IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- European Union’s General Data Protection
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Research Advisors
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- Whistleblower Policy
The purpose is to outline the policies and procedures for expedited review of research involving human subjects.
Expedited review is a method of human subject research review permitted by the federal regulations at 45 CFR 46.110 for certain types of non-exempt research involving no more than minimal risk, or for minor changes in approved research. It is a process of review which is performed outside of a convened monthly meeting of the Institutional Review Board (IRB) by a smaller number of members.
Certain types of research may qualify for expedited review, so long as all activities fit into one or more of the federal categories described below and do not involve a prohibited population or activity.
Minimal risk means the probability of 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.
An expedited review procedure may be used for research which involves no greater than minimal risk but does not qualify for exemption (i.e., does not fit into an exemption category or involves a population prohibited from exemption).
Any investigator who intends to conduct research involving human subjects, and who on the basis of the categories described below believes that research to be expedited, must submit an application package to Marywood University's IRB for review and approval prior to initiation of research activities. The Director of Human Participants Protection and Research Compliance will make the final determination about review type, with consultation of members of the IRB as needed.
Federal regulations allow expedited review to be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among voting members of the IRB [45 CFR 46.110(b)]. Marywood University’s IRB chairperson delegates review to all members of the IRB at the beginning of each fiscal year. Individual review is assigned to one IRB member, who is chosen by the Director of Human Participants Protection and Research Compliance either on a rotating basis or after consideration of the reviewer’s particular expertise. The Director assists with review to ensure regulatory and institutional compliance. The chairperson may serve as one of the assigned reviewers. In examining the research, the reviewer may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. A research activity may only be disapproved after review at a convened meeting of the IRB [45 CFR 46.110(b)]. Research that has been approved by an IRB under this procedure may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB [45 CFR 46.112].
Expedited submissions must be transmitted through IRBNet, Marywood University's online submission and management system, and include an IRB application form and all necessary attachments. In most cases, an informed consent form is required. The form collects signatures, referred to as "documentation of informed consent," for the subject or legally authorized representative, and the person obtaining informed consent. However, in certain circumstances, the requirement for documentation of informed consent or the entire informed consent process itself may be waived or the informed consent altered (FDA excluded except for emergency research). Research with children involves specific requirements for parental permission and child assent.
The IRB must approve both the form and the process by which informed consent is to be obtained. This process begins with recruitment. Please see the Informed Consent policy for further information on the requirements of informed consent, alterations and waivers.
Activities Excluded from Expedited Review
- Prisoner research
- Drugs*, internally taken substances, investigational devices, or biologics
- Research which may place subjects at greater than minimal risk
*Dietary supplements may be considered drugs by the FDA in some studies. Please see our Dietary Supplements Policy for details.
While not all vulnerable populations are excluded from expedited review, review type depends on what activities are taking place in the research and the level of risk posed for the population. On the other hand, some research with vulnerable subjects might instead require full IRB review (e.g., mentally ill residing in a facility).
The US Office of Human Research Protections provides a series of Decision Charts to aid in determination of review type.
Expedited Review Categories – A Regulatory List
The most frequently used categories are 5, 6, 7, and 8.
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, non pregnant adults who weigh at least 110 pounds. For these participants, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
(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. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human participants 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(7) Research on individual or 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 evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
(8) Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of participants; or
(b) where no participants have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Expedited Review of Minor Changes to Approved Research
Federal regulations at 45 CFR 46.110 (b)(2) allow for expedited review of minor changes in previously approved research during the period for which approval is authorized. This applies to research which was previously reviewed and approved under a full or expedited procedure.
