THE COMMITTEE ON HUMAN RESEARCH
RECRUITMENT AND CONSENT PROCESS
UCSF Consent Guidelines
CHR Consent Form Standards - Section
by Section Discussion
by Section Discussion
NOTE: Wherever applicable, section names are listed first in the question
format now recommended by the CHR. Corresponding section titles from the
previous format are in parentheses.
Reference to UCSF, and the information that a research project is being
discussed, should be in the consent form heading, e.g.:
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
If the study will be conducted
at a site such as SFGH, VAMC, or another hospital or clinic,
the name of this institution should also be included.
- The study title must be included in
the first part of the form. If the official title is technical
and difficult to understand, a simplified non-technical
title should be used in addition to the official title.
- If a study has more than one consent form, each
form should be labeled or
titled appropriately and the same references used within the protocol,
in order to avoid confusion.
This section should present the introduction to the study, indicating
who is conducting the research and why the individual has been asked to
be in the study, and making clear that participation in research is voluntary.
- All principal investigators
should be identified by first and last names, titles, and departments.
- The voluntary nature
of participation should be explained.
- The reason a person has
been asked to participate should be simply but specifically stated (e.g., "because you have tried to quit smoking
in the past but have not been successful," "because you are undergoing
surgery and will be given a general anesthetic," "because you
are a healthy person"). Detailed inclusion/exclusion criteria
should not be discussed here, as they are the responsibility of the
not the subject.
- CHR standard wording: Use the phrase "asked to take part in the
study,” rather than "chosen" or "invited to be
in the study.”
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Why is this research study being done? (Purpose and Background)
This section should discuss the aim of the study, giving a brief summary
of the background or reason for the project and information on any study
sponsor, investigators’ financial interests and any conflict of interest,
and investigational drugs or devices to be used.
- The study sponsor(s) should be named. Also, any financial or
proprietary interests of the investigator(s) should be disclosed
CHR requires that all consent forms disclose which agencies
or institutions (e.g., National Institutes of Health, Department
Center for Disease Control, State agencies), cooperative groups
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.
This information should be
included either in the Purpose and Background section, or in
headed with the question Who pays for this study?
- Investigators must also disclose the nature of any financial
or proprietary interests, though this disclosure can be in general
- See Investigator
Conflicts of Interest and CHR Review,
including "Recommended Consent Form Language” for examples
of consent form language.
- Any investigational drug(s) or device(s) to be used in the study
should be noted and named. The name by which the drug or device is
in this section should be used consistently throughout the form.
standard wording: If the study involves an investigational drug
or device, refer to it as "investigational" or "experimental" rather
than "new," since "new" can connote that something
is automatically better.
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How many people will take part in this study?
This section should state the total subject accrual goal. If it is a multi-site
study, the number of subjects from UCSF can be noted as well. Where appropriate,
a short description about cohorts may be given.
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What will happen if I take part in this research study? (Procedures)
The Procedures section should clearly state what will happen to the individual
as a result of taking part in the study, how this differs from
standard treatment (if applicable), and what will happen if the individual chooses
not to participate.
Each procedure should be listed, in the order in which it will occur,
and discussed in a separate point. If screening procedures are involved,
these should be noted first and identified as tests that will determine
eligibility to continue in the study.
- Randomization is considered a research
maneuver, and thus should be described as a study procedure. Terms which
might not be familiar to the
average layperson should be defined the first time they are mentioned
(e.g., “randomized” as “assigned
by chance,” “placebo” as “inactive substance”),
or a lay term used (e.g., "group" rather than "arm").
This section should also indicate, in lay language, the probability of
assignment to each treatment or condition (e.g., “You have a 50/50
chance of being assigned to either group”).
- Amount of time for each procedure and number
of times each procedure
will be done should be noted.
- Location(s) where the procedures
will be done should be stated.
- Amounts of blood or tissue to be
taken for study purposes should be specified using lay equivalents
(e.g., teaspoons, ounces) for metric terms.
- Patients’ medical
records review to be done for purposes of the
study should be listed as a procedure.
- “Standard” medical
procedures included in the study: The
consent form must make clear whether such procedures are being
done for clinical reasons or for study purposes (including whether
are being done more often because of the study).
