GT | Office of Research Compliance

I. GENERAL QUESTIONS

What is the Institutional Review Board (IRB) and what is its purpose?

The Institutional Review Board is an independent, federally-mandated panel that conducts initial and continuing reviews of proposed research, to protect the rights, welfare, and safety of human participants. The Georgia Tech IRB is comprised of Georgia Tech faculty and staff plus student and community members. IRB members come from diverse backgrounds; some have scientific expertise, and some do not. The composition and responsibilities of the IRB are governed by the Code of Federal Regulations (45 CFR 46). (See in the GT Guidelines for Investigators.)

Why must I obtain IRB approval prior to conducting my research project?

Federal regulation requires that research involving human subjects be reviewed by the IRB.

What is GT’s Federalwide Assurance (FWA) Number? What does this number represent?

Georgia Tech’s FWA number is FWA00001731. Georgia Tech is registered with the Office for Human Research Protections (OHRP) within the PHS and maintains an up-to-date IRB record with that federal agency.

What ethical principles guide the protection of human subjects?

Drawn from the enduring Belmont Report, three basic principles of ethics are particularly relevant to the protection of human subjects in biomedical and social and behavioral
research. They are:

Respect for Persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;
Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and
Justice: fairness in the distribution of research benefits and burdens.

Who must apply for human subjects review through the IRB?

Anyone who intends to conduct research involving people must apply for and receive IRB approval before beginning that research. This applies to ALL research involving people including but not limited to clinical, social science, behavioral, historic, linguistic and marketing research projects. IRB review may also be required for work involving human tissues and records. If in doubt, contact Melanie Clark, Compliance Coordinator, via email or via phone at (404) 894-6942.

What are some examples of research with human subjects conducted at Georgia Tech?

Examples are experiments, questionnaires, in-person and telephone surveys, interviews and focus groups, observation of public or private behavior, including classroom observations, evaluation and research components of demonstration and training programs, the collection of existing data, and the development and testing of new or improved medical treatments and treatment delivery devices.

Do I still have to go through the IRB even though I’m not applying for funding for my research?

Yes. Any research protocol involving human subjects must be reviewed and approved by the IRB, prior to its undertaking and regardless of funding source, or lack thereof.

What kind of pilot study can I do before preparing an application for IRB consideration?

None. You cannot collect data involving human subjects prior to receiving IRB approval. If your study changes after collecting a small amount of data, you should submit modifications to the IRB for review and approval. Sometimes faculty require students in one or more of their courses to collect data from human subjects (e.g., a student research project intended to learn research methodology).

Does each student or perhaps the faculty member need to submit these projects for IRB review?

The faculty member should submit an application as PI for IRB review that lists the students in the research personnel section. The faculty member should follow the process for exempt review and submit a description of the course activity to the IRB accompanied by a request for Exempt status. If the project turns into a capstone project or thesis, the student should submit a protocol for the individual project. Faculty should coordinate with the Office of Research Compliance, particularly if numerousstudent applications will be submitted within a short span of time.

When do IRB members meet?

Meetings are generally held on the third Friday of each month, unless otherwise announced. The meeting schedule is on the IRB website with appropriate deadline dates for submitting protocols for full board review.

How does the IRB function?

The Board meets monthly to discuss research protocols that have been submitted for IRB approval. Board approval requires a majority vote of a quorum of members. The Board may require additional information or modifications as conditions for approval. The Board may also “table” the application until more information is provided or until significant changes are made. You will be notified of the Board’s decision and whether any modifications to your
protocol are required before approval is granted.

Can the Board stop me from conducting my research?

Yes. The IRB has the authority to suspend or terminate research that is not carried out according to its requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the IRB’s reasons for its action and will be reported promptly to the principal investigator,
the Vice President for Research, and the funding agency. An IRB determination to disapprove a project may not be overruled by any campus office or official.

What’s the worst that can happen if I don’t request IRB approval?

