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Organization

THE COMMITTEE ON HUMAN RESEARCH

RECRUITMENT AND CONSENT PROCESS

UCSF Consent Guidelines

CHR Consent Form Standards - Section by Section Discussion

• Main heading
• Study title
• Introductory paragraphs
• Why is this study being done? (Purpose and Background)
• How many people will take part in this study?
• What will happen if I take part in this study? (Procedures)
• How long will I be in this study?
• Can I stop being in the study?
• What side effects or risks can I expect from being in the study? (Risks and/or Discomforts)
• Are there benefits to taking part in the study? (Benefits)
• What other choices do I have if I do not take part in this study? (Alternatives)
• Will my medical information be kept private? (Confidentiality)
• What are the costs of taking part in this study? (Costs/ Financial Considerations)
• Will I be paid for taking part in this study? (Payment/ Reimbursement)
• What happens if I am injured because I took part in this study? (Treatment and Compensation for Injury)
• What are my rights if I take part in this study?
• Who can answer my questions about the study? (Questions)
• Consent
  • Experimental Subject’s Bill of Rights
  • Signature Section
• Consent Document Identification Required by the CHR

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.



• Discussion of CHR standard wording for risks
  The CHR has developed standard wording for statements that may be required in the Risks 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 exact wording of statements discussed below).

Venipuncture risks: The standard wording notes temporary discomfort from the needle stick, bruising, and, rarely, infection. Unless a very large amount of blood is being taken, or a special subject population is involved, reference to the possibility of fainting is not necessary. 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.

Radiation risks: The CHR recognizes that the risk from small amounts of radiation exposure is extremely difficult to describe in terms that are meaningful to the average layperson. While comparisons to chest x-rays are often used, most laypeople have no way of estimating the risks of exposure from chest x-rays either, even though they are probably familiar with the procedure itself.

Thus a simple statement is recommended which alerts the individual to the theoretical risk of the radiation exposure and advises him/her to speak further with the investigator if there are concerns about this exposure.

CT scan risks: Radiation risks from CT scans should be described in the same way as those from x-rays (see above). As with MRI, the possibility of claustrophobia or discomfort from being in the CT scanner should be noted. In addition, risks and discomforts of contrast agents and sedation must be included if appropriate.

MRI risks: Because the Magnetic Resonance Imaging (MRI) machine acts like a large magnet, subjects need to be warned of the consequences of this and advised that precautions have been taken to prevent any injury as a result. They should also be warned that they may be bothered by feelings of claustrophobia and by the loud noise during the study. Since risks to a fetus from MRI are unknown, the consent form needs to state that pregnant women may not participate in studies involving MRI procedures.

Reproductive risks: The section describing study procedures should include among the screening procedures any pregnancy testing done for study purposes. If men or women are advised to use birth control or avoid pregnancy before, during, or after the study, these precautions should be described among the study procedures. The section on risks/discomforts should describe the risks to pregnant mothers, fetuses, and/or fertility of subjects as appropriate.

Unknown risks: For studies involving investigational agents, or experimental doses or combinations of drugs and/or treatments, subjects should be told that there may be as yet unknown risks associated with the drug/treatment, but that they will be advised if any new information becomes available that might affect their desire to participate in the study.

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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 cannot be forced to 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)

Preferred terms: When referring to money which subjects will receive in return for participation in a study, "payment" is the preferred word. “Reimbursement” can be used if participants are paid for specific costs they incur. The term "compensation" should not be used, since on consent forms it designates compensation for injury.

Avoiding undue influence: Connotations of undue influence to participate or that the subject is being employed by the investigator should be avoided. Rather, the sense should be that subjects will be paid for their time and the inconvenience of being a research subject.

In addition, the payment section of the consent form should indicate:

• The total dollar amount that the subject will be paid for study participation, plus any relevant information such as pro-rating if a person does not complete the study, or bonus payment at the end of the study. (Note that subjects should not be required to complete the entire study in order to be paid, and any bonuses for study completion should be modest).



• How payment will be made (e.g., in cash, by check).



• When subjects will be paid (e.g., immediately after the interview, approximately six weeks after individual completion of the study). If appropriate, a payment schedule can be included.



• If subjects need to keep and submit receipts to be reimbursed.



• That subjects need to provide their home address and social security number to receive payment (if applicable).



• 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, the University will report this income to the IRS.



• If there will be no payment or reimbursement for study participation.

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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)

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.

A separate paragraph should follow giving the phone number for the CHR office (with 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.

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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: The CHR does not require a witness to sign the consent form. Other institutions may require witnesses. For example, the VAMC requires witness signatures for consent to all studies involving more than minimal risks. Note: If a witness is not required, do not include a witness signature line, as studies have been cited for unsigned signature lines in such circumstances.

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 Consent, Vulnerable Populations (especially Minors, Those with Cognitive Impairments, Those Who Do Not Speak, Read, or Understand English), Surrogate Consent, Research in Emergency Settings, and Emergency Use of an Investigational Drug or Device. 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

Approval date: Approved consent documents will be identified on CHR approval letters. Every consent document (consent forms, assent forms, information sheets) must include the most recent approved version date (month, day, year) in a lower corner of each page. If multiple consent documents are used for the study, a short identifier should be included in the footer on each page to distinguish between the various consent documents.

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.

Other approval information: Investigators may also include a header or footer on consent documents with blanks for the CHR approval date, CHR expiration date, and/or the CHR approval number to be added. After CHR approval has been obtained, investigators may add this data, and this data only, without additional CHR review. Any other changes in the consent documents require CHR review.