1. Who Reviews Projects involving Human Subjects at BGSU?
The Human Subjects Review Board (HSRB) is BGSU's Institutional Review Board (IRB) and reviews all research projects involving
human subjects.
2. How do I have a Project Reviewed by the HSRB?
First, you must complete Human Subjects Training. The University has a requirement that the Principal Investigator (and the
project advisor, if the Principal Investigator is a student) complete the training in order to get a project reviewed. Training
can be accomplished either by attending a "live" training session or completing web-based training. Information regarding
those alternatives can be found here.
Following successful completion of the training, complete the HSRB application, which can be found here.
Next, you should develop informed consent documents. For help in putting the document together, the HSRB web site has an
Informed Consent Checklist that identifies the necessary pieces of information to be included in the consent document, along
with suggested wording and a suggested outline for the consent document. This checklist can be found here.
Finally, submit the completed HSRB application, consent documents and associated data collection instruments or protocol (e.g.,
questionnaires, focus group questions, interview questions, etc.) as appropriate, to HSRB, 201 South Hall.
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3. If my Research Project is Exempt, does it need HSRB Review?
Yes. It is the responsibility of the HSRB to make the determination that a research project is exempt. BGSU’s assurance with the federal government requires all research projects involving human participants to be reviewed by the HSRB.
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4. How long will it take for HSRB Review?
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7. I received an HSRB Continuing Review Reminder. What's that all about?
The federal regulations governing research with human subjects require review of an active research project no less frequently
than once a year. Therefore, the HSRB can only approve a project for a maximum of a 12 month period. After the initial approval
period, a project can be continued for an additional period at the request of the investigator. Any modifications from the
original project must be approved, however (see question 8 for more information on this).
Eleven months (or less depending upon specific project characteristics) after initial review, an investigator (and advisor,
if the researcher is a student) should receive a Human Subjects Continuing Review Update form via campus mail. This form asks
the investigator to provide information regarding the project, such as the status of the project (completed or continuing),
the number of subjects involved, if any adverse events occurred. This form should be returned, along with copies of current
consent documents, to the Office of Research Compliance. If the project has been completed, the file will be marked as such
and archived. If the project is continuing, it will be reviewed by the HSRB. The investigator will be notified of the results
of the review, including any changes to consent documents that may be required as the result of guidance provided by the federal
government. When approval is granted, it will usually be for a 12-month period, but could be shorter depending upon the specific
characteristics of the project. Continuing Review reminders will be sent each year until the project is completed.
Often investigators are students who have finished the project and left BGSU. In that case, it is the advisor's responsibility
to complete the form and return it to the Office of Research Compliance along with current copies of consent documents. It
is also the advisor's responsibility to know the number of subjects used and whether or not there were any adverse events,
withdrawals, etc.
The HSRB and Office of Research Compliance appreciate the efforts taken by many of you to complete updates for projects in
a timely manner. Your reward will be - no urgent reminder regarding the update, a smile from HSRB members and Office of Research
Compliance staff. If you have any questions about the continuing review process contact Richard Rowlands or any member of
the HSRB.
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8. How do I request changes to a project that has already been approved? (Revised 6/4/07)
Complete a Request for Modification/Addendum form and return it and relevant supporting materials (e.g., new/revised recruiting documents, consent forms, data collection
instruments, etc.) to the Office of Research Compliance, 201 South Hall. The form is available through the HSRB home page. The response commitment for review of modification requests is the same as for new applications (see question 4 above).
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9. I am not affiliated with Bowling Green State University but I want to conduct research using BGSU faculty, staff and/or
students as participants. Do I need to have HSRB review of my project?
The HSRB has the authority to require submission of a completed HSRB application by anyone conducting research in which BGSU
faculty, staff and/or students are involved as participants. Please contact the Office of Research Compliance for additional
information. If HSRB review and approval is required, see HSRB Policy/Procedure statement - Initial Review- External Researcher Applications on the HSRB Policy and Procedure web page for instructions.
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10. Do I need to have human subjects related training in order to conduct research involving human participants?
Effective February 1, 2001 BGSU instituted a policy which requires the Principal Investigator (PI) and the PI's advisor (if
the PI is a student) to have obtained human subjects training in order for a research project to be reviewed by the HSRB.
See the HSRB Training Schedule for session times and dates. Note: web-based training is now available. See the HSRB Training Schedule for details.
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11. Can I continue my project after I leave BGSU?
When you leave BGSU, HSRB approval of your project is no longer applicable. If you plan to continue the project at your new
institution you should seek IRB review through that organization.
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12. I just received a continuing review form. I finished my work with human subjects and I'm analyzing the data. Should
I consider my project completed?
