Federalwide Assurance of Compliance with DHHS Regulations for Protection of Human Research Projects
(FWA00005241, Revised July 2004)
The University of Maryland Eastern Shore, hereinafter known as the institution, hereby gives assurance, as specified below, that it will comply with the Department of Health and Human Services (DHHS) regulations for the protection of human research subjects, 45 CFR Part 46, as amended to include provisions of the Federal Policy for the Protection of Human Subjects (56FR280003) as Subpart A, and as may be further amended during the approval period for this Assurance. This institution reserves the right to conduct reviews of all other research (not funded by DHHS or by other federal departments or agencies) according to its own established policies and procedures. This institution has policies and procedures designed to implement and supplement this Assurance. Portions of the policies and procedures are set forth herein for information purposes.
PART 1 – PRINCIPLES, POLICIES, AND APPLICABILITY
I. Ethical Principles
A. This institution is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the “Belmont Report”]), regardless of whether the research is subject to Federal regulations or with whom conducted or course of support (i.e., sponsorship).
B. All institutional and non-institutional performance sites for this institution, domestic or foreign, will be obligated by this institution to conform to ethical principles which are at least equivalent to those of this institution, as cited in the previous paragraph or as may be determined by the DHHS Secretary. Research investigators who conduct research at sites in foreign countries are required to provide the Institutional Review Board (IRB) with a written statement certifying that the regulations specified in this document will be observed.
C. In addition, this institution acknowledges its ethical responsibility to review all other research involving human subjects, not funded by DHHS or other federal sources, but conducted under the jurisdiction of this institution. Examples of such research include university-sponsored research, independent faculty research, graduate student research, and research funded by private foundations, local governments, or other non-governmental agencies. The reviewing procedures for these categories of non-federally-funded research make use of the same UMES IRB procedures as all other types of research that require IRB oversight.
II. Institutional Policy
A. All requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all federally-sponsored research, and all other human subjects research regardless of sponsorship, except as otherwise noted in this Assurance. Federal (all departments and agencies bound by the Federal Policy) funds for which this Assurance applies may not be expended for research involving human subjects unless the requirements of this Assurance have been satisfied.
B. Except for those categories specifically exempted or waived under Section 101(b)(1-6) or 101(I), all research covered by this Assurance will be reviewed and approved by an IRB which has been established under a Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP) or as may be otherwise agreed to by OHRP (see Park 1, II, G). The involvement of human subjects in research covered by this Assurance will not be permitted until an appropriate IRB has reviewed and approved the research protocol and informed consent has been obtained from the subject or the subject’s legal representative (see Sections 111, 116, and 117), unless properly waived by the IRB under Section 116(d), (d) or by any applicable waiver under Section 101(i).
C. This institution acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this Assurance. Federal funds for which this Assurance applies may not be expended for research using human subjects unless the requirements of this Assurance have been satisfied. This institution assures that before human subjects are involved in nonexempt research covered by this Assurance, the IRB will give proper consideration to:
1. the risks to the subjects,
2. the anticipated benefits to the subjects and others,
3. the importance of the knowledge that may reasonably be expected to result, and
4. the informed consent process to be employed.
D. Certification of IRB review and approval for all Federally-sponsored research involving human subjects will be forwarded to the appropriate Federal department or agency by the Office of Sponsored Programs (OSP). Compliance will occur within the time and in the manner prescribed for forwarding certification of IRB review to DHHS or other Federal departments or agencies for which this Assurance applies. Furthermore, the IRB review of research on a continuing basis will be conducted at appropriate intervals but not less than once per year.
As provided for under section 118, applications and proposals lacking definite plans for involvement of human subjects will not require IRB review and approval prior to award. However, except for research exempted or waived under Section 101(b) or (i), no human subjects may be involved in any project supported by such awards until IRB review and approval has been certified to the appropriate Federal department or agency.
As required under Section 119, the IRB will review proposed involvement of human subjects in Federal research activities undertaken without prior intent for such involvement, but will not permit such involvement until certification of the IRB review and approval is received by the appropriate Federal department or agency.
E. This institution will ensure that such other institutions and investigators not bound by the provisions of this Assurance will satisfactorily assure compliance with 45 CFR 46, as required (see Part 2, I, D and II, K), as a prior condition for involvement in DHHS-sponsored human subject research which is under the auspices of this institution (see Part 1, III, A).
F. This institution will ensure that any collaborating entities (i.e., those entities engaged in human subject research by virtue of subject accrual, transfer of identifiable information, and/or in exchange of something of value, such as material support, [e.g., money, drugs, or identifiable specimens], co-authorship, intellectual property, or credits) materially engaged in the conduct of non-federal sponsored research involving human subjects will possess mechanisms to protect human research subjects that are at least equivalent to those procedures provided for in the ethical principles to which this institution is committed (see Part 1, I).
