IRB AND INFORMED CONSENT GUIDELINES: Protocol for GCC
by Karen Huffman-Kelly
The purpose of the review process is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. A key goal of IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy), and seeks to maximize the safety of subjects.
Informed consent is the requirement that an investigator obtain the legally effective informed consent of the human subject or the subject’s legally authorized representative
What is Human Subjects Research?
It can be very difficult to determine what constitutes human subjects research. Unfortunately, there is no clear line in the sand. The Common Rule offers the following definitions as guidance for determining human subjects research. The definitions are intentionally broad to include a wide range of research in hopes of capturing both the biomedical and humanities spectrums. These definitions are the starting point for anyone attempting to determine whether their research requires IRB review.
The first question is if your project is actually research as defined by the common rule:
“Research” as defined by DHHS is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
“Research” as defined by FDA is means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]
The second question to ask is if your project involves human subjects:
A human subject is defined by DHHS as a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information.
- “Intervention” as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR 46.102(f)]
- “Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
- “Private information” as defined by DHHS regulations means 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). [45 CFR 46.102(f)]
- “Identifiable information” as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
For more information see the Office for Human Research Protections and the Food and Drug Administration.
If the answer to both questions is yes, then you need IRB approval to conduct research.
Otherwise you need to ask these questions:
- Does the activity involve the use of a drug (including an approved drug or an over-the-counter drug), other than the use of an approved drug in the course of medical practice?
- Does the activity involve the use of a medical device (including an approved medical device), other than the use of an approved medical device in the course of medical practice? (Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.
- Will data be submitted to the FDA or held for their inspection?
If the answer to one of the above questions is “yes,” then you will need IRB approval to proceed.
Examples of Activities that May or May Not be Human Subjects Research
Classroom activities include instructing students in research methodologies and techniques. If the sole purpose of the activity is to teach students research techniques or methodology with no intention to develop or contribute to generalizable knowledge, it is not considered research. If students will practice research methodologies on human beings, however, they should be instructed in the ethical conduct of such activities and advised to obtain informed consent from their practice subjects.
Service surveys issued or completed by University personnel for the intent and purposes of improving University services/programs or for developing new services or programs for students, employees, or alumni, may not meet the definition of human subject research as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained, and survey participation is voluntary. If the survey is being conducted to produce generalizable knowledge or survey data is used in the future for a new study producing generalizable knowledge, IRB review may be required.
Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves may not meet the definition of human subjects research. Examples include interviewing librarians about inter-library loan policies or rising journal costs. Contact your mentor to determine if IRB review is needed.
Biography or oral history research involving a living individual is not generalizable beyond that individual. Therefore, it does not meet the definition of research and does not require IRB review and approval.
Case reports do not involve systematic investigation and, therefore, do not meet the definition of research involving human subjects and do not require prior IRB review and approval. However, a report of a series of cases may qualify as human subjects research and should be submitted for review and approval by IRB prior to initiation. Contact your mentor to determine if IRB review is needed.
Research involving publicly available data does not require IRB review. Examples of publicly available data include census data and labor statistics.
Research involving secondary use of data may not meet the definition of human subjects research and therefore may not require IRB review, provided that the data set contains no identifiers (either direct or linked code numbers). If the data set contains identifiers but does not contain private information, the project may not meet the definition of human subjects research. Private information is defined as information about behavior that occurred in a context in which the individual could reasonably expect that no observation was taking place or involved no information which had been provided for specific purposes for which the individual could reasonably expect would not be made public.
Educational tests, surveys, interviews, or observations – research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior meets the definition of human subjects research and requires IRB review.
Quality assurance (QA) projects are activities designed to determine if aspects of any practice are in line with established standards. Quality improvement (QI) projects are designed to improve the performance of any practice in relation to an established standard. Both QA and QI projects may involve systematic investigation and contribute to generalizable knowledge and, therefore, may meet the definition of human subjects research. Contact your mentor to determine if IRB review is needed.
Investigational use of marketed drugs, biologics, and medical devices, or use of a product that is not indicated in the approved labeling, requires prior IRB review and approval. Application submissions for either an Investigational New Drug (IND) or Investigational Device Exemption (IDE) to the FDA may be required when the principal intent is to develop information about the product’s safety or efficacy. Contact your mentor to determine if IRB review is needed
Exempt Research (Not FDA Regulated)
The categories for exemption are as follows:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, or reputation.
Note: For HHS-funded research that involves children as subjects, the procedures cannot involve i) survey procedures; ii) interview procedures; or iii) observation of public behavior where the investigators participate in the activities being observed (observation of public behavior where the investigators do not participate is allowable).
- 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 paragraph (2) above, if:
- . Human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- 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 such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.
Note: This exemption would not apply if the investigator(s) collects data in a coded manner since the code would enable subjects to be identified via the code. “Existing” means that the data, documents, records, or specimens must exist and be de-identified at the time the research proposal is submitted.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and that are designed to study, evaluate, or otherwise examine:
- . Public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service programs (e.g., social supportive or nutrition services as provided under the Older Americans Act);
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs.
- The research must be conducted pursuant to specific federal statutory authority.
- There must be no statutory requirement that an IRB review the research.
- Research must not involve significant physical invasions or intrusions upon the privacy of the subjects.
- The exemption should have authorization or concurrence by the funding agency.
- Taste and food quality evaluation and consumer acceptance studies if:
- Wholesome foods without additives are consumed.
- A food is consumed that contains a food ingredient at or below the level and 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.
Exempt Research (FDA)
The categories of research qualifying for exemption are as follows:
- Any investigation that commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB that meets the FDA requirements in effect before July 27, 1981;
- Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date;
- Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review;
- Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and 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.
- The IRB is most concerned with protection of human subjects and their data. Thus the application should be detailed in describing: source of subjects, recruitment methods of subjects, interaction with subjects, informed consent processes, maintaining confidentiality of data, and data storage. These areas of the application, if executed well, will ensure faster processing.
- The IRB does NOT need robust literature reviews and lengthy background information details. The literature review should be no more than two paragraphs and it should cite three to ten references.
- Data collection instruments that are not solidified can be submitted as “semi-structured” and updated later.
- An instructor who expects students to use the class project toward a publication or presentation outside of the classroom may assist students by having them work in pairs, or by creating strict parameters for the class so that the project can be submitted under one application where the instructor is PI and the students are listed as co-investigators.
To apply for IRB review, students must complete the steps below:
1) Complete all required training including:
2) Submit Research Protocol: your proposal document
3) Describe Instruments: all data instruments and other materials to be distributed to and/or used with study participants (e.g., surveys, questionnaires, interview guides, etc.).
4) Describe Recruitment Materials: all flyers, e-mail scripts, verbal scripts, and other materials to be distributed to and/or used to recruit participants.
5) Submit Informed Consent Documents: all form(s), letter(s), or script(s) containing the elements of informed consent.
firstname.lastname@example.org; D365, ext. 6148 (Contact her for more forms or for more info.)