HUMAN
RESEARCH SUBJECTS PROTECTION - FREQUENTLY ASKED QUESTIONS
HUMAN
RESEARCH SUBJECTS PROTECTION - FREQUENTLY ASKED QUESTIONS
Frequently Asked Questions Regarding 45 CFR 46 (The "Common Rule")
TIPS
ON WRITING MUOT IRB APPLICATIONS
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Specific Questions Frequently Asked of the MUOT IRB:
How Do HIPAA and the Common Rule Affect Recruitment of Study Subjects?
When
I Sign a FDA 1572 Form At the Beginning of a Clinical Trial, What Commitments
Am I making?
Is My Project Human Subjects Research as Defined in the Federal Regulations [45 CFR 46.102(f)]? (See Chart #1) [via OHRP]
If the Answer to the Above Question is "Yes," Might it Qualify for Exempt Designation? (See Chart #2) [via OHRP]
Does My Project Require MUOT IRB Review? (A Decision-Support Chart)
What Is the Definition of Research in the Federal Regulations Regarding Human Subjects Protection?
What Are Some Commonly Held Myths Regarding Clinical Research?
May Research-Related
Costs Be Charged to Medicare?
Do You Need IRB Approval to Prepare a Case Report?
Must
I Continue to Maintain IRB Approval Even If Patient Accruals Have Been Closed?
Can Treatment of A Single Patient Constitute
"Research"?
What Is the Difference Between "Compassionate" Use, "Emergency" Use, and "Treatment INDs"?
What Are the Required Elements of Informed Consent?
Are There Specific Things I Should Know, If I Plan to Use Human Biological Material in My Research?
Is Training on Issues Regarding Human Research Subject Protection Available at MUOT?
What Should I Do With Consent Forms Signed by Study Subjects?
Do I Need
To List in My Protocol All Personnel Participating in My Study? [Decision-Support
Chart]
Why Does the MUOT IRB Need Copies of My Grant/Contract Proposal?
What Is the Primary Responsibility of IRBs?
How Does the IRB Protect the Rights and Welfare of Human Research Subjects?
Is My Activity Qualilty Assurance (QA), or Is It Research?
General Information
A good place to start is by reading a brochure recently released by the NIH regarding research conducted using human specimens. This brochure, Research on Human Specimens: Are you Conducting Research Involving Human Subjects?, has been prepared by the NIH for distribution to the research community. It is intended as an information resource for researchers, but also may be useful to IRB members. The brochure was developed by a trans-NIH group of extramural program staff from the institutes and centers that support human specimen resources, OPRR staff, Department of Energy staff and others interested in these issues and was approved by the major NIH extramural policy committee. The brochure may be obtained in either HTML or Adobe Acrobat (pdf) formats by link above.
MUOT-Specific Information
Specific information about requirements for utilization of Human Biological Material at MUOT may be found in the MUOT Policy on Research Involving Human Subjects. If your need is for fresh human tissue obtained during surgery, you should also read the
Is Training on Issues Regarding Human Research Subject Protection Available at MUOT?
Yes, internet-based training is available,
via the MUOT Research Office Human Research Subjects
webpage. This page contains links to internet-based training from the NIH and
from the University of California-Irvine.
What Should I Do With Consent Forms Signed by Study Subjects?
The principal investigator is required
to keep evidence in the study records that informed consent was obtained from
each study subject. The original signed and dated informed consent document
should be kept in the principal investigator's study file. If the study subject
is an MUOT patient, a copy of the signed and dated document should be placed
in the study subject's medical record. REMEMBER: The only valid consent form
is the one most recently approved by the MUOT IRB. The date of use must be within
the valid date range shown on the form.
I'm Really Busy, Can I have My Research Coordinator or Nurse Respond, On My Behalf, to Respond to Requests from the IRB?
Federal regulations require that
the IRB must communicate directly with the lead researcher (principal investigator)
regarding protocol-related issues. Accordingly, all correspondence from (or
on behalf of) the principal investigator must be submitted to the IRB over the
P.I.'s signature. The IRB may return any protocol-related correspondence that
is received without evidence of the P.I.'s approval. All correspondence FROM
the IRB regarding protocol-related issues must be directed to the P.I., but
a copy of that correspondence can be sent to any other individuals, if the P.I.
requests it.
Do I Need To List in My Protocol All Personnel Participating in My Study?