It is only considered minor if it does not represent a material change in the research, falls into expedited categories 1-7, and does not:
- Exhibit a major change to the project's design or aims
- Diminish the project's scientific validity
- Increase the physical and/or psychological risk/discomfort to the participant
- Increase the number of participants at risk
- Expand eligibility criteria
- Add an element that may breach the confidentiality of the participant (e.g., adding focus groups)
- Alter the willingness of subjects to enroll or continue in the study
- Add sensitive information (e.g., questions about depression or sexuality)
- Add a new consent form
- Alter the qualifications of the research team in a way that would not be appropriate for the project
- Alter the facilities available to support the safe conduct of the research
- Include multiple changes to the protocol, instruments, and/or consent process
- Create confusion or questions as to the full scope of the study (e.g., many revisions throughout the life of the project)
- Include any other factor that would warrant review by the convened IRB
Examples of Minor Changes
- Reduction of risk/discomfort to the participant
- Changes to the Principal Investigator
- Addition or removal of research personnel (e.g., research assistant) where competence of the team is maintained
- Addition of a new recruitment site if all procedures are the same
- Adding an instrument similar to the one already approved (e.g., uses many of the same questions)
- Addition of non-sensitive questions to interviews or surveys
- Removing questions from a questionnaire or instrument
- Corrections to documents that do not alter the meaning or procedure (clarification, typographical errors, grammar, etc.)
- Consent form changes that add or remove information so that it is consistent with an already approved IRB requirement
- Defining a phrase more clearly in lay language
- Updating to use IRB approved boiler plate language
- Alteration of the funding source
Minor changes must be submitted to the IRB using a Revisions to Approved Research Request form. The changes must be approved by the IRB prior to implementation.
The Director of Human Participants Protection and Research Compliance makes the final determination regarding eligibility for expedited review under these circumstances. Minor changes to approved research are reviewed by the Director or a member of the IRB as designated by the Director (jointly with the Director).
- The investigator and all research team members (co-investigators, research assistants and advisors/sponsors) complete mandatory online training.
- The investigator reads policies and procedures concerning research with human subjects and instructions on how to submit (center of page).
- The investigator visits www.irbnet.org to register (affiliating with Marywood University), and confirms registration via e-mail. Co-investigators and research advisors/sponsors must also register. Registration by research assistants is optional.
- The investigator downloads necessary forms and templates, completes them, and gathers supporting documentation, as needed. IRB forms and templates are available on the IRB's website or via IRBNet's forms and reference library.
- The investigator proofreads and runs a spellcheck on all completed documents.
- Following the written instructions for IRBNet (video tutorials are also available), the investigator creates a project, shares it with research team members (if applicable), applies an electronic signature, and then submits it to the IRB.
- The investigator monitors his/her e-mail account for communications from the IRB. The IRB will publish a decision letter at IRBNet and will email a notice containing instructions on how to access the letter.
- The IRB's decision letter will communicate required modifications, if any, how to apply tracking to documents prior to modifying them, and how to submit the modifications via IRBNet.
- Once approved, the IRB will email a notice about approval, prompting the PI to access the approval letter and all stamped documents (documents part of the consent process) in IRBNet. Stamped versions of documents must be used in the research.
- The investigator submits to the IRB any requests for revisions after approval, deviations/violations from the approved protocol or materials, unanticipated problems or serious adverse events, should they occur. See appropriate policies and procedures about these topics.
- The investigator submits a status report six months after approval, or a closure report if the study is completed prior to this period. The due date may be found in the approval letter and in the email message sent by staff upon approval.
- As approval is granted for one year only, the investigator submits either a closure report upon completion (at or by expiration date), or if not closing, a continuing review application to the IRB, allowing enough time so there is no lapse.
- Closure or Withdrawal
- Continuing Review
- Dietary Supplements
- Full Review of Research
- Informed Consent, Parental Permission and Child Assent
- Mandatory Reporting
- Records Retention
12/14/2012 - Revised to include minor change information and examples
05/21/2015 - Changed title of Asst. VP for Research to Dir. of Research and Sponsored Programs
05/25/2017 - Updated format, removed outdated staff references, added definitions and exclusions
05/30/2017 - Inserted link to Dietary Supplement Policy
06/08/2017 - Added related policies and regulatory references
05/23/2018 - Updated checklist link and examples of minor changes