The HSIRB was established by the Board of Trustees to implement federal and state laws and regulations concerning protection of research subjects. By submitting your protocol to HSIRB, you are complying with university policy and federal regulations (45 CFR 46). More importantly perhaps, you, along with other ethically minded individuals, are promoting the protection of the rights and welfare of those without whom we could not advance our knowledge-the participants. Faculty are further serving as excellent role models for students, and students are learning about ethical conduct, a critical aspect of human research.
Three basic principles of ethics are particularly relevant to the protection of human subjects in research. They are:
The primary role of the Human Subjects Institutional Review is to protect the rights and welfare of human research participants. All research involving human subjects must be submitted to HSIRB, even if you believe it is exempt (see "Guidelines for Human Subjects Research at WMU" for a summary of exempted research criteria). Federal regulations define "research" as "a systematic empirical investigation designed to develop or contribute to generalizable knowledge." Federal regulations define "human subject" as "a living individual about whom an investigator . . . conducting research obtains:
Since 1972, University policy has required that all research be reviewed regardless of funding source. If human subject data will be aggregated, analyzed, or summarized for publication (whether inside or outside the University), it requires SIRB submission and review.
There are four major areas of concern that are evaluated in determining whether participants' rights and welfare are protected. They are 1) the design of the research, 2) the balance of harm and benefit, 3) the process of informed consent, and 4) the selection of subjects. Many people question why research design is a consideration. Consider this: If a research project is poorly designed, no valuable information is likely to be gained. Such a protocol cannot justify any risks or inconveniences to the participant. This is the risk-benefit analysis. A second issue is that many people think of "informed consent" as a form containing details of the research that is signed by the participant. In developing your research, think of informed consent as a process. Informed consent means that the participants truly understand what they are agreeing to and all of the risks and benefits inherent in the activity.
The HSIRB is located in 251W Walwood Hall (in the Office of the Vice President for Research). Please call the research compliance coordinator at (269) 387-8293 with any questions you may have when completing your application.
The Board is composed of at least five individuals. Some are researchers, others are not. The law (45 CFR 46) requires that there be at least one "non-scientific" member, one physician, and at least one member from outside the university community on the Board. The Board strives for diversity and representation from several different departments. For some protocols, the Board is required to have a special representative on the committee. For example, for protocols involving prisoners the Board must have a prisoner advocate. The purpose of this is to bring to the Board a certain perspective that may not generally be considered. It is not unusual for the advocate to offer a unique and highly relevant perspective in considering these protocols.
NOTE: Be sure to read Troubleshooting your HSIRB Review for more tips.
If your project involves "research" and "human subjects" it must be submitted to the HSIRB for approval prior to implementation. "Research" is defined in the federal regulations as "a systematic empirical investigation designed to develop or contribute to generalizable knowledge." A flowchart is available which may help you to decide if the project must be submitted for HSIRB review.
Any full-time faculty or staff employee of WMU may serve as a Principal Investigator. Students may serve as Student Investigators but not as Principal Investigators. Adjunct or part-time faculty may serve as Co-Principal Investigators or as Collaborating Investigators, at the discretion of the Principal Investigator.
Complete the application and obtain the necessary signatures. Submit the original form, with the paginated research protocol outline, all recruitment materials, consent/assent documents, and research instruments to the research compliance coordinator. If the research will be conducted at a site other than WMU, a letter from officials at each research site granting permission to conduct the research must be included.
Applications submitted as exempt or expedited review must include the original form. There are no deadlines for exempt or expedited review submissions. They are reviewed on a continuous basis.
Applications submitted for full board review must include the original and 15 copies of all of the materials. The submission deadlines and meeting dates for Full Board review are available on line.
How do I complete the HSIRB application and/or review forms when the project has more than two co-principal or student investigators?
The following information is needed for every investigator involved in the project:
For Student Investigators, also include:
If there are more investigators than will fit in the space provided on the form, use two or more copies of page 1 of the form. Remember to provide a signature for each investigator on the last page of the form in the Certification/Signature section. You may use more than one copy of the last page if necessary.
