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CONSENT DOCUMENTS
There are four basic types of consent documents:
- Subject consent form: This is used when you have contact with subjects; subjects need to sign the form.
- Parental/guardian consent form: This contains the same content as the subject consent form but it is written from the perspective of the parent/guardian and has subject assent lines. Often, it is not signed in the presence of the researcher.
- Assent form: This is a simplified version of the subject consent form used with children and subjects with impaired cognitive abilities. It is written with simplified language and with simplified headings. It does not contain all of the information in a consent form.
- Recruitment/consent e-mail and letter: This contains the same content as the subject consent form but it is presented in a letter format. It is used for surveys when there is no contact with subjects (e.g. on-line survey). No subject signature is needed as consent is implied by completion of the survey. If your study has multiple phases and there is no contact with subjects in one phase (e.g., on-line survey) but there is contact with subjects in another phase (e.g., interview), you will need two consent documents (e.g., a recruitment/consent e-mail for an on-line survey and a subject consent form for an interview). If all phases involve contact with subjects, but performance in an initial phase determines participation in a later phase, you will need a consent form for each phase. If your study has one phase or multiple phases in which you expect subjects to participate in all phases, you only need one consent document. Depending on the types of subjects and your specific methodology, you may need to provide separate consent documents for each type of subject. You should think about your design to determine if you can cover all types of subjects in one consent document. If this is not possible or it would be cumbersome/confusing to do so, you should use multiple consent documents. If you are studying subjects in the late teen years, it is important to consider if some of your subjects will be under age 18 and some will be over age 18. In this case, include a subject consent form for those over the age 18 and parental/guardian consent form for those under the age of 18. If your subjects include those who are cognitively impaired, you should use an adapted version of the assent form rather than a consent form. The following pages contain information about creating each type of consent document. The information for each type contains examples for each paragraph of the document. These examples DO NOT contain every possible variation that may be needed. Be sure to follow the guidelines of what should be included in each paragraph rather than cutting and pasting the example paragraph. The information in red should be included on the consent document.
SUBJECT CONSENT FORM
The top of the consent form should have the title of your project (centered). The title should be the same as the one listed in section 1 of the IRB application. One exception is when an experimental method necessitates the true nature of the study not be revealed before participation. In this case, create a research question that is plausible given your title and methodology. The first paragraph should state that they have been invited to participate in a study about the research question you described in number 6 , section A. This should be very brief and general. Identify any cooperating agency/organization(s) listed in number 5 , section A, subsection I. If your project is funded by a federal grant (number 4 , section A, subsection I) or other source (number 8 , section A subsection Ib), it should be disclosed here. The next sentence should state why they were selected as a possible subject by listing the selection criteria provided in number 6 section B subsection IV. The last sentence should inform them that they should read the form and ask any questions they have before agreeing to participate in the study. Example: You are invited to participate in a research study on the effect of frequent organizational restructure on employee perceptions. You were selected as a possible subject because you’ve experienced an organizational restructure a minimum of two times within the past eighteen months. Please read this form and ask any questions you may have before agreeing to participate in the study. The second paragraph should state who is conducting the study. Include you (principal investigator) and co-investigator (if relevant—number 3 , section B). In addition, indicate that the research is being conducted with the help of a research assistant (if relevant—number 3 , section C)) and include the person’s name. Identify the cooperating agency/organization (if relevant—number 5 , section A subsection I). If the principal investigator, co-investigator, or research assistant have a relationship with a cooperating agency/organization (number 5 , section A subsection II) and/or have a close relationship to potential subjects (number 9 , section D, subsection I), it will need to be disclosed here. If your project is funded by a Federal grant (number 4, section A, subsection I) or another external source (number 8 , section A, subsection Ib), it should be disclosed here. If you are student, you should list information about your advisor including your advisor’s name, degree (e.g., Ph.D., Ed.D.), title (Adjunct Professor, Assistant Professor, Associate Professor, or Professor), and department. If a graduate student, you should indicate your degree program. Example: This study is being conducted by me, Jane Doe, as part of the degree requirements for obtaining a Masters Degree in Social Work at Augsburg College and in cooperation with the Minnesota Department of Transportation at which I am currently an intern. My advisor is John Smith, Ph.D. an Associate Professor in the Social Work department. The third paragraph should be titled PROCEDURES (left justified and in a line by itself) followed by a paragraph that describes what subjects will be asked to do. This information was provided in number 6 , section B, subsections II, IV, Vb, and Vc. In addition, if you plan to record an interview, you will need to include that and be sure to indicate that the recording only will occur if granted permission. Example: If you agree to be in this study, I will ask you and your close friend to participate in two interviews each. The first interview is a two-hour, one-on-one interview with me. (I will interview your friend separately). The second interview will be a two-hour interview with both you and your friend. If granted permission I will audiotape both interviews.
