The following are brief explanations about each section of general consent format. Use this information to create your consent document.
When using the template, add all information related to your study. Remove all sections that are not applicable. Then, highlight the remaining sections by removing all “italics” and “underlined” formats and switch text from “blue” highlighting to “black”.
Whom to Contact about this study. An IRB protocol may have one principal investigator or two, in the cases of those with faculty mentors. Investigators should be identified in this section along with the investigator(s) department and direct telephone number or UMBC telephone number.
Title of Protocol. State the protocol’s title. The IRB application form title must match the consent form title.
Purpose of the Research. This section should open with a statement that briefly explains what the study is about, why the potential participant 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. “Key information” must be presented about a study. This is essential to decision making that must appear at the beginning of the consent form and presented first in the consent discussion. Investigators must also present informed consent information in sufficient detail and in a way that helps with participant comprehension, not just running down a list of risks and procedures.
Procedures. The procedures section should provide a clear concise statement of what participants 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 must be listed in chronological order, broken down into the subsections if there are many procedures or visits. Describe the procedures for discontinuation of a participant’s participation, including the right to withdraw data, if applicable. Include statements regarding payments, reimbursements to participants for their participation or the research project provides course credit.
Voluntary Participation. Participants must be informed that participation is voluntary and they may withdraw or discontinue participation at any time. Include any alternatives other than participating. State if withdrawing from the research study, participants will not be penalized in any way for deciding to stop participating OR lose any benefits to which I am otherwise entitled. Participants must also be informed that investigators will retain their data even if they choose to withdraw or discontinue for analysis purposes. But, if a participant decides to not allow an investigator to use their data, analysis of such data may be used up to the time a participant leaves the study. 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
Risks and Benefits of Being in the Study. This section should include 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 participant. Statements regarding payments, reimbursements to participants for their participation are not “benefits” in the context of a consent document; this are only stated in the Procedures and the Compensation/Costs sections.
Any 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. It should be noted that sometimes risks are not immediate and may appear later. An appropriate contact person’s name and phone must be provided and resources made available.
Compensation/Costs. When appropriate, clearly inform participants about any substantial costs to them that may result from participation in the research. If the participant 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.
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 presentations at scientific or professional meetings, publishing in scientific journals, and 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:
a) When anonymous surveys are planned, state that “the surveys are anonymous and will not contain information that may personally identify me”.
b) 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.”
c) 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. Add these statements:
- “I give permission to record my voice or image (OR, if applicable) and use in scientific publications or presentations.”
AND
- “I do not give permission to record use my voice or image (OR, if applicable) and use in scientific publications or presentations.”
d) When conducting focus groups, either exempt or expedited review: Add 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.”
e) 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: Add this 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.”
f) Include if performing research when participants are likely to reveal reportable activities (for example, abuse): Add this wording: Although my confidentiality in this study is protected, confidentiality may not be absolute or perfect. If the investigators have reasonable cause to believe, suspect or become aware that any person has been abused or neglected or if the investigator observes any person being subjected to conditions that would reasonably result in abuse, neglect or misconduct, they are required by federal, Maryland state law and UMBC policy to file a report with the appropriate [specify the locality] department of social services, [specify the locality] police department and “designated” University of Maryland, Baltimore County employee in UMBC Human Relations Further information about these responsibilities are found at [choose the appropriate one] https://humanrelations.umbc.edu/child-protection/ (Child Abuse) https://humanrelations.umbc.edu/sexual-misconduct/umbc-resource-page-for-sexual-misconduct-and-other-related-misconduct/ (Sexual Misconduct)”
g) 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.”
h) When performing research when participants 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.”
Explanation of Treatment and Compensation for Injury. Use ONLY if submitting an application for Full Committee Review or if the IRB requires this statement following review: “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.”
Sponsor of This Research. List the name of the external sponsor or granting agency who is providing funding for the research. Do NOT use internally funded award information.
Contacts/Questions. The principal investigator must state his/her telephone number and email address. This allows participants to contact the investigator to answer any and all questions related to the research. Student investigators must list their faculty advisor’s contact information as an additional contact, even if the student is only performing the work. This section also has the contact information for the Office of Research Protections and Compliance in the event a participant has questions about their rights as a participant in a research study.
Signature for Consent. At the minimum, all consent forms must have a line for the participant’s name, participant signature and investigator signature.
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 “Minor/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 and discussing the above information with the participant. All signatures must be affixed to the consent document in ink.