EDINBORO UNIVERSITY OF PENNSYLVANIA Edinboro, Pennsylvania CONSENT TO PARTICIPATE IN A RESEARCH STUDY Title of Study: Use the exact name of the study as it appears in the IRB application Principal Investigator: Co-investigator(s): Introduction This section makes it clear that a study is to be conducted and the individual is being “asked” to participate. It can also indicate why the individual was chosen. Who are you and why are you conducting this research? You are being asked by _____ to be in a research study. You should understand that this study involves research. This consent describes your role as a participant in the study. Purpose of The Study Include purpose(s) (either short or long term) of the research AND the expected duration of participation including any follow-up. What Will Happen During the Study? Outline the procedures, in a time-sequence fashion. If there are two groups with different treatments, outline how an individual is selected for each group. Indicate if any procedures are experimental. This should be VERY clear and in terms that someone who is not familiar with the study area would understand. Think - What information would I want to know about a study before agreeing to participate? An example statement: (Researcher name here) will supervise and facilitate several small focus groups consisting of # recruited participants. Using a series of interview questions, you and other members of the focus group will be asked to describe and discuss your _______________: Specific topics to be explored include: ___________ (Place sub topics to be discussed or more specific areas the focus group will cover here). All focus group interviews will be audio recorded for later transcription and analysis. Your identity in verbatim transcriptions will be concealed by a coding system. What Are the Possible Risks or Discomforts? Explain the most serious and common risks that could happen as a consequence of participating in the study (include physical, emotional, psychological, social, financial, and spiritual effects). An example statement: Focus groups are public in nature. The risk of discussed materials being disseminated outside the focus group is a potential risk. However, in reported findings, your identity and the confidentiality of information you disclose in your focus group will be maintained by a coding system. The content of the information you disclose or recall or that is disclosed or recalled by one or more participants during focus group discussions may create anxiety, fear, discomfort, and/or psychological distress. You will be provided with a handout of campus resources where help can be sought should you choose to follow up on any emotional discomfort. What Are the Possible Benefits of Being in This Study? Include benefits to the participant OR to society as a whole. How Will the Data Collected Be Kept Confidential? Explain how information from the study will be kept, if pseudonyms will be used how that will work, and if ultimately the data will be destroyed. An example statement: You should know that your name will be kept as confidential as possible, within local, state and federal laws. Records that identify you and this signed consent form may be looked at by the Edinboro University Institutional Review Board (IRB). The results of this study may be shared in aggregate form at a meeting or in a journal, but your name or individual results/score(s) will not be revealed. What Happens If I Have More Questions? Your questions about a research-related injury or the research study will be answered by_____ at (814) _______. If you have a question about your rights as a research participant that you need to discuss with someone, you can call the Edinboro University Institutional Review Board at (814) 732-2856. What Will Happen If You Decide Not To Be in the Study? Your participation in the focus group activity is strictly voluntary. You may decide to quit at any time without any penalty, retribution, or repercussion. PARTICIPANT’S STATEMENT I had a chance to ask questions about the study. These questions were answered to my satisfaction. I realize that being part of this study is my choice. I am at least 18 years of age. I have read the consent form. I was given a copy of this consent form for my own records. PARTICIPANT’S SIGNATURE DATE Example introductory statement for focus group studies Name of study Introductory Statement (to be read by facilitators) Thank you for agreeing to participate in our study. The purpose of this study is to (re-explain purpose of study here). We ask that all participants remain respectful of other participants during the focus group session. We also request that given the nature of the topic, you would not discuss what occurs in the focus group discussion outside the session. Furthermore, we ask that you refrain from using the specific names of individuals (such as give appropriate list) during the session. Focus groups are public in nature. The risk of discussed materials being disseminated outside the focus group is a potential risk. However, in reported findings, your identity and the confidentiality of information you disclose in your focus group will be maintained by a coding system. The content of the information you disclose or recall or that is disclosed or recalled by one or more participants during focus group discussions may create anxiety, fear, discomfort, and/or psychological distress. You will be provided with a handout of resources where help can be sought should you choose to follow up on any emotional discomfort. Example debriefing statement for focus group studies Debriefing Statement (to be given to participants after focus group session) Thank you for participating in our study. If talking about any of the material today has made you feel upset and you’d like to talk to someone about your feelings, you can contact the following resources: Give names and phone numbers for appropriate resources.