How does the IRB view open records?
The open records act adds a difficult twist to the protection of human data. FOIA data is technically public data but often contains much that could carry subject risk and may have been generated under conditions where there was a clear expectation of privacy. FOIA data collected prior to IRB approval could still be accessed for pre-study formation (like literature review material) but could not be used as research data (including pilot) prior to IRB review and approval.
The GS IRB would look at public data through the expectation of privacy filter and expect the researcher using such data to provide a method of mitigation for data that carries an inherent risk to the subject – (like a plan for data de-identification) to provide approval. The data would not be eligible for exemption under B4 unless obtained from the FOIA source as de-identified data.
Is my project a Clinical Trial?
There are 2 definitions for clinical trial.
NIH Definition: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. You can find a decision tree and additional assistance on the NIH clinical study page at http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials. This decision logic does not include an FDA determination.
Find definitions for terms used in the NIH definition of Clinical Trial here.
FDA definition: A clinical study (trial) in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. FDA Clinical Trials generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation,meaning that the trial has one or more sites in the U.S., involves a drug, biologic, or device that is manufactured in the U.S. (or its territories), or is conducted under and investigational new drug application (IND) or investigational device exemption (IDE).
Is my project Research or Quality Improvement/Program Evaluation?
Quality improvement (QI) activities and/or Service Program Evaluation are important components of maintaining a clinical or public service program. Because these activities are data-driven and involve human participants there can be significant overlap with research methodologies common to human subjects research whether the data is intended for publication or not. The simplest difference lies in the intended use of the data. Will the data gathered be used for current program improvement, accreditation or benchmarking, or will it be analyzed in a manner that could contribute to generalizable knowledge? Where overlap exists between evaluation and research methodologies, the federal regulations that protect human research participants will apply and IRB approval must be obtained.
Whether the evaluation activity is human subjects research or not, it is vital that it be executed in a manner that is ethical and respects the rights and welfare of the human participants.
The links below provide access to some decision trees created by sister institutions that might help you in determine if your project requires IRB approval. You may also contact the IRB office at 912-478-5465 or firstname.lastname@example.org for assistance.
Can I conduct research using my staff as research subjects?
In most cases, you should not use subjects over which you have a power relationship, to prevent unintentional coercion. Depending upon the nature of the data gathered, the relative size of the population, and your ability to gather the data without identifying the subject, it may be possible to eliminate the risk. However, a careful plan would need to be devised and approved.
Can I conduct research in my classroom if I am the teacher?
If the research you are proposing involves using your own students or students which you have some responsibility over, then there is an inherent conflict of interest. Special precautions need to be taken to ensure that this conflict is managed and there is no unintended coercion. Students may feel as if they will be punished, disappoint the teacher or receive a lower grade if they choose not to participate in the project.Some options to remedy the situation are offered below:
- The study can be presented by a colleague or somebody not involved with the students to allow students to make a decision without feeling obligated to comply.
- The study can be completely anonymous. Data must be collected in a manner that does not allow the teacher to determine which students participated.
- The teacher can collect the data and hold it for research use until after the class has been completed and grading is complete. This method can only be used where the same teacher will not teach the same students in the following semester.
- If appropriate, the study may be conducted utilizing assignments that are part of the normal curriculum.
In addition to these precautions, the consent form or assent form needs to state that the students will not receive any penalty nor will the teacher get upset, if they choose not to participate.
To meet the requirements under FERPA: You will need consent to use student data gathered for teaching purposes for research use. This permission should be included in your research informed consent.
Does my teaching require IRB approval?
The answer is yes if any of the following apply:
- Your project contains a methodology for systematic data collection that will provide a conclusion applicable to situations beyond the one examined with or without current intent to publish. (e.g., evaluations that determine an individual teacher’s effectiveness at delivery of a lesson are not generalizable; studies that determine the efficacy of a method of instruction to affect standardized test scores are generalizable.)
- You will be using the data in your honors project, dissertation or thesis.
- The resulting conclusions will be published (including at the Georgia Southern library, any website or available for review by individuals other than the researcher or course instructor).
- The data will be used to create a presentation, poster presentation, and capstone paper or similar and that product will be preserved as an independent work.
The answer is no if:
- You will be collecting the data only to improve your teaching skills, without sharing the data.
- You will present the data only to the principal.
- You will be presenting the data only to your teacher, class members, and other Georgia Southern students and faculty (not for honors project, capstone, thesis or dissertation) and project documentation will be treated as a normal class assignment and not retained by the institution or instructor or reused by the student for any purpose.
If you are teaching a research methods course in which students will conduct independent practice research, you will need to apply for an instructor class exemption for the semester.
How do I de-identify my student data for research use?
De-identifying data requires the researcher to successfully clean the student record used of any information that is directly linked to the student as well as indirect data that could lead allow another individual to figure out the students identity.
The Department of Education has created an overview of the basic strategies that can be used singly or in combination as part of your strategy developed to de-identify student data. We have provided a link to that document below:
The IRB will not mandate how you accomplish data de-identification but you will be asked to describe your strategy in relationship to the data you are collecting. Your description will need to be clear and complete.