Aside from potential ethical implications for the subject and for the investigator, bypassing IRB review brings other risks:

Students

Funding may be withheld: Many funding programs will not release funds without IRB approval.
Credit may be withheld: The University may, at its discretion, refuse to grant students course credit for research conducted without IRB approval.
Dissertation or thesis work will not be accepted: Graduate students must present to the Graduate School evidence of IRB approval for their projects involving human subjects. Thesis or dissertation work will not be accepted without it.
Degrees may not be awarded for work based on non-IRB-reviewed projects .Articles may not be published: Many professional journals require evidence of IRB approval when considering articles for publication.

Faculty and Staff

Funding may be withheld: Federal sponsors and many private sponsors require IRB approval as a condition of funding. Sponsors may postpone review of proposals for which IRB review is not complete/pending at the time of proposal submission. Some sponsors will not release funds to the University for the investigator’s use without IRB approval.
Articles may not be published: Many professional journals require evidence of IRB approval when considering articles for publication.
The University will not support unapproved research: Liability issues arising from unapproved research become the responsibility of the investigator. Persons conducting unapproved research are deemed to be acting outside the scope of authority granted them by the University. The University will not, therefore, provide an investigator of unapproved research the resources to answer a liability complaint.
The Office for Human Research Protections and the Food & Drug Administration have the authority to halt all federally funded projects involving human subjects, should either of those federal agencies determine that Georgia Tech’s research activities are not appropriately reviewed.

Do I need IRB approval if my human subjects activities will be conducted someplace other than the University campus? Do I need IRB approval if my protocol is already approved by another IRB?

Yes. To ensure that Georgia Tech investigators comply with federal and university regulations, it is important that the University, through the IRB, be aware of where and by whom such activities are being done, even if conducted in a foreign country. In many cases the investigator must provide written authorization from that locale.

Does Internet research need IRB approval, even when the information is available online to the public?

Yes. IRB approval is necessary whenever conducting research with human subjects, even if the information is publicly available as on the internet. However, online research raises many new ethical questions and dilemmas that researchers and IRBs have not previously considered. See the Guidelines for more information about internet research.

Does research involving surveys and questionnaires need IRB approval?

Yes, the form of the study does not matter as much as the content of the study. In other words, the IRB determines the level of review based on the degree of risk to the participant. For example, a survey that asks participants to describe their criminal behavior would most likely be given a full review whereas an experiment involving varying types of management procedures would most likely be considered worthy of expedited review. If you are unsure about your particular study, contact the IRB Administrator at 404.894.6942.

May I recruit students for my research from my own class?

Under certain circumstances, yes. However, this recruitment must be done in such a way that there is no hint of undue influence or coercion. Students cannot be pressured into participating, and refusal cannot influence student grades for the course. It is preferable not to use students from your own classes because it is difficult to avoid the perception
that the students must participate. (See Guidelines for Investigators for more information.)

II. IRB REVIEW CRITERIA

What is research?

Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge, or investigation designed to test a hypothesis.

What exactly qualifies as human subjects research?

Any systematic investigation (including curricular evaluation) that is designed to develop or contribute to generalizable knowledge, and which uses living humans or identifiable private information about living humans, qualifies as human subjects research.

Who is considered a human subject?

A human subject is a living individual, human embryo, fetus (or human tissue or fluid), about whom an investigator conducting scientific 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., venipuncture) 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 (e.g., client or medical
records or information obtained in an interview).

What criteria does the IRB use for reviewing research protocols?

Before granting approval, the IRB must be satisfied that the following criteria are met:

risks to subjects are minimized by using procedures that are consistent with sound research design; and whenever appropriate,
risks to subjects are reasonable in relation to anticipated benefits to subjects, and the importance of the knowledge that may reasonably be expected to result;
selection of subjects is equitable in terms of the purposes of the research and the setting in which it will be conducted;
informed consent is sought from each prospective subject and documented to include all appropriate information; the protocol makes adequate provision for monitoring the data collected to ensure the safety of the subjects;
adequate provision is made and documented to protect the privacy of subjects and to maintain the confidentiality of the data; and
where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate safeguards have been included in the study to protect their rights and welfare.