The following guides should be used to determine the extent to which standard
procedures and their associated risks need to be described in consent forms:
- If the standard procedure is not explicitly required by the study
protocol, the consent form need not describe that procedure or
- If the standard procedure is a main focus of the study (e.g., one or more arms of a randomized study is standard), the
consent form must include a full description of the procedure and
- If the standard procedure is explicitly required by the study
protocol, the consent form must include a description of
the procedure and its risks.
In the case of C, the form may include
abbreviated descriptions of the procedure and its risks if
the procedure itself is not being investigated and:
study population is experienced with the standard procedure;
- The study population would undergo the standard procedure
regardless of study participation.
• Study chart or plan (optional): A simplified calendar or schema (study
plan) should be considered as a possible addition to the narrative
explanation of procedures (see Sample Consent Form – Biomedical-Cancer
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How long will I be in this study?
The duration of the study and the total amount of time required for participation
in the study should be specified.
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Can I stop being in the study?
The subject should be reassured that he/she can stop participation at
any time. If there are issues around safely terminating study medication
or procedures, these should be clearly explained.
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What side effects or risks can I expect from being in the study? (Risks and/or Discomforts)
- Describing and organizing risks: The risks and/or possible side
effects or discomforts of all study procedures should be
included in this section. There should be a brief general statement followed
by a listing
of all risks arranged and described according to their severity
and the likelihood of their occurrence. (See Sample
Consent Form – Biomedical
Study for details).
- Consequences of risks: This section should not simply give the names
of risks, but where needed, should also explain the consequences
of these risks in lay terms. For example, "lower white blood cell counts" could
be explained as follows: "The treatment may weaken your immune
system so that you might get more frequent colds or more serious infections."
- Precautions: If appropriate, it should be indicated what precautions
will be taken to avoid certain side effects or outcomes from
occurring, and what will be done should they occur.
- CHR standard wording for risks
The CHR has developed standard wording for risks that may
be required in this section. Unless there is substantive reason
use different wording, these statements should be used verbatim
where appropriate. See Sample Consent Form – Biomedical Study for the
exact current wording of these risks:
- Radiation risks
- CT scan risks
- MRI risks
- Reproductive risks
- Unknown risks
- Venipuncture risks -- Additional note: If more than
one unit of blood is to be drawn within an 8-week period, a medically
appropriate precaution concerning subsequent blood donation is required.
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Are there benefits to taking part in the study? (Benefits)
- Any potential direct benefits to the subject should be described first,
followed by potential general benefits (e.g., to the group of
patients to which the individual belongs, to medical knowledge, etc.).
of possible direct benefits may add the phrase, "...but this cannot
- If there is no direct benefit to the subject anticipated from the study,
this should be stated at the beginning of the section.
- Benefits such as medical or societal benefits are considered separate
from payment for participation in a study; thus, discussion of
payment or reimbursement should be placed in its own separately labeled
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What other choices do I have if I do not take part in this study? (Alternatives)
When appropriate, this section should outline what options are available
to the individual if he/she chooses not to take part in the study (e.g.,
treatment without being in a research study; participating in another study;
getting no treatment). It is not sufficient to say that a patient will
receive “standard care”—if there are specific alternatives,
they must be described.
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Will my medical information be kept private? (Confidentiality)
No guarantee of complete confidentiality: One risk of participating in
any research is a loss of privacy. There is no legal privilege between
investigator and subject as there is between physician and patient or counselor
and client. Thus, a guarantee of “complete” or "strictest” confidentiality
should not be given or implied.
This section should explain how the researchers will protect confidentiality
(e.g., coding of records, limiting access to the study records, not using
any individual identifiers in publications or reports resulting from the
study), and also indicate what regulatory or other agencies might have
access to the research records (e.g., the FDA, sponsoring company, CHR).
Possible discovery of illegal activities: Because
research records do not enjoy the same legal privilege as medical records,
subjects are placed
at risk when they are asked about possible illegal drug use or other
illegal activities. For such cases, the investigator may wish to obtain
of Confidentiality. Whether or not a Certificate is obtained, the prospective
subjects should be warned as follows:
Participation in research may cause a loss of privacy. In this study,
you will be asked about drug use and other possibly illegal activities.
The researchers will keep information about you as confidential as possible,
but complete confidentiality cannot be guaranteed. On rare occasions, research
records have been subpoenaed by a court.