A simple statement that you will de-identify the data will not be sufficient.
Do I need consent to access student data for research or scholarship?
You need 2 types of consent. One is your IRB Informed Consent (research participant understanding) and the other is a FERPA consent or release (use of student data for a purpose other than their education).
Data collected from your students requires consent to release the student data for research purposes to conform with FERPA requirements. This consent is a separate consent requirement from the IRB consent to participate but can be included in the same Informed Consent document to reduce the number of consents you need to acquire and maintain. The FERPA statement in the consent document should identify what student data you want to use and under what conditions you will use it.
E.g., I would like to use your test scores, journal entries and lab reports and other assignments in my analysis. I will de-identify all assignments and classroom data prior to research use. You will not be identified in any report, presentation or publication.
Under the GS FERPA policy consent is required for use of identifiable student data. In order to use student data in your research effort the data must be de-identified data (including inability to go back and re-identify from course records) or you must have a student consent to release the data to you for the secondary use. (E.g., Past student data that you acquire from a colleague that does not contain student identifiers or information/demographics specific enough to identify the student can be used without a FERPA release along with an IRB consent waiver request. Past student data from your own classes would not fit this category since you still retain the course records from your teaching use.)
1. If you are the instructor of record, under current GS policy interpretation of the University FERPA policy, you will need release (consent) from the students to use the data you collected for the purpose of course completion for the purpose of scholarly research. (You are not able to de-identify your own data without knowing the student identity.)
2. If you are not the instructor of record for the course from which the data will be taken and the data can be provided to you in a fully de-identified format as a research data set , then it is possible to obtain a waiver of consent if you are able to describe and meet the following:
- the research involves no more than minimal risk to the participants;
- the waiver or alteration will not adversely affect the rights and welfare of the participants;
- the research could not practicably be carried out without the waiver or alteration; and
- whenever appropriate, the participants will be provided with additional pertinent information after participation.
3. If you are using student data from another institution – You would need to obtain a copy of their FERPA policy stating that access to the data from their students without consent for scholarly research purposes is permissible or a letter of cooperation from an appropriate official that would provide the same assurance (Sample available on the forms page of this website) to potentially obtain the waiver.
I already have access to data about my subjects because of my position. Can I use that data for research purposes without consent?
No. Data you access because of your position is entrusted to you for a specific use. Research use is not normally included in the intended use of the data. You may be able to access the same data but would need to gain access through the same process that an outside researcher would use.
- e.g., a pharmacist may not access patient drug purchase data without permission from the patient and acknowledgement from the pharmacy owner, though the data is available to that researcher in the role of pharmacist.
- e.g., a teacher will have access to student grades, free-lunch status, IEP data, etc. for the purpose of education facilitation but does not have access to the data for the purposes of generalizable research.
Can I collect data from campus buildings, pedestrians, or random people on campus?
Yes, with an IRB approval and with certain restrictions.
- Collection of research data is not allowed inside of building hallways, or near classrooms doors.
- Collection is not allowed inside of classroom spaces unless prior arrangements have been made with a specific faculty member for a specified class period.
- No data collection may be conducted near building doorways.
- Data collection in food service areas must be unobtrusive. You may not approach individuals more than once and may not block traffic patterns.
- Data collection in the library, the RAC or in and outside of Russell Union must be registered with the facility office in advance.
Any data collection effort should not impede traffic on the sidewalk or Pedestrium. Each subject may only be approached once.
When do I need a letter of cooperation to access my population and what does it have to look like?
A letter of cooperation is simply a way to acknowledge that you are using resources that belong to another party for your purposes. Anytime you are accessing employee or student time, the resources of a business or institution or data that belongs to another entity, you will need a statement/letter of cooperation. Anytime you are accessing subjects, data or resources from another institution you will need a letter of cooperation.
If you are accessing data from a GS resource (e.g., you want to collect data in a classroom), the letter can be as simple as an email acknowledgement or handwritten permission from an individual with adequate authority to provide access (e.g., the faculty member who teaches the class).
If subjects are students or employees of another institution, a more formal method of documentation would be appropriate. This may be a letter or email from the institutional official’s professional address with the institutional officer and title identified in the email body.
- All letters of cooperation must clearly identify the investigator and project by title.
- If using education data obtained from school records you must include documentation of parental permission for the release of such data under the Family Educational Privacy Act (FERPA). This may be a copy of the release form, informed consent, or an assurance from the institutional official that such permission has been obtained prior to data release.
- If you are using medical/patient data, you will need to include a HIPAA data security release statement. See the sample LOC on the forms page for an example.
Do I need an informed consent for an anonymous survey?
Ethically, consent preserves the autonomy of your subjects. The consent statement tells the participant why you are asking the questions and what you will do with the information they are providing.
