All research involving human subjects conducted on the Finlandia University campus must be approved by the Finlandia University Institutional Review Board (IRB).
The principle investigator (PI) is responsible for submitting the project to the IRB and ensuring that the project is approved prior to beginning research. On this page, you will find an overview of the requirements for research submission to be completed by PI. Complete procedures for researchers are outlined in the Finlandia University IRB Manual (PDF).
Step-by-step instructions for submitting a research proposal
Below you will find an outline for submitting a research proposal. Below that you will find details on each step.
- Determine if the research activity qualifies as human participant research.
- Have all researchers and personnel involved successfully complete IRB training and submit documentation to the IRB Committee.
- Determine whether the research activity is exempt.
- Determine whether the research activity is eligible for expedited review.
- Determine whether informed consent can be waived.
- Determine whether documentation of informed consent can be waived.
- Determine whether vulnerable participants will be involved.
- Complete and submit the IRB Project Application.
Step 1: Determine if the research activity qualifies as human participant research
Not all research needs to be submitted to the FinnU IRB. Your research activity qualifies as human participants research if:
- the activity is a systematic investigation designed to develop generalizable knowledge. (The FinnU IRB considers institutional research or program evaluation, or systematic investigations conducted by students to be research.)
- the research information about living individuals is obtained.
- the information obtained is public or private.
- the research involves intervention or interaction with individuals.
- a federal agency supports or sponsors the research.
Step 2: Have all researchers involved successfully complete IRB training and submit documentation to the IRB Committee
Like most other IRBs, the FinnU IRB requires all researchers involved in human participants research to have successfully completed IRB training within the past five years. Acceptable training includes successfully completing the FHI 360 Research Ethics Training Curriculum, Second Edition. Other IRB training certifications will be considered on an individual basis. To take the FHI 360 training, go to: https://www.fhi360.org/sites/all/libraries/webpages/fhi-retc2/index.html.
When you have successfully completed the training, you will receive a certificate, which you will then send to the IRB Committee for archiving at email@example.com bring in person to the current IRB Administrator.
Step 3. Determine Whether the Research is Exempt
Although all human participants research activities need to have a proposal submitted to the FU IRB, not all research activities need to be formally reviewed by the IRB. Human participants research is exempt from review if:
- Research is conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular education instructional strategies, or on the effectiveness of instructional techniques, curricula, or classroom management methods.
- Research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless human subjects can be identified or the research could place the subjects at risk of criminal or civil liability.
- Research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
- Research involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, and if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects are designed to study or evaluate, public benefit programs, procedures for obtaining benefits or services, changes in those programs or procedures; or changes in methods of payment for benefits under those programs.
- Wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at a level found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Use Charts 2-7 in Appendix A to determine if your research activity is exempt from IRB review. If you do believe it is exempt, check “Exempt from review” and check the reason that you believe it is exempt in the Category for Review section when you fill out FU IRB Project Application, which can be found in Appendix C.
Note: A proposal must be submitted to the FU IRB, even if you believe that your research is exempt from review.
Step 4. Determine Whether the Research Activity is Eligible for Expedited Review
In some cases, research is eligible for expedited review, which is a review conducted only by the IRB Chair, rather than being reviewed by the entire IRB. The circumstances under which research is eligible for expedited review is given below:
- Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
- The categories in this list apply regardless of the age of subjects, except as noted.
- The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability or reputation.
- The expedited review procedure may not be used for classified research involving human subjects.
- IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review–expedited or convened–utilized by the IRB.
- Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
- Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.
- Research on medical devices for which they are cleared for marketing and is being used in accordance with its approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- from 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; or
- from other adults and children2. 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; (c) permanent teeth which indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected in an unstimulated fashion; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane; (h) supra- and subgingival dental plaque and calculus; (i) mucosal and skin cells; (j) sputum.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation).
