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THE COMMITTEE ON HUMAN RESEARCH

STANDARD WORDING USED IN CHR LETTERS TO INVESTIGATORS (Revisions in process)

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

The following brief statements are boilerplate used by the CHR staff when preparing letters to investigators following review of a protocol. We are making them available so anyone who is interested can become familiar with concerns frequently raised by the CHR, beyond the information already contained in the Guidelines.

At present only the boilerplate regarding consent form wording is posted; in the near future we will post additional boilerplate regarding protocol issues.

The title for each statement is a memory jog used by the CHR staff. We will provide longer titles when we next revise the list.

Caution: Most of the "boilerplate" statements must be revised to apply to particular studies. We almost never use any of these comments without making a few changes, either major or minor.

Alternatives

The members asked that the consent form include a section discussing the various alternatives to participation in the study. This could be a short statement, but it should name the possible choices, including standard therapies and other experimental treatments, that are available if the individual chooses not to participate in the study.

Benefits - None

The Benefits section should begin by stating that there is no direct benefit to participants in this study.

Benefits versus Reimbursement

The FDA has asked that any possible medical or social benefits resulting from a research study be considered separately from reimbursement for participation in the study. Therefore, the discussion of reimbursement should be deleted from the Benefits section and placed in its own labeled section.

Chart Review

The Procedures section should say that you will review the subject's medical records and should briefly say what kind of information you will gather.

CHR Contact Information

So that subjects know they can also contact the CHR, please include the following paragraph in the Questions section of the consent form:

If you have any comments or concerns about participation in this study, you should first talk with the investigator. If for some reason you do not wish to do this, you may contact the Committee on Human Research, which is concerned with the protection of volunteers in research projects. You may reach the committee office between 8:00 and 5:00, Monday through Friday, by calling (415) 476-1814, or by writing: Committee on Human Research, Box 0962, University of California San Francisco, San Francisco, CA 94143.

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Confidentiality Statements

1.	Simple request to include a discussion of confidentiality: Federal regulations require that a statement about the extent of confidentiality of records be included in the consent form. One accepted version of this statement is:
		Participation in research may cause a loss of privacy, but information about you will be kept as confidential as possible. Your name will not be used in any published reports about this study.
2.	For industry-sponsored studies: Federal regulations require that a statement about the extent of confidentiality of records be included in the consent form. Since officials from both the sponsoring company and the FDA have at least some limited right to review individual records, patients should be forewarned about this intrusion into their privacy. One accepted statement of this risk is: Participation in research may cause a loss of privacy, but information about you will be kept as confidential as possible. Representatives from the sponsoring drug company ([insert company name in parentheses]) and the Food and Drug Administration may review information about you to check on the study. Your name will not be used in any published reports about this study.
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3.	When all that's missing is "loss of privacy": The members asked that the discussion of confidentiality begin by stating that participation in research may cause a loss of privacy.
4.	When the protocol fails to discuss confidentiality: The issue of confidentiality of patient records was not addressed in your protocol. In all future submissions of this and any protocol, please describe how subjects' identities will be protected and confidentiality will be maintained.
5.	When illegal activities may be revealed by a study but a Certificate of Confidentiality would be excessive: Because research discussions and records do not enjoy the same legal privilege as medical records, research subjects are placed at risk when they are asked about possible illegal drug use or other illegal activities. Subjects should be warned about this risk in the consent form's discussion of confidentiality. Wording like the following is recommended:
		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. Your name will not be used in any published reports about this study.
6.	When members suggest getting a Certificate of Confidentiality: Because research discussions and records do not enjoy the same legal privilege as medical records, research subjects are placed at risk when they are asked about possible illegal drug use or other illegal activities. In order to protect your subjects, you may wish to ask your Federal funding agency to issue a Certificate of Confidentiality which prevents courts from compelling researchers to reveal information about their subjects. Whether or not you obtain a Certificate, subjects should be warned in the consent form about the risk of loss of confidentiality. Wording like the following is recommended:
		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. Your name will not be used in any published reports about this study. On rare occasions, research records have been subpoenaed by a court.
	If you obtain a Certificate of Confidentiality for the study, the end of the statement can be revised as follows:
		On rare occasions, research records have been subpoenaed by a court, but the National Institute for Drug Abuse [or other issuing agency] has given the researchers a Federal Certificate of Confidentiality which says courts cannot force the researchers to reveal information about your participation in the study. [If applicable, add the following: You will receive a copy of this Certificate along with the consent form.]
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7.	When subjects are likely to reveal reportable activities: In studies in which researchers think it is likely that subjects will reveal actions that the researchers are legally or morally obligated to report to authorities, a statement should be added to the consent form's discussion of confidentiality, briefly saying that such circumstances may arise. For example, if the study personnel find evidence that suggests that you have been physically or sexually abused, they are required by law to report this to local law authorities.
8.	When Focus Groups are conducted: Since participation in focus groups necessarily involves a loss of privacy, the discussion of confidentiality should be revised. The first sentence should say participation will involve a loss of privacy. In addition, wording like the following should be included: "The researchers will ask you and the other people in the group to use only first names during the group session. They will also ask you not to tell anyone outside the group what any particular person said in the group. However, the researchers cannot guarantee that everyone will keep the discussions private."
9.	When "within the law" is used: Please delete the words "within the law" from the discussion of confidentiality.

