General IRB FAQs

IRB applications can be signed with a physical signature (sign with a pen and then scan the document for submission) or signed electronically.  To sign electronically, please use DocuSign or Adobe Digital ID.  There are multiple ways to “sign” in Adobe, but this is the only method the IRB accepts.

For directions on setting up your Adobe Digital ID signature, please go to https://helpx.adobe.com/acrobat/using/digital-ids.html.  Once your Digital ID is set up: in Adobe, go to the “Certificates” tool and select “Digitally Sign.”  DO NOT use the Fill and Sign tool.  Digital ID is available in the free version of Adobe.

• Anyone who is “engaged” in the research must be included in the personnel section of the application. This includes anyone who will conduct research procedures including consenting participants and data collection as well as anyone who will have access to raw data.
• All personnel DO NOT have to be listed as PI or Co-PIs on the cover page. The decision on who is listed as PI and Co-PI is at the discretion of the research team. Student researchers should consult their thesis or dissertation committees.

To submit a change to your approved IRB protocol:

• Submit an amendment form explaining the changes being made
  • The “Amendment #” on the form is referring to number of amendments you have submitted (ie. if this is your first amendment, the Amendment #is 1)
• Submit an updated application with the changes underlined
• Submit any other documents that require updating due to the changes being made (informed consent(s), recruitment materials, etc.). 
• For personnel additions, please include a copy of their “Human Subjects-Social & Behavioral Research – Basic/Refresher” training certificate.
• All revised documents should have any changes from the currently approved versions underlined- previously approved changes should NOT be underlined.

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.

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.

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.

Passive or Opt-out consent is not generally considered legally valid consent and requires the IRB to grant a waiver of informed consent or documentation of consent. Passive consent should not be used when participants will be recorded or provided with significant compensation or incentives.  

From the hhs.gov informed consent FAQ:  If the IRB has approved this alteration of the consent process and has waived the need for documentation of consent, then such procedures are permissible under the regulations. By sending back a completed survey the recipient has implied that he or she consents to participate but has not signed an informed consent document. Although some might call this “implied informed consent,” OHRP would consider this to be a permissible informed consent process if the IRB has approved the informed consent alteration and waived the requirement for documentation of informed consent.  

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html

The IRB provides a consent alteration or waiver request form on the IRB website to walk you through the requirements.  The form is located on the IRB Forms – other forms tab.  It is titled Informed Consent or Authorization Waiver Request.

The required elements are:

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 (i.e., it would not be possible to do this research with active signed parent/guardian permission)
4. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
5. If the research involves using identifiable private information or identifiable biospecimens, the research could not be carried out without using such information or biospecimens in an identifiable format (i.e., it would not be possible to do this research without obtaining identifiable information and/or biospecimens)  This would require an explanation of how you will protect that data and destroy identifiers at the earliest possible time.
6. Subject selection should be based upon class or group membership or open enrollment and not exclusionary unless the investigator can depend solely upon exclusion criteria documented in the consent language for subject self-selection.

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.  

Research

DHHS Definitions:

Research is as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

Examples of systematic investigations include:

• surveys and questionnaires
• interviews
• focus groups
• photovoice studies
• analyses of existing data or biological specimens
• epidemiological studies
• evaluations of social or educational programs
• cognitive and perceptual experiments
• evaluation of business process effectiveness
• medical chart review studies

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (like a class assignment).

Research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.

Examples of activities that typically are not generalizable include:

• biographies
• oral histories that are designed solely to create a record of specific historical events
• service or course evaluations used only for the purpose of improving the service by the collector without presentation of application to outside entities.
• classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
• quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the GS community.

Human Subjects

DHHS definitions:

A human subject is as a living individual or a biospecimen about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

• Intervention includes both physical procedures by which data are gathered (e.g., blood draw) and manipulations of the subject or the subject’s environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject.
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record or opinion poll).

Investigators conducting human subjects research must satisfy DHHS (OHRP) regulations [45 CFR Part 46] known as the Common Rule and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable.  Find a comparison of FDA and DHHS regulations at https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm

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.

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.

There are some research questions that require techniques that involve deception in the study design to achieve the purpose and answer the question. In order for such a study to gain approval, the researcher will have to explain in their application how the use of deceptive techniques is justified by the study’s significant prospective scientific, educational or applied value and how alternate nondeceptive alternative procedures are not feasible. Most studies that contain deception techniques will be reviewed by a full board committee process. Low risk deception, such as passive deception studies that contain risk control (e.g., debriefing) may be reviewed by an expedited format at the board’s discretion.

Active deception involves intentionally providing inaccurate or false information to participants to seek a more valid result (e.g. the researcher tells participants that they will be completing a task engaged with a described partner of a specific age, race or gender, but instead they will really be interacting with the researcher or other investigator on the team to measure potential biases).

