For expedited and full board studies, the following criteria must be assured through appropriate procedures. These procedures must be described in the protocol application:

• Legally effective informed consent must be obtanied;
• The potential participant must have sufficient opportunity to discuss and consider whether to participate;
• The possiblity of coercion or undue influence in the informed consent process must be minimized;
• Information provided to the potential participant must be in a language understandable to the participant;
• The information provided must be what a reasonable person would want to have in order to make an informed decision about participating. NOTE: This is a higher standard than for consent to clinical care, because the risks may be unknown and/or the benefits may not be direct to the participant;
• Information must be concise and focused on the key information that will assist a potential participant in understanding why they may want to, or not want to, participate in the research;
• There must be sufficient detail relating to the research. The information must be organized to help with comprehension; and
• There must be any exculpatory language through which the potential participant waives or appears to waive any of their legal rights, or releases the researcher(s) from liability for negligence.

Further, the following information must be provided, usually both verbally and in an informed consent document:

• A statement that the study involves research;
• An explanation of the purpose(s) of the research;
• The expected duration of the person's participation;
• A description of the procedures to be followed;
• Identification of any procedures that are experimental;
• A description of any reasonably foreseeable risks or discomforts to the subject;
• A description of any benefits to the subject or others that may reasonably be expected from the research;
• A disclosure of appropriate alternative procedures, courses of treatment
• A disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject;
• A statement describing the extent to which confidentiality of the records identifying the subject will be maintained;
• An explanation of whom to contact for answers to questions about the research, about participant rights, and whom to contact in the event of a research-related injury; and
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional information that must be included, when applicable or appropriate:

• When the research is more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs (with detail about the available treatments and where more information may be obtained);
• When the research involves collection of identifiable private information or identifiable biospecimens, one of the following statements:
• That identifiers might be removed from the identifiable private specimen or identifiable biospecimens and that after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject of the legally authorized representative; or
• That the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
• A statement that the particular treatment or procedure may involve risks to the subjct (or embryo/fetus) that are currently unforeseeable;
• Anticipated circumstances under which participation may be terminated by the researchers without regard to the participant's consent;
• Any additional costs to the participant that may results from participation in the research;
• The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation;
• A statement that significant new findings developed during the course of the research that may relate to the participant's willingness to continue participation will be provided;
• The approximate number of participants invovled in the study;
• A statement that the subject's biospeciments (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in any commercial profit;
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
• If biospecimens are involved, whether the research will or might include whole genome sequencing.

If your project seeks broad consent to store, maintain, or collect data for other research purposes (e.g. creating a repository of data or biospecimens), the following additional information must be included as part of the informed consent:

• A general description of the types of research that may be conducted with the identifiable private information or indentifiable biospecimens. This description must include sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
• A description of the identifiable private information or identifiable biospecimens that might be used in research, whether sharing of identifiable private information or identifiable biospecimens might occur, and the types of institutions or researchers that might conduct research with the identifiable private information or identifiable biospecimens;
• A description of the period of time that the identifiable private information or identifiable biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the identifiable private information or identifiable biospecimens may be used for research purposes (which period of time could be indefinite);
• Unless the subject will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the subject's identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
• Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject; and
• An explanation of whom to contact for answers to questions about the subject’s rights and about storage and use of the subject’s identifiable private information or identifiable biospecimens, and whom to contact in the event of a research-related harm.

Below are some resources or templates for creating your own Informed Consent documents. Additionally, when a protocol is exempt or not human subjects research, the UA IRB still requires some information be provided to the participants. A couple examples are provided below.

• Sample Informed Consent Form
• Note that Parental consent form information is the same as a regular informed consent, except that the phrasing should indicate, "Your child is being asked to..." or "Your child will receive..." etc. The header/title of the document and the signature information should be edited to make it clear that the document is parental/guardian consent for a minor to participate.
• Sample Child Assent Form
• Sample Cover Letter for exempt or not research studies
• Sample Introduction to Online Survey

  CITI Login and Registration Page          Step-by-step CITI IRB Instructions 

BASIC CERTIFICATION REQUIREMENT FOR RESEARCHERS:

All individuals (faculty, staff, students, advisors) involved in the conduct of research involving human subjects, including research that qualifies for exemption, must take and pass the core modules under Group 1 - Social and Behavioral Researchers (SBR) in the Collaborative Institutional Training Initiative (CITI) curriculum. The certification is effective for 3 years, after which the Refresher Course, under Group 4 - Social & Behavioral Research –Refresher Course must be completed. It is the responsibility of the researcher to insure certification is current, as the IRB cannot approve a protocol unless all researchers are certified.

The CITI Social Behavioral Research (SBR) curriculum includes:

• Introduction ‘Belmont Report’
• History and Ethical Principles
• Defining Research with Human Subjects
• The Regulations and the Social Behavioral Sciences
• Assessing Risk in Social and Behavioral Sciences
• Informed Consent
• Privacy and Confidentiality    
• The University of Akron module

Modules are presented in succession.  An e mail verification, which certifies successful completion of the curriculum, will be sent once the last module is completed.  Learners may assess their status at any time.  Our office will receive the same verification.

Upon receipt of the verification, a ‘passed date’ will be displayed.  Certification is valid for three years from this date.  Researchers are required to monitor their status and complete the ‘Refresher’ in order to maintain their certification.

Approval for new and renewing protocols will be withheld until/unless certification is current for the PI and other personnel on the protocol, including advisors.

