The following information has been compiled from a review of past IRB applications and outcomes in order to help clarify some specifics, remind applicants of salient points, and facilitate the application process so that outcomes are more favorable and frustrations can decrease. These are organized according to the categories of the review process plus some general information highlights. It is designed to augment the application packet, not replace it.
- General Information
- Common IRB Errors and Mistakes to Avoid
- Subject Selection
- Informed Consent
- Subject Debriefing
- IRB Review Outcomes
All research that involves human subjects and that is conducted at or under the auspices of Augsburg University by faculty, staff or students is subject to Augsburg policy guidelines and IRB approval. The Augsburg IRB process follows federally established guidelines and format.
- The IRB application must be complete and on the correct form. Any approval letters, questionnaires, interview guides, data gathering instruments, etc., must be submitted with the application. IRB approval will not be granted without these. (*N.B. An exception to this might be agency access-granting letters which are pending. IRB approval may be granted conditionally until such letters are received and forwarded to IRB Chair, after which an approval number will be granted.)
- The application must be submitted well in advance of any anticipated deadlines or before commencing the investigation–allow four to six weeks for a decision.
- It is expected that the application be reviewed and proofread by the researcher before it is submitted so that typos and other errors are corrected. The application is expected to be a finished product; questionnaire interview guides, other data gathering instruments are to be in final form and substantive changes may not be made after IRB approval.
- Research design and methodology are not the concern of the IRB unless these directly affect potential risk to the subjects/participants.
- Outcome letters are written by the IRB chair. If there are questions or need for discussion the researcher/applicant should contact the IRB Chair.
- Projects which are determined to be program evaluation or oral history projects, in general, do not meet the federal definition of “research” and therefore are not subject to IRB review. Any questions should be directed to the IRB chair.
COMMON IRB ERRORS AND MISTAKES TO AVOID
Sometimes the simplest things are the most troublesome.
- The start of the project is after IRB approval, not when you first begin to explore the topic.
- Spelling and grammar errors, especially on the consent forms, are embarrassing for you and for the University
- Do not get creative with the consent form. Use the basic template, removing segments that do not apply to your project. For example: If you are working with adults, remove the clauses about children.
- Don’t confuse confidentiality and anonymity. It is hard to guarantee anonymity where you have only a few subjects, no matter how much you disguise them.
- Minors assent; Parents/guardians/adults consent. Take that into account in the consent form.
- Don’t give the completed form to your adviser at the last minute and demand that he/she sign it immediately. The adviser needs time to look it over.
- Exempt means exempt from full review, not exempt from IRB review. The proposal still has to be reviewed.
- Be sure to have a script to contact your subjects whether for oral or written contact.
- Write your lay summary in clear language that can be understood. Purpose has to be the same as what you tell the subjects.
- Always tell subjects that they may omit one or more questions and still be part of a study
- If you have a “reward,” it has to be given at the beginning, not the end of the interview or focus group.
- If the interview/study is likely to give subjects some distress or discomfort, please have a referral to which they may go.
- Consent and assent forms must be submitted to the IRB as a separate word document, in the final format you intend to provide to the subjects in your research.
- The person who will be recruiting potential subjects/participants for a study must not be in a position of power or control over potential subjects/participants. The actual script, what will actually be said by the recruiter, must be written verbatim in the IRB application.
- Any outside person (e.g., interpreter, transcriber) involved in the research must be told of the ethical obligations of confidentiality and is required to sign a statement promising such confidentiality. It should be stated on the IRB application who will be transcribing audio tapes.
- In research using support groups, therapy groups, etc., the potential members must be told that they can participate in the group without participating in the research or that they have an equal option available.
- Potential risks and benefits must be clearly delineated and separately listed in the IRB application and as part of informed consent.
- Sensitive (or other) demographic data may pose special risks as an identifier of subjects/participants when there is a small number (fewer than 10) and when there is other potential use of data. Collecting these data should be justified by the research question. It is prudent to exercise caution with few subjects/participants in collecting and reporting such data.
- In a case study the person or entity may be identifiable and must be informed of that possibility by the researcher.
- When case study research is conducted on one’s own client, the issue of coercion/informed consent must be clearly addressed in the proposal.
- If agency access is required to conduct a study, the letter allowing such access must be signed by the person with administrative authority to do so, and the letter must include the title of that person (e.g., CEO, agency director, school principal, university president or designee, etc.). Such permission must be obtained prior to recruitment of subjects/participants.
- The potential subjects/participants must be informed as to why and how they were selected. If an exception to this is requested it must be justifiable and must not pose undue risk. Approval is rarely granted for such departure from this standard.
- When there are fewer than five subjects/participants (e.g., staff members of a small agency or business, all those supervised by an individual, etc.), this must be justified by the research question and they must be informed of their possibly being recognized.
- E-mail is not confidential! The use of e-mail to conduct interviews is strongly discouraged. If e-mail is used is must be justified by the research question and potential subjects/participants must be warned prior to consenting to participate that their interviews will not be confidential.
- Potential subjects/participants must be informed as to the purpose of the research. If an exception to this is requested it must be justifiable and must not pose undue risk. Approval is rarely granted for such departure from this standard.
- Separate consent must be obtained for 1) participation in the research; 2) audio taping or videotaping; and 3) the use of direct quotations in writing the results.
- Potential subjects/participants must be informed that they are free to withdraw from the study at any time without negative consequences and that they may skip/not answer questions. If the latter interferes with the validity and/or reliability of the data collection instrument and all are required, subjects/participants must be informed of this prior to consenting to participate. They must still be allowed to withdraw at any time without negative consequences.
- When potential subjects/participants are children (age 0-18, unless an “emancipated minor”) parents/guardians must give written consent for the child to participate, and children should give written assent (agreement). A person with authority over the child must not serve as recruiter for participation.
- A facsimile (fax) signature of informed consent to participate in research is not acceptable and will not be approved.
- When giving contact information for questions and concerns, do not use home addresses or telephone numbers of the individuals named. This is a safety issue for the researcher.
- A specific referral for follow-up counseling is required if the research topic has any potential for causing distress or unpleasant feelings (e.g., abuse, violence, death, sexual assault, any emotional or personal experience, etc.). Such follow-up may not be provided by the researcher.
- Subjects/participants must be informed if this referral will cost money and that they or their third party payer will have to pay for it.
- The consent form must state the specific agency or person for this referral and how they may be contacted. Such a referral agreement must be in place prior to IRB approval.
IRB REVIEW OUTCOMES
There are four possible outcomes to a review:
- Approved: No further action is required from the investigator, and the study may begin with receiving the IRB approval number. Recommendations may be offered and incorporated into the study at the discretion of the researcher.
- Conditional Approval: Changes must be made and submitted to the IRB Chair before the study may begin. If the changes satisfy the conditions delineated, the IRB approval number will be given and the study may begin.
- Revise and Resubmit: More extensive changes are required before IRB approval will be granted. Proposal must be revised and resubmitted for full IRB approval.
- Denial: The proposed research, because of the level of risk involved, cannot be approved or carried out.