Compliance

Human Subjects Institutional Review Board (HSIRB)

Guidelines for human research at WMU


Introduction

The HSIRB is WMU's Institutional Review Board (IRB). It was established by the WMU Board of Trustees in accordance with federal regulations to interpret and apply federal regulations, state law, and research sponsor requirements for the use of human subjects in research. The HSIRB is charged with the protection of the rights and welfare of human subjects in research conducted under the aegis of Western Michigan University.

The three basic ethical principles that guide the HSIRB are respect for persons, beneficence, and justice. By submitting a protocol for HSIRB review, researchers are complying with University policy and federal regulations.

All WMU research involving human subjects - including undergraduate honors college theses, and graduate theses and dissertations - must be reviewed for the protection of human subjects. The research must be approved by the HSIRB before the research is begun.

A complete statement of WMU's compliance with federal regulations can be found in the "Western Michigan University Assurance of Protection of Human Research Subjects and Compliance with DHHS Regulations" (WMU Assurance).

The HSIRB at Western Michigan University has been formed to assure the Department of Health and Human Services (DHHS) that human subjects will be protected and that WMU will comply with "DHHS Regulations for the Protection of Human Research Subjects (Title 45 Code of Federal Regulations, Section 46") and the ethical principles described in the "Belmont Report" (Copies of both are available on line and from the HSIRB office.) The HSIRB is composed of no fewer than five members representing diversity in gender, culture, profession, and discipline.

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Institutional policy

It is the policy of WMU that all research involving human subjects will be reviewed by the HSIRB. The involvement of human subjects in research is not permitted until the HSIRB has reviewed and approved the research protocol. This means that no contact with subjects (including recruitment and obtaining consent) can be initiated until the research has been approved, although researchers may contact organizations from which subjects will be recruited. Furthermore, unless the consent process has been specifically waived by the HSIRB in accordance with , no subjects may be included in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.

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When to contact the HSIRB for review

The HSIRB reviews research involving human subjects if one or more of the following apply:

    1. The research is sponsored by WMU, regardless of the location of the project.
    2. The research is conducted by, or under the direction of, any staff, faculty, student, or other agent of WMU in connection with his or her institutional responsibilities.
    3. The research is conducted by or under the direction of any employee or agent of WMU using any property or facility of WMU.
    4. The research involves the use of WMU's non-public information to identify or contact human research subjects or prospective subjects.
    5. The research is a thesis or dissertation that involves human subjects. Neither Lee Honors College nor The Graduate College will accept as a dissertation or thesis any research involving human subjects which was not reviewed by the HSIRB prior to the research being conducted.
    6. Note: Most funding organizations and foundations will not support a research project until IRB approval has been received.
    7. Note: Special consideration is required for research involving fetuses, pregnant or lactating women, human ova in vitro fertilization, prisoners, children, persons with cognitive impairment, or other potentially vulnerable groups.

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Components of HSIRB review

The HSIRB must be assured that your application addresses the following areas.

    1. Project description: Include purpose, procedure, research design, location, and duration.
    2. Benefits of research: Indicate specific benefits to the subjects as well as more general benefits.
    3. Subject recruitment>: Describe how you intend to contact and recruit participants.
    4. Risks to subjects: Describe potential physical, psychological, and social risks, including discomforts or inconveniences.
    5. Protection for subjects: Describe how you intend to protect subjects from possible risks.
    6. Confidentiality of data: Describe how you intend to protect the privacy of subjects and confidentiality of information.
    7. Instrumentation: Include all questionnaires, interview scripts, and data collection instruments.
    8. Informed consent: Describe how you will obtain informed consent.

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All research involving human subjects must be reviewed by the HSIRB. A flowchart has been developed to help researchers determine whether their project involves human subjects. If you are unsure whether your project involves human subjects, contact the research compliance office.