- Research involving materials (data, documents, records, or specimens) that have been 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 behavior including 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 convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
NOTE: Appendices A through C are found in the manual, entitled, “Finlandia University Procedures for Conducting Research with Human Participants.”
Step 5: Determine whether informed consent can be waived
Most human participant research requires that participants provide informed consent prior to participating in a research study. Informed consent is typically an agreement between the researcher and participants that ensures that participants understand their rights and responsibilities associated with the study. Federal Guidelines stipulate the requirements of informed consent (45 CFR 46.116 (b)(c)) which include (but are not limited to): an explanation of the study goals and procedures; discussion of risks, costs, and benefits associated with participation; disclosure of alternatives available to the participants; discussion of confidentiality concerns; and an explanation of the voluntary nature of the research project. A template for an informed consent form can be found in Appendix C of the Finlandia University Procedures for Conducting Research with Human Participants Manual.
In some cases, informed consent may be waived [45 CFR 46 (c)(d)]. Instances include times when research cannot be carried out without informed consent and when research is conducted by state or local government officials for specific evaluative purposes. Please refer to page 11 of the Finlandia University Procedures for Conducting Research with Human Participants Manual for more information.
Step 6: Determine Whether Documentation of Informed Consent can be waived
In some cases, documentation of informed consent can be waived. According to 45 CFR 46.117 (c), informed consent can be waived under two conditions. First, if the only record linking participant’s identities to the research would be informed consent and there is substantial risk associated with this record, documentation for informed consent may be waived. Second, if research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context, documentation of informed consent may be waived.
See Chart 11 in Appendix A of the Finlandia University Procedures for Conducting Research with Human Participants Manual to determine if documentation of informed consent can be waived. If you believe it can, please indicate so on the IRB Project Application.
Step 7: Determine whether Vulnerable Populations are involved
If research involves vulnerable populations, (i.e., pregnant women, human fetuses, and neonates; prisoners; or children) require that the research take special precautions and must be denoted on the IRB Project Application (link).
Step 8: Complete and submit the IRB Project Application
The final step in submitting a proposal for initial review is to fill out the IRB Project Application in Appendix C and e-mail it to firstname.lastname@example.org or deliver it in person to the current IRB administrator. Each proposal must include a brief summary of the project, a copy of the informed consent agreement (where applicable), and a copy of documents that participants will be exposed to (e.g., surveys, interview protocols, etc.). The brief summary of the project should include an explicit statement of methods, data collection, and how confidentiality of participants/data will be protected, including consent forms.
All proposals will be reviewed by the IRB. For exempt and expedited proposals submitted during the academic year, you will receive a decision regarding the approval of your application within two weeks. Proposals for full review protocols will be reviewed and decisions made within one month of their submission. The IRB will review protocols during the summer on an as needed basis. Please inquire about summer submissions timelines directly to Chair of the IRB.
Rights and Responsibilities of Researchers
Researchers have the right to a written explanation of why a proposal had been disapproved by the IRB. Researchers also have a right to appeal, one time, an IRB decision in writing or orally at the next full IRB meeting after the date of disapproval.
Researchers are obligated to exactly adhere to the protocol described in the IRB Project Application. Any changes in protocol must be approved by the IRB prior to the changes being implemented. Researchers wishing to make protocol changes should submit another IRB Project Application that details the proposed protocol changes as an amendment.
Researchers are obligated to maintain all necessary documentation for a period of at least three years after the study has ended. The documentation must be stored securely.
Most importantly, researchers are obligated to immediately report any unanticipated problems to the IRB committee. Failure to carry out the obligations of researchers mentioned above, serious noncompliance, or ongoing noncompliance may results in institutional reprimand.
Upon completion of research, researchers must submit a final report of research to the IRB. Long-term projects will be re-reviewed at least once per year. Researchers are required to submit the Continuing Review Form (link) upon request of the IRB. The number of continuing reviews per year will depend on the amount of risk involved.
The IRB reserves the right to audit a research project at any time.