Confidentiality - No guarantees (1)

Although you state that the information will remain confidential, because there is not the legal privilege between investigator and subject as there is between physician and patient or counselor and client, a guarantee of complete confidentiality should not be given or implied. What can be said, instead, is that confidentiality will be protected "as much as possible."

Confidentiality - No guarantees (2)

One hindrance to maintaining the confidentiality of individuals who participate in research is that there is no absolute legal protection of confidentiality between investigator and subject as there is between physician and patient or counselor and client. When a research record is created, a document which is open to subpoena is created; thus, when sensitive data are contained in the research record, the risk to subjects in the event of a loss of confidentiality could be significant, and the members agreed that subjects should be warned of this risk. The information which will be obtained from this study (e.g., regarding illegal drug use), along with the information that will be obtained elsewhere, and included in the research record, could place the subject at legal risk; a discussion of this potential risk therefore should be included in the Risks section of the consent form.

Consent - Students

Since the proposed subject population may include students attending this University, the clause stating that participation will not jeopardize the subject`s medical care should also contain a sentence indicating that the student's position will not be affected, e.g.:

Your participation in this study is entirely voluntary. You may decline to enter the study or withdraw at any time. If you do so, this will in no way interfere with your employment or right to health care, nor will it affect your grades or standing at this University.

Costs

Specific information regarding the costs of participation in this study should be provided in the consent form. If either the subjects or their insurance carrier will be billed for any of the tests or the procedures being done in this study, this information should be clearly stated in a section labeled "Costs" or "Financial Considerations" or in a paragraph in the "Risks" section labeled "Financial Risks." In addition, subjects should be informed that because this therapy is experimental, the costs may not be covered by their third party carrier. If a subject requires more detailed information regarding the possible financial risks, please describe how this will be provided.