There are four parts to the application for HSIRB review:

    1. the Application for Initial Review is available on line. All sections must be completed. The principal investigator must be a faculty or staff member. WMU policy does not allow students to be principal investigators.
    2. a protocol in the format described on page 2 of the application form. The protocol must include a complete description of the proposed research in non-technical language.
    3. Consent and Assent Documents, in accordance with the Consent Document Development Checklist on page 3 of the application form. All documents appropriate to the proposed research should be included. Consent and Assent Documents should be written in simple, non-technical language that can be easily understood by the prospective subjects. A written justification is required for all items excluded. Examples of Consent and Assent Documents are online.
    4. copies of all recruitment materials-including scripts, letters, or other documentation of what will be communicated during recruitment-questionnaires, interview protocols, assessment materials, experiment session outlines, and descriptions of materials that subjects will encounter. Commonly used tests and inventories, such as the Wechslers or Stanford-Binet intelligence tests and the MMPI personality inventory, need not be submitted.

Approval will be delayed for HSIRB applications that do not carefully attend to the application checklist and consent checklist. Please do not submit existing research proposals in lieu of HSIRB applications.

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Categories of review

The NIH defines three categories for HSIRB review: full board, expedited, and exempt. Research in all three categories must be submitted to the HSIRB for review.

FULL BOARD

  • Research scheduled for full board review shall be distributed to Board members prior to the meeting. Protocols must be submitted to the HSIRB office two weeks before the meeting date to allow adequate time for Board members to read the proposal, usually by 5:00 p.m. on the first Wednesday of each month. Requests for further information from investigators shall be made prior to the meeting. Investigators are invited and strongly urged to attend. Meetings usually occur on the third Wednesday of each month. At convened meetings of the Board, proposals are either approved, approved with revisions, or disapproved.
  • A protocol may be distributed to a consultant or expert to advise the Board in its review of a protocol.
  • A quorum, constituted of a majority of HSIRB members, is required to convene a full board meeting, with at least one member of that quorum representing social and ethical non-scientific concerns.
  • A protocol can be approved after receiving the approval of the majority of those members present at the convened meeting.
  • The HSIRB at a minimum will conduct annual reviews of approved research. It is the responsibility of the researchers to inform the HSIRB of any changes in research design, adverse events, and to request annual renewal of HSIRB approval, if necessary.

The full board must review research where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or would be stigmatizing.

Full board review process takes one month or longer and usually requires revisions. Full board approval indicates that although the research might involve risk to subjects, it is likely to make an important scientific contribution to a field of study.

EXPEDITED

Expedited review is performed by a sub-committee consisting of the HSIRB chair plus one or two other board members. The recommendations of the sub-committee are submitted to the full board for a consideration. When appropriate, preliminary approval is given by the sub-committee to researchers in order to speed the research process. However, the full board has the right to reverse the sub-committee's approval.

The following categories of research are eligible for expedited review, except as noted:

  • Clinical studies of drugs and medical devices only when:
    • Research on drugs for which an investigational new drug application is not required
    • Research on medical devices for which (i) an investigational device exemption application 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
  • Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows
    • from healthy, non-pregnant adults weighing at least 110 pounds with a total volume collected not exceeding 550 ml in an 8-week period and collection occurring no more frequently than twice per week.
    • from other adults and children, considering the age , weight, and the health of the subject, the collection procedure, the volume of blood to be collected, and frequency with which it will be collected not exceeding the lesser of 50 ml or 3ml/kg in an 8-week period and collection occurring no more frequently than twice per week
  • Prospective collection of biological specimens for research purposes by noninvasive means
  • Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves
  • 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) in a confidential manner
  • Collection of data from voice, video, digital or image recordings made for research purposes
  • 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 confidential research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
  • Continuing review of research previously approved by the convened HSIRB as follows:
    • where (i) the research is permanently closed to the enrollment of new subjects, (ii) all subjects have completed all research-related interventions, and (iii) the research remains active only for long-term follow-up of subjects
    • where no subjects have been enrolled and no additional risks have been identified
    • where the remaining research activities are limited to data analysis
  • Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the HSIRB has determined and documented at a convened meeting that the research involves no more than minimal risk and no additional risks have been identified
  • Minor changes in previously approved research
  • Other categories added to this list by DHHS and published in the Federal Register

HSIRB members participating in expedited review can either approve the research as expedited or refer it for full board review. At the next full board meeting the HSIRB chair shall inform members of research protocols that were approved as expedited. Any board member may request that the research project be re-reviewed by the full board. Members shall then vote on the request with a majority deciding the issue.

The expedited review process requires a minimum period of ten days following receipt of an appropriately completed protocol by the HSIRB office.

EXEMPT

Research that meets certain conditions may qualify for exemption from certain federal regulations. The HSIRB chair alone is authorized to grant exemptions.