G. This institution will comply with the requirements set forth in Section 114 of the regulations regarding cooperative research projects. When research covered by this Assurance is conducted at or in cooperation with another entity, all provisions of this Assurance remain in effect for that research. This institution may accept, for the purpose of meeting the IRB review requirements, the review of an IRB established under another DHHS FWA. Such acceptance must be (a) in writing, (b) approved and signed by an official of this institution’s IRB, and (c) approved and signed by correlative officials of each of the other cooperating institutions (i.e., a Cooperative Amendment to this FWA). The original of the signed understanding will serve as an addendum to this Assurance and will be forwarded to the OHRP of DHHS by the IRB for OHRP approval.
H. This institution will exercise appropriate administrative overview to ensure that the institution’s policies and procedures designed for protecting the rights and welfare of human subjects are being effectively applied in compliance with this Assurance.
I. Description of this institution’s policy for the protection of human subjects is contained in its internal written procedures which are available to OHRP and other Federal departments or agencies, upon request.
J. It is the policy of this institution that unless informed consent has been specifically waived by the IRB as appropriate in accordance with 45 CFR 46.116, no research investigator shall involve any human being as a subject in research unless the research investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.
A. Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under Section 101(b)(1-6) or 101(i), this Assurance applies to all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, if one or more of the following apply:
1. the research is sponsored by this institution, or
2. the research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities, or
3. the research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or
4. the research involves the use of this institution’s non-public information to identify or contact human research subjects or prospective subjects.
B. All human subject research which is exempt under Section 101 (b) (1-6) or 101 (i) will be conducted in accordance with: (1) the Belmont Report, (2) this institution’s administrative procedures to ensure valid claims of exemption (see Part 2, IV, D, and Part 2, V, E, 20), and (3) orderly accounting of such activities (see Part 2, V, E, 15-17).
C. The components of this institution which can be expected to participate in human subject research sponsored by DHHS or other Federal departments or agencies are bound by the provisions of this Assurance.
D. This Assurance must be accepted by other Federal departments or agencies that are bound by the Federal Policy for the Protection of Human Subjects when appropriate for the research in question and therefore applies to all human subject research so sponsored. Research that is neither conducted nor supported by a Federal department or agency but is subject to regulation as defined in Section 102(e) must be reviewed and approved, in compliance with Sections 101, 102, and 107 through 117.
PART 2 – RESPONSIBILITIES
A. This institution acknowledges that it bears full responsibility for the performance of all research involving human subjects, covered by this Assurance, including complying with Federal, state, or local laws as they may relate to such research.
B. This institution will require appropriate additional safeguards in research that involves: (1) fetus, pregnant women, or human ova in vitro fertilization (see 45 CFR 46 Subpart B), (2) prisoners (see 45 CFR 46 Subpart C), (3) children (see 45 CFR 46 Subpart D), (4) the cognitively impaired, or (5) other potentially vulnerable groups.
C. This institution, including all its components, acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this Assurance.
D. This institution is responsible for acquiring appropriate Assurances or Amendments, when requested, and certifications of IRB review and approval for federally sponsored research from all its standing affiliates and Assurances or Agreements for all others, domestic or foreign, which may otherwise become affiliated on a limited basis in such research.
E. This institution is responsible for ensuring that no performance site cooperating in the conduct of federally sponsored research for which this Assurance applies does so without Federal department or agency approval of an appropriate assurance of compliance, in whatever appropriate form, and satisfaction of IRB certification requirements.
F. In accordance with the compositional requirements of Section 107, this institution has established the IRB listed with the OHRP. Certain research supported by the U.S. Department of Education will be reviewed in accordance with the requirements of Title 34 CFR Parts 350 and 356 which require that the IRB include at least one person who is primarily concerned with the welfare of handicapped children or mentally disabled persons.
G. This institution will provide both meeting space and sufficient staff to support the IRB review and record-keeping duties.
H. This institution recognizes that involvement in research activities of any OHRP-recognized Cooperative Protocol Research Programs (CPRPs) will involve additional reporting and record-keeping requirements related to human subject protections.
I. This institution is responsible for ensuring that it and all its affiliates comply fully with all applicable Federal policies and guidelines, including those concerning notification of seropositivity, counseling, and safeguarding confidentiality where research activities directly or indirectly involve the study of human immunodeficiency virus (HIV).
J. This institution encourages and promotes constructive communication among the research administrators, department heads, research investigator, program staff, IRB, and other institutional officials and human subjects as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects.