recordings. Transcriptions and audio recordings will be kept in a locked file and only my advisor and I will have access to them. Example for a study not using recordings and the data contain no identifying information: The records of this study will be kept confidential, unless required by law. Only the researcher and his advisor, Dr. Smith, will have access to the data. The results will be disseminated in a final paper and presented to the faculty in the Psychology department for departmental honors. The results also may be published in a professional journal or at local, regional, national, or international conferences via a poster or oral presentation. In any form of dissemination, I will not include any information that will make it possible to identify you because the data contain no identifying information. Example for a study not using recordings and the data contain identifying information: The records of this study will be kept confidential, unless required by law. All data will be kept in a locked file and only the researcher and her advisor, Dr. Smith, will have access to the data. The results will be disseminated in a final paper and presentation to the Undergraduate Research and Graduate Opportunities Office. The results also may be published in a professional journal or at local, regional, national, or international conferences via a poster or oral presentation. In any form of dissemination, I will not include any information that will make it possible to identify you. The seventh paragraph should be titled VOLUNTARY NATURE OF THE STUDY (left justified and in a line by itself). This should be followed by a paragraph indicating that the subject’s decision about whether or not to participate will not affect their future or current relations with Augsburg College, the researcher (or researchers if there is a co-investigator), research assistants (if relevant) or the cooperating agency/organization (if relevant). Include the information about the required precautions to minimize risk provided in number 8, section D, subsection I and “other” precautions (number 8, section E) if they relate to the voluntary nature of the study. Example: Your decision about whether or not to participate in this study will not affect your current or future relations with Augsburg College, the researcher, or the Brian Coyle Center. If you decide to participate, you are free to skip questions in the interview or withdraw at any time without affecting those relationships. The eighth paragraph should be titled CONTACTS AND QUESTIONS (left justified and in a line by itself) followed by a paragraph that begins by informing subjects that may ask any questions they have now. Provide the contact information of the principal investigator, co-investigator (if relevant), and advisor (if relevant) if they have questions later. Provide both e-mail (must be an Augsburg e- mail) and phone contact information. Do not use home telephone numbers; use work or cell phone numbers. Include information about contacting the IRB (at IRB@augsburg.edu) if they have concerns/questions about their rights as a research subject or want to report problems/complaints about the research study and reference the IRB approval number (once the approval number is assigned). On a separate line, include a sentence indicating they will be given a copy of the form for their records. Example: You may ask any questions you have now. If you have questions later, you may contact me, Jane Doe, at 612- 123 - 4567 or doe@augsburg.edu. You may also contact my advisor, John Smith, at 612- 330 - 5555 or smith@augsburg.edu. If you have questions about your rights as a research subject or want to discuss problems/complaints about the research study, send an e-mail to IRB@augsburg.edu.