Passive deception or deception by omission involves withholding information, or providing incomplete information, with the intention of misleading the participants about the research purpose or procedures. (e.g. the researcher tells participants that they will be taking a quiz but aren’t told that the researcher will evaluate how background noise affects their ability to concentrate.)

As long as certain conditions are met (e.g., debriefing), this approach is generally considered acceptable, because researchers may not want to reveal their hypotheses to study participants in case this leads them—consciously or unconsciously—to adjust their behavior. (APA standard for use of deception)

When a study uses deception, fully informed consent cannot be obtained from subjects because they are not provided with enough information to make an informed decision. A waiver form to request an alteration of the required elements of consent must be included in the IRB application to waive the element of consent associated with the deception (e.g., waive the requirement to provide an accurate description of a procedure).

1. The alteration to the consent must provide a truthful description of the study to the extent possible.

2. Either the consent should state that the description of the study includes inaccurate or incomplete information and they will be provided with a full explanation including the reason for withholding the information at the end of the study or the application must include a justification for why this statement would impede the research.

3. The study must include a debriefing at the end, including an opportunity for the subject to withdraw and have their data deleted from the data set if they wish. The debriefing should include when the debrief will be done, who will be responsible for the debriefing and how it will be done.

• If the research proposed involves gathering data from, about, or engaging a student or students they have some responsibility over to gather data for the researcher, 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.  The consent/assent should be clear about what controls will be used.
• To meet the requirements under FERPA:  The researcher will need consent to use student data gathered for teaching purposes for research use.  This permission should be included in the research informed consent or the course syllabus with instructions for how to opt out.

More information on Faculty Use of Student Data in Research Policy

The answer is yes if any of the following apply:

1. 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.)
2. You will be using the data in your honors project, dissertation or thesis.
3. 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).
4. 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:

1. You will be collecting the data only to improve your teaching skills, without sharing the data.
2. You will present the data only to the principal.
3. 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.

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:

Data De-identification: An Overview of Basic Terms

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.

You need 2 types of consent.:

1. 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).
2. 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.  

For more information on using student data for research, please read the Faculty Use of Student Data in Research policy and the Faculty Use of Student Data in Research Policy Procedures.

University Researcher sometimes provide an incentive to obtain sufficient participation in a research project. That incentive can take many forms including monetary (e.g. gift cards, phone minute cards) and non-monetary items (e.g., T-shirts, books) or intangible benefits (e.g., nominal extra credit option where alternate methods of obtaining equal extra credit are available).

• The value of the incentive must be nominal and in alignment with the effort expended by the participant so as to avoid becoming potentially coercive.
• Incentives can not be considered as a benefit of the research. Incentives are compensation to offset the inconvenience of participating in the research.
• Incentives can not exert undue influence over the participant. (HHS – addressing payment concerns)
  • each situation is evaluated on a case-by-case basis to determine appropriate balance of incentive to effort and assure clear description of how the incentive will be fairly distributed. (HHS – Addressing ethical concerns, offers of payment to research participants)
• The incentive must be clearly described in both the narrative and the informed consent. The incentives must not be overstated or sensationalized in recruitment materials.
• Any incentive utilized must be clearly described in the narrative and informed consent. (See details below)
• For studies that extend over several sessions or stages, incentives must accrue in alignment with effort. Incentive credit should be accrued as the study progresses and not contingent upon the subject completing the entire study. (FDA – Payment and Reimbursement to Research Subjects)
• Any limitation on incentive accrual must be in agreement with the participant effort in terms of time, money or other resources and clearly stated in the informed consent.
  • E.g., single effort short duration studies can assign a nominal incentive that does not impact participant costs to accrue at the end of the effort. (e.g., a nominal gift card may be provided at the end of a interview or survey, while reimbursement for parking to attend an interview or focus group meeting should not be withheld if the participant ends participation early. )

Important: When you describe the incentive in your informed consent it must include:

• An explanation of how participants will be compensated
• The amount and form of compensation
• How the researcher will distribute the incentive to participants — including any identifiable information that will be collected during that process
• Circumstances under which participants will or will not receive the full or partial incentive.
• Timeframe in which the incentive will be distributed.

Related FAQ links –

Can I use a drawing as an incentive?

Human Subject Incentive Payment Policy and Procedure – FS-AP-1304-01

A drawing style format may only be used as a research recruitment incentive if potential participants can elect to participate in the drawing without being required to participate in the research to be eligible to win. (For information on incentives not presented as a drawing see Human Subjects Incentive Guidance)

To use a drawing as an incentive within the law –

• The IRB narrative recruitment section must include a description of how individuals, including those who do not consent to participate in the research, will be notified of the drawing and provided with access to participate. Everyone who elects to participate in the drawing must have an equal chance of winning all prizes.
• The informed consent must include statements that participation is not required to enter the drawing, that participants will remain eligible to win even if they withdraw from the study before completion, and state how non-participants can enter into the drawing.
• The drawing must be conducted in a way that does not compromise any participant anonymity or confidentiality that is promised within the approved protocol.
• The research may not include activities that are more than minimal risk and may not include participants who are under the age of 18.

