests, treatments or products. In some instances these may have potential
commercial value. Your personal health information cannot be used for additional research
without additional approval from either you or a review committee.

 Your specimens will be kept for [State how long specimens will remain in the repository. If
they will become part of a permanent collection, they will be kept indefinitely]. If you decide
later that you do not want your specimens and information to be used for future research, you
can notify the investigator in writing at [insert address], and we will destroy any remaining
identifiable specimens and information if they are no longer needed for your care. However,
if any research has already been done using portions of your specimens, the data will be kept
and analyzed as part of those research studies.

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Can I stop being in the study?
Yes. You can decide to stop at any time.

If you withdraw from the study, any data or specimens we have already collected from you will
remain part of the study records. [Add this if appropriate to the study:] After you withdraw, the
researchers may still get information from your medical records if it is relevant to the study (e.g.,
laboratory results, treatment courses, health outcomes). You must tell the study team you do not
want this information to be collected when you withdraw, otherwise it will be collected. [Note to
researchers: If the subject does withdraw, remind them that follow-up data will still be collected
unless they ask otherwise.]

What risks are involved with donating specimens for research?

Describe any risks of any additional sampling. For example: Any extra tissue or blood we take
from you will come through cuts or tubes needed for your surgery, and should not cause you any
risk, discomfort, or pain beyond what we normally expect from your surgery.]
Confidentiality: Donating specimens may involve a loss of privacy, but information about you
will be handled as confidentially as possible. Study data will be physically and electronically
secured. As with any use of electronic means to store data, there is a risk of breach of data
security. Your name will not be used in any published reports from research performed using
your specimen. The manager of tissue bank [insert name] and select tissue bank staff members
will have access to information about you but they will not release any identifying information
about you to researchers using your specimen. The UCSF Institutional Review Board and other
University of California personnel also may see information about you to check on the tissue
bank.

Although your name will not be with the sample, it will have other facts about you such as
[insert specific details]. These facts are important because they will help us learn if the factors
that cause [insert specific condition] to occur or get worse are the same or different based on
these facts.

Genetic information that results from this study does not have medical or treatment importance at
this time. However, there is a risk that information about taking part in a genetic study may
influence insurance companies and/or employers regarding your health. To further safeguard
your privacy, genetic information obtained in this study will not be placed in your medical
record.

Taking part in a genetic study may also have a negative impact or unintended consequences on
family or other relationships. It is possible that future research could one day help people of the
same race, ethnicity, sex or gender as you. However, it is also possible through these kinds of

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studies that genetic traits might come to be associated with a particular race, ethnicity, sex or
gender. In some cases, this could reinforce harmful stereotypes.

[Use the following statement if your protocol involves the research collection of non-exempt
tissue derived from clinical specimens (in this context, “non-exempt” means the tissue is not
exempt from pathology review). See UCSF’s Research Tissue Acquisition Policy for more
information, and contact research@ucsf.edu if you have questions. Note: This statement is not
required for studies collecting designated research biopsies.]

Risk of inadequate specimens for diagnostic purposes: Providing parts of your surgically-
removed tissue for research could, in rare cases, result in too little tissue being available for your
doctors to make a clinical diagnosis (or complete other clinically important tests). To minimize
this risk, a Pathologist (or a pathology designee) carefully evaluates every tissue specimen at the
time of surgery to decide if it can safely be provided for research. With this process in place, we
believe the risk of negatively impacting your clinical care through providing tissue for research is
extremely small (below 1%).

[Include the following section only if extra blood or other tissue will be removed or there are
other biomedical procedures performed on the subjects for research purposes.]

How will my specimens and information be used?

Researchers will use your specimens and information to conduct this study. Once the study is
done using your specimens and information, we may use the remaining specimens and
information collected for future research studies or share them with other researchers so they can
use them for other studies in the future. We will not share your name or any other personal
information. We cannot guarantee that this will prevent future researchers from determining who
you are. We will not ask you for additional permission to share this de-identified information.

[Include the following statement only if applicable to your study:]

Research results: There may be times when researchers using your information and/or
specimens may learn new information. The researchers may or may not share these results with
you, depending on a number of factors.