Sample consent statement for exempted research:
You are being asked to participate in a survey research project entitled “Project Title” which is being conducted by “Researcher Name”, a “faculty member/staff member/student” at Georgia Southern University for the purpose of scholarly presentation. This survey is anonymous. No one, including the researcher, will be able to associate your responses with your identity. Your participation is voluntary. You may choose not to take the survey, to stop responding at any time, or to skip any questions that you do not want to answer. Your completion of the survey serves as your voluntary agreement to allow the anonymous data gathered to be used in this study and in future research.
Questions regarding the purpose or procedures of the research should be directed to “Researcher Name” at “phone number” or “email address”. This study has been reviewed by the GU Institutional Review Board (IRB) under tracking number “Insert tracking number here” in accordance with Federal regulations.
Do I need IRB approval for my pilot study?
Yes and no. Read this entire answer before you proceed.
Generally, a pilot study is defined as a preliminary investigation to determine the feasibility of a study. It is usually done on a small scale (usually fewer than 10 subjects) and exploratory in nature. Its purpose is to refine data collection procedures, instruments, or research design.
Pilot studies answer questions such as “in what order should the survey instruments be distributed”. These questions do not qualify as questions that will contribute to generalizable knowledge and thus pilot studies do not qualify as research and do not need IRB review and approval. Nonetheless, it is assumed that the proper steps will be taken to protect human subjects (e.g., use of informed consent, confidentiality, etc.).
NOTE: If sensitive data, vulnerable populations, or methods with more than minimal risk are to be used, a consultation with the IRB Chair or Administrator must occur before data is collected without IRB review and approval. The IRB retains the right to require review of a project characterized by the faculty member as exploratory (pilot) in nature.
If it is possible that the data collected in your pilot study will be used solely or in combination with other data for generalizable or publication purposes, IRB review and approval is required BEFORE data collection begins. Pilot data collected for the purpose of research process refinement without inclusion in an IRB approved protocol may not be repurposed as study data. The IRB cannot provide retroactive review. Researchers are cautioned not to confuse pilot data with preliminary data. Preliminary data requires normal review processes.
How does the University Survey Policy affect email distribution of survey research on GS campus?
The GS survey distribution policy requires an approval beyond the IRB approval for research that specifically distributes survey research via the Georgia Southern email system. Where the GS email system will be used to distribute survey requests, a condition of your IRB approval will to obtain the required approval to use the GS email system to distribute your survey research.
If you are faculty or staff and plan to distribute your survey via the GS email system, your request must be approved through the Provost’s office. If you are a student, your request must be approved through the Office of Strategic Research & Analysis. You will need to supply a copy of your IRB conditional approval letter with your request.
Marketing surveys still require compliance with the survey policy even though IRB approval is not required for surveys where the data will only be used internally to evaluate the effectiveness of your service.
Find the Survey Distribution Policy on Digital Commons – (http://digitalcommons.georgiasouthern.edu/legal/4/)
What platforms are considered anonymous for surveys?
To be considered an anonymous survey, the platform used can not collect any identifying information from the user (including email address and IP addresses). Currently, Qualtrics (which is available to Georgia Southern faculty, staff, and students through their My.GeorgiaSouthern account) and SurveyMonkey offer an anonymous option that does not collect IP addresses. At this time, Google forms is not considered anonymous as Google does collect IP addresses.
If you would like to use a survey platform not mentioned here, please contact our office to verify if it meets the criteria for anonymous research.
What does a researcher safety plan require?
Safety of the researcher is a component of the safe and ethical conduct of research. Students who are collecting data in the field in a private or secluded locations should have a safety plan prior to contact with subjects in the field. The content of the plan and detail in the plan is dependent on the risk level of the study and the locations where data will be collected but must account for the safety of the researchers. At a minimum, the plan should include a buddy system, a positive notification (someone you call before you go to the home of the subject to collect data and call again upon leaving the subject home, who will send help if you do not check back in within the expected time-frame) and a plan for how to handle the emotional content of the intended interview vetted through your faculty adviser/mentor. The faculty adviser should be fully aware of the time and place of all interviews that take place in secluded or private locations. If the content of the data collected is likely to cause significant emotional upset or a strong emotional response, students should not conduct the study without appropriate faculty support.
What is Single IRB review and how can I use it?
How does a researcher from off campus obtain site access permission to conduct research on GS campuses or with GS populations?
In a single email to email@example.com submit:
- A copy of the approval letter from your home institution IRB or a conditional approval.
- A copy of the methodology for the portion of the research to be conducted on GS campus or with GS populations. This should include a clear description of any assistance you will need from GS to conduct your research. (e.g., assistance in survey distribution, identification of subjects or recruitment.)
- A copy of the researcher’s human subjects training certification
- A copy of any recruitment materials to be utilized
- A copy of data collection instruments used (survey, interview questions, etc.)
- Appropriate contact information for the principal investigator (from the home institution).
The IRB office will forward reasonable and complete requests to the Provost’s office for institutional determination. Please note that GS policy does not allow us to provide email addresses or assistance in sending survey materials to students. The institution reserves the right to decline any third party research request at the institutions discretion. Third party research that duplicates GS studies in progress or requires significant local resources to accomplish will not be approved.
Last updated: 10/14/2019