IRB

Welcome to Orchard Human Services, Inc.’s Institutional Review Board informational and training page.

An IRB, or Institutional Review Board, is a committee that makes decisions regarding research-related activities of the organization with a primary focus on maintaining the protection of human subjects, as set forth by the Office for Human Research Protections, which can be found at this link.

Membership Agreement Form

After reviewing the information on this page, including viewing the training videos, please return here to complete the IRB Membership Agreement.

Training

Training requirements shall be maintained on this page. All participants must complete the training set forth herein.

IRB Training Video 1 1 – Bing video

Part 3 – The Belmont Report: Basic Ethical Principles and their Application – YouTube

Quorum and Voting in IRB Meetings – YouTube

The list of required annual training components shall be updated as necessary.

Regulations

Please click on the link below to download Orchard’s IRB Regulations Manual.

https://orchardhumanservices.org/wp-content/uploads/2021/03/irb-procedures-handbook-Dana-S.docx

Meetings

IRB meetings shall be held on an as-needed basis, with the first being scheduled for Thursday, March 4th at 7 PM Eastern in the year 2021. The meeting shall be conducted via Zoom and the link shall be shared with members before commencement of the meeting.

Minutes of each minute shall be recorded in this online application.

Consent

Participants of approved research projects shall signed an Informed Consent form. Click here to download a consent form.

Non-IRB Activities

The federal regulations [45 CFR 46.102(l)] outline the following as not involving human subjects research:

  1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
     
  2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
     
  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
     
  4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

In addition, the following activities do not meet the definition of human subjects research requiring IRB review:

Case Reports

A summary of clinical data, including medical history and other relevant information, that was collected initially for the purposes of analyzing and diagnosing the individual’s condition and/or for instructional purposes, is considered by the IRB to be a ‘case report’ or ‘case study’. Because this information was not collected with any intent to test hypotheses or otherwise produce ‘generalizable’ knowledge, the activity does not meet the criteria for ‘research’ (45 CFR 46.102(l)), and ordinarily does not require IRB oversight. If the investigator intends to present more than three case studies at one time, this shall constitute research and require IRB exemption or approval.

Although publishing a case report may not require submission to the IRB, investigators should be aware of the use of individually identifiable health information in their publications.  Under HIPAA, the disclosure of an individual’s protected health information must be authorized by that individual. In other words, if a case report contains any identifiers as defined by the HIPAA regulations, authorization to disclose this information in a publication must be sought from the individual whose information is being disclosed. The subject must sign an authorization to disclose this information and that authorization must be reviewed by the institutional Privacy Board (the IRB can serve in that function for UPMC facilities). When the report includes a description of a patient with a rare disorder, condition, or course of treatment, a HIPAA authorization will usually be required because those individuals may be more easily identified.

Innovative Practice

Two passages from the Belmont Report are particularly relevant to any discussion of what constitutes ‘innovative practice’.

“For the most part, the term “practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. By contrast, the term “research” designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is “experimental,” in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project.”

Innovative or newly-introduced clinical procedures or therapies do not require IRB review and approval except when they meet the definition of ‘research’. An innovative clinical practice is an intervention designed solely to enhance the well-being of an individual patient or client. The purpose of an innovative clinical practice is to provide diagnosis, preventative treatment, or therapy to particular individuals. The introduction of innovative procedures or therapies into clinical practice (i.e., independent of a research activity approved by the IRB) should be reviewed with the applicable UPMC oversight committee (e.g., Pharmacy and Therapeutics Committee; Innovative Practices subcommittee of the Technology Assessment Committee) prior to their implementation.

Program Evaluations

Program evaluations involve the systematic collection and analysis of information about the effectiveness of the program in order to make judgments about the program, improve program effectiveness, and/or inform decisions about future program development. These evaluations may involve various methods of human interaction such as surveys, interviews, and the analysis of documents and background information. However, if the intent of these projects is to inform particular programs about that program’s effectiveness and needs rather than to contribute to generalizable knowledge, they are not considered research. Nonetheless, there may still be ethical issues associated with program evaluations such as risks to participants and privacy and confidentiality concerns that should be considered by the investigator.

Quality Assurance and Quality Improvement (QA/QI) Projects

Quality assurance projects do not require IRB review and approval except when they involve “Research” as defined by the federal regulations). Precise definitions to permit the distinction between research studies and QA/QI projects have not been established. In general, QA/QI projects are focused primarily on improving patient care within a given patient care environment (e.g., hospital or health care organization) and, as such, the outcome of the project may not be generalizable to other patient care environments. Publication of a quality assurance project does not, per se, render that project “research”; however, if the outcome of a quality assurance project is published, attention should be given to avoiding the terminology “research” in the publication.

Membership Agreement Form

After reviewing the information on this page, including the training videos, please complete the IRB Membership Form.

Thank you for your valuable contribution of time, expertise, and insight.

IRB Members Collaborate!

Comments are closed