[Include the following statement only if applicable to your study:]

Commercial Use: Your specimens and/or information obtained from your specimens may be
used for commercial use. If this happens, you will not share in any profits.

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What happens if I am injured because I took part in this study?
[Include this section if you are conducting a greater-than-minimal-risk study or a category 2 or
category 4 expedited review study (e.g., studies that involve blood draws or noninvasive, routine
clinical procedures for research purposes)]

It is important that you tell your study doctor, __________________ [investigator's name(s)], if
you feel that you have been injured because of taking part in this study. You can tell the doctor
in person or call them at __________________ [telephone number].
Treatment and Compensation for Injury:  If you are injured as a result of being in this study,
the University of California will provide necessary medical treatment.  The costs of the treatment
may be billed to you or your insurer just like any other medical costs, or covered by the
University of California or the study sponsor [sponsor name], depending on a number of
factors.  The University and the study sponsor do not normally provide any other form of
compensation for injury.  For further information about this, you may call the office of the
Institutional Review Board at 415- 476-1814.

[NOTE: This statement must be used without changes unless any of the following situations
apply:
(1) the Sponsor requests MMSEA 111 Language
(2) this is a clinical trial of a COVID-19 countermeasure and the PREP Act applies
(3) this is a VA study or this consent form will be used at a VA site (for UCSF/VA studies)
(4) the Sponsor chooses to remain silent on this point, in which case all reference to “the
study sponsor” should be omitted from the above statement.
(5) the sponsor is the NIH, in which case all reference to “the study sponsor” should be
omitted from the above statement. The NIH does not have a program in place to provide
compensation for research-related injury and should not be listed in this section.

For (1)-(5), see the IRB website and the notes section at the end of this template for standard
wording for each of these situations. No other changes may be made to the UCSF statement.

The IRB office is not in the position to negotiate indemnification agreements. If the Sponsor
refuses to approve the study with the UCSF statement, please refer them to the UCSF Risk
Management and Insurance Services office.]

What are the benefits of donating specimens for research?

There will be no direct benefit to you from allowing your specimens to be kept and used for
future research.

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What financial issues should I consider before donating?
You will not be charged for donating your specimens. You will not be paid for donating your
specimens. If the data or any new products, tests or discoveries that result from this research
have potential commercial value, you will not share in any financial benefits. UCSF may receive
payment from researchers requesting specimens in order to cover the costs of collecting and
storing the specimens.

What alternatives do I have?

If you choose not to donate your specimens, any leftover blood and/or tissue removed during
your surgery that is not needed for diagnosis will be thrown away [and no additional normal
tissue or blood will be removed for research purposes].

What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in
the study. No matter what decision you make, there will be no penalty to you and you will not
lose any of your regular benefits. Leaving the study will not affect your medical care. You can
still get your medical care from our institution.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek
payment by signing this form.

Who can answer my questions about the study?

You can contact the study team with any questions, concerns or complaints you have about this
study __________________ [telephone number(s)].
If you wish to ask questions about the study or your rights as a research participant to someone
other than the researchers or if you wish to voice any problems or concerns you may have about
the study, please call the office of the Institutional Review Board at 415-476-1814. [If there are
additional informational sources related to the study (e.g., patient representatives or individuals
at other study sites as appropriate), list here with contact information.]

[Only include the following section if this study involves the collection of human fetal tissue from
elective abortion for research purposes. If not, delete the entire “Donation of Human Fetal
Tissue for Research Purposes” section.]
Donation of Human Fetal Tissue for Research Purposes

Federally funded research studies that involve the use of human fetal tissue from elective
abortion for research purposes require that you review the following statements and indicate

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whether they are true for you. Please read this information carefully and put your initials and
date next to each statement that you agree with.

