Necessary Elements of an Informed Consent Form

When and How to Use a Informed Consent Form

You must provide every (participant) in your study with an Informed Consent Form, review that form with the participant and obtain his or her signature before you can begin any data collection with that individual.  Keep the fully signed original of the Informed Consent Form, and give the signer a copy.

A signed consent form is required for all adult study participants and for the parent, guardian, or legal representative of any minor study participants.  For minors, a signed assent form may also be required, depending on the age of the child, as follows:

·   0-6 years old                                 Assent form not required, generally not used

·   7-8 years old                                 Assent Form is optional

·   9-17 years old                              Assent Form is required

Note: An Assent Form does not take the place of an Informed Consent Form signed by the child’s parent, guardian, or other legal representative — the latter is required in all cases.  See the IRB document, “Necessary Elements of an Assent Form,” for details.

General Guidelines for Creating An Informed Consent Form

·   Limit your Informed Consent Form to one or two pages maximum.  You must explicitly address all of the elements and issues described in the next section, but you should do so as clearly and concisely as possible.  

·   Remember that you are writing for non-experts, and keep the educational level of your participant-population in mind.  Avoid scientific jargon when describing the purpose and plan of the research.  If you are taking this or any other information from a grant proposal or prospectus, you must rewrite it so that non-specialist audiences will understand it.

·   Remember that you are addressing the people participating in your study directly in this form.  Use first person (I and we) to talk about what you and other people conducting the study will do and their responsibilities.  Use second person (“you,” or “your child” if speaking to a parent or guardian) to explain what is expected of study participants, what will or may happen to them, and their rights.

Specific Elements to Include and Issues to Address

You do not need to use these specific subtitles, but you should include all of this information on your form. Remember, present information as simply and concisely as possible.

1.     Title of the project or study.

2.     Purpose and general description of the study.  Explain the general goals of the research, who is conducting it, and why.  Your description should include:

·         The goals of the research

·         The names and titles of the people conducting the study and their supervisors

·         The department or program at Bryn Mawr College within which the research is being conducted

·         How many participants will be involved in the study

·         How potential participants have been chosen for inclusion in the study

·         How long the research project is anticipated to last (not just the session the participant will take part in, but the entire process of data collection, analysis, publication, etc.)

3.     Participation. Explain what participation in the study involves for the person signing this form (or his/her child).  You should specifically answer the following:

·         How will data be collected? (in-person interviews, filling out a questionnaire, etc.)

·         Where will data collection take place?  (If you do not yet know, you can state it will be at a spot mutually decided upon by the researcher and subject.)

·         How long will it take to collect data?

·         In general, what kinds of topics will be addressed or what kinds of activities will be required of participants during the data collection? (Participants are not truly informed unless they have some idea of what to expect during a study session.  For example, if you are going to assess their levels of anxiety/and or depression, you can say “there will be questions about your mood.”  If any sensitive areas are going to be addressed, participants must know this from the consent form.)

·         Will there be audio/videotaping, photography, or recording of any kind?  If so, how will it be used?

·         Will participation be anonymous? (Note: this is separate from questions about confidentiality.  Anonymous means that not even the researcher can link specific questions with specific individuals.  The researcher has no record of the identity of the respondents.  For example, if a participant can be identified going into a one-on-one interview, or the researcher has a key that can link code numbers with particular names, then participation would not be anonymous, even though the researcher kept the actual responses confidential.

·         You must include the following boilerplate somewhere on your form: “Your participation in this research is completely voluntary.  You can withdraw from the study at any time without penalty or loss of the benefits to which you are otherwise entitled.  You do not have to answer any questions that you do not want to answer.” 

4.     Confidentiality.  Explain the degree to which collected responses/data will be kept confidential and exactly how you will ensure this confidentiality.  Confidentiality refers to access to data about the identity of participants. Address the following questions, as relevant to your research:

·         How will you use participants’ names, both in the collection and storage of data, and in the papers, reports, and articles that come out of the research? 

o    If you plan to use participants’ names in the papers, reports or articles that will be the product of the research, you must indicate that you will do so, and ask their explicit permission to do so in the signature block at the end of the form.  During data collection, you must inform respondents that if they wish to say something “off the record,” they must let you know, and that you will turn off any recording devices. 

o    If you are not using names, note that no reference will be made in oral or written reports which will link the participant to the study.  Explain how you will detach participants’ names and identifying information from the data they provide.  If a key linking the two must be kept for research purposes, explain where the key will be stored, who will have access to it, and how you will prevent unauthorized access. 

