Institutional Review Board

The Institutional Review Board is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects. The WMed IRB was created through a collaboration with our community partners, Borgess-Ascension and Bronson Healthcare.

  • What is a human subject?
    A human subject is a living individual about whom an investigator conducting research obtains data through intervention/interaction with the individual or identifiable private information. Is an activity research involving human subjects covered by 45 CFR part 46?

    Research means a systematic investigation (including research development, testing, and evaluation) designed to contribute to generalized knowledge.

  • Distinctions between biomedical and social behavioral research

    Biomedical research

    Biomedical research refers to the study of specific diseases and conditions (mental or physical), including detection, cause, prophylaxis, treatment and rehabilitation of persons; the design of methods, drugs and devices used to diagnose, support and maintain the individual during and after treatment for specific diseases or conditions; and/or the scientific investigation required to understand the underlying life processes which affect disease and human well-being, including such areas as cellular and molecular bases of diseases, genetics, immunology. This research is typically quantitative and not qualitative.  Biomedical research is often patient-oriented and the research involves:


    Social-behavioral research

    Social-behavioral research refers broadly to research that deals with human attitudes, beliefs, and behaviors and is often characterized by data collection methods such as questionnaires, interviews, focus groups, direct or participant observation, and non-invasive physical measurements. The research may be qualitative or quantitative. Social-behavioral research also includes epidemiological or outcomes research and health services research:

    • Epidemiological and behavioral studies: These types of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions.
    • Outcomes and health services research: These studies seek to identify the most effective and most efficient interventions, treatments, and services.  


    Important Notes:

    • Social-behavioral studies that involve the use of drugs or devices, radiation and radiolabeled tracers, and other invasive procedures require review as biomedical research.
    • Retrospective and prospective medical chart reviews maybe considered biomedical or social-behavioral research depending on the objectives or aims of the research.


    Information obtained from UCLA IRB: http://ora.research.ucla.edu/OHRPP/Pages/OHRPPHome.aspx

  • Case Reports: Do they Require IRB Review

    In general, an anecdotal report on one or a series of one (1) to three (3) patients seen in one’s own clinical activities, and a comparison of these patients to existing reports in the literature, is not research and does not require IRB approval. A series of more than three (3) patients seen in one’s own clinical activities, or gathering information on patients beyond one’s own clinical activities such as by seeking out patients and reporting cases seen by other clinicians, creates the appearance of a systematic investigation with the intent to contribute to generalizable knowledge and therefore is considered research and requires IRB approval.

    • Single Case Report: The external reporting (e.g., publication, poster, or oral presentation) of an interesting clinical situation or medical condition of a single patient. Case reports normally contain detailed information about an individual patient and may include demographic information and information on diagnosis, treatment, response to treatment, follow-up after treatment, as well as a discussion of existing relevant literature. The patient information used in the report must have been originally collected solely for non-research purposes as the result of a clinical experience. Single case reports are not required to be submitted for review by the IRB but investigators must still comply with all applicable patient privacy policies and requirements.
    • Case Series: The external reporting (eg, publication, poster, or oral presentation) of an interesting clinical situation or medical condition in a series of patients (ie, more than one patient). Case series usually contain detailed information about each patient and may include demographic information and information on diagnosis, treatment, response to treatment, follow-up after treatment, as well as a discussion of existing relevant literature. The information used in the report must have been originally collected solely for non-research purposes as the result of a clinical experience. Case series of more than 3 patients must be submitted for IRB review or determination of exemption.
  • Determining if a Quality Assessment (QA) or Quality Improvement (QI) study requires IRB Review

    Each QA/QI project needs to be reviewed by the IRB.  Some QA/QI projects may meet the definition of Human Subject Research. A protocol needs to be submitted to make that determination. Provide the following documents to the IRB for a determination:

    1. Appropriate Institutional Proposed Study Assurance and Approval form signed.
    2. Copy of the Protocol describing the QA/QI project.
    • No draft copies can be reviewed since the IRB determination will be based off what is described in the submitted protocol.


    After reviewing the protocol, if the IRB determines that the project meets the definition of human subject research, we will ask to have the appropriate IRB review document (Initial Study Review Form or Request for Exemption Form) submitted.


