CCRP (IRB/IEC Roles and Responsibilities)

Minimal Risk

The probability and magnitude of harm 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 examination or tests.

21 Part 56.104

Exemptions from IRB requirement

a) Any investigation commenced before July 27, 1981 and was/wasn't subject to requirements for IRB review under FDA regulations before that date.
b) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days.
c) Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

21 CFR 56.106

Registration

a) Each IRB in the U.S. that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the act and each IRB in the U.S. that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products must register at a site maintained by the Dept. of Health and Human Services (HHS). (A research permit under section 505(i) of the act is usually known as an investigational new drug application (IND), while a research permit under section 520(g) of the act is usually known as an investigational device exemption (IDE).)

b) What information must an IRB register? Each IRB must provide the following information:
1) The name, mailing address, and street address (if different from the mailing address) of the
institution operating the IRB and the name, mailing address, phone number, facsimile
number, and electronic mail address of the senior officer of that institution who is responsible
for overseeing activities performed by the IRB

c) Each IRB must submit an initial registration. The initial registration must occur before the IRB begins to review a clinical investigation. Each IRB must renew its registration every 2 years.

21 CFR 56.107

Membership

a) Each IRB shall have at least 5 members
b) Every effort will be made to ensure that no IRB consists entirely of men/women. No IRB may consist entirely of members of one profession
c) Shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in the nonscientific areas
d) Shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution
e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB
f) An IRB may invite individuals with competence in special areas to assist in the review of the complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

21 CFR 56.108

IRB Functions and operations

In order to fulfill the requirements of these regulations, each IRB shall:

(a) Follow written procedures: (1) For conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (2) for determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review; (3) for ensuring prompt reporting to the IRB of changes in research activity; and (4) for
ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects.

(b) Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1) Any unanticipated problems involving risks to human subjects or others; (2) any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB; or (3) any suspension or termination of IRB approval.

(c) Except when an expedited review procedure is used (see § 56.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be
approved, it shall receive the approval of a majority of those members present at the meeting

21 CFR 56.109

IRB review of research

(a) An IRB shall review and have authority to approve, require modifications in or disapprove all research activities covered by these regulations.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with § 50.25.
(c) An IRB shall require documentation of informed consent in accordance with § 50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context; or
(2) The IRB may, for some or all subjects, find that the requirements in § 50.24 of this chapter for an exception from informed consent for emergency research are met.
(d) In cases where the documentation requirement is waived under paragraph (c)(1) of this section, the IRB may require the investigator to provide subjects with a written statement regarding the research.
(e) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of
the research activity.
(f) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
(g) An IRB shall provide in writing to the sponsor of research involving an exception to informed consent.
(h) When some or all of the subjects in a study are children, an IRB must determine that the research study is in compliance with part 50, subpart D of this chapter, at the time of its initial review of the
research.

21 CFR Part 56.110

Expedited review of research involving no more than minimal risk, and for minor changes in approved research

1) Research with no more than minimal risk
2) minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the IRB chairperson from among the members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.

21 CFR 56.111

Criteria for IRB approval of research

(a) In order to approve research covered by these regulations the IRB shall determine that all of the
following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result.

(3) Selection of subjects is equitable.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with and to the extent required by part 50.

(5) Informed consent will be appropriately documented, in accordance with and to the extent
required by § 50.27.

(6) Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(b) When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects.
(c) In order to approve research in which some or all of the subjects are children, an IRB must determine that all research is in compliance with part 50, subpart D of this chapter.

21 CFR 56.112

Review by Institution

Research covered by these regulations that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.

21 CFR 56.113

Suspension or termination of IRB approval of research

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the FDA

21 CFR 56.114

Cooperative research

In complying with these regulations, institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.

21 CFR 56.115

Records

An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation
of IRB activities, including the following:
1) Copies of all research proposals reviewed, scientific evaluations, ICFs, progress reports, and report of injuries to subjects
2) Minutes of IRB meetings
3) Correspondence between IRB and PI
4) List of members
5) SOPs
6) Statements of significant new findings

Records shall be retained for at least 3 years after completion of the research

Minutes

Minutes should include:

1) Meeting attendance
2) Action taken
3) # of members voting for, against, and abstaining,
4) The basis for requiring changes in or disapproving research
5) Written summary of discussion of controverted issues and their resolutions

Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.