Mount Carmel Institutional Review Board

Human Subject Protection Office
Mount CarmelCorporate ServicesCenter
6150 East Broad Street / Columbus, OH 43213
Phone: 614-546-4325 | Fax: 614-546-4328
Email:

How do I apply to the IRB if I have a new study?

Complete and develop all items below:

  1. One of the following review forms:
  2. Request for Exemption
  3. Full Board/Expedited: Application for Research Involving Human Subjects

For full board review the following must be included:

Research Administration and Financial Obligation Form

Conflict of Interest Disclosure Questionnaire – Part A and/or Part B

Clinical trial agreement

Financial budget for the study

Sponsor or investigator written protocol

IRB fee of $1,500 for all industry sponsored studies

Preliminary Medicare Coverage Determination worksheet

For full board review include the following addenda as applicable:

Drug/Biologic Addendum

Device Study Addendum

Vulnerable Populations: Adults with Decisional Impairment Addendum

Vulnerable Populations: Children Addendum

Vulnerable Populations: Pregnant Women Addendum

Vulnerabe Populations: Prisoner Addendum

  1. Study documents related to human subjects:
  2. Questionnaires
  3. Interview questions
  4. Advertisements
  5. Recruitment letters
  6. Recruitment telephone scripts
  7. Recruitment telephone screening procedure
  8. Investigator’s drug brochure
  9. Device information
  10. Correspondence to or from the FDA
  11. Certificate of confidentiality (if applicable)
  1. Consent document template(s). These are not required for exempt studies.

If minors are involved, submit a copy of the proposed parental permission form and child assent form.

Researchers may request a waiver for the requirement to obtain signed or documented informed consent from subjects by submitting a Request for Waiver of Informed Consent, Documentation of Informed Consent or Elements of the Informed Consent Form.

  1. CV for all investigators.
  1. Documentation of completion of human subject protections training for all investigators. Submission of a certificate is not required; once you have completed the required training at a certificate is automatically forwarded to the Human Subject Protection Office. If you have taken the CITI training at another facility, you will need to forward a copy of that training certificate to the Human Subject Protection Office.

IMPORTANT: It is preferred that submission documents (1-5) be submitted

electronically if possible! Required signature pages can be faxed.

Have the Principal Investigator review the submission and sign the last page of the Application for Research Involving Human Subjects

Email above items to

Mail the original signed “Investigator’s Responsibility” page from the Application for Research Involving Human Subjects to:

Human Subject Protection Office

MountCarmel Corporate ServicesCenter

6150 East Broad Street

Columbus, OH 43213

Read the information below, it is very important.

NOTE:

Provide all required documents as attachments in one e-mail. Do not break items into separate emails unless absolutely necessary, anddo not send the required documents until they are all complete.

The Principal Investigator should thoroughly review the application. If there are any changes necessary to the application these must be implemented into the application before submitting to the Human Subject Protection Office for processing.

The Human Subject Protection Office will not process IRB submissions until all required signatures are received. To speed up the approval process, the signed “Investigator’s Responsibility” page may be scanned and emailed or faxed to the Human Subject Protection Office (fax: 614-546-4328); however, the original signature must also be mailed or delivered to the Human Subject Protection Office for documentation.

If for any reason, part of your submission cannot be submitted electronically, follow these steps:

  • Electronically submit all documents that can.
  • Within the submission e-mail, tell the Human Subject Protection Office staff which documents you are sending hardcopy.
  • Send the hardcopy documents along with the originalsigned “Investigator’s Responsibility” page from the application.
  • Important: do not send the documents without identifying them by the study title.
  • The submission will not be reviewed until all the documents have been received.

Does my study need to go through IRB review?

The Institutional Review Board (IRB) reviews all human subject research conducted by faculty, staff, and students, regardless of the location of the research activity, source of funding (i.e., federally funded, privately-funded or non-funded, including dissertations, masters theses, and pilot studies), and whether the research is exempt under the Code of Federal Regulations for Protection of Human Subjects (45 CFR 46).

There is often confusion about research that is “exempt”. Some have mistakenly assumed that “exempt research” does not need IRB review. However, “exempt” means that it falls within a narrowly defined category of research needing administrative review rather than full board review.

All research must be reviewed and approved in advance by the IRB. This includes research conducted at MountCarmel by individuals from other institutions.

The following sections will provide you with additional guidance for special types of research that may be undertaken by MountCarmel faculty, staff or students.

Research Occurring in Student Courses

The MountCarmelIRB does not require that class research projects be approved by the IRB unless there is intention of publishing or disseminating the study results. This includes independent class projects, class assignments, and undergraduate research. This does not include senior theses and doctoral dissertation research. Research for senior thesis and doctoral dissertation still requiresIRB approval.

Student-Conducted Research

Senior theses and doctoral dissertation research must be independently submitted to the IRB by the student-researcher with the faculty member listed as the Principal Investigator and the student researcher listed as the Co-Investigator. Advisers shoulder the responsibility for students engaged in research. During the design of a project, faculty members should instruct students on the ethical conduct of research and help them prepare applications for IRB approval. In particular, students should:

Understand the elements of informed consent;

Develop a readable consent form (if applicable);

Plan appropriate recruitment strategies for identifying subjects;

Establish and maintain strict guidelines for protecting anonymity and confidentiality; and

Allow sufficient time for IRB review and approval of the project.

As assurance that MountCarmel guidelines will be followed, the adviser or instructor is required to sign the student’s application for IRB approval. After IRB approval, faculty members should take an active role in ensuring that projects are conducted in accordance with the IRB’s requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.

Pilot (Feasibility) Studies

Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in the application to the IRB. Subjects must be told during the consent process that the study is a pilot.