Does the IRB serve as a scientific review panel?

Not officially, but if a proposed project appears to lack scientific merit or rigor, or to duplicate existing work with more than minimal risk to subjects, the Board is required
to consider whether the benefits to individual subjects and society outweigh the potential for harm to them.

What does “risk?mean? What does “minimal risk?mean?

Risk refers to the probability of harm or discomfort (these can be physical, psychological, social or economic) occurring as a result of participation in a research study. Both the probability and the magnitude of possible harm may vary from minimal to significant. A risk is minimal when the probability and magnitude of harm or discomfort anticipated
in the proposed research are not greater than those encountered in daily life.

What does the IRB look for in an application?

The IRB seeks:

Research design that is sound, given the proposed use of human subjects.
Equitable selection of subjects.
Balanced thought and representation of risks and benefits.
A thoughtful and comprehensive informed consent process.

What are the types of IRB review?

There are three levels of IRB review:

Exempt Review: Federal regulations “exempt” some types of research from further review by the IRB, however, “Exempt” does NOT mean IRB review is not required! Research that falls into the exempt category still requires an application to be submitted to the IRB for review. The review process for the “exempt” category does not require extensive initial IRB review, and investigators will usually be notified within 1-2 weeks after* submitting their IRB application. Final determination as to whether the research is exempt lies with the IRB administrator. Some typical examples of Exempt research:
- Anonymous surveys
- Educational tests
- Data studies using publicly available information
- Observation of public behavior that does not put the subject at risk
- Taste and food quality evaluation
Expedited Review: Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. Expedited research involves the collection of data or samples in a manner that is not anonymous and falls within the definition of minimal risk to subjects. Expedited review may be carried out by the Chair of the IRB, the Administrator, or by one or more experienced reviewers chosen from among the members of the IRB. Review is generally completed within three weeks of submitting* the IRB application. Some common examples of Expedited research:
- Studies of existing data that include subject identifiers
- Linguistic/ethnographic studies
- Collection of data through noninvasive procedures
- Research on individual or group characteristics or behavior
- Research employing survey, interview oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
Full Review: Research that involves more than minimal risk, or that is not covered by the Exempt or Expedited categories, must go through the Full review process. Full reviews are conducted by the entire IRB committee at a regularly scheduled meeting with a quorum of members present. Proposals requiring full review should be submitted to the IRB no later than the first weeks of the month* in which the review is to occur. Some common examples of research reviewed at the Full review level: Studies that include children as subjects or participants

Studies that include institutionalized persons (e.g., prisoners)
Studies that include persons with limited mental capacity (e.g., persons with severe mental disabilities)
Studies that cover sensitive topics (e.g., criminal behavior, sexuality or domestic abuse

(*Please note that international studies require the IRB to consult with experts which will add to the review time)

III. STUDENT RESEARCH

Do student research projects have to be submitted to the IRB?

Yes. Course instructors who assign student human subjects activity must submit an application to the IRB.

NOTE: If research is being conducted by a student for a thesis or a dissertation, an IRB application must have IRB approval before this research is conducted. These regulations
are of specific concern to graduate students because “research” includes the preparation of Master’s Theses and Doctoral Dissertations. By regulation, the IRB may not approve data gathered without its prior review and approval of the project. Failing to obtain approval may result in disqualification of these activities in application towards a degree program.

IV. EDUCATION AND TRAINING

Is anyone available to speak to classes and/or groups about the IRB process?

Yes, the Office of Research Compliance staff is available to discuss the importance of protecting human subjects/participants and the procedures with any group on campus. Presentations may be arranged by calling the Director of the Office of
Research Compliance at 404 .894.6949 or the Compliance Coordinator at 404 .894.6942.

What training do Principal Investigators need?

All Principal Investigators must complete the mandatory training in human subjects protections. See the link from the compliance website to the CITI online course. Completion of the required training is required before approval can be granted. For more information about required training, see the Guidelines.

V. INFORMED CONSENT

What is informed consent?

