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FAQs

The following FAQs have been compiled to assist you with your research questions:

Is my project research?

Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge.

It is important to make a distinction between the practice of medicine and that of research in the clinical setting. They are frequently carried out together. This is the case when a clinical research study evaluates the safety and efficacy of a treatment. Practice includes interventions that can reasonably be expected to enhance the well-being of a person, through diagnosis or treatment. In contrast, research involves testing a hypothesis and drawing conclusions. Usually the research study is described in a formal plan or protocol that identifies the objectives and the procedures to be used to reach the objectives.

Other types of research are also conducted at Mount Carmel, in addition to clinical research. One type is survey research, which involves the interactions of individuals with subjects in order to gather information using questionnaires or interviews.

Another type of research involves collection of data through identifiable private information sources, such as the medical record. Analysis of the data collected in this manner will yield a specific conclusion.

Your project will likely be considered research if it contains any of the elements described above.

Does my research require IRB approval?

All research projects involving human subjects or human materials must be reviewed and approved by the Mount Carmel IRB prior to initiation of any research related activities, including recruitment and screening activities.

What is a human subject?

The IRB uses the definitions of Human Subjects provided by the Office for Human Research Protections (OHRP).

HUMAN SUBJECTS: Individuals whose physiologic or behavioral characteristics and response are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [Federal Policy - .102(f)]. Visit http://ohrp.osophs.dhhs.gov/irb/irb_glossary.htm for more information.

There may be circumstances in which the definition may be amended to include the definition of the U.S. Food and Drug Administration (FDA) and/or the Office of Civil Rights (OCR) with regard to the Health Insurance Portability and Accountability Act (HIPAA) of 1996 regulations.

FDA HUMAN SUBJECTS: Human subject means an individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient. Visit http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=56.102 for more information.

The Office of Civil Rights (OCR) further defines human subjects to include decedents.

There are also cultural or ethnic groups whose beliefs are such that they may object to the use of any samples of human tissue for research. One must be aware of these boundaries and respect them.

What are human derived materials?

  • Medical records
  • Datastore (i.e., database, spreadsheet, or other document or electronic information)
  • Fetal material, including placenta, amniotic fluid, fetal membranes and umbilical cord
  • Teeth
  • Pathological specimens
  • Diagnostic specimens (blood, sputum, urine) and hair or nail clippings collected in a non-disfiguring manner
  • Deciduous teeth at time of exfoliation, or if routine patient care indicates a need for extraction; permanent teeth if routine patient care indicates a need for extraction
  • Excreta and external secretions (including sweat)
  • Uncannulated saliva collected either in an unstimulated fashion; or, stimulated by chewing gumbase or wax, or by applying a dilute citric acid solution to the tongue
  • Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
  • Mucosal and skin cells collected by buccal scraping or swab, skin swab or mouth washings
  • Sputum collected after saline mist nebulization
  • Primary cell lines (or those not generally available through commercial sources)

What is the Scope of the IRB's Authority?

All research projects involving human subjects or human materials must be reviewed and approved by the Mount Carmel IRB prior to initiation of any research related activities, including recruitment and screening activities.

Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 45 CFR 46 Section 101(b) (1-6) or 101(i), all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, are subject to IRB review if one or more of the following apply:

  • The research is sponsored by institutional authorities
  • The research is conducted by or under the direction of any physician, employee, faculty member, staff member, student, or agent of the Institution in connection with his or her institutional responsibilities
  • The research is conducted by or under the direction of any physician, employee, faculty member, staff member, student, or agent of the Institution using any property or facility that is partially or wholly owned by the Institution
  • The research involves the use of the Institution's nonpublic information to identify or contact human research subjects
  • A research subject crosses the threshold of a Mount Carmel facility (partially or wholly owned)
  • Any research protocol uses Mount Carmel resources in any manner (i.e. lab testing, X-ray, CT, MRI, and/or Mount Carmel personnel, etc.)
  • Mount Carmel is a party to the Clinical Trial Agreement (contract)

How long does IRB review take?

We recommend that you allow 28 days for review. A well-prepared application will hasten the process. Many projects can be approved in less than 28 days if the application is complete and the informed consent document is well written.

All applications (new and renewal) receive preliminary review by the Office of Research Affairs staff before the application is sent for IRB review. This preliminary review is done to facilitate the review of IRB applications and informed consents. This process assists the researchers by identifying questions and issues that may arise during IRB review. The Office of Research Affairs staff will send comments and recommendations to the principal investigator and/or his/her coordinator. The researcher can then make any recommended changes or additions to the application prior to IRB review.

The process can be facilitated if the researcher prepares the informed consent at an 8th grade reading level prior to submission. Use the sample informed consent format when preparing your informed consent.

