Student Coursework and student research
Student Coursework Policy
If the goal of the student coursework activity is to fulfill a course/major requirement and not to add to generalizable knowledge, the project may not meet the definition of "research" and therefore may not require IRB review.
These projects are conducted by students to fulfill a class assignment and may involve interactions with members of the class and/or external research participants (e.g., Research Methods courses where students design and conduct a research protocol involving data being collected/analyzed for the purposes of learning how to do research under the supervision of the course instructor.) Typically, these assignments are initiated and completed within the timeframe of the course. These projects are not intended to create generalizable knowledge or to lead to publication or presentation outside of OW. Findings may be presented in class to peers.
The IRB is not able to provide retroactive approvals.
If there is any possibility that the project may be presented/published outside of OW or the project does not meet all of the criteria indicated below, the project must receive IRB approval before initiating data collection. Faculty must be fully aware of all aspects of the project and take responsibility for overseeing the project and assuring that all research activities adhere to ethical principles. Faculty also should ensure, to the best of their ability, that students realize any potential for harm and take all possible steps to eliminate the risks to students or individuals outside the classroom involved in the assignment. These risks may include potential physical, psychological, social, economic, or legal harm.
A project that is solely a student coursework activity as described above does not require IRB review if it meets all of these criteria:
• The project involves no more than minimal risk to subjects.
• The project topic and protocol activities are benign in nature; are course appropriate as determined by the instructor; and do not cover sensitive topics (such as sexual activity, substance use, abuse history, and/or other similar subjects).
• The project does not involve deception.
• The project does not involve vulnerable populations such as prisoners, people with diminished capacity for giving consent, and/or minors under the age of 18.
• The project involves the voluntary participation of individuals without any coercion or pressure being placed upon them.
• The research participants/information is anonymous (no identifiable data will be collected).
• The results will not be presented, published or distributed beyond the OW campus.
• The student, not the course instructor, is the principal investigator of the project. In other words, the class may not be a means for the instructor to collect data for their own work.
• Informed Consent information will be provided to all participants. This consent must clearly state that the project has not been approved by the IRB and the data will not be published or presented anywhere.
• Both the course instructor and the student researcher(s) must complete the appropriate OW CITI training course option for research involving human participants. See the IRB web page for more information.
• Projects involving human subjects that do not meet all of these criteria, even if they are conducted as student coursework activity projects, will require IRB review/approval before initiating data collection.
Faculty advisors must submit all protocols related to student work.
If you have any questions, please contact the IRB.
Policy on Minor Modifications
pending final approval
The Institutional Review Board (IRB) is must review any modifications to previously approved research regardless of risk category. These changes must receive approval before being implemented by the investigator. However, certain minor modifications that do not change the risk, burden, nor benefits to participants, have been identified as exempt from IRB submission and review. These minor changes are outlined below. For any questions regarding this guidance, please contact the IRB Chair.
Definitions:
Minor changes refer to modifications that do not increase risk or burden for participants or reduce their benefits. As outlined in this guidance, these changes do not require IRB review or approval. In contrast, substantive changes involve any modifications that are not classified as minor and may lead to increased risk, added burden, or diminished benefits for participants. Such changes must be submitted to the IRB for review and approval before they can be implemented.
General guidance and procedures to determine if modification qualifies as "minor":
Study Procedures
-Rescheduling of data collection (e.g., missed appointments) due to either participant circumstances or researcher concerns that do not increase risk to the participant. This includes biospecimens that are relatively benign.
-Removal of study instrument that does not impact risk or benefit to participant. If removal of an instrument that was once beneficial, then that qualifies as substantive change.
-Minor editorial changes to instruments (e.g., grammar/language modifications that enhance participant understanding)
Recruitment Material
-Change in medium (e.g., flyer to newspaper, so long as both are "print"), location of advertising so long as they are still within the general class or location of approval (e.g., switching from advertising in academic buildings to dorms on campus for flyers), additional e-mail lists (e.g., e-mailing an additional section of a class or a closely-related class). Switches in recruitment methodology (e.g., switching from flyers to direct phone solicitation) are considered substantive and require review and approval.
-Changes in contact information for the PI or key research staff. Additional PI or personnel is substantive and requires approval.
-Minor editorial changes to recruitment materials that enhance potential participant understanding.
-Changes in scheduling, so long as the dates and times are within the approved time period of the protocol and do not reasonably change burden of participants. Major changes to scheduling (e.g., from daytime to overnight procedures) may require approval.