    Note: If the IRB gives the project a QA/QI determination, no changes can occur to the project without verifying with the IRB that the changes do not change the project objectives. The QA/QI determination was based on the information described in the submitted protocol.

  • Investigators Responsibilities

    Principal Investigators are ultimately responsible for the conduct of research for the studies for which they serve as the Principal Investigator. Principal investigators may delegate tasks to appropriately trained and qualified investigators and research staff. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibilities.

    Principal Investigators (PI)

    • At the medical school, only individuals with a faculty appointment at the rank of assistant, associate, or full professor are eligible serve as the PI.
    • Students, residents, fellows, and others whose status is considered as “in-training” may not serve as a PI but may serve as a sub-investigator. The PI must ensure that the elements of the research protocol conducted in part by trainees has sound research design and that trainees are appropriately supervised at all times.
    • The IRB recognizes a single individual as the PI for each study. The PI has ultimate responsibility for the research activities.
    • Studies that require expertise or skills beyond those held by the PI must either be modified or have expertise and skills supplemented by the inclusion of one or more additional qualified sub-investigators.
  • Responsibilities for Protecting the Rights, Safety and Welfare of Research Participants
    • Design research studies that will most likely develop or contribute to generalizable knowledge, while minimizing risks and maximizing benefits. 
    • Conduct the study in an ethical manner, including protecting the rights and welfare of human subjects who are participants in the research study. 
    • Ensure fair and equitable recruitment practices and avoid recruitment practices that place participants at risk for coercion or undue influence. 
    • Obtain the legally effective consent of the participant or the participant’s legally authorized representative (when IRB approved) prior to participation in research. 
    • Ensure adequate resources (e.g., personnel, time, facilities, funding, access to a study population) to conduct the research in a way that will protect the rights and welfare of participants and ensure the integrity of the research. 
    • Design and carry out the research with adequate data and safety monitoring, when appropriate. 
    • Respond promptly to participants’ complaints and/or concerns or requests for information and report to the IRB any significant Complaints and Concerns Regarding the Conduct of Human Subjects Research 
    • Assure that the Protected Health Information (PHI) created or used in the research study, if any, is the minimum necessary to meet the research objectives, and that PHI is not reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by law. 
    • Report promptly unexpected or serious adverse events, protocol violations, deviations, incidents and complaints to the IRB. 
    • Report promptly updated study safety information to and from regulatory agencies (e.g., audit findings, PI audit response letters).


    Information obtained from UCLA IRB: http://ora.research.ucla.edu/OHRPP/Pages/OHRPPHome.aspx

  • Protecting Privacy and Maintaining Confidentiality - Issues to Consider

    Privacy is about people. Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

    Privacy is:

    • A sense of being in control of access that others have to ourselves.
    • A right to be protected.
    • In the eye of the participant, not the researcher or the IRB.
       
    Subject Population
    • What are the cultural norms of the proposed subject population? Some cultures are more private than others.
    • What are the ages of the proposed subject population? There may be age differences in privacy preferences (e.g., teenagers less forthcoming than older adults)
    Recruitment Methods

    How are potential participants identified and contacted? 

    Acceptable methods: 

    • Advertisements, notices, and/or media 
    • Send introduction letter to colleagues to distribute to eligible individuals – interested individuals contact researcher 
    • Primary care staff contact those patients that qualify to determine interest 

    Unacceptable methods: 

    • Search through medical records for qualified participants or existing database (e.g., registry); then have a researcher with no previous contact with potential participant recruit; this method violates the individuals' privacy 
    • Recruit participants immediately prior to sensitive or invasive procedure (e.g., in pre-op room) 
    • Retain sensitive information obtained at screening without the consent of those who either failed to qualify or refused to participate for possible future studies participation
    Sensitivity of the Information Being Collected The greater the sensitivity, the greater the need for privacy.
    Method of Data Collection (Focus Group, Individual Interview, Covert Observation
    • Will participants feel comfortable providing the information in this manner? 
    • If passively observing the participant; could the individual have an expectation of privacy (e.g., chat room for breast cancer patients)? 


    Confidentiality is about data. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.

