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What is the IRB?
The IRB is a federally mandated university committee established to protect the rights and welfare of human subjects participating in research projects. The IRB reviews research involving human subjects according to policies set forth by the United States Department of Health and Human Services regulations (45 CFR Part 46) and the U.S. Food and Drug Administration (21 CFR Part 56). Compliance with these federal regulations safeguards human subjects, the institution sponsoring the research project, and researchers.
What is a Human Subject?
Human participants are defined as: living individual(s) about whom an investigator conducting research obtains a) data through intervention or interaction (including online interaction) with the individual; or b) identifiable private information.
- Individuals who are asked to complete questionnaires, participate in interviews, or whose behavior is observed in daily activities
- Oral history interviewees whose subjective perceptions are studied
- Student and teachers observed in the classroom for the study of various methods or development of curricula
Is it Research?
The Department of Health and Human Services (DHHS) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Intervention includes “both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.”
- Is the project designed to produce generalizable knowledge?
- Generalizable knowledge builds the knowledge base of the profession is some material way.
- Will information be collected in a systematic way?
- Systematic means the project is conducted using step-by-step procedures organized according to a set of interrelated ideas or principles.
How do I know if I am conducting research with human subjects?
Research is defined as "a systematic investigation when human beings or their environment is manipulated; when information is sought from them directly (as through interview, examination, or questionnaire) or indirectly (as through observation), and when information concerning specific, individually identifiable human beings is asked for from third parties whether through access to files, data banks, or other depositories--or through direct inquiry.
I need to plan data collection around IRB approval. How long does review take?
Please note: You may not begin your research until the IRB has given your research protocol full unconditional approval.
Review of Exempt or Expedited protocols takes about three to four weeks. If the submitted materials need revision, the process will take longer. The review process for protocols submitted for Full Review can take a month or longer to complete. You should include sufficient time in your research plan as allowance for any IRB-required changes to the research protocol.
How often does the IRB meet?
The UWG IRB meets once every month to conduct full-board reviews. Expedited and exempt reviews occur on a rolling basis. Please remember the IRB consists primarily of UWG faculty and follows the University calendar. Review may take longer at the end of semesters and during summer; review is typically suspended over the winter break.
When do I need IRB approval?
The University of West Georgia has assured the federal regulatory agencies that the institution will review and approve all research involving human subjects before it is initiated.
This includes research which falls into any of the following categories:
- The research is conducted by University faculty, staff, or students
- The procedures are performed on the premises of the University
- The procedures are performed with or involve the use of facilities or equipment belonging to the University
- The research involves University students, staff, or faculty
- The research project satisfies a requirement imposed by the University as the condition for the award of a degree or certification in the University
- The research project satisfies an obligation of the faculty appointment at the University, as consistent with departmental research goals and objectives
In addition, IRB review is required under the following circumstances;
- Research requiring "continuing review"
- Research conducted by affiliated faculty/staff
- Research conducted at another institution by UWG affiliated persons
- Research in foreign countries conducted by UWG affiliated persons
- Research conducted in courses (courses in research methods and class assignments involving research with human participants require IRB approval if the research project(s) will be contributing to generalizable knowledge (will be published or presented outside the university community.)
- Faculty-supervised student research (Faculty must take an active role in ensuring that research projects are conducted in accordance with the IRB's requirements)
- Research at a pilot or feasibility stage (pilot and feasibility studies, even those with only one human participant, require the same review as full-scale research projects. Applications to the IRB for pilot studies should be identified as such, and participants must be told during the consent process that the study is a pilot)
- Research involving secondary use of data (projects that use data on humans gathered in earlier projects and in which individual identifiers are present require IRB review.
Do Oral Histories need IRB approval?
Some research involving oral histories incorporate systematic study leading to generalizable knowledge according to federal definitions, and therefore are subject to IRB oversight. Examples might include interviews with Iraq war veterans that are intended to draw general conclusions and learn about the impact of using National Guard soldiers in a war, or open ended interviews intending to create an archive for future research.
Some oral histories are incorporated into projects that are not defined as research under federal regulation. Examples might include folklore research or artistic creations such as documentaries, which may contain a definable point of view, but do not attempt to draw conclusions and therefore do not contribute to generalizable knowledge. Examples might include a video interview with holocaust survivors created to preserve or describe individual experiences, or interviewing a prisoner for a magazine article on prison life. Neither intends to draw conclusions or inform policy. The information is specific to a person, their experiences, and events.
Whether subject to IRB approval or not, participants in oral history projects should be allowed to review the material prior to public archive and decide if they do not wish any or all of the oral history archived.
Do Humanities Projects require IRB review?
