IRB Definitions

Select a Definition:


Adverse Event (also known as "adverse effect" or "side effect"):

An adverse event is a negative reaction that a participant may experience while participating in a study or receiving some type of study treatment. Adverse events may happen suddenly or develop over time (even after the study is complete). Adverse events related to research conducted in this educational setting should be minor such as becoming anxious over a survey of sensitive information.

Assent:

Assent is an agreement by an individual who is not competent to give legally valid informed consent or who is under the age of 18.

Blind (or Double-Blind) Study:

In a blind study, there is more than one treatment being used, and you will not be told which one you are receiving. In a double-blind study neither you nor the study staff will know what type of treatment you are receiving. Blind and double-blind studies are performed so that the procedures and results of a study are not unnecessarily influenced by you or the study staff. For example, it might be difficult for you to continue following the study procedures if you were aware that your study treatment was actually a placebo.

Continuing Reviews:

The IRB review body conducts continuing reviews of nonexempt research at intervals appropriate to the degree of risk, but at least once per year.

Exempt Review Criteria:

In order to establish an individual research project as Exempt from Further Review, the principal investigator must complete the Application for Approval of Investigations Involving the Use of Human Subjects and any appropriate informed consent documents, samples of which are located within the Application. Final determination as to whether a research project is Exempt from Further Review rests with the Chair of the IRB or his/her designee. If the project is certified Exempt from Further Review by the IRB, the principal investigator need not resubmit the project for continuing IRB review as long as there are no modifications in the exempted procedures.
  1. Research on regular and/or special instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), voluntary survey procedures, voluntary interview procedures or observation of public behavior, unless:
    1. information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participant; and
    2. any disclosure of the human participants' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude. achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under (2) above if:
    1. the human participants are elected or appointed public officials or candidates for public office; or
    2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in a manner that participants cannot be identified, directly or through identifiers linked to the participants.
  5. Research and demonstration projects which are conducted by or subject to the approval of State or Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
    1. Public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste and food quality evaluation and consumer acceptance studies,
    1. if wholesome foods without additives are consumed or
    2. if a food is consumed that contains a food ingredient at or below the level for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency, or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited Review Criteria:

Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk or for minor changes in approved research.

The principal investigator shall submit an Application for Approval of Investigations Involving Use of Human Subjects. Research activities involving no more than "minimal risk" to subjects and in which the only involvement of human subjects will be in one or more of the following categories may be reviewed by the IRB and/or a designated IRB Expedited Review Subcommittee:
  1. Collection (in a non-disfiguring manner) of hair, nail clippings, deciduous teeth, and permanent teeth if patient care indicates a need for extraction.
  2. Collection for analysis of excreta and eternal secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
  3. Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also include such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays and microwaves).
  4. Collection of blood samples by fingerstick or venipuncture, in amounts not exceeding 450 milliliters in an eight-week period, and no more often than two times per week, from subjects 18 years of age or older who are in good health and not pregnant.
  5. Voice recordings made for research purposes such as investigations of speech defects.
  6. Moderate exercise by healthy volunteers.
  7. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
  8. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigation does not manipulate subject's behavior and the research will not involve stress to subjects.

    Reference: 7 categories of expedited (even though it had 9 numbers) http://www.hhs.gov/ohrp/policy/expedited98.html

Full Board Review:

Any research or training project involving the use of human subjects which does not fall into the "Exempt from Review" or the "Expedited Review" categories must be submitted to the IRB for a full board evaluation. The principal investigator must complete and submit the College of Coastal Georgia IRB Application for Approval of Investigations Involving the Use of Human Subjects.

Human Subjects:

Living individual(s) about whom an investigator (whether professional or student) conducting research obtains
  1. data through intervention or interaction with the individual or
  2. identifiable private information. (CFR 46:102f)

Identifiable Private Information:

Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record). --- 45 CFR 46.102(f)(2)

Inclusion / Exclusion Criteria:

Inclusion/Exclusion criteria are the standards used to determine whether or not people can participate in research studies. These criteria are based on characteristics such as age, gender, or what a person may be currently experiencing. The purpose of inclusion/exclusion criteria is to keep people safe and to help the study staff select the best participants for a study. Inclusion criteria are the characteristics that you must have in order to participate. Exclusion criteria are the characteristics that you must not have in order to participate.

Informed Consent Document (ICD, also known as "consent form"):

The ICD is a document that the study staff will give you that explains all of the main details of a study, including the purpose, the risks and possible benefits, what procedures will take place, how your privacy will be protected, if and how much you will be reimbursed, how long the study will take to complete, and what alternatives you have instead of participating in the study.

No study procedures may be performed on you until you sign an informed consent document. If all of your questions have not been answered in that document, the study staff is required to answer any other questions you may have. If you sign an informed consent document, you can decide to withdraw your decision to participate at any time, for any reason, with no penalty to you or your care.

This is a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence. (CFR 116:21, CFR 50.20 and 50:25)

Institutional Review Board (IRB):

A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in research.

Interaction:

Interaction included communication or interpersonal contact between Investigator and subject.

Intervention:

Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

Minimal Risk:

The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. (CFR46:102i)

Primary and Secondary Research:

For our purposes, primary research means that the researcher needs to design questionnaires and/or collect data from participants and then analyze the results.

Secondary research means the researcher can access these data from publications, reports, newspapers, etc.

Primary and Secondary Data Source (May also be referred to and Direct and Indirect measures):

Primary data is information collected by the researcher directly through instruments such as surveys, interviews, focus groups or observation. Tailored to his specific needs, primary research provides the researcher with the most accurate and up-to-date data.

Secondary data, on the other hand, is basically primary data collected by someone else. Researchers reuse and repurpose information as secondary data because it is easier and less expensive to collect.

Principal Investigator (PI, also known as "study coordinator"):

The principal investigator, or PI, is the main researcher in charge of a study. The PI agrees to follow the protocol and commits to protecting the safety of the participants in the study. The PI is responsible for what happens during the study, including the actions of every member of the study staff. The study staff may include one or more sub-investigators, study coordinators, and other research professionals.

Private Information:

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. Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45CFR 46:102f(2))

Protocol:

A protocol is a detailed plan that is designed for conducting a research study properly. It explains the questions that the research is trying to answer as well as the steps and rules that the researchers should follow to get accurate results and to help ensure the safety of the participants. If a protocol is not followed correctly, the study results could be incorrect and/or the research participants could be harmed.

Randomization:

Randomization, the act of assigning participants to groups, ensures that the study is being fair to the participants.

Research:

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (CFR 46:102d)

Screening:

Screening refers to the period when tests are performed and questions are asked to see if you can participate in a research study. During the screening (sometimes called a "screening period" or "screening visit") the study staff will find out whether or not you meet the inclusion/exclusion criteria. The screening may take place during one visit or over the course of several visits.

Student Applications:

Student applications must reflect faculty sponsorship. The responsibility for complying with the Policy and Procedures is shared by the faculty sponsor and the student.
powered by finalsite