PARTICIPANTS RIGHTS IN RESEARCH

  Informed Consent - Notification Rights of the Participants/Subjects

  (Right to be Informed of the Following)

1. A statement that the study involves research
2. An explanation of the purposes of the research
3. The expected duration of the subject's participation
4. A description of the procedures to be followed
5. Identification of any procedures which are experimental
6. A description of any reasonably foreseeable risks or discomforts to the subject
7. A description of any benefits to the subject or to others which may reasonably be expected from the research
8. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
9. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
10. For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
11. Research Qs, Rights Qs, Injury Qs - An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
12. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled

  Additional Elements, As Appropriate

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
3. Any additional costs to the subject that may result from participation in the research
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
5. A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
6. The approximate number of subjects involved in the study

          Site Reference - Office of Human Research Protections

  Patient Bill of Rights and Other Sites

• California Coalition for Ethical Mental Health Care

• California Society for Clinical Social Work

  • Includes Ethical Standards

• California Psychological Association

• Health and Human Services Patient Bill of Rights

• Mental Health Patients Bill of Rights

• National Foundation for the Treatment of Pain

  • Includes California Pain Patients Bill of Rights

  • California Senate Bill No. 402

• Patient Bill of Rights California Board of Psychology

• SAMHSA's Health & Human Services Substance Abuse & Mental Health Services Admin.

  • Consumer Bill of Rights and Responsibilities

  Participant or Subject Questions Regarding Research You Participated In - If you as a research participant/subject have any concerns, questions, or notifications in regards to a survey, questionnaire, research project or program you were involved with or participated in please contact the following individuals: Please understand that you have rights and that your privacy will be respected in accordance within Office of Human Research Protection guidelines and the university policies and procedures. We are here to assist you with your concerns in any way possible.

  PARTICIPANT/SUBJECT FORM (CONCERNS) - Submit this form to the below two email addresses if you have concerns or questions in a study you have participated in or are being asked to participate in.

• Samuel "Sid" Kushner - IRB Institutional Administrator at skushner@csusb.edu

• Michael Gillespie, IRB Secretary at mgillesp@csusb.edu

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