The majority of humanities projects do not require review by the IRB. While these projects are clearly scholarly work, they do not always meet the regulatory definitions of research. There are, however, cases where the project would fall under the purview of the IRB. Studies which qualify as “research” and which involve “human subjects,” as defined in the federal regulations, would require IRB review. Examples that do not require IRB review are:
- Interview activities that are categorized as "journalism"
- an interview with content experts or consultants about factual issues only, in which no personal information is obtained from the interviewees
- A Mass Communications student proposed creating a documentary film to tell the stories of street children living in a South American country. The purpose of the film was to establish a sense of urgency to help these children. This is a descriptive case study not intended to be generalizable;
- An art student proposed producing photographs of the visual images in a poem by a famous poet. The images are of living individuals engaged in specific activities. This would also be a descriptive case study and not generalizable.
Do data collection activities for grant-funded reports require IRB review and approval?
If the intended use of the data collected is solely for reporting back to the funding agency as a basis for evaluating the project, then the associated data collection activities typically do not require IRB review and approval (keep in mind that there are some federal agencies, such as the Centers for Disease Control (CDC), that may require evaluative data collection activities to receive IRB review and approval).
However, the IRB recognizes that there may be situations where you want to use the evaluation data for research purposes or to collect additional data from your project participants strictly for research purposes. In these situations, IRB review and approval of the research-related aspects are required. In either case (use of evaluation data for research or collection of additional data strictly for research) your consent document(s) should clearly differentiate the evaluation components (for which participation is generally mandatory) from the research related components (for which participation in or use of collected evaluation data is voluntary).
What sort of review is needed for class-related projects?
IRB review of classroom-related activities is not required at UWG when the collection of information from participants is exclusively for the purpose of class discussion or for the purpose of training in research or research methods*. Instructors who believe that their students’ classroom-related activity does not require IRB review may choose to submit the Classroom Research Form. Instructors who are uncertain about whether their classroom activities require IRB review should contact the Office of Research & Sponsored Projects.
Even when IRB review is not required, activities designed to collect information from human participants should protect the rights of these participants. In such cases, the instructor remains responsible for educating students about the protection of human subjects and providing ethical guidance for all student projects.
*Note: Data collected for a class project may not be used for publication or presentation outside the UWG community, unless the project was reviewed and approved by the IRB prior to recruitment and data collection. Should there be any possibility of or intent to publish, present, or otherwise disseminate research data or findings outside the course in the future (e.g., for a Senior Paper, a Master’s Thesis, by the instructor), an application must be submitted for review and approval by the IRB prior to the start of recruitment and data collection.
How long does IRB review take?
Generally speaking it takes three to six weeks for an IRB project to be approved. Though this may seem like a long time, the materials must be processed by the Office of Research & Sponsored Projects staff, distributed to the IRB members (a week before the meeting for Full Board Review). Most projects require revisions. Sometimes they are minor. An application that is complete, with all attachments, and proofread with no typos can be reviewed more quickly than a project submission that is incomplete or poorly prepared.
When should I submit my application to the IRB?
You may submit your application at any time, but you must receive IRB approval before you begin recruiting participants or collecting data. For a full board review, complete application materials must be received by the first day of the month in which the review will take place.
What do I submit?
You should submit the IRB Cover Page, the appropriate application form, an informed consent form or survey cover letter, training certifications for all researchers involved, and any tests, surveys, interview questions you will be using in your study, and any recruitment materials.
Which IRB application should I complete?
Before starting an application, investigators must identify the appropriate Review Type. This determines which application is completed
- Exempt status is for minimal risk* studies meeting specific criteria. Research is “exempt from full board review”, but an “Exempt” application must still be completed and submitted for review. Only the IRB Chair, committee members, or IRB Administrator may determine if an application meets exempt status.
- Expedited review is for minimal risk* studies meeting specific criteria. Protocols are generally reviewed by one primary IRB reviewer. Protocols approved under Expedited review are subject to IRB continuing review.
- Full Board review is for protocols that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a convened IRB meeting. Examples of protocols requiring Full Board review include randomized double-blind placebo-controlled studies; Phase I, II, III and IV clinical trials. Studies asking questions about drug use, immigration status, or involving “at-risk” populations, etc. may require Full Board review.
*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
What are examples of research that might be exempt?
- An observational study of the public behavior of persons at a tennis club, as long as you are not video taping or photographing the people you are observing.
- An anonymous survey or interview (e.g., no names are collected or can be linked to the participants), as long as the survey does not cover sensitive or psychologically distressing topics
- A study analyzing secondary data sets (e.g., Census Data or Medicare Data) where identifiers have been removed
- Any study using archival documents that are publicly available, such as library archives or legal cases.
What are some common items that may disqualify research as EXEMPT research?
- Use of personal/individual identifiers;
- Use of minors where interaction with researchers is involved (school settings that go beyond observations or where the researcher has contact with the children, e.g. surveys or interviews);
- The subject of research relates to sensitive information where the identities of the subjects may be capable of being recognized;
- Audio taping or videotaping the subjects because then the subjects are not anonymous;
- Use of vulnerable populations including minors, pregnant women, prisoners, and cognitively impaired persons. Other groups may be considered vulnerable populations based on the study design.
What is not NORMAL EDUCATIONAL PRACTICE for an exempt study?
Examples of studies that would not be Exempt under Normal Educational Practices are:
- Collecting privileged information such as socio-economic status, sexual information, abuse, etc.