Consent/Assent Documents
**Note, though these edits do not need approval, non-exempt studies do need to be marked as updated by the IRB.
-Minor editorial changes (spelling/grammar) to increase clarity and understanding for the participant.
-Changes in contact information for the PI or key research staff. Additional PI or personnel is substantive and requires approval.
-Removal of instruments or procedures that reduce the duration or burden of the study (and is noted on the consent).
Miscellaneous
-Changes to non-key personnel do not require IRB approval; however, the Principal Investigator (PI) is responsible for maintaining records of personnel changes, ensuring all study personnel meet required education requirements, and providing these records upon request. Non-key personnel may not participate in any human subjects research until they have completed the necessary CITI training. If a non-key personnel member is later designated as key personnel, this constitutes a substantive change and must be submitted as an amendment for IRB review and approval.
Example Substantive Changes Needing Review:
- Change in principal investigator
- Change in funding source
- Change to study purpose or procedures such as adding a survey on a different topic than previously approved or collection of data falling outside the parameters of the data collection previously approved
- Changes to study population targeted for recruitment such as adding a new population or substantively revising the inclusion/exclusion criteria for the current population
- Changes to the identifiability of the research data you will receive or record. For example, your exempt application states that you will not collect names with the surveys, but you now want to, or you now want to record identifiable data from an existing dataset
- Adding instruments, procedures, biospecimens being collected
- Additional populations being targeted for recruitment
- Changes to the risks involved in the study
Examples of Minor Amendments Needing Review (via expedited review)
- Decrease in the amount of blood drawn
- Title change
- Change in principal investigator
- Additional instruments or questionnaires
- Clarification of issues
- Addition of risks to the informed consent and other study documents at the IRB’s request
- Dose reduction
- Extended accrual period
- Addition of urine pregnancy test
- Addition of audio and/or video recording
translation
Translation Policies
The requirements regarding obtaining IRB approval for translated documents varies depending on the level of risk of the research. Researchers should describe in their submission form whether translated documents and which language(s) will be appropriate for the prospective participants. Regardless of the level of risk, it is recommended that English versions of documents be approved prior to translating, minimizing the number of iterations of translations. If modifications are necessary to the form, it is expected that these modifications will be applied to all forms and all languages; we suggest holding off translation procedures until the forms are settled. All final translated documents must be submitted to the IRB.
Translations for Minimal Risk Research
The qualifications of the translator should be provided (e.g. native speaker, academic degrees, certified translator, etc.) to the IRB, using the Translation Certification form, when foreign language versions of project documents are provided. The translations should be consistent to the English versions in both content and format. Translators must sign the Translation Certification form indicating that they have carried out the translation to the best of their ability.
Translations for More than Minimal Risk Research
For projects involving greater than minimal risk to participants, the IRB requires that the researchers either use certified translators (with a letter of certification from the translator or translation service) or that a “back-translation” by a different translator than the one who performed the original translation be provided. The back-translation (back into English) serves to ensure that the non-English version contains all of the key elements of the English version.
The translated documents (forward and back), as well as documentation of the qualifications of each translator, must be submitted to the IRB for final approval.
Use of a Qualified Translator
The IRB requires the use of a qualified translator. Rather than limiting researchers by having very specific qualifications for translators, the term “qualified” is left open so that researchers have flexibility and the IRB can make a case-by-case determination as to whether the qualifications of the translator/verifier are sufficient based on the project and the specific project documents. For example, the IRB would not expect researchers to use someone who is a native Spanish speaker but has no medical background to translate a complicated clinical trials consent form. If this person does not have a good understanding of medical terminology, then they might not provide an adequate translation of the informed consent. On the other hand, a medical student, physician, experienced nurse, etc. who is a native speaker would potentially be appropriate for translating the informed consent. If the project involves a survey (e.g. about how they view the services they receive, what toothpaste they use, etc.) where the risks are minimal and the research design is very simple, then a native speaker without a scientific/medical background would probably be qualified to translate the informed consent form.
The IRB requires a Translation Certification form be submitted with all foreign-language translations of consent forms, recruiting materials and other project documents. This form attests to the validity of the translation and includes a statement of the English and foreign-language qualifications of the translator.
Research staff may serve as translators, but it is encouraged to have an outside translator to reduce potential bias.
The IRB may invite a consultant to review the translated materials to determine cultural appropriateness.
Translation Certificate may be found in "Forms and Templates" or below.