    Confidentiality is:

    • About identifiable data
    • An extension of privacy
    • An agreement about maintenance and who has access to identifiable data


    With respect to HIPAA, confidentiality protects patients from inappropriate disclosures of "Protected Health Information" (PHI).

    Research Design

    Protocols should be designed to minimize the need to collect and maintain identifiable information about research participants. If possible, data should be collected anonymously or the identifiers should be removed and destroyed as soon as possible and access to research data should be based on a “need to know” and "minimum necessary" standard.

    Collecting and Maintaining Identifiable Data?

    When it is necessary to collect and maintain identifiable data, the researcher needs to ensure that the protocol includes the necessary safeguards to maintain confidentiality of identifiable data and data security appropriate to the degree of risk from disclosure.

    Provisions to Maintain Confidentiality of Data

    If yes to any of the following, measures to maintain confidentiality should be incorporated into the protocol:

    • Will confidentiality of identifiable data be offered?
    • Are there legal/ethical requirements (e.g., HIPAA)?
    • Will release of data cause risk of harm?
    Limit Access to Data
    • When FDA-regulated products are being studied; participants must be informed that the FDA may have access to their study records to protect their safety and welfare. Any information derived from the research project that personally identifies the participant will not be voluntarily released or disclosed by these entities without the participant’s separate consent, except as specifically required by law.
    • Research records provided to authorized, non-WMed affiliated entities should not contain identifiable information about the participant.
    • Research consent form should state who will have access to identifiable data.


    Quick Reference: Protecting Privacy and Maintaining Confidentiality in Research
    AAHRPP Elements – II.2.B., II.3.D-F, II.5.A. 
    Information obtained from UCLA IRB: http://ora.research.ucla.edu/OHRPP/Pages/OHRPPHome.aspx

  • Honest Broker-Definition

    An honest broker is a neutral third party who is not part of the research team in any way (cannot be one of the investigators or study coordinators, and cannot serve as a co-author on any publication.) An honest broker is an individual, organization or system acting for, or on behalf of, the researcher, institution or covered entity to provide information (or specimens) in such a manner whereby it would not be reasonably possible for the investigators or others to identify the corresponding patients/subjects directly or indirectly. The honest broker collects and collates pertinent information on questionnaires/surveys, tissue, data, biological specimens, and/or images, removes identifiers, and releases only coded information to the researcher. An honest broker may not provide researchers with the code or any other means to re-identify subjects.

    Re-identification of subjects

    In some cases, an investigator who obtains coded private information or specimens may (1) unexpectedly learn the identity of one or more living individuals, or (2) for previously unforeseen reasons now believe that it is important to identify the individual(s). If (1) occurs, the investigator must promptly report to the IRB the fact that they now know the identity of one or more subjects and the circumstances by which this occurred. If (2) occurs, the investigator must submit a request to the IRB for re-identification. If re-identification must occur before IRB approval to protect a subject from apparent immediate risk of harm, this must be immediately reported to the IRB office, the IRB office will provide guidance on next steps.

    Benefits of utilizing an honest broker?

    • Enhances protection of PHI and other sensitive information
    • Minimizes impact of influence and risk of harm
    • It helps establish trust between the research participant and the researcher (researcher shows concern for participant’s well-being by providing honest broker option to maintain privacy)
    • Potentially increases validity of data collected from surveys/questionnaires
    • It may increase study participation


    When should I consider using an honest broker?

    You should consider utilizing an honest broker if the research data being collected is not anonymous, when data is held by an outside entity, when the research includes populations that may be considered vulnerable, and when the investigators are in a position of actual or perceived power over the subjects.

    Examples of when it is adventitious to use an honest broker

    Research involving students enrolled in a classroom setting where the research is being conducted. Students are generally considered a vulnerable population because they may feel some pressure to participate, especially if the requesting investigator is their instructor or someone who may have influence with their instructor or input into their grading, opportunities, or advancement. The use of an honest broker may not be necessary when the surveys/questionnaires are anonymous. However, when identifiers will be used for surveys and/or questionnaires to verify completion for mandated curriculum purposes, and it is also proposed as an optional research study, some or all of the subjects are likely to be vulnerable as students may be concerned that their decision whether or not to participate or answers/opinions may impact their grade or future opportunities.

