4. Complete an IRB Application Form
Federal guidelines allow research falling within six specific categories to be classified as exempt from continuing IRB oversight. To apply for an exemption use the Exemption Request Form. For studies not falling within an exempt category, complete the IRB Approval Request. Every question on the form must be answered before an application will be considered complete. A detailed explanation of Questions 2-8 from the IRB Approval Request form follows.
Question 2: The description of the research should include brief comments on:
- a. Purpose of research: Briefly describe the purpose of the research. Describe the problem to be investigated, the reason
for conducting the research. Include any broadly stated research questions or issues being investigated. You may wish to include hypotheses.
- b. Nature of data to be collected: Describe the type of data to be collected such as demographic data, answers to open-
ended questions, responses to Likert scaled statements, specimen to be collected, video tapes, audio tapes, etc.
- c. Data collection procedures: Describe the manner in which data will be collected. This section should describe exactly
what participants are being asked to do; e.g., participants may be asked to participate in a focus group discussion, or participants may be asked to
complete an online survey using SurveyMonkey.
- d. Instruments to be used: Describe the “instruments” to be used; i.e., questionnaire, interview outline, survey, etc.
Email a copy of each with your approval request form and consent form or cover letter. For those conducting classroom research, detail whether instruments are being used strictly for research purposes or are part of normal classroom activity.
- e. Method of selection/recruitment of participants: Describe how participants will be identified and contacted; e.g., if
students in classes will be asked to complete a survey, then list the specific classes and instructors. It is generally better if the person
administering a survey is not the instructor of record. Attach any advertisements to be used.
- f. Participant age range, number and gender: Provide expected age range even if all participants are expected to be
adults. If there is a chance that participants may include minors, make certain that appropriate parental consent and child assent is included. Provide the expected number of
participants and the expected distribution of males and females.
- g. Incentives, follow-ups, compensation to be used: Describe incentives that will be given to participants, as well as any
methods used to avoid penalizing those who do not participate. IRB generally recommends against extra credit in classes.
Question 3. Risk:
Provide a complete description of any procedures that may involve any risk to the participant and indicate alternative procedures that may be used, if any. The legal or ethical concerns involved should be addressed, safety precautions to be taken should be listed, and a justification for procedures involving risks or discomforts included. If the research involves any potential risks to the participant, participants must be advised of the risks and the availability and limits of treatment for any sustained injuries. Note that risks may be physical, psychological, social, economic or legal.
Question 4. Benefit:
Research involving human participants must not be conducted unless the benefit to the participant AND the importance to humankind outweigh any potential risk to the participant. Describe any and all benefits from conducting this study.
Question 5. Informed Consent is a Requirement:
Informed consent means the knowing consent of an individual (or his/her legally authorized representative) is so situated as to be able to exercise free choice without undue inducement or any element of force, fraud, deceit, duress, or other forms of constraint or coercion.
Consent must be obtained by using a consent form, which is signed by study participants, or by using a cover letter, which provides for unsigned consent if study participation is expected to be anonymous. Review of the consent checklist will help ensure that your consent document contains all of the required elements. Different consent document formats may be used, but documents must address all of the items included in the sample consent form or letter. If deception is employed in your research, describe how participants will be deceived, the necessity for deception and your debriefing procedures, including the timing and information to be presented to the participant. The IRB requires a written debriefing for studies involving deception. If you will be utilizing an online survey program to collect data, you must notify your participants in your consent document as to whether Internet Protocol addresses will or will not be collected by the online program, and the first page of your online survey must reflect the consent document.
Question 6. Vulnerable Participants:
In research with minors or other vulnerable populations, informed consent is especially necessary, and in most cases, will be obtained from parents or legal guardians. An understandable explanation of the research procedures and an opportunity to volunteer to participate should be supplied to the participants as well as their authorized representative. This is called “assent.” Their wishes determine their participation. If your research will not include minors, then the consent form or cover letter should state that only persons 18 or older are eligible to participate. Vulnerable populations may include cognitively impaired, economically disadvantaged, educationally disadvantaged, elderly, homeless seeking social services, people with Parkinson disease, Latinos or others with limited understanding of English, pregnant women, students and employees.
Question 7. Future Risk:
Whenever possible, the participants should remain anonymous; otherwise appropriate confidentiality should be maintained. Procedures for maintaining confidentiality should be described in detail, including who will have access to the data and on what basis. If survey instruments are to be used, list the anticipated date identifiers will be removed from the completed instruments. Describe how data will be stored, as well as how and when it will be destroyed. Provide justification if identifying information will be retained and indicate measures used to protect the participants’ confidentiality.
Question 8. Illegal Activities:
Participants must be assured that their data will be confidential in any research, but if individually identifiable data relate to illegal activities by identifiable persons, no guarantee can be given if disclosure of the data should be required by law. When anonymous questionnaires are involved, but written informed consent must be obtained, the consent form can be signed and returned separately to prevent any possibility of linking names with the data.