SAMPLE CONSENT FORM SOCIAL/BEHAVIORAL STUDY (September 2017)

SAMPLE CONSENT FORM – SOCIAL/BEHAVIORAL STUDY (September 2017)

PLEASE NOTE: 1) Statements in brackets and italics are instructions or examples, and should not be included in the actual consent form. 2) Required wording (in regular font, not italics) should be used as is (if appropriate). 3) Suggested wording (in italics) can be revised as needed to provide the simplest and clearest description of the study.

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Study Title: [Insert study title here]

Research Project Holly Smith, M.D., Associate Professor of Psychiatry. Director: UCSF, Room 809, 505 Parnassus Ave, San Francisco, CA. Phone: 415.246.xxxx; e-mail: [email protected]

Study Coordinator: Joan Buttenfield, Phone: 415.246.xxxx [email protected]

This is a research study about [insert brief mention of general subject matter of study]. The study researchers, …,[M.D.,] and …, [Ph.D.,] from the [UCSF Department of . . .], will explain this study to you.

Research studies include only people who choose to take part. Please take your time to make your decision about participating, and discuss your decision with your family or friends if you wish. If you have any questions, you may ask the researchers.

You are being asked to take part in this study because you are/have [specify prospective subject's condition, situation, or other reason for recruitment to study, e.g., "You are being asked to take part in this study because you have come the emergency room three times in the past six months." Or "You are being asked to take part in this study as a healthy volunteer."]

Why is this study being done?

The purpose of this study is to…[Limit explanation to why study is being done, explaining in one or two sentences, e.g., "…learn more about how men and women communicate pleasant and unpleasant feelings."]

[Address sponsorship and financial interests here:

 You must 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

[Sample Social/Behavioral Consent] [September 2017] PAGE 1 OF 8 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 section headed Why is this study being done? (Purpose and Background) or in a section headed 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. For suggested wording, see Conflicts of Interest in Research.

How many people will take part in this study?

About [state total accrual goal here] people will take part in this study. [If appropriate, give a short description about cohorts here. For multi-center studies, it is good to give figures both for the whole study and for local enrollment at UCSF.]

What will happen if I take part in this research study?

[List and describe all procedures/tests/activities and their frequency under the categories below, using bulleted format. Indicate the location where procedures will be done. See examples below.]

If you agree, the following procedures will occur:

[First, you will need to have the following “screening” tests or procedures to find out if you can participate in the main part of the study: [if any screening procedures are needed, list here]

If the screening exam shows that you can be in the main part of the study and you choose to continue, this is what will happen next:]

[List tests, procedures, and activities as appropriate. Use bulleted format. See examples below:]

[Sample procedures:]

 You will view two 15-minute videotapes; one will be of pleasant content and the other of unpleasant content.  After viewing both videotapes, you will be asked to take part in a focus group discussion led by Dr. XXX or Dr. XXX. Everyone in this focus group will have viewed the tapes. You and the other group members will be asked to discuss reactions to scenes in both tapes. An audiotape will be made of this discussion. This discussion is expected to last about 30 minutes.  You will be given a questionnaire to respond to about your reactions to the videotapes. It should take about 15 minutes to complete this questionnaire.  You will also be given a standard paper-and-pencil personality test. It should take about one hour to complete this test.

[Sample Social/Behavioral Consent] [September 2017] PAGE 2 OF 8 [For interviews:]

 The researcher will interview you for about an hour in a private office. The researcher will ask you to describe your experiences with….  The researcher will make a sound recording of your conversation. After the interview, someone will type into a computer a transcription of what’s on the tape and will remove any mention of names. The sound recording will then be destroyed.

 Study location: All these procedures will be done at . . .[If different procedures will take place at different locations, specify accordingly].

[Optional Feature: In addition to the required narrative explanation of study procedures as above, a simplified study calendar or schema may be inserted here if the study is very extended and/or complex.]

How long will I be in the study?

[Short-term/simple study:] Participation in the study will take a total of about XX hours [over a period of XX days/weeks].

[Long-term/complex study: You will be asked to XXX every XXX for [months, weeks/until a certain event]. When appropriate, state that the study will involve long-term follow-up and specify time frames and requirements of follow-up.]

Can I stop being in the study? [Emphasize voluntary nature of participation; also point out that subject can be dropped from study at researcher’s discretion, e.g.:]

Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you wish to stop being in the study.

Also, the study researcher may stop you from taking part in this study at any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.

What side effects or risks can I expect from being in the study?

[Use bulleted format. If there are numerous and/or serious risks involved, list the physical and non-physical risks of study participation in three categories: 1. "likely"; 2. "less likely"; 3. "rare but serious." In the "likely" and "less likely" categories, identify those side effects that may be "serious." "Serious" is defined as side effects that may require hospitalization or may be irreversible, long-term, life threatening, or fatal. In most social-behavioral studies, a simple listing of risks is sufficient, e.g.:]

 Some of the videotapes are likely to produce unpleasant feelings, but you will be able to stop watching at any time if you feel too uncomfortable.

[Sample Social/Behavioral Consent] [September 2017] PAGE 3 OF 8  Some of the focus group discussion questions may make you uncomfortable or upset, but you are free to decline to answer any questions you do not wish to answer or to leave the group at any time.  For more information about risks and side effects, ask one of the researchers.

Are there benefits to taking part in the study?