·         What will happen to notes, questionnaires, tapes, photographs, etc. during the course of your study?

·         Will you computerize data?

·         Who will have access to notes, tapes, etc. and computerized data?

·         Where will notes, tapes, etc. and computerized data be stored?

·         What steps will you take to ensure that unauthorized people do not have access to the data?

·         For non-computerized data, spell out how you will prevent physical access to the material in question.  For computerized data, spell out how you will prevent electronic as well as physical access.

o    Note: Data must be stored in a locked cabinet or file, either in your office, your supervisor/mentor’s office, or some other safe place.  A dorm room or lab is not safe if there is no way to lock up material.

o    IMPORTANT – DO NOT store data on your laptop, as it can be lost.  Download data onto a CD, which then must be stored in a locked, safe place as above.

o    If you will computerize your data, you must indicate that names will not be connected with responses in the data file, and that the key connecting the names with the data will be kept separately from your data, so that only you (and/or your mentor) can connect the two.

o    If you will use a web survey, you must follow the procedures for protecting the confidentiality of data spelled out in the IRB’s Web Policy, and you must include the web survey consent language specified in this policy on your form.  This policy is available on the IRB homepage: (http://www.brynmawr.edu/grants/irb).

·         How long will notes, tapes, etc. and computerized data be preserved?  If they will be destroyed, state when. If anything will be archived for use by future researchers, you must indicate this, explain the conditions under which such data will be used, who will be in charge of the archive, and ask explicit permission for this from participants in the signature block at the end of the form.

·         If there are any limitations to confidentiality, these should be noted.  Where relevant, you should include the following boilerplate text to inform participants when you are legally obligated to report information to disclose information: “Note: If you threaten to do harm to yourself or to others, or we suspect child abuse or neglect, we must report this to the relevant authorities.”

5.     Other Risks of Participating in the Research

·         Research must be low risk.  However, you should explain any possible discomforts or issues the participant might experience.  These include not only physical injury, but also possible psychological, social or economic harm, discomfort, or inconvenience.

·         If there are no potential risks, include a statement similar to the following:  “There are no known risks for participating in this research, other than the violation of confidentiality.  I have indicated above/below the steps I am taking to preserve your confidentiality.”

6.     Benefits to the Subject or Others, or Body of Knowledge (if applicable)

·         If participants can expect any kind of direct benefit from the study you should explain this.

·         If there are no direct benefits, a statement like “There are no direct benefits to you for participating” is common boilerplate for indicating this.

·         If you wish, you can indicate how the results of the study may be useful to others or to scholars generally.

 7.   Compensation

               If you are either paying participants or providing some in-kind compensation, please indicate what this compensation is and when respondents will receive it.  If you are not compensating participants, please indicate that there will be no payment for participating.

8.     Questions about the research and rights of research participants

·         You must use the following boilerplate: “If you have any questions about this study at any time, please feel free to contact either me, [your name], at [phone number] or [e-mail address], or [my mentor, my supervisor, the chair of the XX department], [name and title] at [phone number] or [e-mail address].  If you have any questions about your rights as a research participant, please contact the chair of the Institutional Review Board at Bryn Mawr College, Dr. Leslie Alexander at (610) 520-2600 or at lalexand@brynmawr.edu.  We will do everything possible to prevent or reduce your discomfort and risk to you, but it is not possible to predict everything that might occur.  If you experience unexpected discomfort or think something unusual or problematic is occurring, please contact any of the people listed above.”

 

 

 9.    Deception

·         If your research must involve deception, include a statement on the Informed Consent Form that states that due to the nature of the research, it cannot be described fully at this time, but that you will provide participants with a complete explanation after the research session has ended.

·         Submit a copy of the debriefing script you will use to give this explanation to the IRB along with your consent form.

10.  Signature Block

·         Please use the following boilerplate text for the signature block at the bottom of your consent form.  Note that a signature block should be the last thing on the form, after all of the description of the research, etc.