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Costs - Examples

	Example #1: The drug itself will be provided at no costs. You (or my health care insurance carrier) will be responsible for any charges relating to the preparation or administration of the drug. The costs of monitoring (blood tests, chest x-rays, etc.) necessary will also be your responsibility. Some health care insurers disallow coverage for investigational drugs. If this is of concern to you, you should check with my health care insurer.
	Example #2: You or your insurance company will be billed for the clinic visits, and all standard laboratory tests (e.g., routine blood counts and blood chemistry tests). The study drug will be provided free of charge, and you will not be billed for hospitalization. You will not be billed for tests required for purposes of research, e.g., AIDS virus and immune function tests, extra blood tests for toxicity monitoring and to measure the amount of drug in my blood.
	Example #3: The study drug will be provided to you free of charge. You or your insurance company/third party carrier will be charged for drug administration. It is possible that your medical expenses will be higher as a participant of this study than if you were to receive more standard treatment. In order to determine whether the treatment is working for you, you will have evaluative tests done that will allow your doctor to measure your tumor. Some of these tests would not normally be performed. Insurance companies/third party carriers may not cover the costs of these tests. If your insurance company/third party carrier does not cover these costs, you will be held financially responsible. Financial counselors are available through the hospital accounting department to discuss this with you.
	Example #4:There are costs associated with treatment of lymphoma by all of the proposed programs. These costs will be billed by the doctors and hospital just as they would if you were not in the study. Insurance companies and other third party payers for health care have sometimes refused to pay the costs of treatment for patients on research studies. Since no experimental drugs or treatment are being used in this study, it is not anticipated that insurance or other payers would refuse to pay for your care, but it is still a possibility. The costs of treatment in the four different Groups of this study do differ, although the difference depends on costs at the individual participating hospitals and on patient response to treatment, and cannot be anticipated in advance.
	Example #5: You or your insurance carrier will be responsible for the cost of all treatment and related tests. It is difficult to predict how participation in this study would affect the cost of your medical care. The cost of the two study treatments are expected to be approximately the same. Whether the study treatments will be more expensive, less expensive or about the same as other available treatments will depend on what those other treatments are. Although neither of the study drugs is experimental, it is possible that your insurance carrier may feel that they are being used in an experimental way and may refuse to cover some or all of their cost. You may discuss the various treatment options and their costs with your doctors and a financial counselor from the hospital Accounting Department before you make a decision about participating in the study.
	Example #6: The costs associated with this treatment program will be charged to you or your insurance carrier. Because this treatment is experimental, your insurance company may refuse to pay for it. It is possible that your insurance company will refuse to pay for this treatment program after you have already received your treatment and you will have to pay for your care. You have met with a financial advisor from the hospital, who has provided you with the maximum dollar amount that you will be expected to pay. The costs of this treatment program are expected to be greater than other standard treatment programs. The total cost of the treatment program will depend upon the number of side effects you have; therefore, it is not possible to give an accurate estimate of your exact cost in advance. You will not be paid for your participation in this study. The Division of Cancer Treatment, National Cancer Institute will provide you with the investigational drug free of charge for this study. Should this agent become commercially available during the course of the study, however, you may be asked to purchase subsequent doses of the medicine.

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Costs - Financial Counselors

So that patients will be fully informed regarding the possible financial obligations if they agree to participate in this study, please refer them to the financial counselors available through the hospital accounting department. This referral should be mentioned in the consent form in paragraph XX.

You may discuss the various treatment options and their costs with your doctors and with financial counselors from the hospital Accounting Department and/or a representative of the Department of Radiation Oncology.

Costs - Insurance

Subjects should be informed in the XX section that because this therapy is experimental, costs related to the study treatment may not be covered by their third party carrier.

Costs - No Costs to Subjects

As you indicate on the CHR Cover Page that there will be no costs to the subjects who participate in this study, this information should be clearly stated in the consent form in a section labeled "Costs" or "Financial Considerations." ("Neither you nor your insurance carrier will be charged for any of the study treatments or procedures. Costs of the drug treatment and the other tests will be covered during the study period of nine weeks. If treatment is to continue thereafter, other arrangements must be made to cover its cost.")

Date

When you have incorporated these changes, please place the date in a lower corner of each page of the consent form.

Delete Reference to CHR Approval

Direct reference to CHR approval of a project should not be included within the consent form since this might imply a stamp of approval or encouragement of the individual to participate in a particular study rather than the simple fact that required review by the UCSF Institutional Review Board has taken place. However, the Committee does recommend, for record-keeping purposes, that the approval number and date of approval be placed in a lower corner of the form.

Dose Escalation

Dose escalation should be discussed in both the Procedures and Risks/Discomforts sections of the consent form. The Procedures section should explain that subjects enrolling early in the study will be given relatively low doses of the study drug and that if the low doses appear to be safe, subjects enrolling later will receive higher doses. In the Risks/Discomforts section, the discussion of side effects of the study drug should explain that since subjects will be assigned to different doses of the drug, some subjects may receive a dose of the drug that is too small to be effective while others may receive a higher dose that may cause increased side effects. This section also should inform subjects that they can ask the person obtaining consent how high a dose level they will be given.

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Emergency Phone Number

An emergency number where one of the study investigators can be reached 24 hours a day should be included in paragraph X, which discusses what to do in case of a medical problem, and/or in the Questions section.

If either of the phone numbers listed in the Questions section are emergency numbers where one of the study investigators can be reached 24 hours a day, this should be clearly stated. Otherwise, please include such a number, with explanation, in the Questions section.

