UNIVERSITY OF MASSACHUETTS AMHERST HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD Guidelines for Creating an Informed Consent Cover Letter

for No-Risk Surveys

On the next page is a template for creating a cover letter for surveys where there is little or no risk to the respondents. The same principles, however, must apply to crafting this letter as to any other informed consent document. These include:

Potential respondents must be given all the information that might reasonably be expected to influence their willingness to participate. The information must be presented in simple language so as to be easily understood by persons unfamiliar with research or the specific research topic. A sample letter written at the 8 th grade level is attached. Implicit consent may be approved for studies in which the researcher asks participants to complete a questionnaire that involves no more than minimal risk. Implicit consent means that completion and return of the questionnaire may be taken to document consent. The cover letter may contain wording that says that something to the effect that by completing and returning the survey you have shown your agreement to participate in the study. Address the person you are writing to in the second person. If oral consent is to be obtained the PI should provide the IRB with a script of how the project will be described to the participant. Where oral consent is obtained participants should still be provided with a written document describing the study and providing the name and contact information for the PI and IRB. The letter template attached is a starting point that you can tailor to your study and subjects. You must ensure that your informed consent materials contain the following elements:

A statement that the study involves research A simple descriptive title of the project Name and phone number of the Principal Investigator (students must have a faculty advisor sponsor them as the PI). A clear statement of the research purpose(s) A clear explanation of the procedures to be followed A statement about the risks or benefits, including the societal benefits of the knowledge to be gained from the survey A statement of costs to the participants if there are any A description of how confidentiality will be maintained and who will have access to the data A statement to the effect that a participant is free to refuse to participate Contact information if the participant has further questions about the survey IRB contact information: The Institutional Review Board (IRB) at the University of Massachusetts Amherst has approved this study. If you have any concerns about your rights as a participant in this study you may contact the Human Research Protection Office via email (humansubjects@ora.umass.edu) or by telephone (413-545-3428). A cover letter with the same elements for the parent to read and sign if the survey subjects are minors

UNIVERSITY OF MASSACHUSETTS AMHERST HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD

Template for cover letter for surveys to provide informed consent. If your research involves carrying out a survey, and there is no risk to your respondents if they participate, a simple cover letter will be sufficient to gain your subjects informed consent to participate in the study. The letter template below includes all the elements needed in an informed consent document. Following the template is a sample letter written at the eighth grade level. Dear Respondent, I am inviting you participate in a research project to study xxxx. [This research project is funded by xxxx.] Along with this letter is a short questionnaire that asks a variety of questions about xxxx. I am asking you to look over the questionnaire and, if you choose to do so, complete it and send [or give] it back to me. It should take you about xxxx minutes to complete. The results of this project will be [say what its for]. Through your participation I hope to understand xxxx. I hope that the results of the survey will be useful for [xxxx] and I hope to share my results by [publishing them in a scientific journal][presenting them on the web where students all over the world can use them] I do not know of any risks to you if you decide to participate in this survey and I guarantee that your responses will not be identified with you personally (or make some statement about confidentiality.) I promise not to share any information that identifies you with anyone outside my research group which consists of me [and xxxx]. [You should not put your name on the questionnaire.] If you do not feel comfortable handing in your survey to me (or your teacher), you may also . . .[put option here, e.g., mail it to the following address, drop it off at X office] The survey should take you about xxxx minutes to complete. I hope you will take the time to complete this questionnaire and return it. Your participation is voluntary [and there is no penalty if you do not participate]. Regardless of whether you choose to participate, please let me know if you would like a summary of my findings. To receive a summary, xxxx. If you have any questions or concerns about completing the questionnaire or about being in this study, you may contact me at xxxx. The Institutional Review Board (IRB) at the University of Massachusetts Amherst has approved this study. If you have any concerns about your rights as a participant in this study you may contact the Human Research Protection Office via email (humansubjects@ora.umass.edu) or by telephone (413-545-3428).

Sincerely. Justin Time, Associate Professor

Sample cover Letter for surveys 8th grade level Title: Hiking in National Parks: What Makes a Good Experience. Dear hiker, I am inviting you to participate in my research project to survey hikers to find out what they are looking for when they hike in our National Parks. My work is funded by the National Park Service. I want to understand what hikers like best about our Parks and how the Parks can be improved for hiking. I have attached a short survey about hiking in National Parks which I am hoping you will fill out and return it to me. It should take you about twenty minutes to complete. The National Park Service will use what I find out through this survey to make sure everybodys hiking experience is the best it can be. You will see that I have all sorts of questions about hiking at National Parks. If you choose to participate in my survey please fill in your answers and send (or give) the survey back to me. You should not put your name on the survey when you fill it out, and I promise that I will respect your privacy. I will make sure that your answers cannot be linked to you personally when I send my results to the National Park Service. There are no risks to you or to your privacy if you decide to join my study by filling out this survey. But if you choose not to participate that is fine. Even if you decide not to respond I would be very happy to share my results with you if you are interested. To get a copy of my results call me at 5470233. If you have any questions about the survey, or about being in this study, you may contact me at 547-0233. The Institutional Review Board (IRB) at the University of Massachusetts Amherst has approved this study. If you have any concerns about your rights as a participant in this study you may contact the Human Research Protection Office via email (humansubjects@ora.umass.edu) or by telephone (413-545-3428). Sincerely. Theresa Green, Associate Professor