Sample Consent Form Biomedical Study

Sample Consent Form Biomedical Study

TEMPLATE CONSENT FORM – SOCIAL-BEHAVIORAL STUDY

CONSENT TO PARTICIPATE IN RESEARCH

Title of Study (Designate any subject sub-group here, e.g., “Controls”)

Introduction

My name is ______[if there are co-investigators, note here, e.g., "and my research colleagues are ______and ______"]. I am a(n) [undergraduate/ graduate student/ faculty member] at the University of California, Berkeley, [if lead investigator is a student, introduce faculty sponsor here, e.g., "working with my faculty advisor, Professor ______,"] in the School/Department of______. I am [We are] planning to conduct a research study, which I invite you to take part in.

You are being invited to participate in this study because [specify reason why prospective subject is being recruited for study, e.g., "you have signed up for the Research Participant Pool (RPP)"].

Purpose

The purpose of this study is to ______. [Give brief explanation of why study is being done, using one or two sentences written in clear language understandable to the target population].

[If appropriate:About [state total accrual goal for number of subjects] people will take part in this study. [Give a short description about cohorts, if any. For multi-site studies, give figures for both the whole study and for local enrollment at UCB.]

Procedures

If you agree to be in this study, you will be asked to do the following: [Discuss screening procedures first, if any, or refer to a separate screening consent form if used. List and describe procedures/tests/activities chronologically and their frequency, using bulleted format. Indicate location where procedures will take place (e.g., lab, home, or other setting, and amount of time needed for each procedure. Also note total amount of time required for subject’s study participation, at the beginning or end of this section.]

[If there are any screening procedures:]

Before you begin the main part of the study...

You will need to have the following screening tests/ procedures to find out if you can be in the main part of the study. [List and describe tests/ procedures as appropriate. If more than one screening procedure will be done, use bulleted format.]

[If screening procedures are described above/separately:]

During the main part of the study...

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

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

  • You will be asked to view two 15-minute videotapes; one will be of pleasant content and the other of unpleasant content.
  • You will be given a questionnaire that asks about your reactions to the videotapes. It should take about 15 minutes for you to complete.
  • Aftercompleting the questionnaire, you will take part in a focus group* discussion led by ______or ______. 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. This discussion will last about 45minutes.
  • [Explain any follow-up procedures, including timing of each.]

[Note: If the study involves deception or incomplete disclosure which necessitates a debriefing process, a general statement may be added here or in the Benefits discussion that more information will be given to subjects at the conclusion of the study, e.g., "At the end of the study, we will explain in greater detail what we hope to learn from this research." If the investigator does not wish to include such a statement because s/he believes that it would bias study results, s/he should discuss this in the protocol as part of the justification for use of deception or incomplete disclosure.]

Study time: Your study participation will take a total of approximately 90 minutes (1½hours).

Study location: All study procedures will take place at ______. [If different procedures will take place at different locations, specify accordingly].

Benefits

[Explain possible benefits appropriate to the study, both direct (individual) and indirect (general benefits to society or scientific knowledge), e.g.:]

There will be no direct benefit to you from participating in this study. However, it is hoped that the information gained from the study will help… [e.g.,health professionals better understand/learn more about ______.]

Risks/Discomforts

[List risks and discomforts as appropriate. Use bulleted format. See examples below.]

  • Some of the videotapes are likely to produce unpleasant feelings, but you will be able to stop watching at any time you wish. Just say so.
  • 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 or to leave the group at any time. [State if compensation will be affected should the individual not complete any portion of the study, e.g., "Please note that if you discontinue study participation you will receive payment/course credit only for the hours of the study you complete. If you remain in the study but choose not to answer any questions you don't wish to, you will still receive the full amount of compensation."]

[For all forms:]

  • Breach of confidentiality: As with all research, there is a chance that confidentiality could be compromised; however, we are taking precautions to minimize this risk.

Confidentiality

[Since there is no legal privilege between investigator and subject, a "guarantee" of “complete” or "strict” confidentiality should not be given or implied in the consent form. This section should explain how the researchers will minimize the risk of breach of confidentiality (seeCPHS Data Security Guidelines and Matrix). Any regulatory/other agencies which may have access to the research records should also be noted, e.g.:]

  • Your study data will be handled as confidentially as possible. If results of this study are published or presented, individual names and other personally identifiable information will not be used.

To minimize the risks to confidentiality, we will...[Explain data security measures to be taken, e.g., storage, coding, password protection, encryption, limited access to study records, destruction of video or audio recordings after transcription, and/or destruction of code key after data are collected/matched, etc. (as appropriate).]

[*Focus Groups – special considerations:

There are special confidentiality considerations when a study involves focus groups. A statement such as the following should be added to the consent form:

  • We will keep all of the information provided during the focus groups as confidential as possible, and we will strongly encourage all participants to do likewise. However, please be aware that we cannot ensure that participants will not disclose any information obtained during a focus group.