Enroll Only Those Subjects Able to Consent

The members agreed that only those subjects able to consent for themselves should be asked to participate in this study. Therefore, the signature sections for the relative and the attending physician should be deleted from the consent form.

Experimental Subject's Bill of Rights - Add

In order that subjects know they are entitled to a copy of the consent form and of the Experimental Subject's Bill of Rights, the following statement should be added just before the signature line: "You have been given a copy of the consent form and the Experimental Subject's Bill of Rights to keep."

Experimental Subjects Bill of Rights - Delete

As the Experimental Subject's Bill of Rights is not required for behavioral studies, the members commented that you need not give this document to your subjects. However, if you decide not to give the Bill of Rights, please include the following paragraph in the Questions section so that subjects know they can contact the CHR:

If you have any comments or concerns about participation in this study, please talk with the study investigator. Or, you may also contact the Committee on Human Research, which is concerned with the protection of volunteers in research projects. You may reach the committee office between 8:00 and 5:00, Monday through Friday, by calling (415) 476-1814, collect, or by writing: Committee on Human Research, Box 0962, UCSF, San Francisco, CA 94143.

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Full Name of Investigators

The full names of the investigators should be included in the consent form so that those subjects who decide to contact an investigator will have an easier time doing so.

Header

As reference to UCSF should be made in the form, the CHR recommends that this reference be included in the heading, e.g.:

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO CONSENT TO BE A RESEARCH SUBJECT

Header - Study Title

Please add the study title to the heading of the form.

HIV Testing - Counseling

When HIV testing is being conducted for research purposes, both pre- and post-test counseling must be provided for the participants. Please revise the Procedures section to discuss this counseling.

HIV Testing - Risks

Being tested for HIV may cause anxiety regardless of the test results. A positive test means that you have been infected with the HIV virus, but no one can say for certain when, if ever, you will become sick with AIDS or a related condition. Receiving positive results may make you very upset. If other people learn about my positive test results, you may have trouble obtaining insurance or employment. If your test is negative, there is still the possibility that you could be infected with the HIV virus and test positive at some time in the future. There is always the possibility that the test results could be wrong.

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Identify Principal Investigator

The study investigator(s) should be identified as such in the first paragraph of the form, e.g., "Dr. . . . from the Department of . . . conducting a study to . . . ."

Illegible

The consent form that was submitted with this application was a poorly xeroxed copy and barely legible. It was asked that the forms provided to subjects be clear and legible, and that a copy of this clearer version be submitted for our files.

Increase Font

As the members found the size of the type difficult to read, it was asked that the consent form be re-printed using a larger, more legible typeface.

Invited versus Asked

In the Purpose section, the phrase "You have been invited to ..." should be revised to read "You have been asked to ...." The word "invited" has connotations that are not necessarily those associated with being a participant in a research study, particularly if participation will result in added costs to the subject and/or could wrongly imply that the person is a member of a select group.

Legalistic Language - You Understand (1)

Because the phrase "you understand that" does nothing to increase the participant's comprehension, the Committee asked that it be deleted from the consent form. This deletion [These deletions] will result in a simple statement of fact relaying information about the study.

Legalistic Language - You Understand (2)

Because phrases such as "you understand that," "you are aware that," or "you realize that" do not ensure the subject's comprehension, the Committee asked that these phrases be deleted. These deletions will leave simple statements of fact relaying information about the study.

MRI - Procedures

For the MRI test, you will lie down on a narrow bed which will then be placed in a tunnel that is 6 feet long by 22 inches wide and open at each end. You will lie there quietly for about one hour, during which time you will hear a loud noise. You may feel warm during this procedure.

MRI - Risks (1)

The following risks should be included in the discussion of risks associated with the MRI procedures:

	i)	Because the MRI machine acts like a large magnet, it could move iron-containing objects in the MRI room during your examination, which could in the process possibly harm you. Precautions have been taken to prevent such an event; loose metal objects, like pocket knives or key chains, are not allowed in the MRI room. If you have a piece of metal in your body, such as a fragment in your eye, aneurysm clips, ear implants, spinal nerve stimulators, or a pacemaker, you will not be allowed into the MRI room and cannot have an MRI.
	ii)	Your participation may mean some added discomfort for you. In particular, you may be bothered by feelings of claustrophobia and by the loud banging noise during the study. Temporary hearing loss has been reported from this loud noise. This is why you will be asked to wear ear plugs. At times during the test, you may be asked not to swallow for a while, which can be uncomfortable.
	iii)	Because the risks to a fetus from MRI are unknown, pregnant women must not participate in this study.