·         Instructions for you, the form builder, are in [italicized brackets] — do not include that text on your form.

·         Note that you should sign the form as well in the presence of the participant, and remember to give a copy to the participant to keep.

 

Boilerplate for Adult Participants

Please fill out and sign the consent form below to indicate whether you agree to participate in this research.  You will be given a copy of this form to keep after you have signed it.

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

Have you read this consent form or it has it been read to you?                                                   Yes______     No______

Have all of your questions about the form and the research been answered?                          Yes______     No______

Do you understand the nature of the research in which you are about to participate?           Yes______     No______

Do you agree to participate in this study?                                                                                        Yes______     No______

 

[Include any of the following questions that are applicable to your particular project.]

Do you give us permission to [audio/video]tape your interview?                                               Yes______     No______

Do you give us permission to use your photograph in our research?                                           Yes______     No______

Do you give us permission to attach your name to your responses if they are quoted or summarized in any papers, reports or articles produced from this study? (If you check no, your name will not be used, and the researcher will follow the steps described above to be sure your responses remain confidential.)                                                                                                 Yes______     No______

Do you give us permission to archive your [audiotaped/videotaped if applicable] responses, so that future researchers may study them? (If you check no, your responses will be destroyed at the end of this study and no later than [insert specific date].)   Yes______     No______

[Note: you may want to specify limitations on the scope of future research use, for example “so that future researchers studying cognitive development in children may study them.”]

Do you give us permission to use your [audiotaped/videotaped] responses in other professional settings, such as university classes or conference presentations to other researchers?                                                                               Yes______     No______

[Again you may want to specify limitations on the scope of future use, such as “classes in developmental psychology” or “conference presentations on the results of this study.”]

 

If videotapes are involved, you must add the following question:

Do you understand that even though we will not use your name in connection with these video clips, there is a risk that someone watching the video may recognize your face?”                                                                                                Yes______     No______

 

Name of Participant (please print): _________________________________________________________________

 

Signature of Participant:  ____________________________________________ Date: _______________________

 

Researcher’s Signature     ____________________________________________ Date: ______________________

 

 

Boilerplate for Parents/Legal Guardians of Minor Participants

           Please note that all of the elements of informed consent described previously need to be included before this signature block.

Please fill out and sign the form below to indicate whether you agree to allow your child to participate in this research.  You will be given a copy of this form to keep after you have signed it.

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

Have you read this consent form or it has it been read to you?                                                   Yes______     No______

Have all of your questions about this form and the research been answered?                         Yes______     No______

Do you understand the nature of the research in which your child is about to participate?   Yes______     No______

Do you agree to allow your child to participate in this study?                                                      Yes______     No______

 

[Include any of the following questions that are applicable to your particular project.]

Do you give us permission to [audio/video]tape your child’s interview?                                  Yes______     No______

Do you give us permission to use your child’s photograph in our research?                              Yes______     No______

Do you give us permission to attach your child’s name to his or her responses if they are quoted or summarized in any papers, reports or articles produced from this study? (If you check no, your child’s name will not be used, and the researcher will follow the steps described above to be sure his or her responses remain confidential.)
                                                                                                                                                                  Yes______     No______

Do you give us permission to archive your child’s [audiotaped/videotaped if applicable] responses, so that future researchers may study them? (If you check no, these responses will be destroyed at the end of this study and no later than [insert specific date].)     Yes______     No______

[Note: you may want to specify limitations on the scope of future research use, for example “so that future researchers studying cognitive development in children may study them.”]

Do you give us permission to use your child’s [audiotaped/videotaped] responses in other professional settings, such as university classes or conference presentations to other researchers?                                                                          Yes______     No______

[Again you may want to specify limitations on the scope of future use, such as “classes in developmental psychology” or “conference presentations on the results of this study.”]

If videotapes are involved, you must add the following question:

Do you understand that even though we will not use your child’s name in connection with these video clips, there is a risk that someone watching the video may recognize his or her face?”                                                                      Yes______     No______

 

Name of Participant: ___________________________________________________________________________

 

Name of Parent or Legal Guardian (please print): _____________________________________________________

 

Signature of Parent or Legal Guardian:  ____________________________________ Date: __________________

               

Researcher’s Signature     ____________________________________________ Date: ______________________