Informed consent is a person’s voluntary agreement,based upon adequate knowledge and understanding of relevant information (purpose of study, methods used, risks and benefits involved from participation, etc.), to participate in a research project.

When do projects require consent?

Consent is required from any human subject in research unless informed consent has been specifically waived by the IRB. The IRB may waive written consent if:

the project involves no more than minimal risk and involves procedures that would not normally require consent, if not part of a research study;
the waiver does not adversely affect subjects?rights;
signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality; the research could not practicably be carried out without the waiver; and,
where appropriate, subjects are given information about the project afterwards.

In rare instances, the IRB will waive consent, which differs from waiving written consent. Contact the Compliance Coordinator for details.

What is the difference between informed consent and a consent form?

Informed consent is a process of communicating to prospective participants what their involvement in the research activities entails. That process typically involves a consent form, which documents that the process has been completed. The form alone is not the entire process. For example, if working with an illiterate population, a consent form would not necessarily contribute to participants understanding of the project, and an alternative procedure might be needed to convey the information.

Is getting the subject to sign a consent document all that is required by the
regulations?

No. The consent document is a written summary of the information that should be provided to the subject. Many investigators use the consent document as a guide for the verbal explanation of the study. The subject’s signature provides documentation of agreement to participate in a study but is only one part of the consent process. The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject’s questions, ensuring that the subject understands this information, obtaining the subject’s voluntary agreement to participate and, continuing to provide information as the subject or situation requires. An effective consent process should provide adequate opportunity for the investigator and the subject to exchange information and ask questions.

Is informed consent required even if the data will be collected from my family, friends or colleagues?

Yes. All research involving human subjects requires informed consent, regardless of your relationship with the subjects.

Does the consent document being given to the person signing the form need to be the IRB approved stamped consent?

Yes. The IRB stamps the approved consent document with an approval date and an expiration date. Copies of these dated documents must be used in obtaining consent. Any changes to the approved consent form must be reviewed and approved by the IRB prior to using them.

Do projects involving students in the School of Psychology require any additional information in the consent forms?

Yes. If students are required to participate in the subject pool, you must be clear about the terms under which they will receive credit for full or partial participation, their freedom to not take part in all or any part of the research, and the alternative ways in which they might fulfill their course requirements. In all human-subject activities where sensitive issues of personal behavior, depression, addiction, substance abuse, dietary disorders, suicidal tendencies, or sexual disorders might be revealed, you must include on the consent form sources of professional consultation and care. In addition, efforts must be made to insure that all participants are legally adults. (See next FAQ for information about underage students).

Some of the students who will complete my survey are less than 18 years of
age. Does this matter?

Yes, even if the survey is of minimal risk, federal regulations require special protections for children. In the state of Georgia, children are defined as those under 18 years of age. In cases where these children might participate in research projects, you must either obtain written permission from their parents and assent from the underage students, or obtain approval from the IRB to waive parental permission.

My study participants are even younger than 18. Can you explain assent?

Parental permission and subject assent must be obtained prior to a minor’s participation in a research study, since the minor cannot legally consent to such participation. These young subjects have special protections under federal regulations, and parental (or guardian) permission must be obtained. (Under certain conditions, research involving minimal risk may be granted a waiver of parental permission if requested by the investigator.)

Depending on the age and maturity of potential subjects, the Georgia Tech IRB may require that the minor be presented with an assent form to review and sign. Sections IX (Informed Consent: General Requirements) and XI (Informed Permission/Assent Requirements: Minor Subjects) should be reviewed for full details concerning these requirements. Children above the age of eight are generally old enough and sufficiently literate to give written assent to participate in a study. Assent refers to agreement by a minor or incompetent adult
to participate in human research activities. The assent form must be written in the simplest terms possible. The participants must be able to comprehend what they are being asked to do. You may want to discuss your plans with the Compliance Coordinator prior to preparing an IRB application.

Is assent always required?

Assent must be sought from the child unless:

the child is incapable of providing assent (due to age or condition), or
the intervention holds out the prospect of direct benefit to the child and the intervention is available only in the context of the study.