MRI - Risks (2)

If the MRI or MRS scans being done for this study will exceed the FDA's recommendations for maximum exposure for non-diagnostic uses of electromagnetic fields, and if this will result in any added risks to the subjects, this should be discussed in the consent form.

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New versus Experimental

Because of advertising, many people automatically associate the word "new" with the notion "better." References to "new drugs" should be deleted throughout the form, and replaced with "experimental" or "investigational drug" as necessary.

Pager Instructions

If phone numbers for beepers or long range pagers are to be listed in the Questions section, instructions on how to use these numbers should also be included since subjects may not know how to use them. Alternatively, it may be easier to list a phone number where subjects can ask that a study investigator be paged.

Person Obtaining Consent

The consent form should include the name of the specific individual obtaining consent in order that subjects have a record of who explained the study. This information can most easily be incorporated into the form by adding a line at the end of the signature section labeled "Person Obtaining Consent" to be signed appropriately.

Pregnancy - Delete Legalistic Language

The second paragraph of the For Females Only section must be deleted. Subjects may quit a study at any time and may not be asked to commit themselves to post-study procedures. Legalistic language like "You agree to..." should not be included in consent forms. You should, however, add a sentence like the following to the end of the first paragraph: "You should also notify your regular doctor and talk to him and/or Dr. Laxer about the best options for your ongoing care."

Pregnancy Testing and Birth Control

The Procedures section should be revised to include a discussion of pregnancy testing and birth control during the study, and the Risks and Discomforts section should describe the risks to pregnant mothers or fetuses that necessitate these precautions.

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Printing

For purposes of approval stamping, the consent form should be printed out as a separate document, not printed on the backs of other documents such as the information sheet or patient questionnaire.

Procedures - Do Not Donate Blood

Because the total volume of blood drawn for purposes of this study is similar to that of the usual donation given at a blood bank, you should not donate blood for at least 8 weeks after the study.

Pronoun Problems

The consent form switches from the first person of the subject ("I") to the second person ("you") in several places. The person used should be consistent throughout. (Please note that while the CHR now recommends that the form be written in second person, use of the first person is acceptable as long as it is used consistently.)

Purpose and Background - Shorten

Please simplify the Purpose and Background section. While you always have the option of describing the background of the study in more detail during the consent process itself, the members ask that the initial written description of the purpose be as simple as possible so that subjects will have an easily understood consent form to take home with them. It seems, for instance, that paragraphs X and Y can be deleted.

Purpose and Background - State Purpose

As a primary goal of a consent form [or information sheet] is to give the subject a clear idea of why s/he is being asked to participate in the study and what the investigator hopes to learn when the data obtained is evaluated, a concise statement of purpose, written in lay terms, should be made as a means of introducing the study.

Purpose and Background - Why Me?

The Purpose and Background section should state explicitly why the particular subjects are being asked to participate in the study. This is most easily done by adding a sentence beginning, "You are being asked to participate in this study because you [are/have]..."

Questions - No Blank Lines

The Questions section should permanently identify the principal investigator and provide his/her phone number. Blank lines may be used only for additional contacts.

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Randomization

Just as procedures have risks and benefits to be mentioned in consent forms, so do maneuvers like randomization, which is being performed in this study. Generally, what is involved is the risk of receiving the less effective agent or procedure or the one with greater side effects. The potential benefits involve the opposite: receiving the agent or procedure that is later shown to be more effective or less toxic. This concept should be incorporated in the consent form using wording like the following:

	PROCEDURE: You will have a 50/50 chance (like flipping a coin) of being placed in one of two groups. Neither you nor your doctor will make the choice so that bias in the study is reduced. The two groups are (a)... or (b)....
	RISKS: You will be assigned to a treatment program by chance. The treatment you receive may prove to be less effective or to have more side effects than the other study treatment or than other available treatments. This will not be known until after the study is completed and the data has been analyzed.
	BENEFITS: The potential benefit to you is that the treatment you receive may prove to be more effective than the other study treatment or than other available treatments, although this cannot be guaranteed.