Georgia Southern IRB will not approve an incentive strategy that meets the definition of a lottery or raffle
under Georgia law.

Under Georgia Code 16-12-22.1 (b)(3) – a lottery or “raffle” means any scheme or procedure whereby one or more prizes are distributed by chance among persons who have paid or promised consideration for a chance to win such a prize. For research – that consideration would be the participants time and knowledge.

Related FAQ –

Human Subjects Incentive Guidance

Human Subject Incentive Payment Policy and Procedure – FS-AP-1304-01

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.

What is Single IRB review and how can I use it? –

The single IRB (sIRB) mandate is mix of federal policies and regulations that require certain types of federally-funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all of the institutions.

2 implementation dates

1. The revised Common Rule single IRB provisions, effective January 19, 2020

2. The NIH policy is effective as of January 25, 2018

Options:

• • Check your FOA – NIH may mandate the IRB.
  • External IRB
    • Required for non-observational clinical trials or industry sponsored clinical research.
  • Reliance agreement with an accredited institutions primary IRB
    • Each IRB that serves as a primary IRB will require an agreement with each of the relying IRBs.

Yes, with an IRB approval and with certain restrictions:

• Recruitment of participants and/or collection of research data is not allowed inside of building hallways or near classrooms doors.
• Recruitment of participants and/or collection or data is not allowed inside of classroom spaces unless prior arrangements have been made with a specific faculty member for a specified class period.
• No recruitment or 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.
• Recruitment of participants and/or data collection in the library, the RAC, or in and outside of Russell Union must be registered with the facility office in advance.

Any recruitment of participants and/or data collection effort should not impede traffic on the sidewalk or pedestrium. Each subject may only be approached once.

The GS survey distribution policy requires an institutional approval beyond the IRB approval for research that specifically distributes recruitment for research participants via the Georgia Southern email system. Where the GS email system will be used to distribute research recruitment requests, a condition of your IRB approval will be to obtain the required approval to use the GS email system to distribute your research recruitment. This includes recruitment sent to GS listservs as well as targeted GS email addresses.

For survey distribution and research recruitment to Georgia Southern emails, AFTER you have received IRB approval you must receive additional institutional approval.  Please visit the Office of Institutional Research’s website for Survey Distribution Approval Procedures.

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.

Survey Distribution Website: https://em.georgiasouthern.edu/ir/survey-distribution-approval-procedure/

Find the Survey Distribution Policy on Georgia Southern Commons.

Student population research: GS policy does not allow any GS unit to provide student email addresses to external researchers as directory information under the Family Educational Rights and Privacy Act (FERPA). This applies regardless of whether the survey/data collection is being conducted for research, marketing, or any other purpose.

For all other research project requests include the following in a single email and submit to irb@georgiasouthern.edu:

1.  A copy of the approval letter from your home institution IRB or Human Subjects Ethics committee approval. (If GS approval is a condition of your approval, a conditional approval will be accepted.)
2. 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., identification of subjects or recruitment.)
3. A copy of the researcher’s human subjects training certification
4.  A copy of any recruitment materials to be utilized
5. A copy of the informed consent tool to be used
6. A copy of data collection instruments used (questionnaires, focus group or interview plans, etc.)
7. Appropriate contact information for the principal investigator (from the home institution).
8. If applicable, the name and affiliation of any Georgia Southern contact for this proposed study that you have already established.

The IRB office will forward reasonable and complete requests to the Provost’s office for institutional determination.  The institution reserves the right to decline any third party research request at the institution’s discretion. Third party research that duplicates GS studies in progress or requires significant local resources to accomplish will not be approved.

• Snowball sampling is a recruitment technique in which research participants are asked to provide contact information about another person for the purpose of allowing research recruitment.  The technique for recruitment can be appropriate depending upon the nature and sensitivity of the research topic:
  • For low-risk research it may be appropriate for subjects to provide researchers with names and contact information for people they know who may be interested in participating. The researcher could then contact the new participant directly. This process is acceptable in research where participants are asked to give perceptions on a benign topic or participants are in a place that is open to the public
  • For more sensitive research, the researcher should justify the need for the snowball technique and provide mechanisms to minimize the risk of violating the secondary participant’s privacy.  For example: The researcher may provide their contact information, a link to the approved study recruitment information, flyers or QR code to allow participants/stakeholders to pass the recruitment information to others. This process is essential in instances where identifying a new participant would immediately reveal personal information or health status (e.g., drug use) of the new participant.
• The protocol should clearly articulate
  • the justification for the use of the technique in the context of the study and the target population. 
  • Steps taken to minimize the risk of violating an individual’s privacy in recruitment.
• Care must be taken to account for the local culture, political climate, and individual potential participants’ expectation of privacy when determining relative study of the study for the topic.

See NSF FAQ http://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp#snow

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.

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). 

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.