What is the purpose of the IRB?
The IRB reviews all research proposals to insure protection of both the project participants (e.g., safety and privacy) and Clarke University (e.g., liability). To this end, each proposed project is reviewed to consider such things as the possible physical, mental, and emotional participant risks, invasiveness, and research design.
Do I need IRB approval?
In general, research involving human subjects needs IRB approval.Research is defined as "as systematic investigation designed to develop or contribute to generalizable knowledge" (Code of Federation Regulations, 45 CFR 46.102d). If the research is designed to draw conclusions or contribute new information to the field of study, it requires IRB approval. Any research in which the data is shared with others through publication, presentation, grants should obtain IRB approval before initiating the project. All of the following may be considered research:
- Pilot studies
- Case studies
- Analysis of existing data
Are there types of research that do not need IRB approval?
Certain types of projects may not need formal IRB approval:
- Teacher and student evaluations
- Program evaluation
- Projects designed to enhance curricula offerings at Clarke
- Marketing research designed to market the institution as a project
- Market surveys that do not lead to publication or dissemination of findings
- Searches of existing literature
- Quality assurance activities or evaluation projects designed for self-improvement or program evaluation, not meant to contribute to "generalizable" knowledge
- Interviews of individuals where questions focus on things not people (eg. questions about policies)
Who should submit an application to the IRB?
Any faculty, staff, or student who is conducting research as a part of their job, for their class, and/or utilizing Clarke databases or facilities is required to submit an application to the IRB. This is true even if the project is funded by an outside agency or is being conducted in collaboration with another institution (i.e., IRB approval from another institution does not substitute for Clarke IRB approval).
How does the IRB define research?
Research is defined as any formal or informal, both academic and non-academic, data collection involving human participants (e.g., surveys, interviews, observations). For example, a survey being conducted as part of Clarke operations still must receive IRB approval.
Anyone who conducts research of this type without first filing the project with the IRB and obtaining approval is in violation of Clarke's research standards.
What qualifies as a classroom assignment?
In some instances, faculty members may require students to conduct research as part of a course assignment to learn about the process of doing research. These projects do not meet the strict definition of research since there is no intention to generalize the information; however there is a need to ensure that the assignments do not compromise any IRB or ethical principles. It is important for students to have learning in the ethical and procedural nature of IRB and the need to protect human subjects.
Faculty may obtain a course level review for student research projects when all the following criteria are met. Note this only applies to classroom assignments and does not include independent research projects, honors projects, or any graduate level scholarly research. These always need IRB review.
- The assignment is part of a regular class at Clarke University, taught either face to face, online, or in a hybrid format
- The assignment will be completed during the semester in which the student has registered for the course
- The purpose of the assignment is for the students to learn about the process of engaging in research and not to actually engage in research which would be used for publication, formal reports, or other formal means that would add to the body of knowledge in a particular field
- The project is eligible for exempt or expedited review
- The instructor has completed the on-line training and filed their certificate with the Chair of the IRB
Faculty wishing to use this option should submit the course level IRB form to the committee prior to the beginning of the class in which the assignment occurs.
To emphasize, if you have ANY intention of using future classroom data for presentations, publications, or any other dissemination purposes, you are required to obtain IRB approval prior to the collection of such data, including the conduct of related classroom activities.
How do I submit an application to the IRB?
One (1) complete proposal (i.e., with all copies of measures being used) for all exempt or expedited reviews or six (6) copies for a full review should be submitted to the IRB mailbox. Protocol forms may be found on Clarke’s web site (under Academics, Institutional Review Board (IRB) Protocol Forms).
Incomplete applications will be returned to the Principal Investigator (PI) without review (i.e., an application is incomplete if the questions are unanswered, or information is left blank.).
What is the role of a faculty advisor?
All students conducting research projects are required to name a faculty advisor. By signing the protocol form the faculty advisor both attests to the veracity, accuracy, and completeness of the application and identifies him/herself as the one held responsible for insuring that the research is conducted in compliance with research standards.
Accordingly, should any student project be in non-compliance, the faculty advisor will be held in violation of Clarke's research standards. In addition, the IRB will contact the faculty advisor if there are questions or concerns regarding the student project. For these reasons, the advisor should be conversant with the details of each project sponsored.
Do I need to include the specific consent form/procedures being used?
Yes. Written consent forms are thoroughly reviewed by the IRB to be certain each participant is a) accurately informed of the procedures, b) can understand what is being asked, c) can assess the potential risks involved, and d) can make an informed choice about participation. All consent forms should provide the participant with the opportunity to withdraw from the study at any time without retribution. Consent forms should be written in lay language, typically at the eighth-grade level.
