During the process of informed consent, all Elements of the Consent Form should be carefully, patiently, and clearly explained to the prospective subject. In addition, the researcher should frequently assess the prospective subject’s understanding by asking appropriate questions. During the process for enrolling a subject in non-Exempt research, the investigator should explain to the subjects their Rights as Research Participants. The explanation of a research subject’s rights is considered an adjunct to informed consent and demonstrates the commitment of both the researcher and the university to the conduct of human subject research with the highest integrity and skill possible. The IRB encourages researchers to provide their subjects with a written copy of the UNK's Rights of Research Subjects.
The following are general guidelines for writing the consent form, the required elements that should be included in all consent forms, and the characteristics of each element based on level of risk with samples.
Stationery
Identification
Style
Readability
Length
Format
Exculpatory Language
Storage of Consent Forms
Title of the Research Study
Executive Summary
Invitation to Participate
Basis for Subject Selection
Purpose of the Study
Explanation of Procedures
Potential Risks and Discomforts
Potential Benefits to the Subject
Potential Benefits to Society
Assurance of Confidentiality
Rights of Research Subjects
Voluntary Participation and Withdrawal
Documentation of Informed Consent
Identification of Investigators.
Consent forms for Exempt research should include the above elements as necessary.
Consent forms for all non-Exempt research must contain these additional elements:
Alternatives to Participation
Financial Obligations
Compensation for Participation
In Case of Emergency Contact Procedure
Emergency Care and Compensation in Case of Injury.
Characteristics of the Adult Consent Form for Exempt Research
Characteristics of the Adult Consent Form for Non-Therapeutic Research that is Less Than Minimal Risk
Characteristics of the Adult Consent Form that is Minimal Risk
Characteristics of the Adult Consent Form that is Greater than Minimal Risk
Surveys that are completely anonymous do not need separate written informed consent because completion of the survey implies consent. Likewise, phone interviews that are anonymous do not need written consent because completing the interview implies consent. However, the information typically given on a consent form (for example, information about use of the data, assurance of confidentiality, phone numbers to contact in case of dissatisfaction with treatment by researchers) must be included in the cover letter or opening remarks. Some Exempt projects may ethically require informed consent (written or oral). If, in the researcher's opinion, the study requires informed consent, the method used to obtain it should be described in the IRB application, and any written consent forms or scripts to obtain oral consent should be submitted. If the investigator does not believe that an Exempt study requires written informed consent, it should be stated and justified in the protocol.
Research projects that meet the Exempt criteria may not require documented written informed consent. Projects in educational settings that meet all of the Exempt conditions may not require parental consent; however, the investigator and/or school personnel may decide that parental informed consent and child assent should be obtained. Groups such as 4-H and other club meetings may be considered as educational settings.
The IRB may waive the requirement of a signed consent form if: (a) the research is subject to the approval of state or local government and is designed to study public service programs and the study could not be carried out without the waiver, or (b) the research involves minimal risk, would not adversely affect the rights of the participants, and it could not be carried out without the waiver.
Before submitting your protocol and consent documents to the IRB, be sure to review the Consent/Assent Checklist.
