1. What must Meriter IRB review?

Definition of Research - Human research is any activity, which has the intent of securing information for the purpose of advancing knowledge. Research differs from clinical practice in that it is designed to test a hypothesis, permits conclusions to be drawn and thereby develop or contribute to generalizable knowledge. Research is described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. (Belmont Report, 1979).

Meriter reviews all research activities involving human subjects before the research is started.

Which Research Projects?

• All research that takes place at a Meriter entity involving human subjects, including inpatients and outpatients must have Meriter Hospital IRB approval.
• Any research that is conducted by a Meriter employee in a location outside of a Meriter entity also requires Meriter IRB approval. These requirements ensure Meriter's compliance with federal and state regulations, which apply to the protection of human subjects in research.

Research using Medical Records Only - IRB review is required in studies involving medical record review. Investigators outline in their IRB application how they intend to minimize breach of privacy and confidentiality for patients' records. Most Record Review Research receives an Expedited Review that is a review by one or two voting members of the IRB. The investigator is required to show their Meriter IRB letter of Approval to Health Information Managment when requesting access to data.

Research on Biological Specimens - Studies that use biological specimens even when the donor’s identity is not known still requires IRB review.

2. What is expedited review?

An expedited review is one that is conducted by one or two of the board members outside of the fully convened IRB meeting. An expedited review may be considered for minor changes to a consent form, retrospective chart review, studies that are closed to accrual and in long term follow-up, and other categories that present minimal risk as defined in the Code of Federal Regulations. Please see Expedited Review Criteria below (PDF file). The IRB Chair/designee will determine whether a full board review or an expedited review is needed. A full application to the IRB is still required to meet federal requirements.

3. What proposals are exempt from IRB approval?

There are six categories of research that are exempt from IRB review described in DHHS regulations. They are:

1. Normal educational practices and settings
2. Anonymous educational tests, surveys, interviews, or observations
3. Identifiable subjects in special circumstances
4. Collection or study of existing data
5. Public benefit or service programs
6. Taste and Food Evaluation and Acceptance Studies

To find out more about these categories please contact the Meriter IRB Office.

4. Why should I submit my research to the IRB if it's exempt?

Investigators often submit a proposal they feel may be exempt but are not sure. The IRB reviews not only for exempt status, but also reviews how privacy and confidentiality will be protected (HIPPA regulations). The IRB may make recommendations on a proposal to improve protections so your research will qualify as exempt.

Additionally, even an exempt project may render results that may be published. Some publishers request an IRB's written determination that the project truly was exempt and there was no risk to human beings. The Meriter IRB sends a written determination on every proposal reviewed. Investigators may use the Meriter IRB determination letter to validate their effort to follow all regulatory requirements.

5. Is there a human subject protection training requirement for researchers?

Yes! Investigators conducting research at Meriter must have training every three years in human subject protection. Meriter subscribes to a web-based training program at http://www.citiprogram.org/. You can register and take the basic modules if you haven't received any training or take refresher modules. Meriter accepts other institutions human subjects training courses. Read more about the Meriter Human Subjects Training Requirement.

6. If I already have approval from another IRB, do I still need approval from the Meriter Hospital IRB?

Meriter and UW-Madison Partnership Agreement allow for UW investigators to have just one IRB of record if their study qualifies for deferral.

Investigators from other institutions or multi-site studies require Meriter IRB approval prior to beginning research at a Meriter entity or recruiting subjects from a Meriter entity.

Meriter IRB reserves the right to independently review research for the protection of its patients' health, welfare and rights and to ensure compliance with federal and state regulations governing the protection of human subjects.

7. Does the Meriter IRB want determination letters from other IRBs?

This is not necessary. Meriter IRB reviews a research protocol on its own merits independently of any other IRB decision made.

8. Why do I have to submit my grant application?

This is a federal regulatory requirement by the Office of Human Research Protections within the Department of Health and Human Services. The Meriter Institutional Review Board would like to see that your research proposal is in keeping with your grant and that sufficient funding is available for the completion of your research.

9. How often must the IRB review my research?

Continuing Review - The IRB reviews research no less than 12 months from the date of initial approval. More frequent review might be required by the Board, appropriate to the degree of risk posed to subjects. The investigator is responsible for updating the IRB prior to the expiration of their most current approval. This date can be found at the top of the approval letter sent to an investigator.

10. What if I decide to change something in my protocol?

You may not change your protocol without prior IRB approval unless it is to prevent human subjects from immediate hazards. You will need to submit all changes for IRB review.

11. What changes do I have to report to the IRB?

You must report any changes in your protocol to the IRB. This includes changes that improve human subject protection and changes that may not have a bearing on human subject protection. Here are some examples:

• Adding or deleting study staff.
• Changes in contact information for the investigator and staff that are listed in the consent.
• Changes in drug dosages.
• Changes in number, frequency, or timing of study visits.
• Adding, deleting, or modifying advertising or other recruitment materials.
• Adding, deleting, or modifying labs, blood draws, or study procedures.
• Changing the number of study subjects required. A protocol is approved for the number of subjects (or biological samples, or medical records) originally estimated unless the investigator requests a modification to that number.