Reimbursement - How and When Paid?

The Reimbursement section should state how and when subjects will be paid, i.e., in cash or by check, immediately or after a delay of six weeks.

Please revise the Reimbursement section of the consent form to state how and when subjects will be paid, i.e., in cash or by check, immediately or after a delay of six weeks. The Committee has found that providing this information in consent forms reduces subject complaints.

Reimbursement - Taxable Income

As payments for research participation in excess of $600 per calendar year are reportable to the IRS, the Reimbursement section should explain that subjects will have to pay taxes on the money they receive. Please also explain that subjects must provide their home address and social security number to receive payment.

Results of Animal Studies

Because the members felt that the average layperson would not understand the significance of the animal data or be able to interpret the data in a meaningful way, it was asked that this detailed information be deleted from the consent form. Rather, it was suggested that a version of the following statement be added as a means of informing subjects that there is the potential for side effects, as noted in those animal studies: "The significance of [findings from previous animal studies] as a predictor of human risk is unclear."

Rewrite Consent Form

The members requested that the consent form be rewritten in accordance with the standards outlined in the Guidelines for Research Involving Human Subjects at the University of California, San Francisco. Section X, "Consent Form or Information Sheet" gives detailed information regarding consent documents and includes sample consent forms. If you have not received your copy of these guidelines, please contact our office and a copy will be forwarded to you. The Guidelines are also available at the CHR Website: www.ucsf.edu/ora/chr. If you would like help in preparing your consent form, please call the office and arrangements will be made for a senior member of the staff to assist you.

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Risks - Blood Draw

The members asked that the CHR standard wording for risks of venipuncture be used, i.e., "The risks of drawing blood include temporary discomfort from the needle stick, bruising, and, rarely, infection."

Risks - Frequency

To the extent possible, consent forms should characterize the likelihood of risks using words like "likely," "frequent," "occasional," and "rare." The first time these words are used in a form they should be defined using percentages, as follows: "likely" events are expected to happen to more than 50% of subjects, "frequent" events will probably happen to 10 to 50% of subjects, "occasional" events will happen to 1 to 10%, and "rare" events will happen to less than 1%. Because of the difficulty of quantifying risks, and because consent forms should emphasize the most important risks as well as the most frequent risks, the exact wording and organization of the discussion of risks must be adjusted for this particular study, but a careful attempt to communicate the relative importance and likelihood of risks must be made.

Risks - Interviews and Questionnaires

In studies involving interviews and/or questionnaires, the risks discussion should mention the possible inconvenience of taking part. Additionally, if some of the questions are of a personal nature, subjects should be informed of this fact and advised that they are free to decline to answer any question at any time.

Risks - Radiation (1)

The Committee 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 people have no way of estimating the risks of exposure from chest x-rays either, even though they are probably familiar with them. The statement we have developed and presently recommend is:

The amount of radiation you will be exposed to is relatively small. These doses of radiation could be potentially harmful, but the risks are so small that they are difficult to measure. If you have had a lot of x-rays already or if you might be pregnant, you should discuss this with the investigator.

Risks - Radiation (2)

When larger doses of radiation are involved such as might come from extensive fluoroscopy, the above paragraph might be inappropriate. The Committee has developed the following paragraph for receipt of larger amounts of radiation.

As a result of participating in this study, you will receive a significant amount of radiation. The amount is similar to that received in many standard x-ray procedures, but is far more than you would receive from natural daily exposure or in your normal course of treatment and carries at least a theoretical risk. If you are especially concerned with radiation exposure, you might wish to discuss this with the investigators.

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Risks - Resistance to HIV Treatments

A discussion of resistance should be added to the Risks/Discomforts section, using wording like the following:

Resistance: If you are in this study, your HIV infection may develop resistance to the anti-HIV drugs used in this study. Developing resistance means that the virus would no longer be affected by the drug and you may not receive benefit from other similar medications such as [please list any relevant drugs]. The resistance may limit your future treatment options.