Guidance from OHRP states even projects in the analysis stage should receive continuing review. Therefore, you should fill
out the form indicating the project is in analysis and return it to the Office of Research Compliance for continuing review
processing. For graduate students working on their thesis or dissertation work, it also makes sense to do so just in case
their committee asks them to collect more data or recontact participants.
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13. I need to access health-related (e.g. medical records, medical payment records, health care claims) information for my
participants. Are there any special considerations I should be aware of?
Yes, you should be aware of the Health Insurance Portability and Accountability Act (HIPAA) and its impact on research with
human participants. This act was passed in 1996 as part of an effort by the Federal government to standardize and provide
safeguards for the electronic transmission of health information of U.S. citizens. Two standards or "rules" have been published
- The Transaction Rule and the Privacy Rule. The Privacy Rule has specific requirements related to the use and/or disclosure
of protected health information for research purposes .
This PowerPoint presentation provides basic information regarding the "Privacy Rule" and research. Contact the Office of Research Compliance for assistance.
Click this link for guidance from the Department of Health and Human Services' Office for Civil Rights on research aspects of the Privacy
Rule.
The Department of Health and Human Services has developed a web site to provide the research community with information about
the HIPAA Privacy Rule and how it might affect research. Click this link to go to that web site.
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14. I am conducting a grant-funded project and one of the requirements of the funding agency is to evaluate, and report back
to the agency, the success or effectiveness of the project. Do the data collection activities I need to conduct in order
to gather data for the evaluation report require HSRB review and approval?
If the intended use of the data collected are solely for reporting back to the funding agency as a basis for evaluating the
project, then the associated data collection activities typically do not require HSRB review and approval (keep in mind that
there are some federal agencies, such as the Centers for Disease Control (CDC), that may require evaluative data collection
activities to receive IRB review and approval).
However, the Board recognizes that there may be situations where you want to use the evaluation data for research purposes
or to collect additional data from your project participants strictly for research purposes. In these situations HSRB review
and approval of the research-related aspects are required. In either case (use of evaluation data for research or collection
of additional data strictly for research) your consent document(s) should clearly differentiate the evaluation components
(for which participation is generally mandatory) from the research related components (for which participation in or use of
collected evaluation data is voluntary).
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15. I've heard that consent documents are required to be stamped with approval and expiration dates. What's that all about?
The Office for Human Research Protections has issued guidance that recommends Institutional Review Boards put approval and
expiration dates on all approved consent documents and stipulate that copies of the dated documents be used in obtaining consent.
The thought here is that this will help ensure only the current, IRB approved consent documents are presented to prospective subjects. The HSRB has decided to implement this recommendation
in order to help researchers in their efforts to use the approved versions of consent documents. Click this link to go to the HSRB's policy/procedure statement in this regard.
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16. May I use a consent form that provides prospective subjects with the option to actively decline participation (e.g., provide
both a "yes, I want to participate" and "no, I don't want to participate" option and have the prospective subjects choose
one or the other)?
The federal regulations for the protection of human research subjects do not require documentation that an individual does
not want to participate in a project. In general, the HSRB’s perspective is that the researcher does not need to know the identities of individuals who decline
participation in his/her project.
The Board does, however, recognize that there are situations in which documenting either the willingness or unwillingness
of a prospective subject to participate in a project could be appropriate. For example, a researcher who is introducing a study on a sensitive topic to a group of individuals may want to provide both
a negative (e.g., “I do not want to participate”) and a positive (e.g., “I do want to participate”) option on the consent form and have everyone complete and return the consent form. In this manner the privacy of individuals who opt to participate (or for that matter, to not participate) in the project
is protected because everyone is completing and returning a consent form (some indicating willingness to participate, others
declining participation).
The HSRB would expect that projects where both choices (participation and non-participation) are formally provided on a consent
document would be relatively rare and the need for such an approach would require justification to the Board. That justification should also include an indication of the planned disposition of consent forms obtained from individuals
who decline participation and, if retention of them is desired, an associated justification of that need.
If you believe the use of this type of consent document would be needed for your project, contact the Office of Research Compliance
to discuss the project.
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17. I am planning to conduct a human subjects research project in a foreign country. Are there any laws, regulations or guidelines
that I should be aware of in that regard?
The federal Office for Human Research Protections (OHRP) has developed an International Compilation of Human Subject Research
Protections (Note - this compliation has been updated for 2008). This compilation lists the laws, regulations, and guidelines
of 84 countries (over 900 laws regulations, and guidelines). The compilation can be accessed on the OHRP website at: www.hhs.gov/ohrp/international/HSPCompilation.pdf.