12. What are the rules for advertising for subjects?

All advertising materials (media ads, letters, flyers, etc.) must be approved by the IRB.

FDA guidelines (1998) for advertisements to recruit subjects should be limited to:

1. The name and address of the clinical investigator.
2. The purpose of the research/condition being studied.
3. Eligibility criteria in summary form.
4. Brief list of procedures involved.
5. Time commitment required (number of visits, total duration including follow-up visits, etc.)
6. Compensation/reimbursement
7. The location of the research and the person to contact for further information.

13. How does the IRB handle noncompliance?

If the IRB finds significant violations during any of its reviews of research; the investigator will be notified immediately in writing by the IRB Chair. Enrollment in the study will cease until these violations are corrected. Any continuous or serious noncompliance with the IRB requirements by investigators must be relayed to the IRB Chair, Meriter Hospital and the appropriate regulatory agency. This will result in immediate suspension of the approved protocol.

If the required annual review date has expired or if the investigator fails to correct the deficiencies in the annual review process, IRB approval will be terminated immediately.

14. What are problem events? (Also known as Serous and Unanticipated Adverse Events)

A problem event includes the following:

1. An event that causes a subject or other person:
   • Harm and
   • is unanticipated (not described specifically or to the degree of severity reflected in the informed consent document) and
   • is related to the research
2. New information that indicates a change to the risks or potential benefits of the research, in terms of severity or frequency.
   Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.
3. Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research participant.
4. Incarceration of a participant.
5. Event that requires prompt reporting to the sponsor.
6. Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team.
7. Protocol Violation - meaning an accidental or unintentional change to the IRB approved protocol that placed one or more participants at increased risk, or has the potential to occur again.
8. Unanticipated adverse device effect. This is any serious adverse effect on health or safety, or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application. Any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects should also be reported.

15. What do I do if a subject has a problem event or I have one of the other events listed under question 14?

You must complete a Problem Form (through the electronic submission system) and submit it within five days of becoming aware of the event. Only the events listed in question 14 need to be reported to the IRB.

16. How are administrative changes to my study materials handled?

Administrative changes include a change in name or address, typos, pagination corrections, etc. These may be submitted through the electronic system for review. These documents do not receive IRB approval per se, but a notation of review and receipt will be made for your records.

17. Does the IRB want updated investigator brochures or additional safety data reports?

YES! Any new information about a study drug or procedure should be submitted to the IRB office for review. These documents do not receive IRB approval, per se, but a notation of review will be made for your records.

18. How do I let the IRB know that my research is done?

Completed/Terminated/Closed Research - The investigator is responsible for submitting a Study Closure report using the electronic system when she or he is done with their research. This can be done at any time before the expiration date of IRB approval.

19. Is there a fee for a Meriter IRB review?

Yes - Meriter IRB charges a one-time $2,000 fee for industry sponsored protocols.  This money is used for researcher education and underwriting continuing education for the IRB members. If you are doing research that is funded by a government agency, a foundation, or receives no funding you do not have to pay a review fee. More about IRB Review Fees.

20. How often does the IRB meet?

Meriter Hospital's IRB meets about 11 times a year; on the second Wednesday of the month. Protocols are placed on the meeting agenda in their order of receipt.

21. Who can I talk to about immediate questions?

The IRB Coordinator is a half time position and is available most weekdays. The IRB Coordinator is Liz Michaels (608) 417-6411 or lmichaels@meriter.com.

22. How can I improve my chances of getting my protocol approved?

• Submit your proposal well in advance of the deadline. This gives time for office staff to catch any missing information and allows you a chance to provide that information.
• Make no assumptions. Call or e-mail the IRB office with questions or concerns. The regulations governing human subject research and protected health information are complex. They are intended to promote and guide Good Clinical Practice and the ethical treatment of human subjects. They are not meant as a roadblock to research. We can all comply with the regulations by working together.

23. Can I attend the IRB meeting to defend my proposal?

A representative (principal investigator or sub investigator, study coordinator, etc.) for a newly proposed research protocol may be invited to attend the meeting where her/his research is being reviewed. The purpose of attendance is to answer questions about the protocol. If the board has no questions for the researcher, then they are permitted to leave without an audience with the board. The research representative may not be present during board members' deliberations or voting.

24. How do I find out whether the board approved my research?

The IRB Office will send an electronic letter of determination after the meeting to let you know how the board voted. The IRB may vote to:

1. Approve the study as submitted
2. Request specific modifications before conferring approval
3. Deny approval of the study
4. Table the study to solicit further information

If modifications are required by the board, the investigator must make these changes in writing detailing his/her compliance. Once the IRB Chair/designee deems the changes are sufficient, an approval letter will be sent out and the research may begin.

25. Are there any special tips for UW researchers?

Make sure you "Meriter-ize" your patient consent and information sheet. You may also have to Meriter-ize portions of your study materials if you will be using Meriter locations (i.e. clinic) and services (i.e. lab) for Meriter subjects. Don't hesitate to call the IRB office to clarify issues specific to your proposal. This may save you a great deal of time in the long run.