Certificate of Confidentiality: The one way to protect
research records from subpoena is through a federal Certificate
Certificates are issued by the National Institutes of Health (NIH)
and can be given regardless of whether or not the research is federally
For more information on this, see http://grants.nih.gov/grants/policy/coc/index.htm.
If the Certificate is obtained, the end of the consent form’s confidentiality
statement should discuss it, using the following wording:
us protect your privacy, we have obtained a Certificate of
Confidentiality from the National Institutes of Health. With this Certificate, the researchers can use the Certificate to legally disclose information
that may identify
you, even by a court subpoena, in any federal, state, or local
civil, criminal, administrative, legislative, or other proceedings.
A Certificate of Confidentiality does not prevent researchers
from voluntarily disclosing information about you without your
consent. For example, we will voluntarily disclose information
such as child abuse or intent to hurt yourself or others.
In addition, the Certificate
does not prevent you or a member of your family from voluntarily
releasing information about yourself or your involvement
in this research. If an
insurer, employer, or other person obtains your written consent
to receive research information, then the researchers may
not use the Certificate
to withhold that information. Finally, the Certificate may
not be used
to withhold information from the federal government needed
for auditing or evaluating federally funded projects or information
Confidentiality statement for studies conducted
at a UCSF Clinical Research Center or Veterans Administration Medical
certain sites, including the GCRC, PCRC, and VAMC, every research participant
to have a medical record. A confidentiality statement such as
following (adapted as appropriate) should be used:
Participation in research may involve a loss of privacy, but information
about you will be handled as confidentially as possible. A UCSF medical
record will be created because of your participation in this study. Your
consent form and some of your research test results will be included in
this record. Therefore, your other UCSF doctors may become aware of your
participation. Hospital regulations require that all health care providers
treat information in medical records confidentially.
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What are the costs of taking part in this study? (Costs/Financial
No costs vs. any costs: When there are no costs at all to be charged to
the subject, this should be stated in the consent form. By the same
token, when participation in the study may result in any costs whatsoever
clear, complete information regarding these costs must be provided
in the form.
Describing “split” costs: In many situations, such
as studies where the subjects are also patients, costs are split
(e.g., the subjects
or their insurance carriers will have to pay usual costs of medical
care but will not be charged any extra for participating in the
study, or study
medication will be covered by the study but the subjects or carriers
will have to pay all other charges). One way to avoid potential
to explain who will be charged for most of the procedures, and
then to list any specific procedures, visits, and/or tests that are exceptions.
about insurance coverage: When appropriate, a statement
should be included warning subjects that because the therapy
is experimental, the insurance carriers may not cover the costs involved.
cancer studies, this section should provide subjects with the website
address and phone number of the National Cancer Institute
(NCI), which offers more information on clinical trials and
Consent Form - Biomedical-Cancer Study for exact
wording of statement).
Financial counselors: Whenever
substantial costs to the subject are involved (e.g., for
many oncology, cardiology, and MRI
should be informed that financial counseling is available.
A sample costs statement follows:
The costs of all visits, treatments, and tests described above will be
billed to you or your insurance carrier, with the exception of [list],
which will be paid for by the study sponsor, [name]. Insurance companies
and other carriers sometimes refuse to pay the costs of treatment when
individuals are participating in research. If this happens in your case,
you will be billed for the care your insurance will not cover. Financial
counselors are available through the hospital accounting department to
discuss this with you.
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Will I be paid for taking part in this study? (Payment/Reimbursement)
Follow these guidelines and see the sample consent form wording by payment method below.
Required Information: The payment section should include the following info:
- Refer to money that subjects receive in
return for study participation as "payment." “Reimbursement” can be used if participants are paid
for specific costs they incur. Do not use the term "compensation."
- The total dollar amount that the subject will be paid for study
participation, plus any information on pro-ration of payment
if a person does not complete the study, or bonus payment
at the end of the study.
(Note: Subjects should not be required to complete the
entire study in order to be paid. Any bonuses for study completion
should be modest).
- The method of payment (e.g., cash or check).
- When subjects will be paid (e.g. immediately or in 6-8 weeks). If appropriate, include a payment schedule.
- For payment by check, that subjects need to provide their home address and social
security number to receive payment.
payments for research participation are considered taxable
income. If subjects are paid more than $600 total
in a calendar
year for participation in research studies, UCSF will report this income
to the IRS.
- If there will be no payment
for study participation.