Risks - Secondary Cancers

Please consider the following Risks and Discomforts wording for discussing second malignancies:

Second cancers: A number of chemotherapy drugs are known to cause cancer or leukemia themselves, and this may be true about the drugs you receive in this study. In other words, you could get another cancer later even if your ____ cancer gets better.

Risks - Unknown Risks

A discussion of unknown risks should be added to the Risks section, e.g.: "The drug[s, treatment] being used in this study may cause additional problems that the researchers do not know about yet. As they learn more, the researchers will tell you about any new information that might make you want to withdraw from the study."

Signature Section - When Adolescents are Included

If you wish to participate, you should sign below:

__________________	________________________________
Date	Subject's Signature

The person being considered for this study is unable to consent for himself/herself because he or she is a minor. You have been asked to give your permission to include your child in this study.

__________________	________________________________
Date	Parent's Signature
__________________	________________________________
Date	Person Obtaining Consent

Signature Section - When Studying Those Unable to Consent for Themselves

The person being considered for this study is unable to consent for himself/herself. I have been asked to give my permission to include my relative in this study. I know of no reason why he/she would refuse were it possible to do so now.

__________________	_________________________________
Date	Relative's Signature
______________________________
Relationship

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Technical Language

The words and phrases used in consent forms should be easily understood by the subjects. Please review the form and use everyday language to replace or explain technical terms like . . .

Technical Language - Placebo

The Committee asks that the word "placebo" be defined as "an inactive substance" the first time it is used in a consent form. Please add this definition to . . .

Technical Language - Purpose and Background

Please simplify the Purpose and Background section. Although you define terms, the combination of complex sentence structure and difficult vocabulary does not present the information in a way that would be very accessible to the average lay person. While you always have the option of describing the study in more detail and in more scientific language during the consent process itself, the members ask that the initial written description of the purpose be as simple as possible so that subjects will have an easily understood consent form to take home with them. The explanation of the purpose could be as simple as ". . . ."

Technical Language - Too Many Definitions

The members approved the current wording but suggested that in the future you use everyday language directly rather than in parentheses. For example, you could write "the researchers will insert a plastic tube" rather than "the researchers will insert a catheter (plastic tube)." Use of technical language with parenthetical explanations unnecessarily complicates the consent form and may offend potential subjects.

Tissue Banking

Between Procedures and Risks:

Biologic Studies: Portions of your tissues which are removed as part of care and are not required for routine diagnosis or treatment may be used now or in the future for research purposes. These tissue samples may be used to learn more about how cancer or other diseases develop and/or may result in new products, tests or discoveries. In some instances, these may have potential commercial value. These tissues to be kept for research purposes will be obtained only at the same time as your regular procedures are performed; you will not have to undergo any special procedures for this purpose. There will be no additional charge, and you will not receive any payment or financial benefit from any products, tests or discoveries. You may also be asked in the future if you are willing to be in additional research studies. You will not be told the results of any future research. Participation in this extra research is voluntary, and if you choose not to allow the extra research it will in no way affect your care on the main study. You may at any time contact the researchers that your samples be withdrawn from research use, and any identifiable samples still in their possession will be destroyed. Please indicate whether you are willing to allow this extra research by initialing one of the lines at the end of the form.

Just before the signature lines:

	____ I do not want my tissue and blood samples used for any research or tests other than those needed for the main research study.
	____ The researchers may keep my extra tissue and blood samples for future research.

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Treatment and Compensation for Injury (1)

One required element of consent for biomedical studies involving real, foreseeable risk of harm is a statement regarding treatment and compensation in case of injury. The UCSF statement, which should be used without changes at the end of the risk section, is:

If you are injured as a result of being in this study, treatment will be available. The costs of such treatment may be 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, call the office of the Committee on Human Research at (415) 476-1814 or write: Committee on Human Research, Box 0962, UCSF, San Francisco, CA 94143.

Treatment and Compensation for Injury (2)

The Treatment and Compensation for Injury wording must be revised. When an industry sponsor is involved, the UCSF statement, which should be used without changes except as noted below, is as follows:

If you are injured as a result of being in this study, treatment will be available. The costs of such treatment may be covered by the University of California or by the study sponsor, [sponsor's name], depending upon a number of factors. The University and the sponsor do not normally provide any other form of compensation for injury. For further information about this, call the office of the Committee on Human Research at (415) 476-1814 or write: Committee on Human Research, UCSF, Box 0962, San Francisco, CA 94143.