If verbal consent will be used, the IRB will review the "script" utilized.
NOTE: PIs are responsible for keeping signed consent forms on file for three (3) years after the project’s conclusion. If the PI leaves Clarke prior to that time, the PI is required to leave sealed copies of the consent forms with the departmental chair.
Click here for a sample informed consent document.
What is a protected population?
These populations include the following categories: minors, prisoners, fetuses, mentally handicapped, mentally disabled, test subjects for new drugs or clinical devices, pregnant women, illegal behavior or legally incompetent persons.
Typically, research involving these populations will require a full IRB review.
How will I know if my project is approved?
Written notification of the IRB decision will be sent via email from the IRB to the principle investigator and their advisor.
What if my project begins before I receive IRB approval?
Can't be! If projects are scheduled to begin on a date that antecedes IRB approval, those projects must be postponed until IRB approval is received. Projects begun prior to approval are in violation of Clarke's research standards.
What if my project is not approved?
The IRB will notify the PI of any reason(s) why the project did not receive approval. The PI will be able to submit the application for future review after revising the proposal to meet the concerns of the IRB.
How is project progress tracked?
Principal Investigators (PIs) are required to file progress and termination reports for any approved on-going research projects.
Progress reports are to be submitted at least annually for those projects not completed.
PIs that do not file the reports as required will be in violation of Clarke’s research standards.
What if the project results in complaints or injuries?
Any and all complaints, significant wrongs, unanticipated problems, or injuries (including physical, mental, and emotional harm) in relation to the project must be reported to the IRB Chair immediately. The adverse event form must be completed and sent to mailbox 1521. After informing the Chair, the PI must file a detailed written report of the incident(s) with the IRB Chair for review by the IRB. All incident(s) must also be included, in detail, in subsequent project progress reports submitted to the IRB.
Can the IRB withdraw an approval?
Yes. Under certain circumstances (e.g., verifiable complaints, harm, or violations), the IRB may rescind approval.
What if my project has changes after IRB approval is granted?
New IRB approval is required before any changes to an approved project may be implemented. Incorporating changes into an on-going project without first receiving IRB approval places the PI in violation of Clarke’s research standards.
Changes that require IRB approval include but are not limited to a) increasing the number of subjects/participants on whom data is collected, b) extending the period for data collection, c) altering measures in any way, and d) changing the amount of times measures are collected per subject.
A modification form must be completed and sent to IRB, mailbox 1521.
What does it mean to be in IRB violation?
Any person found to be in violation of Clarke' research standards may be prohibited from conducting, supervising, or advising research under Clarke’s auspices for a period of time as determined by the IRB, but not to exceed three (3) years. Each violation will be reviewed on an individual basis. Repeat violations may result in the IRB prohibiting that individual’s research activity at Clarke for an indefinite period of time.
I have a proposal that needs approval. When is the next IRB meeting? How long will it take to get approval?
Applications are accepted on a rolling basis. Submit completed application to IRB, mailbox 1521. Exempt and expedited applications are reviewed by a member of the IRB committee. Committee members will provide an answer in two to four weeks for the principle investigator. Full reviews may take slightly longer.
The length of the review process depends on several factors: time the application is received, type of review, and quality of the application. Submissions received prior to holidays or scheduled school breaks or at other times when faculty are very busy (advising and registration, midterms, or finals) may experience delays. Please allow enough time for IRB review before anticipating the beginning of your research.
What kind of review do I need?
Research is reviewed for Exempt status (Level I review), by an IRB committee member if it involves very minimal or no risk. There are several types of research that may qualify for Exempt status and are noted in the next section.
In general, research which does not propose to disrupt or manipulate the normal life experiences of subjects, incorporate any form of intrusive procedures, or involve deception will be exempt from full Committee review. Projects that involve more than very minimal risk and those that include any degree of deception do not qualify for Exempt status.
Please note that all of the rights and protection afforded to human subjects in research are required in Exempt status cases. Researchers engaged in human subjects research that qualifies for Exempt status must still complete a full application form and prepare an informed consent statement. Researchers must engage in practices that minimize risk, maximize benefit and ensure privacy.
Any research involving protected classes or vulnerable populations of subjects (such as prisoners, pregnant women, minors, mentally disabled persons, research by a faculty member on his/her own students) is never Exempt.
