All investigators and key personnel who participate in the design, conduct, or reporting of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects.

“Key Personnel” are any individuals responsible for the protocol development or design, conduct, or reporting of research. These include but are not limited to: Principal Investigators (PIs), Co-PIs, faculty advisors, study coordinators, recruitment staff, and anyone else performing study procedures or interventions. If you are unsure whether or not you or someone on your study team needs to take CITI, please contact the Research Compliance Officer at 678/839-4749.

Individuals who are not considered “key personnel” are technical staff such as: coders, statisticians, data entry personnel, IT support, and others. Administrative staff including secretarial support, and logistics coordinators, and others types of administrative staff are also not considered “key personnel”. Although, these folks are not considered “key personnel” for the purpose of human subjects education they may be required to complete the HIPAA education program.

Yes, even if a project is exempt all key personnel are still required to CITI. A special user group is available for key personnel listed on "exempt" applications. Human subjects training certificates for Exempt research projects do not expire so there is no need to renew. The certificates do expire every three years for Expedited and Full Board studies.

No. If a project was determined to be "not human subjects research" (e.g., this applies whether coded specimen/data or not meeting the federal definition) key personnel do not need to take the CITI course.

The University of West Georgia (UWG) Institutional Review Board (IRB) has determined that this training will be a requirement of all UWG researchers involved in human subject research to comply with federal mandates. The National Institutes of Health’s (NIH) policy and National Science Foundation requires that all proposals for contracts and grants for research involving human subjects submitted certify that all key personnel have received training on the protection of human subjects in research. UWG’s FederalWide Assurance with the Department of Health and Human Services/Office of Human Research Protections (DHHS/OHRP) mandates that UWG will ensure the protection of the rights and welfare of all human research subjects, regardless of funding. This means that the same standards for education of key personnel will apply whether a study is funded or not. The UWG IRB has elected to review all protocols involving human subject research.

The CITI Certification is accepted at hundreds of universities, hospitals and research facilities throughout the country. The IRB will accept CITI training taken at another institution in lieu of the UWG CITI Training. Evidence of having completed the CITI training at another institution must be provided to the IRB with the protocol submission. If the certification is more than three years old, the investigator will be required to take the UWG CITI Course. The IRB will only accept CITI training from another institution; no other forms of training will be accepted. However, if the IRB Chair or the Chair’s designee determines that the CITI Training from another institution is inadequate for the research for which approval is requested, he/she may require additional modules consistent with UWG training.

If CITI training was completed through another institution, we recommend that you “Affiliate” your CITI account with UWG through your account’s home page so that UWG ORSP staff can view your completed training directly.

IRB applications will not be reviewed unless all key personnel have completed CITI training.

A passing score of 80% is required.

Researchers should select the track that is most appropriate to the type of research that will be conducted. The Social and Behavioral Research Module (S&BR) relates to studies on sociological, psychological, anthropological, or educational investigations including observational and survey research and work with population and/or epidemiological studies. The Biomedical Research Module would apply for medical, physiological, or pharmacological studies.

A full description of which modules researchers, faculty, staff, and students should take can be found on the IRB CITI training website.

Each module has text to read and a quiz to complete. The average time is estimated at 8 – 12 minutes per module. The Basic Course will take approximately 2 to 3 hours to complete and the RCR course will take approximately 1 hour to complete.

CITI is structured for the required modules to be taken in order, in many cases one building upon the previous. Once you complete the required modules, you may take any or all of the optional modules in the sequence you prefer.

When this is allowed, special procedures must be in place to prevent coercion.

• Generally, this is managed by preventing instructor/supervisor knowledge of who has and has not consented to participate in the study.
• We ask investigators collecting data from their own classes that they be blind to who has been / will be participating until the final exams are graded.
• The researchers must explain how they will be blind to who has agreed to participate until after grades are finalized – or alternatively, how grades are determined “mechanistically” (e.g., objective tests) and the instructor is not making any judgments regarding grades. There is more of a problem if there is a “subjective” component to grading that could be influenced, even slightly, by the instructor’s knowledge of who has and has not agreed to participate.
• The procedure for doing this must be detailed in both the protocol and the consent forms.