What happens after I submit my IRB application?

When a new application is received in the Office of Research Affairs, it is reviewed for completeness and readiness for IRB review. A staff person contacts the researcher if additional information is needed. Once a completed application has been received, it is assigned for full, expedited or exempt review.

If the application requires full board review, a member of the Office of Research Affairs staff will notify you regarding the time of your review. The principal investigator or a co-investigator must attend the IRB meeting to present his/her research study.

The IRB agenda is mailed 10 days in advance of the meeting. The IRB meets monthly at 7 a.m. Click here to see a schedule of meetings..

For applications that qualify for expedited or exempt review, the application is reviewed by the Chairman or a member of the IRB designated by the Chairman.

For all studies, within one week of IRB review, a letter is sent to the principal investigator documenting the IRB's action and any recommendations. After addressing the IRB's conditions for approval and submitting material that responds to these concerns, the researcher will receive a copy of the final IRB approval. The research may begin only after the study has received final approval.

Can I recruit subjects into my study before IRB approval?

No. Research subjects may not be approached until the IRB has given final approval to your research study.

Can I advertise to recruit subjects for my study?

The IRB must review and approve all materials you plan to use to contact potential research subjects. This includes newspaper advertisements, radio or television announcements, and Internet postings. Flyers, letters of approach, and telephone scripts must also be approved.

Recruitment materials should provide basic information regarding your study, including:

  • The amount of time involved
  • The primary purpose of the research (e.g., testing an experimental drug)
  • An overview of procedures and testing
  • A description of potential benefits
  • Any compensation to the participant

Can I pay research study subjects?

The IRB's primary consideration in looking at remuneration plans involves the effect that coercion or undue inducement could have on a prospective participant's ability to make an informed, voluntary choice about taking part in research. This is especially important when participation may include significant discomfort or the assumption of risk, and when involving children in a study.

If compensation or the use of incentives is to be part of your study, it is important to include specific information in the IRB application and to provide detailed information about payment, including terms, in the informed consent document. Procedures for payment distribution of incentives should be established before the first participant is recruited.

What if there are changes to my study after I receive IRB approval?

You are required to obtain IRB approval before implementing any changes to an approved study. The only exception is when an immediate change is made to eliminate a risk or hazard to a subject. In such a case, the change must be submitted to the IRB for review as soon as possible.

Minor changes to a study not involving greater than minimal risk usually undergo expedited review by the IRB Chairman or a designated IRB member. Major changes to a study require full board review. A member of the staff can answer your questions about modifications.

What if an adverse event occurs?

Under federal regulations, the IRB is responsible for receiving and reviewing information about adverse events experienced by research subjects.

Adverse events are those that are not expected to occur, are more serious than anticipated when they do occur, or occur more frequently than reasonably anticipated. Unexpected adverse events must be reported to the IRB by the researcher in a timely manner. Unexpected adverse events that occur in research subjects enrolled under Mount Carmel IRB approval must be reported on the Adverse Event Reporting Form.

How do I renew a study?

The IRB is required to conduct substantive and meaningful continuing review of research at intervals appropriate to the degree of risk, but not less than once per year. Continuing reviews will be conducted by the convened IRB unless the research falls into one or more of the categories appropriate for expedited review.

Prior to the convened meeting, IRB members will be provided with detailed continuing review materials sufficient to conduct substantive and meaningful reviews. These materials will include the currently approved informed consent document and the IRB Continuing Review Application Form, which includes a summary of the research, a status report on the progress of the research, number of subjects enrolled and withdrawn, problems and adverse events, relevant recent literature, and other relevant information.

A Progress Report/Continuing Review Form will be mailed to the Principal Investigator by the Office of Research Affairs staff approximately 60 days prior to expiration of the IRB approval date of the protocol.

This form should be completed following the instructions on the form. This form must be completed for all protocols, including those closed to enrollment and those being terminated. The Progress Report/ Continuing Review form must be signed and dated by the Principal Investigator.

The following must be attached to all Progress Report/Continuing Review forms returned for IRB review:

  • A clean copy of the most recently approved consent form
  • A copy of the consent form signed by the last participant enrolled (unless no subjects have been enrolled or if enrollment was closed prior to your last review)
  • A copy of the last Data Safety Monitoring Board (DSMB) Report, if applicable
  • A Serious Adverse Event Form and all SAEs that have not been reported to the IRB since your last review, with justification as to why they were not reported
  • A copy of any agency (FDA, OHRP) or sponsor audit correspondence, if available
  • A copy of any additional or new data collected that might affect a subject's willingness to participate or that might change the risk/benefit ratio

Conducting human subject research without current IRB approval is a violation of federal and institutional regulations. If IRB approval of a project expires, no new subjects may be enrolled and all ongoing research activities must stop.