[Explain possible benefits appropriate to the study. Or if no direct benefit to the subject is anticipated:]

There will be no direct benefit to you from participating in this study. However, the information that you provide may help health professionals better understand/learn more about XXX.

What other choices do I have if I do not take part in this study?

[If the study includes treatment(s):]

Your other choices may include not getting treatment, getting standard treatment for your condition without being in a study, or taking part in another study. If you decide not to take part in this study, there will be no penalty to you. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.

[OR if the study does not include any treatment(s):]

You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.

Will information about me be kept private?

We will do our best to make sure that the personal information gathered for this study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

 Authorized representatives from the following organizations may review your research data for the purpose of monitoring or managing the conduct of this study: Representatives of the Sponsor [List Sponsor name(s), as applicable]  Representatives of the National Institutes of Health [remove if this is not an NIH-funded study]  Representatives of the University of California  Representatives of the Food and Drug Administration (FDA) [remove if this is not an FDA- regulated study]  [list any other agencies – in or outside the US – that might inspect research records]

[Recommended wording for focus groups:]

[Sample Social/Behavioral Consent] [September 2017] PAGE 4 OF 8 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.

[Sensitive research information/Certificate of Confidentiality: For studies where investigators may obtain especially sensitive information from subjects (e.g., possible illegal drug use) and seek a Certificate of Confidentiality, use specific consent form wording.]

[Confidentiality statement for studies conducted at a UCSF Clinical Research Center or Veterans Administration Medical Center: At certain sites, including the GCRC, PCRC, VAMC, and most imaging scan sites, 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 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 health care providers may see your test results and become aware of your participation. Hospital regulations require that all health care providers treat information in medical records confidentially.

Are there any costs to me for taking part in this study? [If there are clinical procedures (e.g., blood draw; MRI scan), one of the following paragraphs below should be inserted. If there are no clinical procedures (e.g., this is a survey study), this question can be omitted.]

[For studies where subjects may be responsible for some costs:]

Two types of procedures will be done during this study. Some are part of your standard medical care and others are only for research. You or your insurer will be billed for the standard medical care. You will be responsible for your co-pays, deductibles, and any other charges that your insurer will not pay. There is a possibility that your insurer may not cover all standard medical care costs if you are receiving medical services out of network. Any procedures done only for research will not be charged to you or your insurer.

[For studies in which the sponsor pays all costs:]

No. The sponsor has agreed to pay for all items associated with this research study; you or your insurer will not be billed.

Will I be paid for taking part in this study?

In return for your time, effort and travel expenses, you will be paid [$XXX] for taking part in this study. [Describe any pro-rating or bonuses, and specify method and timing of payment. See the IRB website for more info on subject payment and sample consent form language.]

[OR, if there is no payment:] You will not be paid for taking part in this study. [Sample Social/Behavioral Consent] [September 2017] PAGE 5 OF 8 What are my rights if I take part in this study?

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. You will not lose any of your regular benefits, and you can still get your care from our institution the way you usually do.

Who can answer my questions about the study?

You can talk to the researcher(s) about any questions, concerns, or complaints you have about this study. Contact the researcher(s)______[name(s)] at ______[telephone number(s)].

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

[For broad sharing of genomic data in studies that are subject to the NIH Genomic Data Sharing Policy, insert the consent form wording here.]

CONSENT

You have been given a copy of this consent form to keep.

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

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to be in this study, or to withdraw from it at any point without penalty or loss of benefits to which you are otherwise entitled.

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

Date Participant's Signature for Consent

Date Person Obtaining Consent

[Sample Social/Behavioral Consent] [September 2017] PAGE 6 OF 8 [STOP! Only include the following signature line if you may consent non-English speaking subjects using the short form consent method AND this request has been addressed in the IRB application.]

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

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

AND/OR:

Date Legally Authorized Representative

Date Person Obtaining Consent

The person being considered for this study is unable to consent for himself/herself because he/she is a minor. By signing below, you are giving your permission for your child to be included in this study.

Date Parent or Legal Guardian

[Sample Social/Behavioral Consent] [September 2017] PAGE 7 OF 8 NOTES TO PERSON PREPARING CONSENT FORM

1. Collecting long-term tracking information:

If relatives, neighbors, co-workers, employers, or government agencies will be contacted during the study to provide information on subjects’ whereabouts, you should explain so in the “What will happen if I take part in this research study?” (Procedures) section. Subjects should be reminded that they can ask to have these tracking procedures stopped at any time.

2. Handling Health Information and Complying with HIPAA

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

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

3. Consent Document Identification Required by the IRB

Version date and short identifier: Every consent document (consent forms, assent forms, information sheets) must include a version date (month, day, year) in a lower corner of each page. This date should be hard coded -- in other words, the date should not update automatically each time you open the document. The version date should only be changed when the document is modified. If multiple consent documents are used for the study, include a short identifier in the footer on each page to distinguish between the various consent documents. Any changes in the consent documents require IRB review.

Page numbering: The pages of every consent document should be numbered, preferably in a format like "1 of 2," "2 of 2," in the footer of the document.

Approval stamp: Approved consent documents in iRIS will receive an approval stamp. To accommodate the stamp, each consent document should have at least a 1.25" top margin and the upper left-hand corner should be blank. Learn more about IRB approval documentation.

[Sample Social/Behavioral Consent] [September 2017] PAGE 8 OF 8