• All consents and assents must include what activities students may do during testing time if they do not wish to participate in the classroom testing.
• If participants you are observing in the classroom might be stigmatized by being singled out for observation, appropriate precautions must be made so that the other students will not know who is being observed and why. Similar precautions must be taken if select students are being removed from the classroom for some special purpose. Details must be provided in the protocol about how this stigma will be avoided.
• Given the sensitive nature of some surveys, participants may be afraid that their answers will be viewed by other students or tracked back to them. Having the survey be anonymous and providing each participant with a unmarked closeable envelope in which the surveys can be placed prior to handing them to the researcher or advisor may decrease this risk. Providing adequate spacing between students during data collection may be essential to ensure confidentiality in these situations.

• If any participants are going to be taken away from classroom activities for this research, the consent forms and assent script must include information about what classroom activities will be missed by the participants when they are removed from the classroom for testing. If students are to miss some classroom material, it must be detailed how it is that they will make up this material.
• If only a subset of students will be removed from the class to be tested (for example, those with reading difficulties), it must be detailed in the protocol what procedures will be used to prevent these participants from being stigmatized by the other students who notice that the child is being removed because they are of a special population.

If you plan to use your own students, please use these guidelines to facilitate the IRB Review Process:
NOTE: If one’s own students are used as subjects, the investigator must explain why he or she cannot use another instructor’s students, and he or she must follow one of the following procedures:

1. Use a third party for recruiting subjects, obtaining consent, and collecting data (including interviewing). The data must be held by the third party and not given to the instructor until the course is completed and grades are submitted.
2. If the instructor is using as research data the assignments of students that would normally be given during the course, the instructor may request from each student permission to use the student’s work AFTER the course is completed and grades are submitted.
3. If the study is anonymous, the instructor may perform the study. In such a study, no signatures or identifiers or any kind are obtained. The instructor passes out an informed consent document to the class. A survey is handed out to everyone. The instructor then tells the class that if anyone would like to complete the survey, they may do so outside of class time and leave the survey in a designated location other than the classroom.

When course credit or extra credit is given to students who participate in research as part of a course requirement, students are to be given other options for fulfilling the research component, for example; short papers, special projects, book reports, and brief quizzes on readings, research seminars, or completing a similar project. These projects should be comparable in terms of time, effort and educational benefit to participation as a research subject to ensure that students are not being coerced into becoming subjects. Alternatives offered to subjects need prior IRB approval.

The standard expectation is that all subjects will sign a document containing all the elements of informed consent. The informed consent process gives potential subjects a description of the study that is clear and complete enough for the individual to judge whether she or he wants to participate. The consent form should provide readily understandable information in an amount appropriate to the level of risk in participating. Some or all of the elements of consent, including signatures, may be waived under certain circumstances.

The IRB may approve a consent procedure which does not include, or which alters some or all of the elements of informed consent, or waives requirements to obtain informed consent provided that the IRB finds and documents:

1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Eight essential elements:

1. A statement that the study involves research, an explanation of the purposes of the research and expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonable foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or to others that may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. The possibility that the Food and Drug Administration may inspect the records should be noted.
6. For research involving more than minimal risk, an explanation as to whether there is any compensation for injury, and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and who to contact in the event of a research related injury to the subject.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Six additional elements:

1. A statement that the particular treatment or procedures may involve risks to the subject (or the embryo or fetus if the subject is or may become pregnant), which are currently unforeseeable.
2. Anticipated circumstances under which the subject’s participation may be terminated by the investigators without regard to the subject’s consent.
3. Any additional costs to the subject that may result from participation in the research.
4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
5. A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
6. The approximate number of subjects involved in the study.

The IRB seeks:

• Research design that's sound, given the proposed use of human subjects in the project
• Equitable selection of subjects
• Balanced risks and benefits
• A thoughtful and comprehensive informed consent process
• Please ensure the study is described thoroughly in the Procedures section, and can be understood by someone outside your area of expertise, i.e., a layperson.

Exempt studies do not require the researcher to obtain consent using a document containing all of the elements of consent. Though the research is exempt, the investigator has an ethical obligation to respect and safeguard participant’s rights and welfare. The UWG IRB requires the following items be included in an informed consent statement or letter of introduction:

• A statement that the project involves research
• A statement that participation is voluntary
• A statement that the participant may skip any question they do not feel comfortable answering
• The measures that will be used to ensure confidentiality of data collected.