In addition, if the investigator wishes to audio- or video-record focus groups, s/he must discuss in the protocol and convey in the consent form provisions for obtaining consent and securing tapes related to

all participants. (E.g., will individuals who do not wish to be recorded be excluded from participation in the focus group/study? Will the investigator not record the whole group if anyone objects to being taped? What will happen if an individual agrees to being taped but then changes their mind during the discussion?Are there provisions for blurring certain individuals in a videotape and/or disguising their voices in a videoor audio recording? These questions should all be addressed as appropriate.]

[Sensitive/reportable research information:

If there is a reasonable expectation (from the topic under study and/or the subject population) that reportable information may be disclosed to the researcher during the study, an appropriate statement should be added, e.g.:

  • We will keep your study data as confidential as possible, with the exception of certain information that we must report for legal or ethical reasons, such as child abuse, elder abuse, or intent to hurt yourself or others.

Note: Also see CPHS Guidelines on Mandated Reporting for Suspected Child, Elder, or Dependent Adult Abuse or Neglect for further detail in this regard.]

[Certificate of Confidentiality: For certain studies, where especially sensitive information will be sought from subjects (e.g., about possible use of illegal substances or other illegal activities), investigators may wish to obtain a federal Certificate of Confidentiality to protect their research records from subpoena. 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. If the Certificate is obtained, the end of the consent form’s confidentiality statement should discuss it, using such wording as:

  • To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health (NIH). With this Certificate, 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 certain information about you for legal or ethical reasons. For example, we will report information about child abuse, elder abuse, or intent to hurt yourself or others. If an insurer, employer, or other person obtains your written consent to receive research information, we cannot use the Certificate to withhold that information. In addition, 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, e.g., for quality assurance or data analysis.]

  • Retaining research records: When the research is completed, I may savethe[samples/ tapes and notes/ study records]for use in future research done by myself or others. I will retain this study information for up to XX months/years after the study is over. The same measures described above will be taken to protect confidentiality of this study data. [Or if different, give accurate information about retention and use of study data in future, e.g., "I will destroy the samples/ tapes and notes/ study records at the end of this study."]

[If the research involves the collection of identifiable private information, one of the following is required:

Identifiers might be removed from the identifiable private information. After such removal, the information could be used for future research studies or distributed to other investigators for future research studies without additional informed consent from the subject or the legally authorized representative.

--OR--

Your information collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.]

Alternatives [if appropriate]

[Additional bullets should include, if appropriate, alternative specific procedures/treatments.]

Costs of Study Participation [if appropriate]

[Clearly state if there are any costs associated with study participation, and if so, specify what they are. If there are no costs (which is usual for social-behavioral studies), this section may be omitted.]

Compensation

In return for your time and effort, you will be paid $XXX [or “you will receive a ______gift card in the amount of $XXX”] for taking part in this study. [If non-monetary compensation, e.g., course credit, will be offered for participation, state here. Describe any pro-rating or bonuses, e.g.: "If you do not complete the study, you will receive$XXX for each week of participation." Also, specify method and timing of payment, e.g.: "A check will be mailed to you about 6 weeks after your participation in the study has ended."]

[If reimbursement will be offered for subjects’ participation expenses (e.g., transportation and/or parking), describe here, e.g., “We will reimburse you for any costs of public transportation to and from the study site, or for parking costs if you drive to the study site.”]

[OR, if there will be no payment:]

You will not be paid for taking part in this study.

[NOTE: Many social-behavioral studies involveonly minimal risk of harm to subjects. However, if the study involvesgreater than minimal risk, the following statement is required by UCOP:]

Treatment and compensation for injury

It is important that you promptly tell the researcher [investigator’s name], if you believe that you have been injured because of taking part in this study. You can tell the researcher in person or call him/her at [telephone number].

If you are injured as a result of taking part in this study, University of California will provide necessary medical treatment. The costs of the treatment may be billed to your insurer just like other medical costs, or covered by the University of California or the study sponsor [sponsor name], depending upon a number of factors. The University and the study sponsor do not normally provide any other form of compensation for injury. For more information, call OPHS at (510) 642-7461.

Rights

Participation in research is completely voluntary. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.

Questions

If you have any questions or concerns about this study, you may contact ______[PI and student investigator name(s) as appropriate] at ______[phone number] or [email address]. [If there are additional informational sources related to the study, e.g., patient representatives, local contacts, etc., list here with contact information.]

If you have any questions or concerns about your rights and treatment as a research subject, you may contact the office of UC Berkeley's Committee for the Protection of Human Subjects, at 510-642-7461 or .

**************************************************

CONSENT

You will be 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.” See CPHS Guidelines on HIPAA and Human Subjects Research for more detail in this regard.]

If you wish to participate in this study, please sign and date below.

______

Participant's Name (please print)Date

______

Participant's SignatureDate

______

Person Obtaining ConsentDate

[If third party consent is requested and has been addressed in the CPHS application:] (Note: Adapt if applicable; delete if not applicable.)

______

Legally Authorized RepresentativeDate

______

Person Obtaining ConsentDate

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