Information from Truman’s IRB To Help You Get Your Application Approved the First Time It’s Submitted!
The purpose of this information is to assist faculty, staff and students who are planning to conduct projects that involve human subjects. You are urged to read this information carefully in order to avoid unnecessary delay in obtaining Institutional Review Board (IRB) or Peer Review approval. If you have a question that is not answered below, or if you need to determine whether or not your project needs to be reviewed by the IRB, visit the IRB website at http://irb.truman.eduand/or contact the Grants Office, IRB Administrator, McClain Hall 203, 660-785-7245, or talk to the IRB member in your academic department.
What Is the IRB?
The IRB is a campus-wide committee established under the authority of the Vice President for Academic Affairs to ensure that the rights and welfare of human subjects are adequately protected in all research projects. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is charged with ensuring the rights of humans in research and protecting their welfare, and privacy. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both federal regulations and local institutional policy.
What Projects Must Be Reviewed?
All research projects involving human subjects must be reviewed. Projects must be reviewed whether they are funded or unfunded, sponsored or unsponsored, or whether they are carried out by students, faculty, or other University employees, on campus or off campus. Investigators may consult the Grants Office or an academic department’s IRB member for advice about whether or not a project must be reviewed. Final authority for making this determination rests with the IRB.
If I’m not really doing research, I’m just talking to people and asking questions…it’s not like I’m taking blood or anything…do I have to submit an IRB application?
YES! If you are collecting information from an individual (whether it is blood or information about how a person feels about 8 am classes) you are conducting research and your project must be reviewed and approved by the IRB before you begin the project.
How Is A Project Submitted For Review?
Projects are submitted by completing either the Exempt Research IRB Application Form or the Full Review IRB Application Form. You MUST choose the correct form according to the guidelines given on the IRB website. If you submit the wrong application it will be returned to you without review. Submit your application, along with all supporting documentation to the Grants Office in McClain Hall 203. You must submit the original and 5 copies.
Complete the application carefully, answering each question thoroughly. Remember that the reviewers don’t know anything about your project, so be sure to include information that may seem obvious to you. Don’t “blow off” the application! This is the primary document IRB members use to examine your project. If the application is unclear, if information is not included, or if sections are not completed your application will be returned to you for additional refinement.
NOTE: Once you’ve filled in all the blanks, re-read your application, make sure it makes sense, check for misspellings and missing words. Make sure your consent form is well-formatted, includes all the sections described in the Consent Template on the IRB website, and does NOT include language that a lay person cannot understand.
When Does the IRB Meet?
The IRB meets every other week throughout the academic year and as needed during the summer. Specific meeting dates and deadlines for submission are listed on the IRB website.
What Types of Review Are Conducted at Truman?
There are three types of review at Truman State University. These are:
(1) Full Application IRB review conducted by Truman’s IRB
(2) Exempt Application IRB review conducted by Truman’s IRB, and
(3) Exempt Application review conducted by an IRB-approved Peer Review Committee.
What Kinds Of Projects Are Reviewed By the Truman IRB?
The IRB regularly reviews both full review projects and exempt category projects. Any project requiring review may be submitted to Truman’s IRB for review. A project that includes any of the following criteria MUST be reviewed by the IRB:
1. It is externally funded.
2. It places subjects at more than minimal risk (physical, emotional, psychological or social risk, etc.) Minimal risk is defined as those risks experienced in everyday life.
3. It involves minors or other vulnerable populations (prisoners, pregnant women and fetuses, mentally disabled individuals and other special populations).
4. It investigates behaviors and/or experiences related to sensitive topics.
5. It is carried out to partially fulfill a Master’s Degree requirement.
6. The IRB requests full review of the application.
What Kinds of Projects Can Be Reviewed By An IRB-Approved Peer Review Committee?
Peer Review Committees must be approved by Truman’s IRB and function under the guidelines established by the IRB. Peer Review Committees are not available in all academic disciplines. The IRB allows approved Peer Review Committees to review projects submitted within their academic area when the project falls within one of the six Exempt Research Categories. The six Exempt Research categories are listed below.
Category One: Research conducted in established educational settings that involves normal educational practices. Examples include: research involving educational strategies; comparisons of effectiveness of instructional techniques, curricula, or classroom management methods.