"Identifiable information" isn’t limited to just participant names. Consider these types of identifiers, especially when combined, and whether they could allow your subjects to be deductively identified:

• Name
• Geographic subdivisions smaller than state
• All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death
• Telephone numbers
• Fax numbers
• Email addresses
• SSNs
• Medical record numbers
• Health plan beneficiary numbers
• Account numbers
• Certificate/license numbers
• Vehicle identifiers
• Device identifiers
• Web URLs
• IP addresses
• Biometric identifiers
• Full face photo or other image
• Any other number, code, or characteristic that can be linked to identity by researcher

As part of the IRB process, the researcher is requested to identify and address the risks of harm or discomfort to which subjects may be exposed as they participate in the proposed research. Research involving human participants at the University of West Georgia is most likely to be of a social science or behavioral nature. While the associated risks are usually less than in biomedical studies, they still exist. The examples below are not a complete list, but are provided to stimulate the researcher's thought.

Physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. Exercise-induced or repetition-exacerbated physical harm, such as carpal tunnel syndrome, stress fractures, asthma attacks, heart attacks may be risks for certain kinds of research.

Psychological effects may be experienced during the research situation and/or later, as a result of participating. These risks include anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, altered behavior. Boredom, mental fatigue, embarrassment at poor performance, or frustration are minor but common risks. If present, they should be identified on the consent statement.

Alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and powers in relation to others. Economic risks include payment by subjects for procedures, loss of wages or income, and damage to employability.

Risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally or civilly liable.

Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks include invasion of privacy, as well as the social, economic and legal risks outlined above.

Anonymity refers to responses obtained from research participants when there is no way to link responses to the participants. If the investigator cannot, in any way, link the participants with their responses or other recorded data, then anonymity can be assured.

Confidentiality refers to responses/information obtained from research participants that could be linked to the individual participants. Research investigators must assure that the responses provided by the participants will be kept confidential so that no one other than the investigator can connect the information to specific participants.

In both cases you can assign codes to your participants. If the code is random (cannot be linked back to the subject), it would be anonymous. If the code can be linked back to the subject, the data would be confidential.

When subjects do not speak or understand English well, the researcher should prepare documents in the language that subjects can understand. The researcher should provide the IRB with a copy of the document in English, a copy in the language to be used, and a letter from an unbiased individual with expertise in the language (e.g., a UWG faculty member) indicating that the translated version is complete and contains the same information as the English version.

If you plan to continue conducting research beyond your current expiration date, including analyzing data, you must complete a Continuing Review Form and submit it to the IRB between 30-45 days prior to the expiration date of last year's approval. After expiration of the IRB approval, all research activities, including data collection and analysis of identifiable data, must stop.

If you are still in the stage of data analysis the study should remain open. Research protocols must have continuing approval until all analysis of identifiable data has been completed and the Research Completion Form is submitted. After the project has expired, no further research can be done. It is very important if you don't want your project closed that you remain in compliance by submitting your application for renewal in adequate time for review. If your project is not reviewed and approved prior to the expiration date, no further research can be done. All research must stop.

If you are uncertain about the expiration date of your project, consult the initial approval letter. The expiration date does not change despite other submissions about the project during the year.

Yes, you should notify the IRB that your study is completed by submitting the Research Completion Form.

Each approved study is expected to submit a brief report annually to the IRB (unless a more frequent renewal cycle is required). The report should summarize all procedures and interactions with human subjects in the study during the year.

Principal Investigators must promptly report to the IRB, appropriate institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any unanticipated problems involving risks to subjects or others.

Changes in approved research protocols must be reported promptly to the IRB, and the changes may not be initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject.

When subjects do not speak or understand English well, the researcher should prepare documents in the language that subjects can understand. As described above, the researcher should provide the IRB with a copy of the document in English, a copy in the language to be used, and a letter from an unbiased individual with expertise in the language (e.g., a UWG faculty member) indicating that the translated version is complete and contains the same information as the English version.