If you have any questions about any of these statements, please ask the study team:
1. Informed consent for the donation of human fetal tissue for research purposes is being
obtained by someone other than the person who obtained informed consent for the
abortion;
Initial:______ Date: __________

2. Informed consent for the donation of human fetal tissue for research purposes is
occurring after the informed consent for abortion;
Initial:______ Date: __________

3. The informed consent obtained for the use of human fetal tissue for research purposes
does not affect the method of abortion; and, additionally, no enticements, benefits, or
financial incentives have been used at any level of the process to incentivize abortion or
the donation of human fetal tissue for research purposes.
Initial:______ Date: __________

Consent
Please read each sentence below and think about your choice. After reading each
sentence, put your initials in the "Yes" or "No" box. If you have any questions about this
study, please talk to the study doctor or nurse.
No matter what you decide to do, it will not affect your care.
1. My identifiable specimens and associated data may be kept for use in research to learn
about, prevent, or treat [list the disease the specimens are being collected to study].

YES NO

2. My identifiable specimens and associated data may be kept for use in research to learn
about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease,
or heart disease).

YES NO

3. Someone may contact me in the future to ask me to take part in more research.

YES NO

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[Include if collecting additional specimens:
4. Additional tissue [and/or blood] may be taken for this research, as described in the
What Will Happen If I Agree… section above.

YES NO

You have been given copies of this consent form and the Experimental Subject's Bill of Rights to
keep. [Delete mention of Bill of Rights if not needed for this study.]

[If Protected Health Information as defined by HIPAA will be accessed, used, created or
disclosed, add the following: You will be asked to sign a separate form authorizing access, use,
creation, or disclosure of health information about you.]

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to

participate or to withdraw at any point in this study without penalty or loss of benefits to which
you are otherwise entitled.

If you wish to participate in this study, you should sign below.

Date Subject's Signature for Consent

Date Person Obtaining Consent

[STOP! Only include the following signature line if you may consent non-English speaking
subjects using the short form consent method AND this request has been addressed in the
IRB application.]

Date Witness – Only required if the participant is a non-English speaker

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[STOP! Do not use the following signature lines unless third party consent is being
requested and has been addressed in detail in the protocol.]

AND/OR:

Date Legally Authorized Representative

Date Person Obtaining Consent

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 NOTES TO PERSON PREPARING CONSENT FORM
1. Consent Document Identification Required by the IRB
Version date and short identifier: Every consent document (consent forms, assent forms,
information sheets) must include a version date (month, day, year) in a lower corner of each
page. This date should be hard coded -- in other words, the date should not update automatically
each time you open the document.  The version date should only be changed when the document
is modified. If multiple consent documents are used for the study, include a short identifier in the
footer on each page to distinguish between the various consent documents. Any changes in the
consent documents require IRB review.
Page numbering: The pages of every consent document should be numbered, preferably in a
format like "1 of 2," "2 of 2," in the footer of the document.
Approval stamp: Approved consent documents in iRIS will receive an approval stamp. To
accommodate the stamp, each consent document should have at least a 1.25" top margin and the
upper left-hand corner should be blank. Learn more about IRB approval documentation.

2. "Treatment and Compensation for Injury" Statement

Treatment and Compensation for Injury Statement (standard)

Treatment and Compensation for Injury:  If you are injured as a result of being in this study,
the University of California will provide necessary medical treatment.  The costs of the treatment
may be billed to you or your insurer just like any other medical costs, or covered by the
University of California or the study sponsor [sponsor name], depending on a number of
factors.  The University and the study sponsor do not normally provide any other form of
compensation for injury. For further information about this, you may call the office of the
Institutional Review Board at 415- 476-1814.
[NOTE: This injury statement must be used without changes unless any of the following
conditions apply:
(1) the Sponsor requests MMSEA 111 Language
(2) this is a clinical trial of a COVID-19 countermeasure and the PREP Act applies.
(3) this is a VA study or this consent form will be used at a VA site (for UCSF/VA studies)
(4) the Sponsor chooses to remain silent on this point, in which case all reference to the
sponsor should be omitted from the above statement.
(5) if the sponsor is the NIH, all reference to the sponsor should be omitted from the
above statement

See below for the allowable wording for these scenarios.]

VAMC Studies with Sponsor: The VA has specific wording that must be used, which can be
found on the IRB website.