The site where I intend to conduct my research has its own IRB. Does my protocol have to be reviewed by the site IRB and HSIRB? If so, how do I do this?
Some sites of research activity, such as hospitals, community mental health organizations, and other universities, have IRBs to review the research conducted at that site. If the site of your research has an IRB, both the site IRB and WMU HSIRB must approve your project prior to implementation.
You may submit your protocol for review to both boards simultaneously or to each board consecutively, whichever you prefer. Each board may request different revisions based on its interpretations of the federal regulations. It is your responsibility as the investigator to notify each board of the decisions of the other board. You must also submit any revisions to both boards and you must receive approval from both boards before implementing any aspect of the research.
If the site of the research does not have an IRB, a letter from official(s) at the research site must be included with the HSIRB submission. This letter must indicate that official(s) from the site have read the protocol and grant the investigator(s) permission to conduct the research at that particular site.
Why do I have to disclose potential sources of funding and agency submission dates on my HSIRB application?
Some sponsors (funding sources) have specific guidelines for the protection of human research subjects. The HSIRB must review your proposal using those guidelines or the sponsor may not accept the decision of the HSIRB.
In addition, each sponsor has a specific deadline for the submission of institutional regulatory approvals. Some sponsors require the original HSIRB approval letter to accompany the proposal submission, other sponsors require the approval letter to be forwarded within 30, 60, or 90 days. The HSIRB is aware of these deadlines and will make every reasonable effort to meet them. The HSIRB does not inform the sponsor of project approvals; that is the responsibility of the investigator(s).
The above list is not exhaustive because the modes of data collection are unlimited.
I know that my data must be securely stored (locked) on-campus at WMU in the Office of the Principal Investigator or other departmental office for a minimum of three years. Is it true that I, as a student, cannot have the data that I collected for my thesis or dissertation?
NO, that is not true. Students who have conducted the research as fulfillment of a degree requirement may have a copy of the data as long as the original data are maintained on WMU's campus.
I'd like to keep my data for a longer period of time, but HSIRB demands that I destroy everything after 3 years. What do I do?
In compliance with federal regulations () the HSIRB requires a minimum data storage period of 3 years. There is no maximum storage period; data may be stored indefinitely. AFTER the 3-year minimum storage period, the disposition of the data is at the discretion of the Principal Investigator.
If my research involves collecting anonymous survey data from 10,000 subjects, do I have to keep all of the returned surveys for a minimum of three years?
If the research is completely anonymous, including the consent process, data may be stored electronically as follows. All collected data must be input to a database or spreadsheet, and a printout generated. The printout must be verified against the actual returned surveys and must be 100% accurate; researchers should initial and date the verified printout. The database or spreadsheet must be saved to a disk (or larger storage disk or magnetic tape, as appropriate) and an additional back-up copy created.
Researchers must include the method (above) and secure location of storage for the printout and disk in the HSIRB protocol outline. The separate storage location of the back-up disk must also be disclosed.
Why does the HSIRB review the design of the research?
As part of the risk-benefit analysis, the HSIRB must be concerned with the design of the research. If the research is poorly designed, and the information to be gained is likely to have little value, the HSIRB cannot justify any risks or inconveniences to the subject.
Sometimes the members of the HSIRB are able to suggest modifications to the research design which reduce the level of risk and/or increase the benefits to the subjects.
How can I create a method of anonymous data collection (to satisfy one of the exemption criteria) if my research design involves administration of multiple instruments (e.g., follow-up mailing)?
The data collection instruments can be coded in a corner, and the code linked to a mailing list. As instruments are returned to the researcher by the subjects, the corner is snipped from the instrument. By matching the corner code to the mailing list, the researcher will have a record of replies received without having an identity attached to the data. The mailing list should be destroyed following data collection.
Other methods that can be used to create an anonymous data set include:
What happens to my protocol after it is submitted to the HSIRB?
