Office of Research Compliance

1. Who Reviews Projects involving Human Subjects at BGSU?
2. Does my project/research need to be reviewed by the HSRB?
3. How do I have a Project Reviewed by the HSRB?
4. If my Research Project is Exempt, does it need HSRB Review?
5. How long will it take for HSRB Review?
6. How soon before I want to start recruiting and data collection should I submit an HSRB application for review?
7. Which Types of Projects Need Full Board Review? (Revised 03/19/2012)
8. I received an HSRB Continuing Review Reminder.  What's that all about?
9. How do I request changes to a project that has already been approved?
10. 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?
11. Do I need to have human subjects related training in order to conduct research involving human participants?
12. Can I continue my project after I leave BGSU?
13. 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?
14. 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?
15. 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?
16. I've heard that consent documents are required to be stamped with approval and expiration dates.  What's that all about?
17. 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)?
18. 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?
    

  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.  Does my project/research need to be reviewed by the HSRB? 

If your project/research meets the federal definitions of “research” with a “human subject” your research must be reviewed by the HSRB (see below).  

The HSRB strongly suggests that you confirm if your project needs review with the Office of Research Compliance.  An informal determination can be made by calling the office (419-372-7716) and a formal determination can be made by completing and submitting the Review Determination Form.

The Review Determination Form can be found in IRBNet.  The completed form must be submitted in IRBNet to the BGSU HSRB.  Instructions for using IRBNet can be found on the HSRB home page and in IRBNet under the Forms and Templates section.

“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” (45 CFR 46.102.d)

“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” (45 CFR 46.102.f)

  3. 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 in IRBNet.org.

Next, you should develop informed consent documents.  For help in putting the document together, the HSRB created an Informed Consent Checklist that identifies the necessary pieces of information to be included in the consent document, and a suggested outline for the consent document.  These documents can be found in IRBNet.org. 

Finally, submit the completed HSRB application, recruiting materials, consent documents and associated data collection instruments or protocol (e.g., questionnaires, focus group questions, interview questions, etc.) as appropriate, in IRBNet.org.  Directions on how to submit materials using IRBNet are found on the HSRB home page. 

[Top]

  4. 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.

[Top]

  5. How long will it take for HSRB Review?

• For projects receiving expedited review during the academic year, expect to receive results of the initial review in 10 to 14 business days following submission.  Note that the turnaround time may vary depending upon the number of submissions in IRBNet.
• Projects requiring full board review are reviewed at the Board's monthly meetings, generally held on the 1st Wednesday of each month. The Office of Research Compliance strives to get review results back to Principal Investigators within 7 - 10 business days of the meeting at which the project is reviewed, depending upon the number of projects on the meeting agenda.  See the HSRB Review Schedule for submission deadlines.
• Important - Regardless of the type of review, if you have not heard back from the Office of Research Compliance within 15 - 20 business days of submission, please check the status of your submission in the IRBNet.org system or call the office at 419-372-7716.  

[Top]

  6. How soon before I want to start recruiting and data collection should I submit an HSRB application for review?

• For projects receiving expedited review you should submit your HSRB application at least five weeks in advance of your planned start.
• For projects receiving full Board review you should submit your HSRB application for review at the HSRB meeting two months in advance of your planned start.  See the HSRB Review Schedule for monthly meeting dates and associated submission deadlines.
• In most cases, following these guidelines should provide sufficient time to allow your project to receive final approval in advance of its planned start date.

[Top]

  7. Which Types of Projects Need Full Board Review? (Revised 03/19/2012)

• Research involving prisoners (e.g., individuals in prisons, halfway houses, certain parolees - e.g., those residing in a treatment facility as a condition of parole)
• Some types of research with children (<18 years old) - for example if a waiver of parental consent is requested
• Research with other vulnerable populations (e.g. institutionalized individuals, pregnant women)
• Research presenting more than minimal risk

[Top]

  8. 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 email. 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 IRBNet.org. 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 Hillary Harms or any member of the HSRB.

[Top]

  9. How do I request changes to a project that has already been approved? 

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 IRBNet.org.  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).

[Top]

  10. 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. 

[Top]

  11. 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.

[Top]

  12. 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.

[Top]

  13.  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 IRBNet.org 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.

[Top]

  14. 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.

[Top]

  15. 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).

[Top]

  
16. 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.

[Top]

 
17. 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.

[Top]

 
18. 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 compilation 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: http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html.