The following are brief explanations about each section of the consent form. Use this information to create your consent document.
CONSENT FORM HEADING. The consent form heading should contain the following: (a) identification of the consent form as involving participation in research; and (b) the title of the protocol. Each page of the consent form should be numbered consecutively with the total number of pages given (e.g., “Page 1 of 3,” etc.).
LISTING OF P.I., DEPARTMENT, TELEPHONE NUMBER. An IRB protocol can have only one principal investigator. The P.I. should be identified at the top of the consent form (Whom to Contact about this study) along with the P.I.’s department or division and direct telephone number or UMBC telephone number and extension. Any other participating investigators may be listed as co-investigators and their contact information should also be included.
PROTOCOL TITLE USED AS SECOND TITLE. Below the first title indicating that this is consent to participate in research activities, indicate the protocol title. The IRB submission form, project title, consent form title and, if applicable, the grant/contract title should match
INTRODUCTION/PURPOSE. This section should open with a statement that briefly explains what the study is about, why the potential subject is being asked to participate, and what the purpose of the research is. The descriptions should be in simple lay language the sample population can understand. A statement of how many persons will be studied should also be included. If this is a web-based survey, indicate how you will provide anonymity (e.g., not collect IP addresses) Also indicate that absolute anonymity cannot be guaranteed over the Internet.
PROCEDURES – WHAT WILL BE DONE. The procedures section should provide a clear concise statement of what subjects will experience during their participation, preferably written at a 6th-8th grade level. This section should include a statement indicating the total duration of the study, include a brief description of the procedure (i.e., for a questionnaire, the type and topic of questions to be asked), and add the number of visits involved and if appropriate, the length of each visit. The study procedures should be listed in chronological order, broken down into the subsections if there are many procedures or visits. Describe the procedures for discontinuation of a subject’s participation, including the right to withdraw data, if applicable.
POSSIBLE RISK AND BENEFITS. This section should include foreseeable risks and discomforts that may occur as a result of participation in the study. Investigators should be forthcoming about risks and not underestimate reasonably foreseeable risks. Emotional discomfort and psychological risks should also be addressed in the consent form. It should be noted that sometimes risks are not immediate, and anger, emotional upset, or stress may appear later. An appropriate contact person’s name and phone must be provided. Finally, include a statement about withdrawing from the study. A participant always has the option of withdrawing from a study and should be made aware of that right.
Any reasonable benefits to the participant should be stated in a way that is not potentially coercive. Investigators should be frank about benefits and not overestimate or magnify the possibility of benefit to the subject. Exclude statements regarding payments, reimbursements to participants for their participation or the research project provide course credit. This should only be stated in the compensation and costs section.
CONFIDENTIALITY. Provisions for confidentiality must be specified as well as a description of procedures for protecting privacy, the procedures to maintain the confidentiality of the data, e.g. having locked filing cabinets and storage areas, using identification codes only on data forms, and using password-protected computer files. If data are to be in the form of audio/video tape recordings or photographs, procedures protecting confidentiality should be described. Be sure to describe to participants the steps used to preserve confidentiality. In the course of certain projects, there are some circumstances where UMBC investigators and members of the research team are required by law to share information provided by participants and confidentiality may not be absolute or perfect. This must be expressed to participants.
Participants also are provided the opportunity to agree all information collected from them may be used by current and future researchers in such a fashion that personal identities will be protected. Such use include sharing anonymous information with other researchers for checking the accuracy of study findings and for future approved research that has the potential for improving human knowledge.
Specific types of research may require the following information:
When anonymous surveys are planned, state that “the surveys are anonymous and will not contain information that may personally identify me”.
When coded identifiable information is planned for use, state that “if applicable (1) my name will not be included on the surveys and other collected data; (2) a code will be placed on the survey and other collected data; (3) through the use of an identification key, the researcher will be able to link my survey to my identity; and (4) only the researcher will have access to the identification key.”
When recording instruments are planned, participants should provide permission. Photographs, audio or video recordings collected in the duration of the research can ONLY be used and shown in presentations if a participant gives permission. Participants that do not give permission to use the recordings during class or to use the recordings should not be recorded. Use these statements:
- I give permission to record my voice or image (OR, if applicable) and use in scientific publications or presentations.
- I do not give permission to record use my voice or image (OR, if applicable) and use in scientific publications or presentations.
When conducting focus groups, either exempt or expedited review: Please be advised that although the researchers will take every precaution to maintain confidentiality of the data, the nature of focus groups prevents the researchers from guaranteeing confidentiality. The researchers would like to remind participants to respect the privacy of your fellow participants and not repeat what is said in the focus group to others.