The research compliance coordinator processes the submitted protocol, inputs necessary information into the database, and assigns the protocol a unique number. The protocol is forwarded to the HSIRB chair for determination of the level of review. The chair may request that additional members of the board also review the protocol. Investigators are notified as soon as possible of the decisions relating to the protocol (i.e., request for revisions or approval). A flowchart details the entire review process from beginning to end.
What are the differences between the three levels of HSIRB review (exempt, expedited, and full board)?
For more detailed information, see "Guidelines for Human Subjects Research at WMU".
Research in the exempt category is exempt from applicable federal regulations, although review by the HSIRB is still required by WMU policy. Exempt research must be anonymous and at meet least one of the following criteria:
Note: The IRB Chair makes the initial decision about what type of review is necessary, the IRB may request more extensive review.
Research in the expedited category is that which poses no more than minimal risk to the subject involving no more than:
Research which is neither exempt nor expedited requires the full board category of review. All research which does not clearly fit into the exempt or expedited categories of review should be submitted to the HSIRB, assuming it will need full board review. (Deadlines and Full Board Meeting Schedule)
How are exempt research protocols handled differently from other protocols?
Exempt protocols are reviewed by the chair of HSIRB. Exempt protocols are reviewed as they are submitted to the office. If protocols submitted as exempt do not meet exemption criteria they will be subjected to either expedited or full review.
What kind of timeline should I expect for being able to begin data collection?
Remember, no research may begin until HSIRB has given your research protocol full approval with no revisions. The review process for protocols submitted for exempt or expedited review takes approximately ten days. The review process for protocols submitted for full board review can take one month or longer to complete. You should expect to be asked to make at least a few revisions. Most revisions can be considered by subcommittee and do not have to go before a second board meeting. To speed the review process when revisions are required, please submit the revisions in memo form. If you insist on revising the protocol you originally submitted, please highlight the changes.
Some protocols at the full board level of review must come back to the full board the next month. Why? Typically these protocols were not prepared with care, and they require substantial revisions and additions. The HSIRB cannot approve applications in which critical information is missing or poorly articulated. If you need help writing your proposal, contact your department chair or the research compliance coordinator.
How often does the HSIRB meet and who attends the meetings?
The HSIRB meets each month unless there are no protocols requiring full board review. At least six HSIRB members will be in attendance. Most of the members are faculty of WMU in departments that frequently conduct research with human subjects. At least one is a member of the Kalamazoo community who is not affiliated with the University. Generally, while your protocol is being reviewed, only the investigators on your project will be in the room with the Board. There is a waiting area outside of the meeting room for investigators involved in other projects to be reviewed at that convened meeting.
Should investigators attend HSIRB meetings in which their protocol is reviewed?
Yes. It is very helpful for the Board, and it can save the investigators considerable time and trouble. The project's principal investigator should attend the meeting along with the student investigator(s). If investigators are present to answer questions, the revision process can be greatly expedited.
What happens at an HSIRB meeting?
If your protocol requires full board review, you will receive written notification of the meeting date, time, and location. You will not need to be present for the entire meeting. Inves
tigators are scheduled at 20 minute intervals. During those 20 minutes, your protocol will be discussed in detail. You should be prepared to respond to questions from individual Board members. Aspects of the federal regulations may be discussed as they impact your protocol. Following the meeting, you will receive written notification of the requested revisions.
My data collection is going to take longer than I thought. How do I extend my HSIRB approval period?
First, regardless of the dates of the research activity that you provided on your HSIRB application form, the HSIRB issues approvals for up to one year. The termination date of that approval period is included on your approval letter. If your data collection needs to continue beyond that termination date, you will need to complete the Project Approval Review Form and submit it to the HSIRB. Include any changes or adverse events not yet submitted to the HSIRB. If your project was reviewed before the full board, you may be requested to appear before the Board again. Most extensions and renewals are reviewed by the HSIRB chair only and are processed within approximately ten days.
Questions? Email the research compliance coordinator