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THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH

RECRUITMENT AND CONSENT PROCESS

UCSF Consent Guidelines

CHR Consent Form Standards - Section by Section Discussion


Section 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.


Main heading

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.


Study title

  • 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.

Introductory Paragraphs

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 investigator, 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

    • The CHR 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. This information should be included either in the Purpose and Background section, or in a section 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 terms.


    • 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 referred to in this section should be used consistently throughout the form.


  • CHR 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 the procedures 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:

  1. If the standard procedure is not explicitly required by the study protocol, the consent form need not describe that procedure or its risks.


  2. 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 its risks.


  3. 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:
    1. The study population is experienced with the standard procedure; or


    2. 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 Study).

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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 to 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.). Descriptions of possible direct benefits may add the phrase, "...but this cannot be guaranteed."


  • 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 section.

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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 a Certificate 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 of Confidentiality. These Certificates are issued by the National Institutes of Health (NIH) and can be given regardless of whether or not the research is federally funded. 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:

To help 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.

Exceptions: A Certificate of Confidentiality does not prevent researchers from voluntarily disclosing information about you without your consent. For example, we will voluntarily disclose information about incidents 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 needed by the FDA.

Confidentiality statement for studies conducted at a UCSF Clinical Research Center or Veterans Administration Medical Center: At certain sites, including the GCRC, PCRC, and VAMC, every research participant is required to have a medical record. A confidentiality statement such as the 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 Considerations)

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 to subjects, 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 confusion is 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.

Warning 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.

For 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 insurance coverage (See Sample 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 studies), subjects 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.


  • That 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 statement.

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 to Treatment 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 the study.


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 may also be included.

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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Consent

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 rights.

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 that subjects 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).

Voluntary nature 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 the signature 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 sign the form; signature will indicate agreement to participate.

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Signature Section

Subject Signature: Unless waiver of signed consent (i.e., use of an Information sheet rather than a consent form) is approved by the CHR, this section must include lines for the subject's signature and the date of signature.

Signature of Person Obtaining Consent: In order that subjects have a record of who explained the study to them, this section must include lines for the signature of the specific individual obtaining consent 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."

Third Party Signature: If the study involves subjects who cannot give consent for themselves (e.g., unconscious patients, some 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 form.

For details on study-specific requirements in this regard, see CHR guidelines on the following: Consent,

Also, see Sample 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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Consent 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.