You will be given a copy of this form to keep for your records. The ninth paragraph should be titled STATEMENT OF CONSENT (left justified and in a line by itself) followed by consent statements to (1) participate in the study, (2) be audio or video taped (if relevant), and (3) use direct quotes (if relevant). Each consent statement should include a signature line for the subject. For the consent statement to participate in the study, you will need to include (1) a line for the subject to print their name, (2) a line for the date after the subject signature line, (3) a line for the investigator to print their name, and (4) a signature and data line for the investigator. Example : _I have read the above information or have had it read to me. I have received answers to questions asked. I consent to participate in the study. Subject Printed Name_________________________________________ Subject Signature ____________________________________________ Date_____________ Investigator Printed Name______________________________________ Investigator Signature _________________________________________ Date_____________ I consent to be audio-taped Subject Signature ____________________________________________ Date _____________ I consent to allow use of my direct quotations Subject Signature ____________________________________________ Date_____________
_Example: I have read the above information or have had it read to me. I have received answers to questions asked. I consent to have my child participate in the study. Parent/Guardian Printed Name_____________________________________ Parent/Guardian Signature ________________________________________ Date_____________ Subject Printed Name____________________________________________ Subject Assent Signature__________________________________________ Date___________ Investigator Printed Name_________________________________________ Signature of investigator __________________________________________ Date_____________ I consent to have my child audio-taped Parent/Guardian Signature ________________________________________ Subject Assent Signature__________________________________________ I consent to allow use of my child’s direct quotations Parent/Guardian Signature _________________________________________ Subject Assent Signature___________________________________________
ASSENT FORM
The wording of the assent form may be adapted based on the age and/or ability of the subjects. The top of the assent form should have the title of your project (centered). In the first paragraph, you should introduce yourself and state that you are doing a research study. The next sentence should explain what a research study is, followed by your specific research question described in section 6/A of the IRB application. This should be very brief and general. The last sentence should tell them that you would like them to participate in the study. Example: My name is John Doe and I am doing a research study. A research study is a special way to learn about something. I am doing this research in order to understand how a place, like a garden, shapes how children think about each other and the earth. I would like you to be in this research study. The second paragraph should be titled Why am I being asked to be in this research study? (left justified and on a line by itself) followed by a paragraph explaining why they are being asked to participate in the study. Example: You are being asked to be in this research study because you are in Miss Smith’s kindergarten class. The third paragraph should be titled What will happen during this research study? (left justified and on a line by itself) followed by a paragraph explaining what the subjects will be asked to do (if the minor will be asked to do multiple things, it is helpful to use lists), where it will take place, and how long it should last. Example: I want to tell you about some things that will happen if you are in the study. This study will take place right after school is over. I think it will last 20 minutes. If you want to be in this study, here are the things that I will ask you to do:
_1. Tell me about the things you do at recess
- Draw a picture of you and your friends during recess_ The fourth paragraph should be titled Are there any bad things that might happen during the research study? (left justified and on a line by itself) followed by a paragraph about the risks of participating in the study. Example: Sometimes bad things happen to people who are in research studies. These bad things are called “risks.” The risks of being in this study might be that you may get sad or angry talking about your brother or sister who is sick. This may not happen to you. If it does, I will make sure that you get help to deal with those bad feelings. The fifth paragraph should be titled Are there any good things that might happen during the research study? (left justified and on a line by itself) followed by a paragraph about the benefits of participating in the study.
RECRUITMENT/CONSENT LETTERS AND E-MAILS FOR SURVEYS WITH NO SUBJECT CONTACT
When utilizing a survey methodology in which the researcher has no direct contact with the subject, consent letters or e-mails are used. The communication serves as both recruitment and consent. Therefore, the content is identical to the subject consent form. However, it is written in a letter format and this leads to some changes in the order of the information. You should begin with an opening salutation (e.g., Dear_____). In the first paragraph, you should introduce yourself and your affiliation with Augsburg College (e.g., graduate student in social work, undergraduate student in psychology, faculty member in the business department). Include the co-investigator (if relevant—number 3 , section B). Indicate that the research is being conducted with the help of a research assistant (if relevant—number 3, section C) and include the person’s name. Identify the cooperating agency/organization (if relevant—number 5, section A, subsection I). If the principal investigator, co-investigator, or research assistant