Category Two: Research involving the use of educational tests(cognitive, diagnostic, aptitude, achievement), IF information taken from sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Category Three: Research involving survey or interview procedures. Full review must be conducted when responses are recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subject; or the subject’s responses could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation if they became known; or the research deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
Category Four: Research involving the observation (including observation by participants) of public behavior. Full review must be conducted when observations are recorded in such a manner that the human subject can be identified, directly or through identifiers linked to the subject; or the subject’s responses could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation if they became known; or the research deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
Category Five: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. Sources must be publicly available and the information collected must be recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Category Six: Taste and food quality evaluation and consumer acceptance studies, IF (1) wholesome foods without additives are consumed, or (2) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or (3) a food contains an agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration, or (4) the food is approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Doesn’t “Exempt Category Research” mean that the project is excused from review?
No! The federal guidelines, which set the minimum standard, requires that exempt category research be reviewed to determine that it is, in fact, minimal risk, provides adequate protection to subjects that are involved, and falls within one of the six categories listed above. In addition, Truman’s IRB policies require that every Exempt project be reviewed. Exempt level projects go through a similar review process to that of Full Application projects.
What Kind of Criteria Does the IRB Use to Review A Project?
The overall criterion for IRB reviewers is that your research plan provides adequate protection for the rights and welfare of the human subjects involved. In particular, IRB reviewers focus on the following areas:
**The purpose of the project.
**The methodology as it relates to the protection of human subjects.
**The risks and benefits of the project.
**Adequate handling of informed consent
**Whether the research deals with high risk or sensitive issues and if so,whether they are handled in a way that minimizes risk to subjects.
**The degree to which confidentiality is both assured (commitment made to the participant) and protected (steps taken to fulfill that commitment).
Do Student Research Projects Have To Be Reviewed?
Yes, student investigations that involve human subjects must be reviewed. Student investigators work under the direction of their faculty supervisor who is responsible for ensuring that the research is carried out according to the procedures that were approved. The faculty supervisor should thoroughly review the student’s project before it is submitted for review. After reviewing the project the faculty supervisor must sign the student’s application certifying that the project will be carried out under his/her supervision.
Student projects most commonly include class assignments or questionnaires and surveys, and educational research conducted in school settings. Projects must be reviewed whether they are initiated by the student or assigned during a class. Student organizations that are conducting surveys or questionnaires, or initiating an activity that involves human subjects may also need to have the project reviewed by the IRB. If uncertain, a representative of the organization should contact the IRB Administrator in the Grants Office.
What Mistakes Are Most Likely to Keep My IRB Application from Being Approved?
The project is submitted on the wrong application form.
Do not automatically submit your project on the Exempt Research Application Form! If your project does not fall within one of the six exempt criteria areas it will be returned to you for resubmission on the correct form. Read the criteria carefully.
The Project start date is earlier than the date the project will be reviewed.
Your start date must reflect the date that your project will begin and CANNOT be a date prior to approval by the IRB.
The Faculty Advisor did not sign the Certification and Approval section.
For student projects, the faculty must sign the cover page of the application on the line designated for him or her. This indicates that the faculty member is aware of the project, supports it, and is making a commitment to supervise the work of the student researcher.
The informed consent document does not include all of the sections required, or is inconsistent with the information in the application.
This is one of the most frequent reasons that student applications are not approved. The informed consent document must clearly provide all of the information that is described in the Consent Template available on the IRB website. The consent document will be given to a participant to sign or to read, and should reflect high standards of neatness, organization, and accuracy. It should be written in language for an eighth-grade reading level, and it should not include jargon or technical terms. Your consent form is a
reflection of your research project, your faculty sponsor, and of Truman State University.
Issues of confidentiality and anonymity are misstated.
A participant’s responses or participation is Anonymous only if he/she cannot be identified by name or by any other descriptor that might indicate his/her identity. This means that you, the researcher, cannot identify which person completed which survey once the surveys are collected. If the project does not require identifying individual subjects, then names should not be recorded, (i.e. subjects will be anonymous).
Confidentiality means that only the investigator(s) can identify the responses of the individual subjects. If identification of individual subjects is important, then every effort should be made to prevent anyone outside of the project from connecting individual subjects with their responses. One common method to maintain confidentiality is to assign codes to subjects, record codes only on the data sheet, and keep a copy of subjects’ codes only until no longer needed.
