If it’s exempt why do I need an IRB review anyhow?

surveyThere is often confusion about “exempt review” among researchers, and this is entirely understandable. Sometimes we are asked: “well, I’ve already determined that this is an exempt study—so why do I need an IRB to do a review?” Projects that involve human subjects can be reviewed at one of three levels according to the federal regulations. The levels are exempt, expedited, and full committee.  The IRB does not actually approve an exempt study but makes a determination that the project meets at least one of the federal exempt categories criteria. 45 CFR 46.101(b) tells us that the categories for exempt human subjects research include:

 

CATEGORY 1

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.

 

CATEGORY 2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.

 

CATEGORY 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 paragraph (2) of this section. If (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 

CATEGORY 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 such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

 

CATEGORY 5

Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

 

CATEGORY 6

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.

 

Each one of the categories requires additional explanation.

 

CATEGORY 1 The research conducted in the educational setting must only involve accepted and normal educational practices—so this would not include a comparison of an accepted method to a new and untested educational practice. It also must take place in normal educational settings.

 

CATEGORY 2 The individuals participating in the surveys, interviews, educational tests, or observations cannot be children, nor can they be part of a vulnerable or protected population. Also, they cannot be asked questions that increase the level of risk for participation in the study. Note: The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.

 

CATEGORY 3 Under this category, the program The program must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). In addition, there can be no significant physical invasions or intrusions of the privacy of the participants.

 

CATEGORY 4 “Existing” means existing before the research is proposed to the institutional review board to determine whether the research is exempt. If the investigator will record the data so that no individuals can be identified, a step by step plan is required. Previously collected data can range from large data sets that are created by government-funded studies that occur at research institutions across the United States, to data that is recorded during the normal course of doing business in a setting such as a school, hospital or a corrections agency.

 

CATEGORY 5 This research involves organizations that provide a public benefit (such as broadcasting or public transportation) or service programs (such as Medicaid). No physical invasion or intrusion of privacy is allowable.

 

CATEGORY 6 This research involves consumer acceptance of products or services or taste and food quality studies—keeping in mind that these must normally be accepted foodstuffs!

 

As you can tell, after reading this blog, the determination of what is exempt and what requires a higher level of review is actually quite nuanced. This is the reason, an IRB is tasked with making the determination. If you have questions about a possibly exempt study—don’t hesitate to contact us and ask!

OHRP provides decisions charts for exempt and expedited reviews.

 

 

Deception in Research

Generally, Institutional Review Boards (IRBs) require investigators clearly and accurately inform human subjects about research during the recruitment and consent process. Human subjects are defined as a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information (§46.102(f) Definitions). Researchers must disclose the purpose of the study, benefits, potential risks and a description of what participants will be asked to do. Additional protection and safeguards may be needed for vulnerable populations. There are however, some instances in which deception or incomplete disclosure is allowed.

  • Deception occurs when the researcher provides false information to subjects about the research.
  • Incomplete disclosure is defined as the withholding of information about the purpose of the study.

The IRB considers several factors when reviewing studies using deception or incomplete disclosure. There must be a clear justification for the use of deception, why it is needed, and whether it is possible to conduct the research without it. Participants cannot be deceived about significant aspects of the research that would affect their willingness to participant or that would cause them physical or emotional harm. In most cases, a debriefing is required including a detailed description of the deception.  

There are instances in which the only way the research can be conducted is with deception or incomplete disclosure. Research examining the placebo effect may use deception. The American Psychological Association provides guidelines for the use of deception in research under Standard 8.07. The use of deception in research is allowable under certain conditions and carefully considered during the IRB review.

IRB Membership

The Common Rule (45 CFR part 46) published in 1991 is used by 15 Federal departments and agencies to provide protections for human subjects involved in research activities. The Common Rule also provides guidelines for the administration of the IRB and the composition of the board. Like many Federal regulations, some elements of 45 CFR part 46 are definitive while others are open to interpretation. This is true for the membership and qualifications of the board.

  • 46.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

(e) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB

 

The Common Rule does stipulate the board must have no fewer than 5 members and 1 must be a non-scientist. The Common Rule does not specify the education or training required for board members, only that they are “qualified” to conduct the reviews. Many IRBs require the same human subjects training for reviewers and researchers. Solutions IRB also requires initial and ongoing training of all reviewers.

The board of Solutions IRB consists of a diverse group of individuals. Many of the members of our board hold doctoral degrees and are experienced educators and researchers. Our membership includes the following:

Certified IRB Professional (CIP)

Registered Nurse

Registered Dietitian

Family Medicine Physician

Forensic Psychologist

Social Worker

Television Producer

Director of Research Information Systems

Licensed Behavior Therapist

Occupational Therapist

International Researcher

No convened board meeting can be held without the non-scientist. The non-scientist fulfills a very important role. These members often are drawn from the community in which an IRB resides. They may be members of local clergy, interested volunteers, teachers, retirees, nurses or ethicists. They also may represent ethnic, socio-economic or patient groups that add a needed voice to IRB decisions.

The guidelines provided by the Common Rule for IRB membership are followed by all IRBs. The specific membership of each will differ based on the types of studies reviewed, study populations, and settings. All IRBs strive to provide a thorough review to evaluate the risk/benefits and ethics of the proposed study for the protection of human subjects. For additional information on our IRB, please visit www.solutionsirb.com.

 

 

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