- Educational activities involving procedures that are rarely used and are not considered “best practice” in the field.
- Studies that may involve normal educational practice, but are greater than minimal risk to the students.
- A teacher surveys students in the classroom about their after-school activities. The setting is typical, but the activity is not normal education practice.
- A teacher randomly divides the classroom into two groups and conducts an experimental educational program with one group and conducts the normal educational program with the second group for research purposes. This activity is not normal educational practice for most classrooms.
How do I know the IRB will understand my proposed research?
The IRB consists of faculty, researchers and members of the community at large. Individual experiences and interests cross diverse areas. Protocols should be written in layman terms to be clearly understood by members of all disciplines.
The IRB will seek assistance from qualified persons outside its membership when it receives protocols that require expertise beyond that available on the Committee. While outside experts may inform the IRB's decisions, they do not vote on research protocols presented for review.
What is CITI Training?
The Collaborative Institutional Training Initiative (CITI) is a well-respected, web-based training product designed and maintained by a number of nationally known professionals. Currently, the CITI program is used by over 1,130 participating institutions around the world. Over 1.3 million people have registered and completed a CITI course. UWG chose CITI training because the content is extensively reviewed, critiqued and updated. The University uses the Collaborative Institutional Training Initiative (CITI) web-based human research courses to satisfy the requirement for UWG researchers training in human research subjects protection. Initial and continuing education (every 3 years) are required.
Who is required to take the CITI Human Subjects Protection training?
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.
Who are KEY PERSONNEL?
“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.
Who are NOT considered key personnel?
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.
Do I need to take CITI if a project is exempt?
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.
Do I need to take CITI if a project was determined to be NOT HUMAN SUBJECTS RESEARCH?
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.
Why must I complete the CITI training?
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.
What should I do if I complete human subject protections training at another institution?
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.
Will the IRB review an initial application if all key personnel are not trained and certified?
IRB applications will not be reviewed unless all key personnel have completed CITI training.
Is there a minimum passing score required in order to be certified?
A passing score of 80% is required.
Which CITI training modules should I take?
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.
How long will it take to complete the courses?
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.
Can the CITI modules be taken in a different order?
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.
I would like to use my classroom/employees/clients as research subjects, can this be done?
Sometimes. While it is convenient, there are reasons not to use your students/employees/clients as research participants. Unless there is a compelling reason, it is best not to use anyone in a subordinate position to you to eliminate all appearance of coercion. The idea is that potential participants may feel obligated to participate even if there is no direct compulsion to do so.
What information must I provide to be able to use students in my classroom as research subjects?
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.
How do I observe/survey students in a classroom setting?
- 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.
What do I do if I am taking students out of the classroom setting for testing?
- 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:
- 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.
- 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.
- 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.
Can I give extra credit for participating students?
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.
My research may be impacted by requiring consent signatures. What can I do?
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.
Some of my participants could be under 18. Must I get parental consent for participation?
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:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
What are the eight essential and six additional elements of consent?
Eight essential elements:
- 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.
- A description of any reasonable foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
- 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.
- 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.
- 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.
- 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:
- 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.
- Anticipated circumstances under which the subject’s participation may be terminated by the investigators without regard to the subject’s consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- 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.
- The approximate number of subjects involved in the study.
What does the IRB look for in an application?
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.
My research is exempt, do I need to use informed consent?
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.
What is considered IDENTIFIABLE INFORMATION? I'm not using names.
"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:
- 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
- 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
It is just a survey. What kinds of RISKS could occur to a research subject?
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.
Loss of Confidentiality
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.
What is the difference between confidentiality and anonymity?
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.
What if some of my subjects don't speak English?
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.
What if I change something about my study?
If you are making changes to personnel only, that can be processed by sending an email to firstname.lastname@example.org with the IRB number and the specific changes to personnel. Note: All new personnel will be required to complete the online CITI Training. All other changes require the submission of the IRB Modification Form. The modification form can be found on our forms page.
When do I need to apply for Continuing Review?
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.
Should I notify the IRB when my research study has been completed?
Yes, you should notify the IRB that your study is completed by submitting the Research Completion Form.
When do I have to report to the IRB?
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.
Research in Foreign Countries
When faculty, staff, or students conduct research with human subjects in a foreign country, there may be cultural differences that should be considered in the IRB review. Some of the differences are listed below.
- Language: When documents are translated into a language other than English, the researcher should provide 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.
- Minors: When subjects are younger than 18, researchers are required to get written parental permission. However, if local regulations are such that parental permission for research in a school setting would be inappropriate, the researcher should give the IRB proof that this is inappropriate.
- Audio/video taping: When researchers audio/video tape subjects, the IRB requires a signed consent form. But in some cultures, subjects would be reluctant to sign an official form. This should be explained in the application, and the IRB will consider alternative means of documenting consent such as obtaining verbal consent. Subjects should be informed of their rights, confidentiality, and all other aspects of consent.
Non-English Speaking Subjects
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.