Neither anonymity or confidentiality may be stated when subjects’ names are going to be included in the research. Oral history projects sometimes may have reason to include the subjects name with statements or reflections he/she made. In this case, the consent document must clearly make this request to participants and a signed consent document must be secured by the investigator.
The risks of the project are not described, even though they may be minimal.
In the informed consent document and the application, under the section on Risks simple saying “Risks are minimal,” or “there are no risks” is not sufficient. You must explain what the possible risks might be or state that there is no risk more than encountered in normal daily activity.
Confidentiality of data is not adequately addressed
Under the Confidentiality section, it is not sufficient to say that all records will be kept confidential. You must explain your plan to keep the records confidential. How will data be stored, with or without identifiers? If identifiers are used describe the type: name, job titles, number code, etc. How long are identifiers kept? If coding system is used, is there a link back to the subject’s ID? If yes, where is the code list stored in relation to the data and when is the code list destroyed? How will reports be written, in aggregate terms, or will individual responses be described? Will subjects be identified in reports? Describe disposition of tapes/films at the end of the study. If tapes are to be kept, indicate for how long and describe future uses of tapes.
Surveys, questionnaires, questions and other instruments are not included.
If you are using questionnaires, survey, or instruments of any kind you must include a copy of the instrument or a script of the questions that will be asked.
The way you will recruit or select participants is not adequately described.
When you inform individuals about your study (through posters/fliers, verbal announcements, e-mails, letters, etc.) you are recruiting an individual to be a part of your study. Copies of all recruitment materials must be submitted to the IRB with the application to ensure that appropriate information is shared with these individuals. If you are verbally asking other students or individuals to participate in your project you must describe in detail exactly how, where, and when you will do this. You should submit a script of what you will say to potential subjects. Individuals must understand exactly what you are asking of them and that their participation is completely voluntary and that if they choose to participate, they can withdraw at any time without any consequences. Recruitment may not begin until full approval has been granted by the IRB.
Audio or video taping is included in the project but is not explained.
You must explain why the taping is being done and you must get permission from your subjects to tape them. You must clearly explain how the tape is to be used, who will have access to the tapes, who will listen to or view the tapes, how the tapes will be stored, who will transcribe the tapes, and when the tapes will be erased or destroyed. This information should appear in both the application and in the informed consent document. Projects that include audio or videotaping cannot be reviewed as Exempt Category Research.
The documents are sloppy and have grammatical errors in them.
Taking time to proofread your documents before submitting them can go a long way toward getting your application approved.All submitted materials must be written using clear, easy to understand language this includes proper grammar, spelling and punctuation. Your application may be returned to you by the IRB.
Statement of Ethical Principles
Truman State University is committed to excellence in teaching, research, and public service. Concomitantly, the University is committed to the conduct of these activities with the highest possible ethical standards. For projects involving humans as subjects of research and research-related projects, Truman State University is guided by the ethical principles regarding all research involving humans as subjects as set forth in theDeclaration of Helsinki, the Nuremburg Code, and the National Commission for the protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research: The Belmont Report. In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations will be followed for all applicable federally funded research.
Thus, the following broad principles are the basis for development of Truman State University’s policies concerning review of research involving humans:
A. Whereas, the participation of humans in research and training projects may raise fundamental ethical and civil rights questions, no distinctions in the monitoring of projects will be drawn between funded and unfunded projects, sponsored and unsponsored projects, or between projects carried out by students, faculty, or other University employees, on campus or off campus.
B. All activities involving humans as subjects must provide for the safety, health, and welfare of every individual. Rights, including the right of privacy, must not be unduly infringed upon.
C. The direct or potential benefits to the subject, and/or the importance of the knowledge gained, must outweigh the inherent risks to the individual.
D. Participation in projects must be voluntary and informed consent must be obtained from all subjects, unless this requirement is waived by the Institutional Review Board.
E. An individual does not abdicate any rights by consenting to be a research subject. A subject has the right to withdraw from a research project at any time or may refuse to participate without loss of benefits to which the subject would otherwise be entitled.
F. Safeguarding information about an individual that has been obtained in the course of an investigation is a primary obligation of the investigator.