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Treatment and Compensation for Injury Statement (with MMSEA 111 Language- Only if
Sponsor requests MMSEA 111 Language)
Treatment and Compensation for Injury:  If you are injured as a result of being in this study,
the University of California will provide necessary medical treatment.  The costs of the treatment
may be billed to you or your insurer just like any other medical costs, or covered by the
University of California or the study sponsor [sponsor name], depending on a number of
factors.  If the study sponsor covers these costs they will need to know some information about
you like your name, date of birth, and Medicare Health Insurance Claim Number, or, if you do
not have one, your Social Security Number. This information will be used to check to see if you
receive Medicare, and, if you do, report the payment they make to Medicare. The study sponsor
will not use this information for any other purpose. The University and the study sponsor do not
normally provide any other form of compensation for injury.  For further information about this,
you may call the office of the Institutional Review Board at 415- 476-1814.

Treatment and Compensation for Injury Statement (for studies of COVID-19

countermeasures that are covered by the PREP Act Declaration)

Treatment and Compensation for Injury: If you are injured as a result of being in this study,
the University of California will provide necessary medical treatment. The costs of the treatment
may be billed to you or your insurer just like any other medical costs, or covered by the study
sponsor or another entity, depending on a number of factors. Due to the coronavirus public
health crisis, the federal government issued a Declaration under the Public Readiness and
Emergency Preparedness (PREP) Act. If the Declaration applies, it limits your right to sue and
recover for losses from the researchers, healthcare providers, any study sponsor or manufacturer
or distributor involved with the study, including the University of California, while participating
in this COVID-19 clinical study. However, the federal government has a program that may
provide compensation to you or your family for certain claims if you experience serious physical
injuries or death and these costs are not covered by other payors.

To find out more about this “Countermeasures Injury Compensation Program” go to

https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.

Treatment and Compensation for Injury Statement for VA studies, or studies in which this
consent form will be used at a VA site:

Treatment and Compensation for Injury: If you are experiencing a medical emergency,
please call 9-1-1. If you incur an injury or illness as a result of being in this study, the
Department of Veterans Affairs (VA) will ensure that treatment is made available at a VA
medical facility or non-VA facility, as appropriate. If you were following study instructions, the
costs of such treatment will be covered by the VA or the study sponsor (if applicable). If you
were NOT following study instructions, the costs of such treatment may be covered by the VA or
the study sponsor (if applicable), or may be billed to you or your insurer just like any other
medical costs, depending on a number of factors. The VA and a study sponsor do not normally

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provide any other form of compensation for injury or illness. For further information about this,
call the study team at the number(s) provided.

Treatment and Compensation for Injury Statement (for studies where the Sponsor chooses to
remain silent, and/or the Sponsor is the NIH)
Treatment and Compensation for Injury: If you are injured as a result of being in this study,
the University of California will provide necessary medical treatment. The costs of the treatment
may be billed to you or your insurer just like any other medical costs, or covered by the
University of California, depending on a number of factors. The University does not normally
provide any other form of compensation for injury. For further information about this, you may
call the office of the Institutional Review Board at 415- 476-1814.

3. Handling Health Information and Complying with HIPAA

HIPAA has specific and strict requirements for use of identifiable information from medical records
(which HIPAA calls protected health information or PHI). HIPAA uses different terminology from
other human subject protection regulations. Under HIPAA, research subjects must give
authorization (consent) for use of their PHI. For almost all studies, UCSF requires using separate
forms for research consent and for HIPAA-specific authorization for research access to health
information. See HIPAA guidance.

Under HIPAA, any disclosure of PHI that is not specifically included in an individual’s
authorization is prohibited and is subject to penalties. Neither the type of information that will be
shared, the use that will be made of the information, nor the persons with whom information will be
shared can be changed unless the subject signs a new authorization. This means that if the
researchers want to share PHI with any person, company, or institution not already included in the
authorization form, the IRB Application and authorization form (and sometimes the consent form)
must be modified and each person about whom information would be shared must be asked to sign
the new form(s).

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