"Procedure Consent Forms"
Eastern University Institutional Review Board CONSENT FORMS A.FREQUENTLY ASKED QUESTIONS CONCERNING CONSENT PROCEDURES 1. Do I need to get consent? Can I get a waiver from the consent requirements? If you are using archived data, consent may not be necessary or even possible. Some data do not meet the definition of “archived data”, but researchers may still seeks a waiver of consent requirements. Only studies with a restricted set of conditions may use this option, and each waiver request is separately reviewed and considered by EUIRB. 2. What if I want to give my subjects anonymity? You should not use a written consent form. Instead you can use a consent script (e.g., phone surveys) or a cover letter (e.g., mail surveys). These documents do the same basic job as a written consent form does informing subjects about the study and their rights. The only difference is that subjects do not sign their name. 3. Do I need to get consent if my project is exempt? The requirement for some form of consent applies to ALL research, although most exempt projects (particularly mail or phone surveys) can use a consent script or cover letter (for implied consent). 4. What if I audio or video tape my subjects? You will need to get a written consent. The consent procedure needs to specify WHEN the tapes will be destroyed, WHERE they will be stored, and WHO will have access to the tapes. Use a version of the WRITTEN CONSENT FORM. 5. What if I want to intentionally identify individuals in my research report (s) (i.e., quote individuals who you interviewed and gave their identities)? Then you will be required to get their written consent. 6. What if my project is BIOMEDICAL in nature? Use the sample for written consent forms and the BIOMEDICAL CONSENT FORM CHECKLIST. 7. What are the special consent considerations for children? If a child is between the ages of 7 and 18, then you should seek consent both written parental and child assent. The assent form language should be at about the same grade level as the child. If the child is between the ages of 3 and 7, then you should use a VERBAL ASSENT, which is a 11-10-06 Consent Form 1 Eastern University Institutional Review Board consent script with language appropriate for the child’s age. A child younger than age 3 is considered incapable of participating in the consent process. At all age levels, the final power of consent is usually left to the parents or guardians. 8. Are there laws that affect the consent process? In the course of your research, if you become aware that any specific individual is in imminent danger of harming himself or others (i.e., due to acute depression) or is currently suffering mental or physical abuse, or abusing another individual, you are required by Washington state law to inform the appropriate authorities. If there is a reasonable chance that you may discover such information about your subjects, you must tell them of this requirement when you ask for their consent, because the law requires you to break confidentiality in these circumstances. Contact IRB for more information on this topic, including specific language to be used. B. SAMPLES OF FORMS OF CONSENT The following samples are provided to help you compose your own consent procedure. Decide which form of consent you will need, and then use the appropriate sample to make your own. Place the specific information for your project in the appropriate places, as indicated. Once you have written your own version, read it to make sure all the necessary information is there, that there are no mistakes, spelling or grammatical errors, and that it is not ambiguous or otherwise confusing. Below is the Bill of Rights that reflects the philosophy of informed consent and may be included in your consent form. SUBJECTS’S BILL OF RIGHTS The rights below are the rights of every person who is asked to be in a study. In participating as a human subject I have the following rights: 1. To be told what the study is trying to find out; 2. To be told what will happen to me and whether any of the procedures, drugs or devices are different from what would be used in standard practice; 3. To be told about the frequent and/or important risks, side effects or discomforts of the things that will happen to me for research purpose; 4. To be told if I can expect any benefit form participating, and, if so, what the benefits might be; 5. To be told of the other choices I have and how they may be better or worse than being in the study; 6. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study; 7. To be told what sort medical treatment is available if any complications arise; 11-10-06 Consent Form 2 Eastern University Institutional Review Board 8. To refuse to participate or to change my mind about participation after the study is started (This decision will not affect my right to receive the care I would receive if I were no in the study.); 9. To receive a copy of the signed and dated consent form; and 10. To be free of pressure when considering whether I wish to agree to be in the study. SAMPLE COVER LETTER Identify who is doing the study. Define the purpose of the study (see example). You are being asked to take part in the fifth periodic community-wide survey sponsored by the _________ Police Department. Your participation is very important to the department’s future plans for service. This series of surveys was designed by the ____________ P.D. as another step in its commitment to Community Oriented Policing. This commitment reflects three goals: First, to give our clients – taxpayers – an opportunity to identify problems in their own neighborhoods as well as citywide problems that might involve police services. Second, to suggest how much information citizens have about various services police provide. Third, this survey will provide a yardstick against which to measure new programs and enhanced services that result form the information gained here. This is a request for completely voluntary participation, and your responses will remain totally anonymous – neither your name not any other identifying information will be asked or recorded. This survey is being conducted for _________ P.D. by ______. Your participation in this survey should take about ___ minutes. This study has been reviewed and approved by the Eastern University Institutional Review Board. If you have questions or concerns regarding this study you may contact the Chairperson of Institutional Review Board (IRB): Institutional Review Board Mailbox 859, McInnis, 1300 Eagle Rd., Eastern University, St. Davids, PA 19087 Email: IRB@eastern.edu SAMPLE VERBAL CONSENT SCRIPT Hello, my name is ____, and I am a graduate student with the Eastern University Department of ____. I am collecting data for my research project on (brief description of the project), and I’d like to ask you for your help by answering a few questions for me regarding (describe topic of questions). Your participation in this survey should take about ___ minutes. These data will be strictly confidential and I will not record your name. Also, your participation is completely voluntary. You are free to not answer any questions you may find objectionable, and may withdraw from the study at any time without penalty, just by letting me 11-10-06 Consent Form 3 Eastern University Institutional Review Board know you would not like to continue any further. This research has been reviewed and approved by the Eastern University office of the Institutional Review Board. If you have any questions or concerns about this research project, you can contact the Chairperson of IRB at IRB@eastern.edu. Are there any questions about my study that I can answer for you at this time? (answer questions). Would you like to participate in my study? SAMPLE WRITTEN CONSENT FORM Identify who is doing the study. Define the purpose of the study. The information in this consent form is provided so that you can decide whether you wish to participate in this study. It is important that you understand that your participation is completely voluntary. This means that even if you agree to participate you are free to withdraw form the experiment at anytime, to decline to participate in any portion of the study, without penalty. Define what the subjects will be asked to do. In addition, you will be videotaped while you ______, so that we can observe you as you do the task. These videotapes will be viewed only by project personnel, who will transcribe them, and then the tapes will be places in a locked file cabinet in my office until the following date: _____, when they will be destroyed. During this period only ___________ will have access to these tapes. This experiment poses no known risks to your health and your name will not be associated with the findings. Your participation will take approximately ____ minutes. You will receive $____ at the end of the session for your participation in this research project. Also, upon completion of your participation in this study you will be provided with a brief explanation of the question this study addresses. If you have any questions not addressed by this consent form, please do not hesitate to ask. You will receive a copy of this form, which you should keep for your records. Thank you for your time. ___________________________ Researcher’s Signature (researcher’s name, office and phone number) CONSENT STATEMENT: I have read the above comments and agree to participate in this experiment. I give my permission to be videotaped, under the terms outlined above. I understand that if I have any questions or concerns regarding this project I can contact the investigator at the above location or the Eastern University Institutional Review Board at IRB@eastern.edu. ________________________ ____________ (participant’s signature) (date) 11-10-06 Consent Form 4 Eastern University Institutional Review Board GUIDELINES FOR COMPOSING A BIOMEDICAL PROJECT CONSENT FORM Determine if the consent form is going to be written using first person (I) or second person (you). The language should avoid technical medical terminology; use uncomplicated and understandable words. If technical terms must be used, clearly explain in simple language. (e.g., Placebo is an inactive medication or “sugar pill” or a placebo contains no medication). Consider attaching a glossary of terms. The name of the investigator and telephone number should appear in the consent form. BIOMEDICAL CONSENT FORM CHECKLIST ___ Title of study ___ Investigator name, title and phone number ___ Investigator affiliation HEADINGS FOR CONSENT FORM Introduction Reimbursement/Compensation for Illness/Injury During Study __ Description of the study __ Name/phone number of treating doctor __ Role of participant __ Where will treatment be given __ Other forms of compensation, if any Purpose Confidentiality __What is being studied __Indicate records are confidential __Why it is being studied __ Safeguards used if data published __ Purpose of research __ Who will have access to records __ Indicate experimental/research Procedures Patient Rights __ List of all procedures __Name/phone number of investigator __ Intervals of procedures __ Listing of EU IRB (215) 769-3114 __ Length of time participant in study __What will be given or received and how administered __ Length of hospital stay, if required __ Prior experience with drug or device Risks Voluntary Participation/ Withdrawal __ Describe all risks in detail __ Statement regarding voluntary participation __ Describe all possible side effects __ Statement regarding withdrawal by participant during study (in consent form or as attachment) __Statement regarding withdrawal of participant by physician. (in consent form or as attachment) Benefits to Participant Legal Rights/Patient Consent 11-10-06 Consent Form 5 Eastern University Institutional Review Board __ Describe in detail __ Statement regarding legal rights __ State if none __All questions answered __ Emergency phone number Alternative Treatment/Procedures __ Copy of consent form given to participant __ Describe in detail __ Signature and date line for participant (or guardian) __ Signature and date line for investigator Exclusions for Nonparticipation __ Signature and date line for witness __ Describe in detail Other Participant Costs/Payment __ Written in first person/second person __ Payment to be received by participant __ Technical medical terminology explained __ Costs to participant, if any __Insurance coverage, if any 11-10-06 Consent Form 6