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IRB Format for Submissions
IRB Format for Submissions
Researchers: In preparing your protocol, please address and organize your materials as shown below. Provide complete information in a narrative style. Please include your writing in a different color font, such as red, so that it can be easily found.
The IRB Coordinator acts as the initial contact for the proposal. Proposals must be sent electronically to firstname.lastname@example.org.
a. Primary Researcher Information
** If applicant is a student, the Faculty sponsor must write a Faculty Verification and Sponsorship letter or sign at the end of this submission in acknowledgement of the project and their role in the project.
b. Research Assistant Information - Names of any others who will make contact with human participants. Indicate type of assistant and how and by whom they will be trained and supervised.
c. All researchers must have completed a certification in Protecting Human Research Participants - Proof of completion of such training must be included for each person who will be involved in data collection, analysis and reporting. The NIH offers a free online training. At the end, you will be provided with a certificate. Please save and paste that image here for each researcher.
d. Project Status
1) Indicate project status: for example, grant supported, independent research, master’s thesis, capstone project, and etcetera. If you are a student researcher, please describe how this project connects to or serves your studies and progress toward graduation.
2) Are you receiving any funding for this research? If so, please explain and provide details.
3) Will multiple institutions be used to collect data? If so, approval from those other sites may be required before the IRB will consider your proposal. Feel free to consult with the IRB Coordinator about this.
e. Purpose and objectives of the research - State the research problem and aims of the research. Include background literature that helps to place this research in the context of the field. Describe any benefits to participants or to society, including compensation. Also include some information about your intention for public dissemination of your findings.
f. Methods and procedures – please note that responses here should relate to your purpose and objectives (if not clear, explain how they relate).
Participants - Describe the subject population, recruitment activities, and criteria for selection or exclusion. Justify the use of any special populations (e.g., children, prisoners, participants who might have issues that challenge or impair their ability to give consent, pregnant women).
Materials - Summarize instruments (questionnaires, interviews, observations, tests, etc.) and other methods of data recording (notes, audiotapes, videotapes, etc.). All instruments, experimental stimuli and other materials must be submitted in their full and final versions for review. Clear indication of the recording, scoring and intended analysis of data must be described.
Procedures - Provide a concise and complete description of your procedures, taking care to emphasize any and all potential risks and potentially sensitive issues. Address risk-benefit issues; i.e., do the benefits justify the risks? Describe all activities involving the human subject, including duration and frequency of each activity. Consent and debriefing information is requested below.
g. Consent/Assent and Debriefing
Consider the following: What information is necessary to insure that consent is adequately “informed”? If individuals with impaired abilities to give consent, such as children, will be used, what manner of assent is appropriate? Note that the term “children” includes anyone under the age of 18 and that Western New Mexico University enrolls a substantial number of students under the age of 18 years as dual enrolled high school students who require parental consent in order to participate in any research study. All proposals that involve students from WNMU must address the following:
· how minor students will be identified,
· how written parental consent will be obtained,
· how such students will be excluded if consent cannot be obtained or is declined.
In addition, the intended use(s) of the results of the study must include description of how the identities of the students will be protected and any identifying information eliminated if used in publication. Measures to prevent unintended uses of the data collected in the implementation of the study. (Including digital recordings of images and sounds as well as written notes.)
Attach your consent and or assent form. Note: the form must contain the following statement: “If you would like to discuss or comment on any aspect of this project, please contact the WNMU Institutional Review Board at email@example.com”
h. Data Use and Storage - Describe any procedure or measure to protect the privacy of subjects and to maintain the confidentiality of the data. Describe data handling and storage to insure appropriate use and protection of human participants.
i. Changes. Indicate that you agree to promptly bring to the attention of the IRB any changes in methods or procedures from those described above or any unexpected consequences adversely affecting the subjects.
j. Certification statement. I have reviewed the protocol and application materials and certify that the proposed study involves no known risks other than those specified. Furthermore, I certify that the protocol procedures conform to the norms, ethical standards, and accepted methods within my discipline, to the best of my knowledge.
Signature (electronic, ok) Date
Note: if you are submitting as a student, the signature of the faculty/staff mentor with whom you are working/being supervised must be included, and that mentor must also submit a letter of support.
Signature of Mentor (electronic, ok) Date
This form is largely a modified version of the current UNM form of which WNMU has gained permission to use.