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[Insert title of the study.]
[If the study involves using different consent forms for different populations, identify the population group as the subtitle of the study.]
You are asked to participate in a research study conducted by [insert names and degrees of all investigators] , from the [insert department affiliation] at California State University, Long Beach. [If student, indicate that results will be contributed to senior project, thesis or dissertation.] You were selected as a possible participant in this study because [explain succinctly and simply why the prospective subject is eligible to participate].
[State what the study is designed to assess or establish.]
If you volunteer to participate in this study, you will do the following things:
[Describe the procedures chronologically using simple language, short sentences and short paragraphs. The use of subheadings helps to organize this section and increases readability. Medical and scientific terms should be defined and explained. Identify any procedures which are experimental.]
[Specify the subject's assignment to study groups, length of time for participation in each procedure, the total length of time for participation, frequency of procedures, location of the procedures to be done, etc.]
[Describe any reasonable foreseeable risks, discomforts, inconveniences, and how these will be managed.]
[If there are significant physical, psychological, or social risks to participation that might cause the researcher to terminate the study, please describe them.]
[Describe benefits to subjects expected from the research. If the subject will not benefit from participation, clearly state this fact.]
[State the potential benefits, if any, to science or society expected from the research.]
[State whether the subject will receive payment or other form of incentive. If not, so state. If subject will receive payment, describe remuneration amount, when the payment is scheduled to be paid, if there is a proration schedule, so state, in case the subject decides to withdraw or is withdrawn by the investigator.]
[Note: The following is a required element of informed consent for research involving more than minimal risk. If this does not apply to your research, please omit this entry and delete the heading:]
"If you are injured as a direct result of research procedures not done primarily for your own benefit, [... describe the form of professional medical advice or treatment you will make available.]
Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission or as required by law.
[If information will be released to any other party for any reason, state the person/agency to whom the information will be furnished, the nature of the information, and the purpose of the disclosure.]
[If activities are to be audio- or videotaped, describe the subject's right to review/edit the tapes, who will have access, if they will be used for educational purpose, and when they will be erased.]
You can choose whether to be in this study or not. If you volunteer to be in this study, you may withdraw at any time without consequences of any kind. Participation or non-participation will not affect your [Note--choose appropriate term: grade, treatment, care, employment status, etc,] or any other personal consideration or right you usually expect. You may also refuse to answer any questions you don't want to answer and still remain in the study. The investigator may withdraw you from this research if circumstances arise which in the opinion of the researcher warrant doing so. [Note: If you are providing a benefit to subjects or an incentive payment, and if you know or can anticipate the reasons for withdrawing a subject, you should state them briefly. These reasons should relate to the original eligibility requirements in your protocol. Do not include reasons which are crimes or otherwise covered in penal codes; these are covered in your authority over the research.]
If you have any questions or concerns about the research, please feel free to contact [identify research personnel: Principal Investigator, Faculty Sponsor (if student is the P.I.), Co-Investigator(s)] . Include day phone numbers for all listed individuals. For greater than minimal risk studies, include night/emergency phone numbers.]
You may withdraw your consent at any time and discontinue participation without penalty. You are not waiving any legal claims, rights or remedies because of your participation in this research study. If you have questions regarding your rights as a research subject, contact the Office of University Research, CSU Long Beach, 1250 Bellflower Blvd., Long Beach, CA 90840; Telephone: (562) 985-5314 or email to email@example.com.
Signature of Research Subject (and) or Legal Representative [Note: Use "and" when both required.]
I understand the procedures and conditions of my participation described above. My questions have been answered to my satisfaction, and I agree to participate in this study. I have been given a copy of this form.
|Name of Subject:|
|Name of Legal Representative (if applicable):|
|Signature of Subject or Legal Representative: | Date:|
STATEMENT and SIGNATURE OF INVESTIGATOR [Note: The IRB will normally require that the investigator sign the following statement when the risk to subjects is greater than minimal or when physically invasive procedures will be used or when there is a probability* of some subjects being of diminished autonomy.
* Probability in this situation means at least one standard deviation greater than mean statistical possibility.]
In my judgment the subject is voluntarily and knowingly giving informed consent and possesses the legal capacity to give informed consent to participate in this research study.
|Signature of Investigator Date|