The following categories of research are eligible for exempt review, except as noted:

  • educational settings involving normal educational procedures
  • educational tests, survey procedures, interview procedures or observation of public behavior UNLESS a) subjects can be identified AND b) such disclosure results in risk.
  • educational tests, survey procedures, interview procedures or observation of public behavior not exempt or under (2) if subjects are public officials or where confidentiality is required by federal law
  • study of existing data or records IF a) sources are publicly available OR b) subjects cannot be identified
  • federally funded research and demonstration projects designed to study public benefit or service programs
  • taste and food quality evaluation and consumer acceptance studies

Note: The IRB Chair makes the initial decision about what type of review is necessary, the IRB may request more extensive review.

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Notification of decisions

The HSIRB sends written notification to researchers regarding HSIRB decisions, conditions, and requirements. Researchers are also informed of the reasons for the disapproval of an investigation and given an opportunity to respond.

Administrative officials of WMU may choose not to permit research that the HSIRB has approved; however, they may not permit research that the HSIRB has disapproved.

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Responsibilities of the principal investigator

The principal investigator is responsible for:

  • the compliance of all co-investigators, student investigators, and research associates with the HSIRB decisions, conditions, and requirements
  • reporting to the HSIRB any changes to the research protocol (e.g., research design of the study, recruitment procedures)
  • requesting renewal by completing the Application for Continuing Review when contact with subjects will extend beyond the approval termination date
  • reporting to the HSIRB chair any unanticipated adverse reactions or unanticipated events associated with the conduct of this research
  • seeking clarification and advice from the HSIRB regarding ethical aspects of the research

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Informed consent process

The consent document should have three parts: beginning, middle, and end.

Beginning:

  • Who is doing the experiment.
  • The nature, purpose, and duration of the experiment-including the fact that the procedure is experimental.
  • The uses to be made of the data.

Middle:

  • The methods to be employed.
  • The hazards, inconveniences, and risks the subjects will undergo, as far as they are known.
  • The availability of compensation and treatment, if injured.
  • The benefits that might be expected.
  • Disclosure of alternate procedures the subject may choose if the experiment is therapeutically related.
  • The conditions of participation, if any.

End:

  • A statement that the data are confidential and a description of the procedures to be employed in maintaining confidentiality.
  • The fact that the subject is at liberty to withdraw his/her consent prior to the experiment, discontinue participation in the experiment at any time, or refuse to answer any questions, without prejudice.
  • An offer to answer any questions as well as instructions as to how to contact the researcher, the HSIRB and the vice president for research, should questions arise later.
  • A place for the date of signing and for the signature of the subject (and witness, is required).

Note: There can be no exculpatory language anywhere in the form.

Administering the Consent Document

  • Pass out two forms-one for subjects to sign and return to you and one for them to keep for their records.
  • Read the form aloud as the subjects read it to themselves.
  • After reading it aloud, summarize what is stated on the form.
  • Allow time for questions.
  • Schedule a break to allow subjects time to consider whether they want to participate or not.

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Glossary of terms

  • Anonymous data collection means that even the researcher does not know the identity of the subjects.
  • Confidential data collection means that the researcher knows the identity of the subjects either directly or through the use of a master list used for coding but will not release identifying information when sharing the data with others.
  • A human subject under is defined as "a living individual about whom an investigator ... conducting research obtains:
  • "Interaction includes communication or interpersonal contact between investigator and subject."
  • "Intervention includes both physical procedures ... and manipulations of the subject or the subject's environment that are performed for research purposes."
  • Principal investigator is an employee or faculty member of WMU who accepts responsibility for the research. The principal investigator cannot be a student even if that research is the student's dissertation.
  • Research is defined in as a systematic empirical investigation designed to develop or contribute to generalizable knowledge.

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Bibliography

Office of Human Research Protections, Department of Health Services National Institutes of Health, Title 45 Code of Federal Regulations 46, June 18, 1991.

The Belmont Report. Office for Protection from Research Risks, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979.

Grundner, T.M. (1986). Informed Consent: A Tutorial. Owings Mills, MD: National Health Publishing.

Questions? Email the research compliancecoordinator.

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Office of the Vice President for Research
Western Michigan University
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Kalamazoo, MI 49008-5456 USA
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