- Avoid connotations of undue influence to participate
or that the subject is being employed by the investigator.
Rather, the sense should be that subjects will be paid for their time and
the inconvenience of being a research subject.
Sample Consent Form Wording by Payment Method
No Payment: You will not be paid for taking part in this study.
Payment by Check: If you complete the entire study, you will be paid $120 -- $25 for each clinic visit and a $20 bonus for finishing the study. If you withdraw from the study early, you will receive $25 for each visit you complete. You will be paid by check, and you should receive the check four to six weeks after your last visit. You must give the researchers your address and Social Security number so the check can be processed.
Payment by Debit Card: In return for your time, effort and travel expenses, you will be paid up to $45 for taking part in this study. We will give you a prepaid debit card worth $15 after each study visit. We will give you separate instructions on how to use the debit card.
Payment by Debit Card (over $600/year): In return for your time, effort and travel expenses, you will be paid up to $650. We will give you a prepaid debit card worth $50 after each study visit. We will give you separate instructions on how to use the debit card.
UCSF must notify the Internal Revenue Service (IRS) when it pays a subject $600 or more in a year, so your payment will be reported to the IRS. You must give the researchers your address and Social Security number for IRS reporting purposes.
Payment by Cash: You will be paid $10 in cash for participating in the focus group. You will be paid immediately after the focus group ends.
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What happens if I am injured because I took part in this study?
(Treatment and Compensation for Injury)
In response to federal regulations requiring reference to an institution's
or agency's treatment and compensation for injury policy on consent forms,
the University of California and UCSF have developed a simple standard
This statement tells the subject that the University of California and/or
the VAMC does have such a policy (as does the sponsor if one is involved),
and provides the telephone number of the Committee on Human Research
office where the individual can obtain detailed information about these
policies should the need arise. See Treatment
and Compensation for Injury Statement: Background and UCSF Policy for the complete UC policy and
further information regarding the exact required wording of this statement.
Studies being conducted at UCSF, SFGH or Mount Zion must use this standard
UCSF statement. Consent forms for studies being conducted at the VAMC
require slightly different wording.
NOTE: If sponsors ask that the wording of this statement be altered,
even if only very slightly, they should be advised that any change in
the wording will delay if not prevent approval of the consent form. Refer
and Compensation for Injury Statement: Background and UCSF Policy for a more detailed discussion of this policy or call the CHR
office and ask for advice and/or assistance.
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What are my rights if I take part in this study?
This section emphasizes the individual’s freedom to choose to
participate or not participate in the study, and to do so without penalty.
It promises to inform the person of any new information or changes in
the study that may affect his/her health or willingness to continue in
Who can answer my questions about the study? (Questions)
Questions for the Study Team: This section should provide contact information to the participant in
case of questions, concerns, complaints about the study. Even
if the principal investigator is a faculty advisor only, his/her name and phone
number must be included
in this section, as subjects may wish to contact the person who
is supervising the project. Additional names and phone numbers of study staff
Questions for the CHR and Other Resources: A separate paragraph should follow giving the phone number for the CHR
office. Also include a brief explanation about the role of the IRB, which
specifically includes information that the CHR is independent of the research
team and available for questions regarding the rights and welfare of research
participants. Any additional informational sources related to the study (e.g.,
local patient representatives
or individuals at other study sites as appropriate) can also be
listed here with contact information.
ClinicalTrials.gov Registration: The FDA issued a final rule requiring that consent forms for applicable drug and device clinical trials include a specific statement that clinical trial data will be entered into ClinicalTrials.gov.
The mandatory language only needs to be entered if the study meets the FDA’s definition of a clinical trial. The language must appear verbtaim in consent forms for all clinical trials approved on or after March 7, 2012.
The FDA will not retroactively apply this requirement. Clinical trial consent forms approved before March 7, 2012, do not need to be amended, and subjects do not need to be re-consented.
Reminders about Clinical Trial Registration:
The FDA's definition of a clinical trial is as follows:
- For any trials of drugs and biologics: controlled clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation.
- For trials of biomedical devices: controlled trials with heath outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.
In addition to the FDA, The International Committee of Medical Journal Editors (ICMJE) also requires registration of clinical trials in order for results to be published in member biomedical journals. ICMJE adopted a broader definition of a clinical trial, as follows:
Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
Note: The mandatory consent form language does not need to be entered if the study meets the ICMJE's definition of a clinical trial, but not the FDA's definition.
