IRB Cover Letter Preparation and Samples
Five sample cover letters that you may edit for your own application are available along with this detailed list of items typically needed in a cover letter. Depending on your specific project, your cover letter will need to address many of the following items:
- Stationery for cover letter. All cover letters should appear on appropriate letterhead (University/Institutional or other Agency affiliation).
- Purpose of research. A statement of the purpose for the research project must be included in the introductory paragraph of the cover letter.
- Invitation for subject to participate. By giving an invitation, the subject will be assisted in understanding that a choice is to be made regarding her/his participation in the research project.
- Benefits, if any, for subject. The benefits, if any, that the subject can reasonably be expected to receive must be indicated. Since any suggestion of a benefit can be a strong inducement to participation in a research project, any such suggestions should be limited to substantial and likely benefits.
- Explanation as to why subject was selected for participation. This information will assist the subject in assessing the nature and importance of her/his participation.
- Size of intended sample. The total number of subjects to be included in the eligibility pool/sample should be provided for the potential respondent.
- Description of research protocol. A description of the procedures to be followed by the subject must be stated clearly and with sufficient information to allow the reader to determine the risks and/or benefits of the study.
- Consideration of time allocation. The approximate length of time required to complete the research activity/survey instrument should be clearly stated.
- Voluntary nature of participation. State that participation in the research project is voluntary and:
a. Not a part of any job or instructional requirements
b. Not a condition for being the recipient of benefits or services from UW-Eau Claire
c. Subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
- Description of any risks to subject. A description of any risks (see definition) and/or inconveniences that might reasonably be anticipated to occur for the subjects must be provided (Wherever appropriate, a statement should appear that the given procedure(s) may involve unforeseeable risks.
- Description of any provisions made for harmful or negative physical or psychological effects Subjects should be informed of any provisions made for handling negative physical or psychological effects that may occur from participation. If appropriate, the name of a specific person, office, or clinic should be indicated in the cover letter, e.g., Ms. Janice Jones or your social worker.
- Protocol to address concerns about treatment of human subjects. The name, address, and telephone number of the Chair of the Institutional Review Board for the Protection of Human Subjects must appear as the contact person for any questions or concerns regarding the treatment of human subjects in the research project.
Dr. Michael Axelrod, Chair IRB
Eau Claire, WI 54702-4004
- Protocol to address questions. The name, address, and telephone number of the investigator(s) must appear so as to provide a contact person(s) for any questions about the nature or procedures of the research project.
- Confidentiality of data. Confidentiality, as herein used, means that the investigator(s) will not make unauthorized disclosure of identifying information and/or data that have been obtained from a participant. An investigator needs to tell to what extent the subjects identity and personal data will be protected in any publication or presentation resulting from the study. Likewise, an investigator must disclose any individuals or agencies with which the information will be shared.
- Anonymity of data. Anonymity, as herein used, means that the investigator(s) cannot associate the identity of a particular subject with her/his data. If anonymity will be maintained by the investigator, that process should be clearly explained.. .
- Question of compensation and/or cost reductions. If subjects will receive payment for participation in the research project, the amount must be stated. If subjects will receive services at a lower cost than would ordinarily be charged to non-subjects, said services constitute subject compensation and should be explained. If the investigator intends to use some type of prorated payment system for partial participation, this procedure also must be described.
- Decline of or discontinuance of participation. The subject must understand that she/he is free to decide not to participate or to later withdraw consent and discontinue participation in the research project without prejudice. It is not permissible to utilize any exculpatory language (e.g., "before you withdraw, you must inform the investigator") in providing the option to discontinue. If appropriate, the conditions under which the investigator would terminate a subject's participation in the research project also must be described. In addition, the subject must be informed if withdrawal could lead to any undesirable consequences, and otherwise be informed that withdrawal does not jeopardize the subject in any way. If the potential subject declines participation in a questionnaire-type research project, she/he should be instructed as to the appropriate disposition of the questionnaire.