In these two situations, consent from parent(s) is sufficient. In certain circumstances, both parents must grant permission.

Is it necessary to explain to the subjects ahead of time how data from the study will be used?

Yes. If data obtained will be made available to any person or organization other than the subject, the investigator, and the investigator’s staff, the informed consent must disclose: the person or agencies to whom information will be furnished; the purpose of the disclosure; and the nature of the information to be furnished.

What do I do with the consent forms once they are signed?

You must keep the signed consent forms in a secure location and retain them for a period of three years after the study is complete. For some disciplines the forms and data must be kept longer. For example, the American Psychological Association requires forms and data be kept for six years.

VI. AMENDMENT OR MODIFICATION TO AN APPLICATION OR STUDY

When should study subjects be informed of changes in the study?

Protocol amendments must receive IRB review and approval before they are implemented. Those subjects who are presently enrolled and actively participating in the study should be informed of the change if it relates to the subjects willingness to continue their participation in the study and particularly if it changes the level of risk to subjects.

How do I modify an application that has already been approved?

To submit proposed changes for IRB review, submit a modification request for your protocol via IRBWISE. Attach new or revised instruments, measures, consent documents, etc., as appropriate. An example of an “addendum to consent form” is provided in the Guidelines. The IRB will review your modifications and inform you when they have been approved.

VII. IRB APPLICATION PROCESS

On the application for approval, what do I put in the section for Location of
Study?

Name all of the study sites where data collection will occur, i.e.: Grady Hospital, Perimeter Mall, Centennial Research Building, other university? Please note that written permission from non-Ga Tech sites is generally required.

Does the IRB require that the full copy of the grant application be submitted
with the submission application?

YES! The IRB reviews the grant application for proposed research. Do I need to list all the researchers or investigators participating in the research project? Yes. All researchers and investigators, either collecting or reporting data or receiving credit as authors, should be included. They must also complete the required training in human subject protections.

What do you mean, “use lay language?

The informed consent process involves three steps: (1) the researcher telling participants about the research; (2) participants understanding what the researcher told them; and (3) participants agreement to participate. If, as the researcher, you tell participants about the research, but in a way that they cannot understand, then their agreement is without value, and you have not obtained informed consent. Researchers will often use terms with which they are familiar, but with which participants are not: What is an inventory? What is anemia? What does a “usability test” involve? The IRB often asks researchers to edit a consent form so that it is more understandable to someone not an expert in the field (i.e., a lay person). That can easily be done by explaining terms that are used. Consent forms are more understandable if they are written at about an 8th grade level for a “normal” adult population, or lower for individuals for whom English is not their first language or whose reading skills are suspected to be lower. Use shorter sentences, words with fewer syllables, and simplify terms (e.g., “complete a questionnaire” might be phrased “circle your answer to questions on a piece of paper”).

Do I have to attend the IRB meeting when my application is reviewed?

No, you do not have to attend the meeting. However, the IRB occasionally invites a principal investigator to attend an IRB meeting, in order to address the board’s questions.

How long does the IRB review process take?

Review of Exempt or Expedited protocols make take up to 21 working days.

The review process for applications requiring Full review can take up to a month or longer to complete, depending on potential modifications, when the application is submitted, etc. If a protocol is tabled at a full board meeting, approval may take two or more months. Substantive revisions must usually be reviewed at the next regularly scheduled IRB meeting.

Most applications require revisions upon initial review. You should include sufficient time in your research plan to allow for any IRB-required changes to the research application. Many revisions can be considered by the chair or a subcommittee of the full IRB.

How do I know when my application has been approved?

You will receive written notification via email of the status of your application following IRB review; a written letter of approval will also be sent to you.

Once the Board reviews my study, when can I start enrolling subjects?

If the Board has asked for revisions, you will receive a notification outlining the revisions that are needed. Once you have made the required revisions and received written IRB approval, you may begin enrolling subjects.

How do I know the IRB will understand my proposed research?