NIH CERTIFICATION:

If applicants (or other project personnel) are currently certified through NIH, that will be acceptable in place of the UA requirement. Submit the NIH completion documentation with the IRB application.

CERTIFICATION THROUGH CITI, WHICH HAS BEEN COMPLETED AT ANOTHER INSTITUTION:

Applicants are not required to duplicate CITI certification for research, which has been completed elsewhere.  Log in to the CITI site and update your affiliation to The University of Akron.  Select Group 1- Social & Behavioral Researchers (SBR) from the Human Subjects Curriculum. If the Course Status is Incomplete, you can view which modules are missing by clicking on the course name. Once all required modules are completed, a completion report will be generated and our office can access your member information on CITI.

STUDENTS COMPLETING MODULES TO MEET COURSE REQUIREMENTS:

The CITI site also includes a course for students who are completing modules for a class, but not submitting a research application to the IRB. These students will complete modules under Group 2 - Students. Completion of modules in this group does not satisfy the IRB requirement for researchers submitting protocols. If students are conducting independent research with human subjects, they must complete the modules under Group 1 – SBR Researchers in order for a completion report to be sent to the IRB for our records. This is the database that the IRB uses to check on certifications.  If modules have already been completed under the Student Group, update your Learner Group and select Group 1 – SBR Researchers. If the course status shows as Completed, you have completed all necessary modules and a completion report will be sent to the IRB. If the course status shows as Incomplete you can see which modules are missing by clicking on the course name. Once all modules are completed, a completion report will be generated and sent to the IRB.

If you have any questions or problems in accessing the CITI site, please contact UA's IRB.

• For all submissions that are not full-board reviews, protocol are reviewed within 10 business days of all PI, Co-PIs, and Faculty Advisors certifying the submission. Often, however, the protocol is reviewed more quickly.
• For protocols required full board review, the submission must be submitted and certified by all the PI, Co-PIs, and Faculty Advisor at least 14 business days in advance of the next IRB meeting. This requirement is to facilitate distribution to all the IRB members and to ensure they have sufficient time to review the protocol prior to the IRB meeting.
• However, it is the norm for revisions to be required for an initial protocol submission. In that case, the submission will be returned to the researchers for revisions. Once revisions are completed and the protocol is re-submitted and re-certified by each PI, co-PI, and Faculty Advisor, the review time is as above. However, usually review of revisions is much faster.
• Thus, the length of time that it takes to have a new protocol approved depends on how complete the initial submission is and how quickly revisions, if any are required, are addressed.

Yes. You will need to submit to the protocol to the UA IRB. In some cases, UA may have an agreement with the local entity, so that UA may rely on their review. In other cases, UA must do their own review. In either case, UA still needs the protocol and supporting approvals to be submitted to UA, prior to the researchers starting at the other entity.

Cases in which UA must do their own review:

• Generally, any project deemed not human subjects research (e.g. QI projects). These projects are not typically covered under the agreements that UA has with other entities.
• Generally, any project that is considered Exempt. These projects are not typically covered under the agreements that UA has with other entities. However, there are some exceptions to this generality. Feel free to reach out to the ORA to determine whether your protocol will fall into this exception.

Yes. UA is willing to enter into an agreement with another University, as long as they have a Federalwide Assurance and a human research protections program. To initiate this process, submit your IRB protocol in the cloud-based system, but select the options indicating there is an external site. Further, select the option where UA should rely on the other University. Then provide the appropriate information. UA will need to have the contact information.

Note that not all Universities are willing to enter into reliance agreements, unless it is required by the funder. In those cases, the UA IRB will also have to review the IRB protocol.

Your protocol must be submitted through the cloud-based application system. Here is a link to the system: IRB Submissions. Note that you will still need to navigate to the Human Ethics part of the system. To do that, click on "Products" in the upper right and choose "Human Ethics."

Additional information information on applications, training links, and how to use the cloud-based system, is available here.

Instructors and students often use the term Research in a broad sense when teaching about research methods. However, the Federal definition of Research is more narrow. In certain classes, like research design, statistics, and other educational experiences, faculty create class assignments in which students model the research process. However, these assignments do not necessarily meet the Federal definition of research. In contrast, classroom projects are designed to be normal educational activities to train students in research.

• The Federal definition of research is "A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generlizable knowledge" (45 C.F.R. 46).
• The Federal definition is important because if a classroom project meets the Federal definition of research, then that individual project must receive IRB approval prior to implementing it.
• Conversely, if the assignment models the research process, but does not meet the Federal definition, the faculty must submit a request for certification that the classroom assignment does not meet the Federal definition of human subjects research. That certification would permit students to undertake the project, but not require them to receive IRB approval prior to doing the projects.
• It is important that faculty who engage students in these learning activities make clear the distinction between the colloquial use of the term research and the Federal definition. This will facilitate student understanding of when IRB approval is required prior to implementing a human subjects research project. This will help students, faculty, and/or advisors avoid violations of Federal regulations.
• The IRB encourages instructors to include the following language in the assignment directions, to clarify the distinction between the colloquial use of research and the Federal definition of research: "This project is not permitted to be presented publicly in a senior thesis, websites, social media sites, blogs, conference presentations (including symposia), or journal articles. These projects may be presented to the class but not in more public venues. If the student wants to use the data in public presentations, theses, websites, etc., they must submit a full IRB protocol for approval PRIOR to implementing the project or collecting the data."