have a relationship with a cooperating agency/organization (number 5, section A, subsection II) and/or have a close relationship to potential subjects (number 9, section D, subsection I), it will need to be disclosed here. If you are student, you should list information about your advisor including your advisor’s name, degree (e.g., Ph.D., Ed.D.), title (Adjunct Professor, Assistant Professor, Associate Professor, or Professor), and department. Example: Hello, my name is John Doe. I am a graduate student in the Social Work Department at Augsburg College and I am interning at the Minnesota Human Services HIV/AIDS unit who is a cooperating with me to conduct this study. My advisor is Jane Smith, Ph.D., an Associate Professor in the Social Work Department. In the second paragraph, you should invite them to be in a study about the research question you described in number 6, section A. This should be very brief and general. If your project is funded by a Federal grant (number 4, section A, subsection I) or another external source (number 8, section A subsection Ib), it should be disclosed here. The next sentence should state why they were selected as a possible subject by listing the selection criteria provided in number 6, section B, subsection IV. The last sentence should ask them to read the entire e- mail or letter before completing the survey. You should inform them how to contact you (co-investigator and advisor, if relevant), before completing the survey. Provide both phone (not a home phone number) and Augsburg e-mail contact information. Include information about contacting the IRB (at IRB@augsburg.edu) if they have concerns/questions about their rights as a research subject or want to report problems/complaints about the research study and reference the IRB approval number (once the approval number is assigned). Example: You are invited to participate in a research study about the communication modes (email, face-to-face meetings, instant messaging, phone calls, and teleconferences) used in a health-related business environment. This project is funded by the National Healthcare Association. You were selected as a possible subject because you are a member of the Health Management division at Unity HealthCare and report to John Doe. Please read this entire e-mail before completing the survey. If you have any questions now or later, you may contact me, Jane Doe, at 612- 123 - 4567 or doe@augsburg.edu. You also may contact my advisor, John Smith, at 612 - 330 - 5555 or
smith@augsburg.edu. If you have questions about your rights as a research subject or want to discuss problems/complaints about the research study, send an e-mail to IRB@augsburg.edu. The third paragraph should inform the subjects about what they will be asked to do if they choose to participate (number 6, section B, subsections I, IV, and V, if relevant). Example: If you agree to be in this study, I will ask you to click on the link below and complete a 25- item survey about how St. Lawrence Church is meeting your needs as a parishioner. The first 20 items are multiple choice and the last 5 are open-ended. It should take approximately 25 minutes to complete. The fourth paragraph should describe the risks and benefits associated with participation in the study. Be sure to list the direct benefits (number 8, section B, subsection I) and indirect benefits number 8, section B, subsection II). If there are no direct benefits, state that. If providing monetary compensation (number 8 section A subsection Ia) that needs to be stated and worded as a thank you gift for participating in the study. If not providing monetary compensation state that. Be sure to include all the risks checked in number 8 section C subsection Ia (except inability to guarantee anonymity and the use of deception). If your study could cause psychological distress or physical injury provide the referral information. If the service is free indicate that and if it is not free be sure to indicate that it is the responsibility of the subject or third-party payer(e.g., personal health insurance) to pay for the service. Example: The risks to participation are the following: possible invasion of privacy of subject or family. There are no direct benefits to participating in this study. The indirect benefits are that the Minnesota Veteran Association may be able to use the results to advocate for improved services and programs for veterans. There will be no monetary compensation for participating in the study. Example referral information statement: In the event that this research activity results in psychological distress, you may contact Jane Doe, Ph.D., L.P. at 651- 123 - 4567, ext. 555 for counseling and follow- up care as needed. However, payment for treatment is the responsibility of the subject or a third party payer (e.g., personal health insurance). The fifth paragraph should describe the ways in which you will maintain confidentiality. This includes information from number 8, section E about “other” precautions (if they relate to confidentiality), the risks from number 8, section C subsection Ia about the inability to guarantee absolute anonymity due to the stated reason (if relevant), as well as the information provided in number 10, sections A, B, and C and all subsections within A, B, and C. The paragraph you should begin with a sentence indicating that the records of the study will be kept confidential, unless required by law. Example: The records of this study will be kept confidential, unless required by law. The results of this study will be disseminated in a final paper and presented to the faculty in the Education department at Augsburg College. The final paper will be placed in the Lindell Library. The results also may be published in a professional journal or at local, regional, national, or international conferences via a poster or oral presentation. In any publication or conference presentation, I will not include any information that will make it possible to identify you. All data will be kept in a locked file and only my advisor and I will have access to it.