    You should also consider utilizing an honest broker if the research involves employees that are employed by the research site or institution where the research is being conducted. Employees may also be considered as vulnerable and feel an obligation or pressure to participate, especially if the requesting investigator has an affiliation or relationship with their supervisor potentially effecting their performance evaluations and/or future employment advances.

    Investigators requesting protected health information (PHI) or specimens associated with PHI from a covered entity to collect. Many institutions already have this mechanism or a similar requirement established when external researchers request PHI or specimens.

  • When does the WMed IRB meet?

    The WMed Institutional Review Board meets the first Thursday of each month at 7:30 a.m. Full Board proposals submitted 3 weeks prior to the scheduled meeting are assigned an IRB primary reviewer. Researchers and primary reviewers work together to prepare the proposal for the meeting agenda. Research proposals submitted after the three-week deadline will be reviewed the following month. For more information, see the 2017 Full Board Meeting Calendar.

    Timelines for review:

    • 7 Business Days
      • Quality improvement studies
      • Not human subjects research
      • Exempt studies
    • 14 Business Days
      • Expedited reviews
    • 1 month
      • Convened board meets once monthly
  • Requirements for IRB Review and Approval

    Researchers and IRB members share responsibility for ensuring that human research meets the ethical principles of the Belmont Report and federal criteria for IRB approval of research and informed consent. These criteria are outlined below.

    To be approved, a study must meet the criteria listed below.

    1. Risks to subjects are minimized.
      • Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk.
      • Study utilizes procedures already performed for diagnosis/treatment -- when appropriate.
    2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.
    3. Selection of subjects is equitable.
      • Inclusion/exclusion criteria are adequate.
      • Research purpose and setting are appropriate.
      • Recruitment process is fair.
      • Special requirements for vulnerable populations are addressed.
    4. Informed consent will be sought or waived in accordance with 45 CFR 46.116— and 21 CFR 50.25 for FDA-regulated research.
    5. Informed consent will be documented or documentation waived in accordance with 45 CFR 46.117—and 21 CFR 50.27 for FDA-regulated research
    6. Provisions for monitoring collected data are adequate to ensure the safety of subjects – when appropriate.
    7. Provisions to protect privacy of subjects are adequate – when appropriate.
    8. Provisions to maintain confidentiality of data are adequate – when appropriate.
    9. Vulnerable populations are adequately protected by additional safeguards.
      • Children
      • Prisoners
      • Pregnant women, fetuses and neonates
      • Cognitively impaired persons
      • Economically and educationally disadvantaged persons
      • Non-English speaking persons
    10. If multi-site research study management of information relevant to protection of subjects is adequate.
    11. For continuing review or review of modifications, new information that might affect the willingness of participants to continue to participate will be provided – when appropriate.
    12. The IRB shall set a continuing review period at intervals appropriate to the degree of risk, but not less than once per year.


    Requirements for IRB Review
    AAHRPP Elements II.2.D-E, II.3.A-G, II.4.A-C.

    Information obtained from UCLA IRB: http://ora.research.ucla.edu/OHRPP/Pages/OHRPPHome.aspx

  • Documents required to initiate IRB review

    If the documents below are not received with the IRB application, no review of the submission will begin until the IRB receives them.

    Institutional Proposed Study and Approval document

    This document needs to be signed by the appropriate institutional officials.

    • WMed: Department Chair and Associate Dean for Research, Dale Vandré, PhD
    • Borgess-Ascension: Robert Hill, CMO or Paul Lange, MD
    • Bronson Health Group: Scott Larson, VP/CMO or Katie Harrelson, COO


    CITI Human Subject Protection training certificate for all study team members

    • All study team members must affiliate with WMU Homer Stryker MD School of Medicine


    CVs for the Principal Investigator and Co-investigators on the study

    • Research Team members not a Co-I do not need to submit a CV


    IRB application, all support documents (spreadsheets, surveys, consent, etc.) and any supplement forms indicated in application.