The IRB is a standing committee of at least five individuals, including faculty, researchers and at least one member from the community at large. If the IRB receives protocols that require expertise beyond that available on the Board, it may seek assistance from qualified persons outside its membership. While outside experts may inform the IRB’s decision, they do not vote to approve or disapprove. Applicants may be invited to present their plans to the full board and to address the board’s questions. The IRB will work in partnership with applicants to ensure appropriate review and to secure approval.

Why does the IRB need to know what I plan to do with my research findings?

The IRB committee needs to know how you will disseminate your research results in order to determine risk to individual human subjects. For example, if the researcher intends to publish the results of a study in a professional journal or other source, then IRB approval often provides reassurance to the readers that the rights of human subjects have been
considered in the research process.

What are the most frequent problems encountered by the committee in reviewing proposals?

One of the most frequent problems is a poorly constructed proposal that does not supply information about the type of data being gathered, the role of the human subjects or the use of the data. Secondly, some proposals are submitted without consent forms or a letter of introduction to the subject to inform them of their role in the project. Before
submitting an IRB application, see the “checklist” at the end of the Guidelines to determine whether you have included all the necessary information in your proposal.

VIII. RECORD-KEEPING

What IRB records should investigators keep in a study file?

The principal investigator must maintain a protocol file. This file must include:

The original IRB application and all subsequent revision and renewal applications.
All correspondence between the investigator and the IRB, as well as communications regarding the study from a sponsor.
The signed IRB approval letter.
Signed consent forms obtained from all participants (or information where these documents can be found). Remember, consent forms must be retained for at least three years after the project closes.
Final reports
Reports of all adverse event incidents and any follow-up to these incidents.

This file will act as the investigator’s documentation regarding the proper performance of the study.

This file may be randomly audited by the IRB. The purpose of this audit is to provide internal procedural monitoring to ensure compliance with federal human subject protection regulations. Additionally, it provides a cooperative forum to educate investigators in correcting problems and to solicit suggestions in improving the IRB process.

IX. RENEWALS/TERMINATIONS

What is needed for an application renewal?

An application is valid for a period of up to one calendar year from the date of IRB approval. The expiration date is clearly indicated on the letter of approval and in the IRBWISE database. The IRB will send the principal investigator an automated email renewal reminder approximately 60 days prior to the expiration of approval. A final automated email reminder will be sent 30 days later. If renewal materials are not received by the end of the month in which an approval expires, the project will be automatically inactivated and all data collection and human subject interaction must stop.

Note: an application may be renewed no more than four times. After the fourth renewal, a new application must be submitted. See the Guidelines for more information about renewals.

What happens when a project finishes?

The IRB will send the principal investigator an automated email renewal reminder approximately 60 days prior to the expiration of approval for a given application. This email is also the Principal Investigator’s reminder to inform the IRB that the research project has finished. The IRB requires principal investigators to formally close their research projects by notifying the IRB administrator that the project is closed and submitting a final report for the project.

X. MISCELLANEOUS QUESTIONS

Can deception or misrepresentation be used in studies with human subjects?

Yes, if the benefits outweigh the risks to the subjects for participating in such a study, and if the investigator provides a compelling scientific justification for such experimental manipulation. For research where deception or misrepresentation is involved, the subjects must receive an explanation (a debriefing) about the nature of the experiment and why such manipulation was critical to its success. Generally, during debriefing, subjects must be offered an opportunity to withdraw their data and not to continue participation. The debriefing script should be included with the materials submitted for IRB review and approval. All research and class projects that involve deception must be approved by the IRB. For more information about using deception in research, see the Guidelines.

Are any special steps required to protect data collected on film, photographs, and audio or videotape?

Yes. The subject must be informed that the data is being collected through such recordings. If you have received approval to use deception in your research, the subject must be informed of the true nature of the research as soon as possible and given a debriefing afterwards. Consent forms must describe specifically who will use these recordings, how they will be used, for what purposes, how long they will be stored, and how they will be disposed of at the end of the study. Use of such data for other purposes must be disclosed and permission obtained for subsequent use in a special part of the consent.