Yes, you must list all faculty (including volunteer faculty), staff, and students that participate in a MUOT-approved research project. This would include everyone who is INTERACTING WITH STUDY SUBJECTS (including obtaining informed consent), performing INTERVENTIONS ON STUDY SUBJECTS, or who has access to IDENTIFIABLE PRIVATE INFORMATION (e.g., medical and/or study records) regarding study subjects, ie., everyone who is "Engaged in Research with Human Subjects." If your research team changes after the project is approved, you must submit a modification to your protocol adding the new personnel and/or removing those no longer involved. If a MUOT faculty member's or MUOT staff member's sole role in your protocol is part of his/her regular paid duties, and involvement in the project is limited to performing those duties without contributing to the research endeavor (e.g., a radiologist who is NOT a co-investigator, but who reads X-rays from study subjects or an MUOT Hospital phlebotomist drawing blood for lab tests required by the study), then such individuals need not be listed.
An up-to-date list of MUOT student/trainee research staff (e.g., MUOT graduate students, MUOT research fellows, or MUOT housestaff, or MUOT students performing research as part of a class project) associated with a project must be maintained by the IRB at all times when students/trainees actively interact with human subjects for the purpose of collecting research data or have access to identifiable private information regarding study subjects. Regardless of the duration of a student's/trainee's participation in the research, if a student/trainee will perform research, or analyze results as a paid research assistant or as part of his/her educational activities (e.g., thesis research), students must be listed on the MUOT IRB protocol for the research.
MUOT policy requires that only MUOT faculty and employees, Registered MUOT Students, and Registered MUOT Volunteers may participate in research approved by the MUOT IRB.
For additional assistance on this
issue, we have prepared a Decision-Support
Chart
Why Does the MUOT IRB Need Copies of My Grant/Contract Proposal?
In short, because federal regulations require the IRB to review the proposal itself. The protocol forms used by the MUOT IRB are constructed to provide IRB reviewers necessary information in an easy to find format and to request some specific information that may not be in the proposal. Recent federal guidance regarding this requirement for IRBs, which is quoted below, has reiterated the requirement for these committees to review the entire proposal, not just information abstracted from it onto an institutional "Protocol Form." Although this guidance speaks only of federal proposals, MUOT's Assurance for Human Research requires us to apply these rules to ALL research.
Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(f) require that each application or proposal for HHS-supported human subject research be reviewed and approved by the Institutional Review Board (IRB).
Over the past several years, OPRR has identified numerous instances in which human subject research described in an application for HHS support differed significantly from the IRB-approved protocol that was claimed by the investigator to constitute the research in the application. In each case, the application added important elements (e.g., targeting of vulnerable subjects; additional treatment arms; different drug dosages; additional collaborators or performance sites) that were ultimately implemented without IRB review and approval.
In view of these findings, OPRR reminds IRBs that HHS regulations require that the IRB review the actual application or proposal for HHS support. The IRB's review should ensure that all research described in the application or proposal is entirely consistent with any corresponding protocol(s) submitted to the IRB. [click here for a copy of the full text of this Guidance Document]
Why Does the MUOT IRB Need to Review the Work that I am Subcontracting to Another Institution? Isn't That Institution's IRB Responsible for the Work Done There?
Although the IRB at the subcontracting institution IS required to approve the work, MUOT, as the Prime Grantee or awardee institution, is held responsible for ALL of the work described in the proposal. Thus, in addition to requiring proof that the work was approved by the IRB of the subcontracting institution, the MUOT IRB also is obligated to perform an independent review of ALL of the work described in the proposal. Recent federal guidance regarding this requirement, which is quoted below, has reiterated the requirement for the MUOT IRB to review the entire proposal, not just that portion of the work actually being performed at MUOT. Although this guidance speaks only of federal proposals, MUOT's Assurances for Human Research and Animal Research require us to apply these rules to ALL research. [Click here for a copy of the full text of this Guidance Document]
Multi-Site Research: The requirement for IRB review of each application or proposal for HHS-support applies only to the awardee institution. The application or proposal need not be reviewed by the IRBs at non-awardee institutions participating in the research.
What Is the Primary Responsibility of IRBs?
The primary responsibility of IRBs
is to protect the rights and safeguard the welfare of human subjects of research.
Committee membership is diverse with expertise in science, ethics, and other
non-scientific areas, fostering a comprehensive approach to the protection of
human subjects.