If the industry sponsor's indemnification policy is different from UCSF's and/or the industry sponsor does not wish to include its name in the UCSF standard statement, then there are two other options available. Either the sponsor may remain silent on this point and its name may be deleted entirely from the above paragraph or a brief paragraph (one or two sentences) may be added below and separate from the UCSF standard statement informing the subject of the sponsor's policy. Please note, however, that no changes may be made to the UCSF statement, except for the deletions of any references to the sponsor, and any description of the sponsor's policy must state what the sponsor will cover, not what it will not cover. As a further limitation, the sponsor's statement may not make reference to third party carriers, government programs, or lost wages. Any further discussion of indemnification or subject injury should be made during contract negotiations, not within the consent form itself.

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Treatment and Compensation for Injury (3)

The University of California will not accept a sponsor's additions to university statements regarding treatment and compensation for injury when such additions are more restrictive than the university's own policy. Please note that indemnification should be discussed during the process of negotiating contracts to conduct research. The wording in consent forms, on the other hand, is intended to inform subjects about studies, not to limit the liability of researchers or sponsors; and standard UCSF wording must be used. Thus, . . . must be deleted.

Treatment and Compensation for Injury (4)

Please note that the details of the treatment and compensation for injury provisions to be made by the study sponsor are to be negotiated in the contract for this study. This CHR approval of the protocol and consent form language is not the contract.

Treatment and Compensation for Injury (5)

As there is no real or foreseeable risk of biomedical harm to participants in this study, please delete the statement on treatment and compensation for injury.

Treatment and Compensation for Injury - VAMC (1)

One required element of consent for biomedical studies involving real, foreseeable risk of harm is a statement regarding treatment and compensation in case of injury. The UCSF/VAMC standard statement, which should be used without changes at the end of the Risks section, is:

If you are injured as a result of being in this study, treatment will be available. If you are eligible for veteran's benefits, the costs of such treatment will be covered by the Department of Veterans Affairs. If not, the costs of such treatment may be covered by the Department of Veterans Affairs or the University of California, depending on a number of factors. The Department of Veterans Affairs and the University do not normally provide any other form of compensation for injury. For further information about this, call the V.A. District counsel at (415) 750-2288 or the office of the UCSF Committee on Human Research at (415) 476-1814.

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Treatment and Compensation for Injury - VAMC (2)

Only the standard UCSF/VAMC statement regarding Treatment and Compensation for Injury may be included in the consent form. When a sponsor's indemnification policy is involved, the UCSF statement is as follows:

If you are injured as a result of being in this study, treatment will be available. If you are eligible for veteran's benefits, the costs of such treatment will be covered by the Department of Veterans Affairs. If not, the costs of such treatment may be covered by the Department of Veterans Affairs, the study sponsor [sponsor's name], or the University of California, depending on a number of factors. The Department of Veterans Affairs, the study sponsor, and the University do not normally provide any other form of compensation for injury. For further information about this, call the V.A. District counsel at (415) 750-2288 or the office of the UCSF Committee on Human Research at (415) 476-1814.

If the industry sponsor's indemnification policy is different from UCSF's and/or the industry sponsor does not wish to include its name in the UCSF standard statement, then there are two other options available. Either the sponsor may remain silent on this point and its name may be deleted entirely from the above paragraph or a brief paragraph (one or two sentences) may be added below and separate from the UCSF/VAMC standard statement informing the subject of the sponsor's policy. Please note, however, that no changes may be made to the UCSF/VAMC statement, except for the deletions of any references to the sponsor, and any description of the sponsor's policy must state what the sponsor will cover, not what it will not cover. As a further limitation, the sponsor's statement may not make reference to third party carriers, government programs, or lost wages. Any further discussion of indemnification or subject injury should be made during contract negotiations, not within the consent form itself.

Typographical Errors

The following spelling and/or typographical errors should be corrected: XXX. As there may be other errors that the members did not notice at this time, the entire consent form should be proofread again before it is resubmitted.

Voluntary - Consent

"PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate and to withdraw at any point in this study without jeopardy to.... If you wish to participate you should sign this form."

(Updated June 10, 1999)