Research Using Clinical Records or Data Previously Gathered

Projects that use data on human subjects gathered in earlier projects require IRB review. If the data are gathered by someone who has legitimate access to the records and who gives the investigator only “blinded” data (so that the investigator is unable to identify the subjects), the level of risk is lowered.

Research Conducted at Another Institution

For a MountCarmel researcher to participate in a research project at another site, the project needs to be reviewed by the MountCarmel IRB as well as by the other institution’s IRB. Researchers who have received approval from another institution’s IRB must include copies of the approval letter issued by that IRB. Changes in protocol or consent forms required by the other IRB should be brought to the attention of the MountCarmelIRB.

Definition of Human Subject

Human Subject is defined as a living individual about whom a research investigator (whether faculty, professional, research staff, or student), conducting research, obtains either data through intervention or interaction with the individual, or specific identifiable private information about that individual [45 CFR 46.102(f)].

Generally, any Mount Carmel research that uses humans, human tissue, surveys of human subjects, or human subjects’ records requires IRB review, irrespective of its funding source. The IRB’s charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture, electrocardiogram, etc.) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

What Qualifies as Research?

Human subjects research (as defined and regulated by federal law and Mount Carmel policies) involves a systematic investigation, including research and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)]. This is usually interpreted to mean that if the results of the work are meant to be published or disseminated to an unrestricted audience, it is considered as regulated human subjects research. However, the benchmark/goal of “publishing” is not a part of the federal code. If an activity follows a deliberate plan whose purpose is to develop or contribute to generalizable knowledge, such as an exploratory study or the collection of data to test a hypothesis, it is research. Examples of regulated human subjects research include: surveys, interviews, observations of activities or behaviors, exercise tests, blood collections, psychological or medical measurements or intervention, sensory responses to taste, smell, etc., and research involving responses from people or access to records about people.

Which Review Form Should You Choose?

Exempt Review

Exempt human subject research projects may be reviewed by the IRB Chair or designee, and do not require full IRB review. The research will not involve any members of protected classes, and poses no more than minimal risk to subjects. Minimal risk means that the probability and magnitude of the harm or discomfort anticipated 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. More specifically, it means the risks encountered inherent to the daily lives of the population or class of research subjects involved and the additional risk added by the research. Thus, a treadmill test of low intensity might be minimal risk for the population in general, but more than minimal risk for research conducted with a group of cardiac patients.

There are no specified deadlines for exempt submissions, and they will be reviewed by the IRB Chair or designee as they are received. Obtaining, informed consent from subjects is not mandated for exempt studies. If the subjects are children, research involving interviews or survey procedures and research involving observation of public behavior in which the researcher(s) participate in activities being observed are not exempt. However, research involving the use of educational tests and research involving observations of public behavior in which the researcher(s) do not participate in the activities being observed are exempt [34 CFR 97.401(b)].

To qualify for exemption, the research must meet all of the following criteria:

  1. Be of minimal risk to the subjects; and
  2. Must not involve pregnant women, prisoners, or mentally impaired persons; and
  3. Must not include survey research with minors unless involving standard educational activities (e.g., educational tests) within the particular education system; and
  4. Must not include observation of a minor’s public behavior unless there is no researcher interaction, and
  5. Research must not involve video or audio recording of subjects; and
  6. Must be in one or more of the following categories:

Research will be conducted in established or commonly accepted education settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness or the comparison among instructional techniques, curricula, or classroom management methods.

Research will involve the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless the subjects can be identified directly or through identifiers linked to the subjects and disclosure of responses could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability or reputation.

Research will involve the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under item (2) above, if (a) the subjects are elected or appointed public officials or candidates for public office; or (b) Federal statute(s) require(s) that the confidentiality or other personally identifiable information will be maintained throughout the research and thereafter.

Research will involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in a manner that subjects cannot be identified directly or through identifiers linked to the subjects.

Research and demonstration projects which are conducted by or subject to the approval of federal agency sponsor the research, and which are designed to study, evaluate or otherwise examine (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures, or (d) possible changes in methods or levels of payment for benefits or services under those programs.

Taste and food quality evaluation and consumer acceptance studies, if (a) wholesome foods without additives are consumed, or if (b) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited Review

Expedited review of human subject research projects may be performed by the IRB Chair or designee. The research should involve no more than minimal risk to subjects. The use of audiotaping or videotaping, even for “Exempt” type activities, automatically places the protocol in the expedited review category. Since most Expedited reviews are performed by the IRB Chair, there is no specific deadline for submission of the protocols. However, the IRB Chair may decide to request full-IRB review of some Expedited protocols if they involve protected classes of subjects, or pose more than minimal risk to the subjects. Unless waived by the IRB, Informed Consent must be obtained from all subjects involved in Expedited research activities prior to their involvement in the research.

To qualify for expedited approval, the research activities must meet all of the following criteria:

  1. Be of minimal risk to the subjects; AND
  2. Must not involve pregnant women, prisoners or mentally impaired persons; AND
  3. Must be in one or more of the following categories:

Clinical studies of (a) drugs for which an investigational new drug application is not required (Note: research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review), or (b) medical devices for which 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.

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds (Note: amounts drawn may not exceed 500 ml in an 8 week period and collection may not occur more frequently than two times per week) or (b) from other adults and children, considering the age, weight, and health of the subject, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected (Note: amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight week period and collection may not occur more frequently than two times per week).

Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) Hair and nail clippings in a nondisfiguring manner; (b) Deciduous teeth at time of exfoliation or if routine patient care indicates need for extraction; (c) Permanent teeth if routine patient care indicates need for extraction; (d) Excreta and external secretions (including sweat); and (e) Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) Placenta removal at delivery; (g) Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) Sputum collected after saline mist nebulization.

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: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amountsof energy into the subject or an invasion of the subject’s 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.