How Does the IRB Protect the Rights and Welfare of Human Research Subjects?
IRBs are responsible for prospective review of all research involving human subjects. They evaluate proposed research activities using the following criteria: (1) the design of the study is consistent with sound scientific principles and ethical norms; (2) the protocol meets the MUOT Multiple Project Assurance (MPA) criteria necessary for approval; (3) the necessary elements of informed consent have been fulfilled, and (4) additional appropriate safeguards have been provided if potentially vulnerable subjects (e.g., children, prisoners, fetuses) are to be studied.
In addition, IRBs conduct continuing
review of each approved research protocol or activity at least yearly, although
an IRB may request earlier evaluations or updates if it determines that the
research presents significant physical, social, or ethical risks to subjects.
The IRB may modify, suspend, or terminate approval of research that has been
associated with serious harm to subjects or is not being conducted in accord
with the MUOT MPA or the IRB's decisions, stipulations, and requirements.
Is My Activity Qualilty Assurance (QA), or Is It Research?
In order for individuals to have a better grasp of the distinction between these two activities, one needs a clear interpretation of the federal definition of "Research", particularly the interpretation of the term "generalizable knowledge", as it is used in the definition of Research. The NIH has recently published a "Primer" on the proposed HIPAA Patient Privacy Guidelines. In this Primer, the term "Research" has the standard federal definition, i.e., "A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge". In addition to this definition, however, this Primer further defines "Generalizable Knowledge" as follows: "Generalizable Knowledge is knowledge related to health that can be applied to populations outside the population served by the covered entity."
From the above, it seems clear to that QA studies, the results of which are intended solely for MUOT's (the "covered entity" in the above definition) INTERNAL use, probably do NOT rise to the level of Research. BUT when data are to be transmitted outside of MUOT, either in the form of a publication, report, or in the form of data sent to others for compilation into reports, the studies generating those data probably ARE research and should receive prior review and approval by the MUOT IRB.
The MUOT IRB is not involved in reviewing
or approving MUOT QA activities, but it is very clear that when QA activities
rise to the level of being Research, prior review and approval by the MUOT IRB
is required.
Why Must I Complete Every Question on the MUOT IRB Application when I have also Submitted Copies of the Full Protocol Provided by the Company for a Clinical Trial?
In short, the MUOT IRB Application Form is designed to provide every member of the IRB a summary of the protocol which provides them with the information necessary for them to review the study in accordance with federal regulations governing protection of human subjects. Since, by federal requirement, an IRB must include some members who are non-scientists and some who are not affiliated with MUOT, it is essential that the protocol summary provided on the application form reviewed by all members be written such that individuals with non-technical backgrounds can understand it. Only the primary reviewers receive copies of company protocols that are submitted with the IRB application, while the MUOT IRB Application Form is received by every IRB member.
Below is a description of what federal regulations require IRB members to have for their review of protocols.
Initial Review of a New Protocol
When reviewing a protocol IRBs must be provided information in sufficient detail to make the determinations required under HHS regulations (45 CFR 46 <http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm>. If the IRB uses a primary reviewer system (as the MUOT IRB does), the primary reviewer(s) should do an in-depth review of all pertinent documentation, including: 1) the full protocol; 2) a proposed informed consent document; 3) any relevant grant applications, the investigator's brochure (if one exists), and any advertising intended to be seen or heard by potential subjects. All other IRB members should at least receive and review a protocol summary of sufficient detail to make the determinations required under HHS regulations (45 CFR 46), [NOTE: the MUOT IRB Application form is designed to provide all IRB members this required protocol summary] the proposed informed consent document, and any advertising intended to be seen or heard by potential subjects.
Continuing Review (Annual Renewal Applications)
In conducting continuing review, the IRB should review, at a minimum, the protocol and any amendments as well as a status report on the progress of the research, including (a) the number of subjects accrued; (b) a description of any: adverse events or unanticipated problems involving risks to subjects or others, withdrawal of subjects from the research, or complaints about the research; a summary of any recent literature, findings, or other relevant information, especially information about risks associated with the research; and (d) a copy of the current informed consent document. Primary reviewer systems may be employed, so long as the full IRB, at a minimum, receives the above information. Primary reviewers should also receive a copy of the complete protocol including any modifications previously approved by the IRB.
Page Updated: 7/30/2004
research@meduohio.edu