Review the UCSF Announcement Regarding Clinical Trial Registration for more information on this topic.
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Receipt of consent form copy and Experimental Subject's Bill
of Rights: This section should state that the subject has been given (not just "offered")
a copy of the consent form, and also, if it is a biomedical study, a
copy of the Experimental Subject's Bill of Rights. The current UCSF
version of the Bill of Rights should be attached to the consent form. Use of
the Experimental Subject’s Bill of Rights and the CHR contact information
it includes satisfies both California law and the federal requirement
that subjects be told who they can contact with questions about their
While California law requires that the Experimental Subject's Bill of
Rights be given only to subjects of biomedical research, there
is CHR contact information contained in the UCSF Bill of Rights
in all types of studies should receive. Therefore, for non-biomedical
studies, either the Bill of Rights should be given to each participant,
or the paragraph with CHR contact information should be included
in the consent form. (See Sample
Consent Form - Social/Behavioral Study
for exact wording).
of participation in research: This section should re-state
the fact that participation in research is voluntary and that
the individual has the right to decline to participate or withdraw
from the study at any time without penalty or loss of benefits
to which prospective
subjects are otherwise entitled.
Because communicating the voluntary
nature of consent is so important, the CHR recommends that the
statement to that effect be in capital
letters, and this section be placed at the end of the form, near
section, for emphasis.
Consent to participate: In this section,
the Committee discourages such wording as "I have read this form
and understand it” or “based
on this understanding, I hereby agree to participate," since this
does not guarantee an individual's comprehension, legally or otherwise.
Rather, it is recommended that investigators simply state that
if the person wishes to participate in the study, he or she should
form; signature will indicate agreement to participate.
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Subject Signature: Unless waiver of signed
consent (i.e., use of an Information sheet rather than a consent form)
by the CHR, this section must include lines for the subject's signature
and the date
Signature of Person Obtaining Consent: In order
that subjects have a record of who explained the study to them,
must include lines for the signature of the specific individual
and the date of signature.
Witness Signature: Only include a witness signature line if you may consent non-English speaking subjects using the short form consent method AND this request has been addressed in the CHR application. This signature line should read, "Witness – Only required if the participant is a non-English speaker."
Signature: If the study involves subjects who cannot give consent
for themselves (e.g., unconscious patients,
individuals with Alzheimer's Disease, or minors), a separate,
appropriately worded and labeled signature section for
the parent(s) or legally
authorized representative may be required for the consent
For details on study-specific requirements in this regard, see CHR guidelines
on the following: Consent,
Consent Form - Biomedical Study for examples of
these types of signature sections.
Translator and/or Interpreter Signature: See
UCSF guidelines regarding Those
Who Do Not Speak, Read, or Understand
English for a current, detailed
discussion of requirements and guidance in this regard.
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Document Identification Required by the CHR
Labeling consent documents in iRIS: When uploading consent forms in iRIS, give each consent document a unique name so the CHR can easily identify the forms (e.g. Control Group Consent, Parental Consent, Optional Specimen Collection Consent, Information Sheet, etc.).
iRIS also requires that each consent document have a version date and version number. Please note that time you modify the consent document, iRIS will automatically update the version number. For example, if you add a revision to version 1.0, iRIS will then create version 1.1. We strongly suggest that you also update the version date when you modify the consent document.
If you wish, you can include an internal version number or date in the footer. However, remember to update the date or number each time you revise the document.
Approval stamps: Approved consent forms will be stamped in iRIS, and study subjects should sign the stamped version. The approval stamp appears in the upper right-hand corner of each page, so do not include any information in this section of the header. In addition, the upper margin should be at least 1.25" to leave room for the stamp.
After the consent form expires or is superseded, iRIS will automatically void the consent document. If you need a copy for your records, please print out the consent form before it is voided.
Approval letters: Approved
consent documents will not be identified on CHR approval letters.
To obtain a list of all documents that were approved with a particular submission, follow these steps: Go to My Studies and open the study – Click on Submissions History – Go to Completed Submissions – Locate this submission and click on the Details button to view a list of submitted documents and their outcomes.
For a list of currently approved consent documents, follow these steps: Go to My Studies and open the study – Click on Informed Consent – click on the Printer Friendly button to print the page.
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.