Types of Exempt Research
In order to be considered for Exempt (Level I) status, research must fall into one of the categories listed below. However, even for these types of research, the IRB may determine that an Expedited (Level II) or Full (Level III) review is necessary because the research has risk or there are potential ethical concerns. The checklist at the bottom of this page can help you determine whether your research qualifies for Exempt status.
Categories of research that qualify for Exempt status:
- Normal Educational Practices.
Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:
a. research on regular and special educational instructional strategies
b. research on the effectiveness of or a comparison among instructional techniques, curricula, or classroom management methods.
c. If the research involves individuals under the age of 18, the project will not qualify as Exempt; it will require either Expedited or Full Review. Furthermore, an assent form is required for minors as well as a consent form to be signed by a parent/guardian.
- Educational Tests.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) unless:
a. the research involves minors;
b. information taken from these sources is recorded in such a manner that the subjects can be identified;
c. any disclosure of the subject's responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
- Survey/Interview Procedures.
Research involving survey or interview procedures with legally competent noninstitutionalized adults, except where any of the following situations exist:
a. responses are recorded in such a manner that the subject can be identified, either directly or through identifiers linked to the subjects;
b. the subject's responses, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation within the community;
c. the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, use of alcohol, drugs or other addictive products;
d. questions that ask about sexual attitudes, preferences, practices;
e. questions that request information pertaining to a subject's psychological well-being or mental health.
Non-Exempt Survey Research
Other areas may be considered sensitive due to specific cultural values or other factors. Such areas may include:
- Survey research that involves HIV status information, either with the general public or with vulnerable populations is subject to full Committee review. This is based on recent federal guidelines declaring persons with HIV status to be members of a vulnerable population and that attitudes or information about HIV status is stressful. Any survey that is likely to cause stress in the subject population requires Full Review.
- Any survey of or interview with children (minors under 18 years of age or adults of diminished mental capacity) requires Full Review. This includes research with school children concerning their attitudes or perceptions regarding the school system. In most cases, you will need to develop a consent form to be signed by the parent/guardian and an age-appropriate assent form for the child.
Research involving the observation of public behavior of legally competent noninstitutionalized adults, except where the conditions explained in 3. a., b., and c. above exist. No active consent is required for observation of public behavior. You must obtain consent, however, if you will take photographs, films or videotapes of subjects.
- Secondary Use of Data.
Research involving the collecting or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified. For example, the review of medical records or student school records where subject identifier numbers are available is subject to full Committee review unless the data is gathered by an employee who has legitimate access to the records and who turns over "blinded" data to the investigator.
- Evaluation of Federal Research and Programs.
Research and demonstration projects which are designed to study, evaluate or otherwise examine public benefit or service programs.
- Taste Tests.
Research involving taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed.
Special considerations regarding online surveys
Online surveys should always allow a "no response" option for every question. That is, a survey design where one cannot proceed without answering every question is in violation of the respondent's right to choose to withhold information. Sensitive data must be protected as it moves along communication pathways between computers. If using a commercial site such as Survey Monkey, the researcher should review the site's security measures for protecting respondent privacy and confidentiality.
An expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the entire IRB. The term "expedited" can be misleading: reviews of this type are not "quicker" or conducted with less rigor, but fewer reviewers are required for approval. There are several types of research that may qualify for Expedited review.
In general, research may be considered for Expedited review if it involves no more than minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate consent procedures. Expedited review may also be used when minor changes have been made to a previously approved research project during the period (of one year or less) for which approval is authorized.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or during the performance of routine physical or psychological examinations or tests. Please keep in mind that research does not count as having "minimal risk" simply because it involves minimal physical risk or is non-invasive. There are many kinds of risk including financial risk, employment risk, criminal/civil liability, stigmatization, insurability and embarrassment. It is important to consider all of these when assessing risk.
Researchers engaged in human subjects research that qualifies for Expedited (Level II) review must still complete a full application form and prepare an informed consent statement. Researchers must engage in practices that minimize risk, maximize benefit and ensure privacy.
Types of Expedited Reviews
- Clinical studies of drugs and medical devices only when:
1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from:
1. healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week;
2. other adults considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid at time of rupture of the membrane or prior to or during delivery.
- Collection of data on subjects 18 years of age or older through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or microwaves as well as procedures involving general anesthesia or sedation. Where medical devices are employed, they must be cleared/approved for marketing.
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes such as medical treatment or diagnosis.
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior); or Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the entire IRB as follows:
o where the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects; or
o where no subjects have been enrolled and no additional risks have been identified; or
o where the remaining research activities are limited to data analysis.
- Continuing review of research in which the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.