Exempt Review Guidelines

  1. While the Department of Health and Human Subjects does not dictate who determines whether research is exempt, CU-IRB’s policy is to review exempt research in the same manner as expedited research; however, the research can still be classified as exempt. Exempt review can be conducted by the IRB chair, other IRB members designated by the chair, or a subcommittee of the IRB.
  2. The criteria for exempt status follow all applicable federal regulations including: 45 CFR 46.101(b) (1) through (6), 45 CFR 46.301(a), 45 CFR 46.306 (a) and (b), 45 CFR 46.401(b) and 21 CRF 56.104.  The criteria apply to all research regardless of funding or funding source.
  3. These regulations identify specific categories of exempt research activities and also identify when there are exceptions.  For research under CU-IRB policy, if a specific research activity meets the exemption criteria for one applicable regulation but not another, the research activity will not be given the exempt status but will be processed under procedures for expedited from full review.
  4. To be classified as exempt, the following criteria must be met:
    1. Research projects for instructional purposes and/or class demonstration, provided that the data obtained is not for formal analysis or future publication.  This type of research only needs to be reviewed from the CU-IRB chair.  See “Research Not Needing Approval” on the website.
    2. Research conducted in established or commonly accepted educational settings, involving normal education practices such as
      • Research on regular and special educational instructional strategies or
      • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
    1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior UNLESS:
      • The information taken from these sources is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects; or
      • 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; or
      • The research involves children, except for research involving observations of public behavior when the investigator(s) does not participate in the activities being observed.
    1. Research involving the collection or study of existing data from publicly available sources.  Any identification of data by subject must be avoided unless the subject studied is a public figure.

Criteria for Protection of Human Subjects in Exempt Research:

While the research may be deemed Exempt from Expedited and Full Board Review, the research is not exempt from protection of human subjects. The following criteria must be met:

  • The investigator assures that all investigators are trained in ethical principles.
  • The investigator assures that human subjects will voluntarily consent to participate in the research when appropriate and will provide subjects with pertinent information.
  • The investigator assures that human subjects will be selected equitably, so that risks and benefits of the research are justly distributed.
  • The investigator assures the IRB will be immediately informed of any complaints from participants regarding their risks and benefits.
  • The investigator assures that confidentiality and privacy of the subjects and research data will be maintained appropriated to ensure minimal risk to subjects.

Expedited Institutional Review Board Review Guidelines

DHHS and FDA recognize that not all research warrants review by the full IRB at a convened meeting. Certain types of research may be reviewed and approved by expedited review. Expedited review is a type of review that can be conducted by the IRB chair, other IRB members designated by the chair, or a subcommittee of the IRB. IRB members designated to conduct expedited review must be experienced reviewers who are also voting members.

With an expedited review, the IRB chair conducts the expedited review, designates a reviewer, or ensures that a subcommittee is formed. He or she also mediates in discussions between reviewer(s) and investigator(s) if they are unable to come to agreement over an issue raised.

OHRP Regulations empower reviewers to approve research qualifying for expedited review or require modifications of a study for it to gain approval. Reviewers are not permitted to formally disapprove any research in the course of expedited review. Only the full IRB can exercise disapproval. In addition, the full IRB will receive notification of any projects approved through an expedited review, and they have the authority to question and disapprove the project even if preliminary approval was granted by the reviewers conducting the expedited review. Notification of projects can be accomplished by providing a list of all such approved studies accompanied by a brief synopsis of the nature of the research and the expedited category under which the research qualifies for review. Current regulations are available through the Health and Human Services website (www.hhs.gov).

Eligibility Criteria for Expedited Review  

Research activities that present no more than minimal risk and are listed in a NIH guidance document as an adjunct to DHHS and FDA regulations.

  • DHHS and FDA regulations define minimal risk to mean that “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 examinations or tests.”
  • IRBs need to be cognizant of the restrictions and considerations related to determining what is “minimal risk”
  • A study involving a relatively minor procedure such as venipuncture, considered to be minimal risk in the life of a normal, healthy individual, would constitute more than minimal risk in the hemophilia population.

Minor changes in previously approved research during the period (of one year or less) for which approval has been granted.

  • Regulations do not specify what types of modifications qualify as minor changes.
  • Closure of a study to new subject accrual, minor clarification of eligibility criteria, consent form clarifications, changes in advertisements, addition of monitoring procedures that are on the adjunct lists, and other no more than minimal-risk changes would all qualify as minor.

 Other criteria for an expedited review:  

  • The proposed procedures must be consistent with sound research design, and where possible, procedures already being performed on subjects should be used. For example, obtaining additional blood at the time of routine venipuncture is preferred rather than doing an extra needle stick to obtain the research sample.
  • The risks of the research must be reasonable in relationship to the anticipated benefits, if any, to the subjects and the importance of the knowledge that may be gained.
  • Subject selection must be equitable.
  • Informed consent should be sought and documented unless a waiver of consent or documentation of consent has met the DHHS and FDA waiver of consent criteria.
  • Where appropriate, there is a plan to collect and monitor data to ensure subject safety.
  • The privacy of subjects and maintenance of confidentiality of data are protected. IRBs also fulfilling the role of privacy boards should be cognizant of the HIPAA regulations related to these issues.
  • Where necessary, additional safeguards have been included to protect vulnerable subjects.

 

The expedited review process cannot be used in the following projects:

  • Those involving more than minimal risk
  • Those not appearing in the OHRP expedited review categories, even if minimal risk
  • Those involving classified research
  • Those involving prisoners
  • Those where identification of the subjects and/or their responses would reasonably place them at risk of criminal/civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks are no greater than minimal.

 

Expedited Review Categories  

  1. Clinical studies of drugs and medical devices only when condition a or is met
    1. Research on drugs for which an investigational new drug application is not required
    2. Research on medical devices for which application is not required and marketing and labeling criteria are met
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture
    • from healthy, non-pregnant adults who weigh >110 pounds (
    • from other adults or children after considering the age, weight, and health of the subjects, the collection procedure, the amount and frequency of blood collected.
  3. Prospective collection of biological specimens for research purposes by noninvasive means; a list from “a – j” of various specimens is given which includes: hair and nail clippings, teeth, excreta, sweat, saliva, amniotic fluid (post-rupture), dental plaque and calculus, mucosal and skin cells
  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Note that if medical devices are employed, they must be cleared/approved for marketing.
  5. Research involving materials (data, documents, records, or specimens) that have been collected solely for none research purposes (such as medical treatment or diagnosis).
  6. Some research in this category may be exempt from the HHS regulations for the protection of human subjects. Collection of voice, video, digital, or image recordings made for research purposes.
  7. Research on individual/group characteristics or behavior (including but not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program or human factors evaluation, or quality assurance methods.
  8. Continuing review or research previously approved by the convened IRB as follows:
    • research closed to enrollment, interventions all complete, and long term follow-up
    • no new subjects enrolled and no additional risks have been identified
    • only data analyses still to be performed
  9. Continuing review of research, not concluded under an investigational new drug application or investigational devise exception where categories 2 – 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risks and no additional risks have been identified. 

Institutional Review Board