Informed Consent Letter Template for Adult Participants
(May 2018 Version)
Instructions: Replace red type with appropriate information and print letter on department or personal letterhead. Remove sections/information not relevant to the study.
Date:
Dear (insert name of participant or general phrase such as "family" or "student"):
I am (insert your position at UNH, e.g., a faculty member in the "x" department at UNH) and I am conducting a research study to find out (insert purpose of the research). I am writing to invite you to participate in this study.
This consent form describes the research study and helps you to decide if you want to participate. It provides important information about what you will be asked to do in the study, about the risks and benefits of participating in the study, and about your rights as a research participant. You should:
· Read the information in this document carefully, and ask me or the research personnel any questions, particularly if you do not understand something.
· Not agree to participate until all your questions have been answered, or until you are sure that you want to.
· Understand that your participation in this study involves you to (describe participation [e.g., complete a survey]) that will last about (explain anticipated time commitment).
· Understand that the potential risks of participating in this study are (insert any potential risks, including any related to breaches of confidentiality; if risks are anticipated to be minimal, state this).
I plan to work with approximately (insert anticipated number of participants) in this study. You must be at least 18 years old to participate in this study (include this statement where appropriate).
If you agree to participate in this study after reading this document, you will be asked to (insert description of what participants will be expected to do and anticipated time commitment. If audio or videorecording, explain the purpose of the recordings and how they will be used). You will not be paid to participate in this study (if there is compensation or an incentive, modify this sentence stating the type and amount of compensation/incentive, and any conditions that need to be met to receive the compensation/incentive).
Although you are not anticipated to receive any direct benefits from participating in this study (if direct benefits to participants are anticipated, modify this part of the sentence accordingly [compensation is not a benefit]), the benefits of the knowledge gained are expected to be (state the benefits of the study at the community and/or societal levels [not at a personal level].).
Taking part in this study is completely voluntary. You may choose not to take part at all. If you agree to participate, you may refuse to answer any question. If you change your mind, you may stop participating at any time. Any data collected as part of your participation will remain part of the study records (modify this sentence where applicable; if the research involves data collection in the European Union [EU] or the United Kingdom [UK], whether in-person or via the web [e.g., Zoom], and you will not anonymize the data after collection, delete this sentence). If you decide not to participate or if you stop participating at any time, you will not be penalized or lose any benefits for which you would otherwise qualify (modify this sentence if there are conditions to receive compensation/incentive).
(If your study takes place in a classroom setting and extra credit is awarded, include the following sentences, modified to fit the specifics of your study.) Taking part in this study is not part of your required coursework. If you want to earn the extra credit offered for being in the study but you do not want to participate in the study, the non-research extra-credit assignment is (describe the alternative assignment).
I plan to maintain the confidentiality of all data and records associated with your participation in this research. (If your study involves individually identifiable information, include the following sentence and bullets.) There are, however, rare instances when I may be required to share individually identifiable information with the following:
· Officials at the University of New Hampshire,
· Regulatory and oversight government agencies, or
· The sponsor(s). (include this last bullet only if your study is being sponsored by an external entity)
(If your study may lead to disclosure of information covered by New Hampshire mandatory reporting laws, such as suspected child abuse or neglect, or hazing, or Federal laws relating to sexual harassment and violence include the following sentence and applicable bulleted language. [See the document, Information Individuals in New Hampshire are Legally Required to Report at http://unh.edu/research/irb-application-resources for more information.]) I also may be required by law to report certain information:
· To government and/or law enforcement officials (for example, child abuse, threatened violence against self or others, or hazing). If I believe that such a report is required, I will follow the guidance of the UNH Institutional Review Board for the Protection of Human Subjects in Research (and of the University’s General Counsel) in making any such report, in order to provide as much protection for your privacy as possible while still complying with the law.
· To appropriate UNH authorities (e.g., disclosures involving Sexual Violence - which includes sexual harassment, sexual assault, unwanted sexual contact, sexual misconduct, domestic violence, relationship abuse, stalking [including cyber-stalking] and dating violence - must be reported to the UNH Title IX Coordinator or UNH Police).
(If your study involves transmitting data via email or the web [e.g., web-based survey], include the following sentence.) Further, any communication via the internet poses minimal risk of a breach of confidentiality. (If your study involves focus groups, include the following sentence.) While I plan to maintain confidentiality of your responses, other focus group participants may repeat responses outside the focus group setting.
To help protect the confidentiality of your information, (address the following: (1) explain procedures in place to protect confidentiality of study data; (2) identify everyone named in the application with access to the data; if applicant is a student, the faculty advisor must have access to data; (3) explain whether identifiable information may be shared with a third-party data processor (e.g., transcription service); (4) [select as appropriate] explain if data, once de-identified, may be used for future studies or may be shared with other researchers OR if data, even if de-identified, will not be used for future studies; (5) if audio and/or videorecording, explain how and where recordings will be stored, and what will happen to them during and after the study [e.g., transcribed and then destroyed].) I will report the data (explain how data will be reported [e.g., in aggregate, using pseudonyms]). The results may be used in reports, presentations, and publications (modify this sentence to reflect how the results may be used).
If you have any questions about this research project or would like more information before, during, or after the study, you may contact (insert name of contact person, phone number and/or email address). If you have questions about your rights as a research subject, you may contact Melissa McGee in UNH Research Integrity Services at 603-862-2005 or to discuss them.
(If the consent document will be mailed and returned, include the sentences in this paragraph.) I have enclosed two copies of this letter. Please sign one indicating your choice and return in the enclosed envelope. The other copy is for your records.
Thank you for your consideration.
Sincerely,
Researcher’s name
Researcher’s title/position
(If the consent document is for participation only in a non-web-based survey [see below the format for web-based surveys], remove the participant signature block below [the IRB generally does not require signed consent forms for surveys]. If the consent document will be given in person, remove the “No” section of the participant signature block below [i.e., collect signed consent document from only those individuals who consent to participate].)
Yes, I, ______consent/agree to participate in this research project.
No, I, ______do not consent/agree to participate in this research project.
______
Signature Date
(If the research involves data collection in the EU or the UK, whether in-person or via the web [e.g., Zoom], include the following paragraph, checkboxes, and signature block:)
If you are participating in this research study while in the European Union or United Kingdom, you have certain rights under the European Union General Data Protection Regulation 2016/679 (“EU GDPR”). The research may include questions about, or your responses may disclose information about, your ethnic origin, political opinions, religious or philosophical beliefs, sexual activity or sexual orientation, health, trade union membership, or criminal convictions and offenses ( “Sensitive Data”). You do not have to provide Sensitive Data; if you provide it, you are doing so voluntarily. If you provide Sensitive Data as part of your participation in the research, your signature below [or check box] confirms your agreement that UNH and the researcher(s) may process your Sensitive Data for the purposes described in this document and in accordance with applicable law. Data processing will be done either by the researcher(s) affiliated with UNH in the United States, or by a third-party information technology solution hired by UNH or the researcher(s). You can withdraw your agreement for UNH and the researcher(s) to use your Sensitive Data at any time by notifying the researcher(s) (contact information above); however, UNH and the researcher(s) may still process or anonymize your Sensitive Data prior to the date that you notify the researcher(s) of your withdrawal.
I give my consent
I do not give my consent
For UNH and the researcher(s) to use my information, including Sensitive Data, for the research study.
______
Signature Date
(If the consent information is for participation only in a web-based survey, [e.g., using Qualtrics], use the following format for participants to give consent or decline participation).
o Click here if you consent to participate in the research study.
o Click here if you decline to participate in the research study.
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