Compliance

Human Subjects Institutional Review Board (HSIRB)

Frequently asked questions (FAQ)



General and background information

Protocol submission process

Data storage

Research design

Review process

Meetings

Changes or extensions after project approval


General and background information


Why do we need the HSIRB?

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.

Top

What ethical principles guide the HSIRB in the protection of human subjects?

Three basic principles of ethics are particularly relevant to the protection of human subjects in research. They are:

    1. Respect for Persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;
    2. Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and
    3. Justice: fairness in the distribution of research benefits and burdens.
Top

What is the role of the HSIRB, and what research must be reviewed?

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:

    1. data through intervention or interaction . . . , or
    2. identifiable private information."

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.

Top

What are the primary issues of concern to the HSIRB?

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.

Top

Where is the HSIRB located?

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.

Top

Who constitutes the Board?

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.

Top

Protocol Submission Process


Protocol Submission Process

NOTE: Be sure to read Troubleshooting your HSIRB Review for more tips.

Top

How do I know if my project needs to be approved by the HSIRB?

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.

Top

Who is eligible to be a Principal Investigator?

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.

Top

How do I submit a protocol for HSIRB review?

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.

Top

How many copies of the protocol do I have to submit and what are the deadlines?

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.

Top

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:

  • Name
  • Social Security Number
  • Degree Attained
  • Electronic Mail Address
  • Department
  • Title
  • Street or Campus Address
    City, State, ZIP
    Office/Home Phone

For Student Investigators, also include:

  • Status (undergraduate, masters level graduate, or doctoral level graduate)
  • Level of involvement (assisting faculty research, thesis, dissertation, or specify other)

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.

Top

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.

Top

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).

Top

Data Storage

What types of data must be maintained for a minimum of three years?
Federal regulations require that all data be maintained. That may include the following:
  • Surveys and forms containing subject-reported data
  • Printouts of computer-mediated activities
  • Observation forms or notes
  • Audiotapes and/or transcripts
  • Videotapes and/or coding notes and analysis
  • Summarization, extraction, or compilations of data
  • Statistical manipulations and input
  • Consent/assent documents
  • Subject screening forms

The above list is not exhaustive because the modes of data collection are unlimited.

Top

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.

Top

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.

Top

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.

Top

Research Design

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.

Top

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:

  • Ask the subject to "self-code" the instruments using a number that he/she can remember, such as a special day, ages of children, combination of ZIP code and last four digits of social security number, etc.
  • Ask each subject to roll one die five times, and record the numbers in sequence to create a unique 5-digit number for each subject.
  • Distribute pre-coded instruments. A master list could be used to maintain the code for each particular subject throughout the project but must be destroyed following data collection.
Top

Review Process

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.

Top

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:

  1. Educational settings involving normal educational procedures
  2. Educational tests, survey procedures, interview procedures or observation of public behavior UNLESS a) subjects can be identified AND b) such disclosure results in risk
  3. 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
  4. Study of existing data or records IF a) sources are publicly available OR b) subjects cannot be identified
  5. Federally funded research and demonstration projects designed to study public benefit or service programs
  6. 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.

Research in the expedited category is that which poses no more than minimal risk to the subject involving no more than:

  1. Clinical studies of drugs and medical devices only when an investigational new drug application is not required OR an investigational device exemption application is not required OR 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 from healthy, nonpregnant 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 OR 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
  3. Prospective collection of biological specimens for research purposes by noninvasive means, such as hair and nail clippings in a non disfiguring manner, teeth at the time of exfoliation or if routine patient care indicates a need for extraction, excreta and external secretions (including sweat), uncannulated saliva, placenta removed at delivery, amniotic fluid obtained at the time of rupture of the membrane prior to or during labor, supra-or sub gingival dental plaque and calculus, mucosal and skin cells (collected by buccal scraping or swab, skin swab, or mouth washings), or 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 include (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 subject or an invasion of the subjects 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 nonresearch purposes (such as medical treatment or diagnosis) that are not publicly availiable
  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
  8. Continuing review of research previously approved by the convened HSIRB
  9. 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

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)

Top

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.

Top

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.

Top

Meeting

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.

Top

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.

Top

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.

Top

Changes or Extensions After Project Approval


What about changes in the protocol once it has been approved?
All changes in a research protocol must be approved before the change is incorporated into the protocol. These should be submitted to the HSIRB (251W Walwood Hall) in a memo.
Top

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.

Top

Questions? Email the research compliance coordinator

 
Office of the Vice President for Research
Western Michigan University
210 W Walwood Hall
Kalamazoo, MI 49008-5456 USA
(269) 387-8298 | (269) 387-8276 Fax