For focus group research that is above minimal risk (full board research), it may be necessary to include a statement of non-disclosure that participants would agree to in the informed consent: Non-Disclosure Statement: I agree to maintain the confidentiality of the information discussed by all participants and researchers during the focus group session. If you cannot agree to the above stipulation please see the researcher(s) as you may be ineligible to participate in this study.
Include if performing research when participants are likely to reveal reportable activities (for example, abuse): Although my confidentiality in this study is protected, confidentiality may not be absolute or perfect. There are some circumstances where research staff might be required by law to share information I have provided. For example, if an interviewer has reason to believe a child or elderly person is being abused (or has been abused), the interviewer is required by Maryland state law to file a report with the [specify the locality] police department or [specify the locality] department of social services and the UMBC President’s Designee for the USM Policy on the Reporting of Suspected Child Abuse and Neglect (see –http://umbc.edu/ogc/hr/faq_usm.html). Similarly, if I report that I have been abused in the past, the interviewer may also have to file a report. In addition, if I am threatening serious harm to myself or another person, it may be necessary for the interviewer to warn an intended victim, notify the police or take the steps to seek hospital based treatment for me.
When performing research when participants are likely to reveal illegal activities but a Certificate of Confidentiality will not be acquired state: In this study, I will be asked about [specify illegal activity]. The researchers will keep information about me as confidential as possible, but complete confidentiality cannot be guaranteed. On rare occasion, the courts have subpoenaed research records.
When performing research when subjects are placed at risk when they are asked about possible illicit drug use or other illegal activities and a Certificate of Confidentiality has been obtained state: In this study, I will be asked about illegal activities or highly personal behavior. The principal investigator has obtained a Certificate of Confidentiality from the federal government. My study records cannot be subpoenaed (released to courts at their request), and the investigator(s) will only release my study records if I ask in writing.
When conducting focus groups, either exempt or expedited review, include this wording
Please be advised that although the researchers will take every precaution to maintain confidentiality of the data, the nature of focus groups prevents the researchers from guaranteeing confidentiality. The researchers would like to remind participants to respect the privacy of your fellow participants and not repeat what is said in the focus group to others.
For focus group research that is above minimal risk (full board research), it may be necessary to include a statement of non-disclosure that participants would agree to in the informed consent.
____I agree to maintain the confidentiality of the information discussed by all participants and researchers during the focus group session.
If you cannot agree to the above stipulation please see the researcher(s) as you may be ineligible to participate in this study.
SPONSOR OF THIS RESEARCH. List the name of the external sponsor or granting agency who is providing funding for the research.
COMPENSATION/COSTS. When appropriate, clearly inform subjects about any substantial costs to them that may result from participation in the research. If the subject will receive financial compensation for participation in the study, the amount should be included. In addition, if withdrawal from the study would result in no compensation for participation, this should also be included.
EXPLANATION OF TREATMENT AND COMPENSATION FOR INJURY. An investigator will make the initial assessment if the protocol involves more than minimal risk*; the Board makes the final determination. If the answer is yes, investigators shall include this section in the consent form and use the following statement:
If you suffer from an injury as a direct result of this research, medical care may be obtained by you in the same manner as you would ordinarily obtain medical treatment. No provision has been made for financial payments or other forms of compensation (such as lost wages, medical cost reimbursement, lost time or discomfort) with respect to such injuries. However, you do not waive any legal rights by signing this consent form.
CONTACTS/QUESTIONS. The principal investigator and his/her telephone number and extension must be listed. The investigator should answer any and all questions related to the research, the rights of individuals as research subjects. Student investigators must list their faculty advisor’s contact information (name, phone number and email) as an additional contact, even if the student is only performing the work. This section also has the contact information for the Office for Research Protections and Compliance in the event a participant has questions about their rights as a participant in a research study.
VOLUNTARY PARTICIPATION. Subjects must be informed that participation is voluntary and they may withdraw or discontinue participation at any time. Subjects must also be informed that investigators will retain their data even if they choose to withdraw or discontinue for analysis purposes. But, if a subject decides to not allow an investigator to use their data, analysis of such data may be used up to the time a subject leaves the study.
SIGNATURE LINES. At the minimum, all consent forms must have a signature block for the participant and the investigator. Other signature blocks, such as witnesses, translators, etc. should be added when necessary or specific to the type of research.
Participants under the age of 18 will need to complete an Assent form; a separate parental consent form is required for these participants providing parental permission to participate. Replace the line “Participant’s Name” with “Child’s Name” and replace “Participant’s Signature” with “Parent/Guardian’s Signature”.
Note: in order to complete the consent process, investigators must sign the consent form after reviewing the above information with the participant. This section must be included on the consent. All signatures must be affixed to the consent documents in ink.