    Research COI

    • Note: this form is now available using the electronic submission process which can be accessed by logging in at http://imedris.med.wmich.edu.
    • Any questions concerning COI process needs to be vetted through the WMed Research Integrity Officer.
  • Research Training Requirement (CITI)

    For any new IRB applications submitted for review, all investigators and study team members will be required to complete applicable WMed Collaborative Institutional Training Initiative (CITI Program) training modules. CITI Program is a leading provider of research education content. All applicable online training modules must be completed and documentation of completion submitted prior to IRB approval.

    You can access the required modules on the CITI Program website.

  • IRB Application Process

    The WMed IRB currently oversees research projects conducted at Borgess-Ascension, Bronson Heath Group, and WMU Homer Stryker MD School of Medicine. Step-by-step guidelines cover the application process for new submissions and any supplemental forms that may be necessary for your particular research project (i.e., research Involving the internet or children).

    Approval

    The research, proposed modification to previously approved research, or other item is approved. The IRB has made all of the determinations required for approval, meeting approval criteria and any applicable special determinations such as required waivers, alterations, or accommodations for vulnerable population determinations. No further action is needed.

    Conditions Required for Approval

    The research, proposed modification to the previously approved research, or other item is approved but conditions must be satisfied before the approval becomes effective.

    The IRB may approve research with conditions if, given scope and nature of the conditions, the IRB is able, based on the assumption that the conditions are satisfied, to make all of the determinations required for approval, meeting approval criteria and any applicable special determinations such as required waivers, alterations, or accommodations for vulnerable population determinations.

    Any time the IRB cannot make one or more of the determinations required for approval, the IRB may not approve the study with conditions.

    The IRB may require the following as conditions of approval of research:

    • Confirmation of specific assumptions or understanding on the part of the IRB regarding how the research will be conducted (eg, confirmation that research excludes children).
    • Submission of additional documentation (eg, certificate of training).
    • Precise language changes to the study, consent, or other study documents.
    • Substantive changes to the study, consent, or other study documents along with clearly stated parameters that the changes must satisfy.

    When the IRB approves research with conditions, the conditions will be documented in the IRB minutes for research reviewed at a convened meeting or in the Initial Study Review Checklist for research reviewed under an expedited review procedure.

    Partial Approval

    The IRB may stipulate that certain components of the research, which the IRB has determined to meet the criteria for approval, may commence or continue while other components of the research that require modification or clarification cannot begin or continue until the outstanding issues are resolved and approved by the convened IRB. For example, the IRB could determine that a study may begin but that children cannot be enrolled until the investigator submits, and the IRB approves, a plan for assent. The IRB may also stipulate that an approval is limited to certain components of the research (eg, phase 1 of a proposed research project) or populations (eg, approved for adults but not children).

    Deferred

    This action is taken by the IRB when modifications are required of the nature or amount that the full IRB cannot make or specify exact changes or parameters, or additional information or clarification is needed in order to determine that one or more criteria for approval are satisfied (eg, the risks and benefits cannot be assessed with the information provided).

    The deferral and the basis for the deferral is documented in the IRB minutes (for convened review) or Initial Study Review Checklist (for expedited review) and is communicated to the investigator in writing.

    Disapproved

    The IRB may determine that the proposed research cannot be conducted at the site or sites included in the IRB submission. Disapproval can only be decided at the convened IRB meeting. An expedited reviewer cannot disapprove a study.

  • FWA & IRB Registration

    WMed Federalwide Assurance is an agreement between the Department of Health and Human Services (DHHS) and WMed to review and approve research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations 45 CFR Part 46.

    The Federal Policy (Common Rule) for the protection of human subjects at Section 103(a) requires that each institution "engaged" in Federally-supported human subject research file an Assurance with the DHHS Office of Human Research Protections (OHRP). The Assurance formalizes the institution's commitment to protect human subjects. The FWA expiration date is revised each time WMed FWA is modified.

    Borgess Hospital and Bronson Hospital maintain their own Federalwide Assurance since research is being done at both institutions.

    • WMed FWA is 00009755
    • Borgess FWA is 00001711
    • Bronson FWA is 00002688


    IRB Registration Information

    The WMed IRB is registered with OHRP and FDA. Borgess Hospital- Ascension and Bronson Health Group de-activated their IRB in 2017 and indicate in their FWA application on file with DHHS that the WMed IRB will serves as their IRB of Record.

    WMed IRB Registration Number is IORG0008954.