I have an opportunity to conduct my research surveys/interviews in my friend’s apartment, which is temporarily empty. This would help keep some of my research costs down. Is that okay with the IRB?

The Georgia Tech IRB does not allow research to be conducted in the private residences of any study staff, family member, or friend of study staff. In certain situations research may be conducted in the home of the research participant. These cases will require review and approval by the IRB and will depend on the type of research being conducted.

What if I disagree with the IRB’s decision about my proposal? Is there an appeal process?

If the IRB makes a decision that an investigator believes to be unfair, unsubstantiated, or unduly restrictive on his/her proposed research, the investigator should first discuss the matter with the IRB Chair, the IRB Administrator, or the Director of the Office of Research Compliance. The investigator should be prepared to present reasons that he or she believes the proposed research to be in compliance with University policy and Federal regulations for the protection of human participants. If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision, in writing, to the IRB. In developing the appeal, the investigator is encouraged to seek the advice or opinion of an objective, qualified consultant (or consultants) to support the claim that the proposed research is in compliance with human participant policy and regulations. The investigator must appear before the IRB to present the appeal and any supportive material or documentation obtained through consultation. Based upon this appeal, the IRB will issue a final recommendation on the proposed research. It should be noted that a final decision by the IRB to disapprove a project may not be overruled by any office or official.

Are there any requirements after my study is approved?

Once a project is approved by the IRB, the investigator must:

conduct every aspect of the project as approved by the IRB;
promptly report any revisions or amendments to the research activity for review and approval by the IRB before implementing the revisions;
promptly report any unanticipated problems involving risks to subjects or others;
assume full responsibility for selecting subjects in strict accordance with the inclusion/exclusion criteria outlined in the application materials, and,
where consent/permission/assent form(s) have been approved for the research activity, only Georgia Tech IRB-approved, stamped forms may be used in the consent process.

The Georgia Tech IRB has the authority to suspend, terminate, or place restrictions on any study in which the investigator has not met the above requirements, or if it becomes evident that the rights and/or welfare of human subjects are at risk.

Can I still participate in a research project if I have financial or other connections to it?

A conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the University, such that an independent observer might reasonably question whether the individual’s professional actions or
decisions are influenced by considerations of personal gain, financial or otherwise.

Investigators (or their family members) who have a substantial financial interest in the outcome of the research must, during the consent process, disclose the conflict to potential subjects. This includes providing a written disclosure on the consent form to explain and document the disclosure. The management plan for the conflict of interest will be noted by the IRB, which will determine whether it is appropriate, given the level of risk to subjects.

No Georgia Tech IRB member participates in the review of any study on which he or she is an investigator or co-investigator, or where a potential for conflict of interest exists.

How can I participate on the IRB?

Typically, IRB members are nominated and appointed by the Institutional Official for research compliance issues (Ms. Jilda Garton, Associate Vice Provost for Research).
If you have an interest in participating, you should contact Ms. Garton (jilda.garton@gtrc.gatech.edu).

May Georgia Tech employees participate in research projects during the work day?

Yes, if employees have their supervisors approval and are classified as exempt. Non-exempt employees must make arrangements to be in the study during lunch or after hours. All employees may want to check with OHR regarding tax implications for participation compensation.

May I offer gift cards/certificates instead of money for participants’ compensation?

Yes

Am I allowed to pay foreign students?

Yes, they should not be treated differently.

I want to have a raffle/lottery as part of my compensation.

Raffles and contests must be administered according to state law in order to avoid potential legal problems, please see our policy at:
IRB Policies

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Georgia Institute of Technology

Did You Know?

FAQ’s about Human Subjects Research Review

I. General Questions

II. IRB Review Criteria

III. Student Research

IV. Education and Training

V. Informed Consent

VI. Amendment Or Modification To An Application Or Study

VII. IRB Application Process

VIII. Record-Keeping

IX. Renewals/Terminations

X. Miscellaneous Questions

XI. Compensation for research subjects

Events Calendar

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21	22	23	24	25	26	27
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