What is emergency use?

Emergency use is defined as the use of a test article on a human subject in a life-threatening situation, in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval for the use. The Investigator is still required to obtain informed consent under these circumstances.

The IRB requires the Investigator to submit a letter, within 24 hours, describing the nature of the situation as well as requesting approval for use of the test article. The Chairman must be contacted prior to Emergency/Compassionate use of the test article to determine whether the request meets the emergent use criteria. The Chairman has the option to convene an Ad Hoc committee to review the merit of the request. The Chairman also has the option to decide whether the test article may be used prior to full IRB committee review.

Any subsequent use of the test article is subject to IRB review [21 CFR 50.23; 21 CFR 56.104(c)]. "Subsequent use" means any use of the test article that occurs after its initial emergency use. When an IRB receives a report by a clinical Investigator of an emergency use, the IRB must examine each case to assure itself and the institution that the emergency use was justified.

Although 21 CFR 56.104 is designed to permit only a single emergency use of a test article for the treatment of one patient by one physician within an institution, the regulation is not intended to limit the authority of a physician to provide emergency care in a life-threatening situation. Should a situation arise which would require the emergency use of the test article for a second patient, either by the same or a second physician, for the same test article, subsequent emergency use should not be withheld for the purpose of gaining IRB approval. If it appears probable that similar emergencies will require subsequent use of the test article at the institution, every effort should be made either to sign on to the sponsor's protocol or to develop a protocol for future emergency use of the article at the institution. Either of these protocols would need to be prospectively reviewed and approved by the IRB for future use of the test article.

Does a project using only medical records require IRB approval?

Yes. The use of medical records or clinical databases (paper, electronic, or any form) for research purposes requires IRB review. This is in accordance with the federal regulations for the protection of human research subjects, Ohio State law pertaining to healthcare records, and the federal privacy rules, known as HIPAA Privacy Rules. Generally, if you will be gathering information from sources that already exist (retrospective review) and need to collect identifiers such as patient name and medical record number so that the data can be linked to individuals, your project qualifies for expedited review.

What if my research involves other sites that may have their own IRB review?

If the project involves Mount Carmel patients, Mount Carmel staff as research subjects, or Mount Carmel facilities; or, if the funding for the research is based at Mount Carmel, the Mount Carmel IRB must review the project. The only exception is research involving the Columbus Community Clinical Oncology Program (CCOP). The Columbus CCOP and Mount Carmel have an agreement whereby the CCOP IRB reviews all research projects initiated by the Columbus CCOP involving Mount Carmel patients.

What is a Federal-Wide Assurance (FWA)?

The Mount Carmel IRB has a Federal-Wide Assurance (FWA) on file with the Office for Human Research Protection (OHRP). This Assurance is an agreement between Mount Carmel and OHRP, which acts on behalf of the Secretary of the Department of Health and Human Services.

The FWA outlines the principles and guidelines that govern the institution, faculty, staff, and students in the protection of the rights and welfare of subjects in research conducted at or sponsored by Mount Carmel and its affiliated research organizations, regardless of the funding source.

What is the link between the grant proposal and the IRB application for funded projects?

The funding agency expects the IRB to review and approve the use of human subjects as described in the funding proposal. Before funds are awarded, the agency requires certification of approval from the IRB. If the funding agency requires IRB approval before the funding proposal will be reviewed by the agency, then an IRB application must be submitted and pending approval in the IRB office before the funding proposal is mailed to the funding agency.

What is minimal risk?

The federal regulations define minimal risk as follows: The probability and magnitude of harm or discomfort anticipated by participating in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

What is informed consent and when is it needed?

In almost all cases, consent must be obtained from the research subjects or their legally authorized representatives (parents or guardians) before participation in research begins.

The informed consent process is a basic ethical obligation for researchers. It consists of providing adequate information to the subject about the study, giving the subject the opportunity to consider options, responding to questions the subject has, and ensuring that the subject or his/her legal representative (parent or guardian) understands the information. In addition, the process includes obtaining the subject's voluntary agreement to participate in the research, indicated by the participant's or his/her parent's signature on the written consent document.

Consent is a process that does not stop after a signature is obtained. During the conduct of the entire study, researchers should check with subjects and their parents to be sure they understand what will happen during the study and agree to continue in the research.

The IRB may approve a waiver of consent in limited circumstances. Consent may be waived if the IRB determines:

  • That no more than minimal risk to research subjects would be involved
  • That the rights or welfare of subjects would not be adversely affected
  • That the research could not be practicably conducted without a waiver
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