K. The IRB will maintain documentation of activities as prescribed by 45 CFR 46.115.
L. This institution, upon request, will make available to each individual conducting or reviewing human subject research (e.g., principal investigators, department heads, program staff, research administrators, IRB members) a copy of this Assurance of compliance and copies of any future modifications which may be made to this Assurance, with the exception of changes in IRB membership. Copies of this Assurance will be available in the Office of Sponsored Programs (OSP) and the Dean of the Graduate School.
II. Institutional Review Board (IRB)
A. The IRB will review, and have the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human subject research. For approved research, the IRB will determine which activities require continuing review more frequently than every twelve months or need verification that no changes have occurred if there was a previous IRB review and approval.
B. The IRB is responsible for reviewing the preliminary determinations of exemption by investigators and supervisors and for making the final determination based on Section 101 of the regulations. Notice of concurrence for all exempt research will be promptly conveyed in writing to the investigator. All nonexempt research will be forwarded to the appropriate IRB members for review.
C. The IRB will make the preliminary determination of eligibility for expedited review procedures (see Section 110). Expedited review of research activities will not be permitted where full board review is required.
D. IRB decisions and requirements for modifications will be promptly conveyed to investigators, in writing. Written notification of decisions to disapprove will be accompanied by reasons for the decision with provision of an opportunity to reply by the investigator, in person or in writing.
E. Initial and continuing convened IRB reviews and approvals will occur in compliance with 45 CFR 46 and provisions of this assurance for each project unless properly found to be exempt (Section 101[b] or [i]). Continuing reviews will be preceded by IRB receipt of appropriate progress reports from the investigator, including available study-wide findings.
F. The IRB will observe the quorum requirements of Section 108(b). This institution’s IRB has effective knowledge of subject populations, institutional constraints, differing legal requirements, and other factors which can possibly contribute to a determination of risks and benefits to subjects and subjects’ informed consent and can properly judge the adequacy of information to be presented to subjects in accordance with requirements of Sections 103(d), 107(a), 111, and 116.
G. The IRB will determine, in accordance with the criteria found at 45 CFR 46.111 and Federal policies and guidelines for involvement of human subjects in HIV research, that protection for human research subjects is adequate.
H. The IRB will ensure that legally effective informed consent will be obtained and documented in a manner that meets the requirements of Sections 116 and 117. The IRB will have the authority to observe or have a third party observe the consent process.
I. Where appropriate, the IRB will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners, and children, as required by Subparts B, C, and D of 45 CFR 46. The IRB will notify OHRP promptly when IRB membership is modified to satisfy requirements of 45 CFR 46.304 and when the IRB fulfills its duties under 45 CFR 46.305(c).
J. Scheduled meetings of the IRB for review of each research activity will occur not less than every 12 months and may be more frequent, if required by the IRB on the basis of degree of risk to subjects. The IRB may be called into an interim review session by the Chairperson(s) at the request of any IRB member or institutional official to consider any matter concerned with the rights and welfare of any subject.
K. The IRB will prepare and maintain adequate documentation of its activities in accordance with Section 46.115.
L. The IRB will forward to the Office of Research Administration any significant or material finding or action, at least to include the following:
1. injuries or any other unanticipated problems involving risks to subjects or others,
2. any serious or continuing noncompliance with the regulations or requirements of the IRB, and
3. any suspension or termination of IRB approval.
M. In accordance with Section 113, the IRB will have the authority to suspend or terminate previously approved research that is not being conducted in accordance with the IRB requirements or that has been associated with unexpected serious harm to subjects.
N. The IRB for this institution will ensure effective input (consultants or voting or nonvoting members) for all initial and continuing reviews conducted on behalf of performance sites where there will be human research subjects. IRB minutes will document attendance of those other than regular voting members.
O. The IRB will act with reasonable dispatch, upon request, to provide full board review of protocols of OHRP-recognized Cooperative Protocol Research Programs (CPRP). The IRB will not employ expedited review procedures for CPRP protocols when they are to be entered into for the purpose of research. Although emergency medical care based on such protocols is permitted without prior IRB approval, patients receiving emergency care under these conditions will not be counted as research subjects and resultant data will not be used for research purposes.
P. Certifications of IRB review and approval will be forwarded to the appropriate Federal department or agency for research sponsored by such departments or agencies.
III. Research Investigator
A. Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Assurance.
B. Research investigators and faculty advisors will make a determination as to whether research will involve human subjects as defined in 45 CFR 46.101.
C. When it is not clear whether the research involves human subjects as defined in 45 CFR 46.102 or institutional policy, research investigators should seek assistance from the IRB in making this determination.
D. Research investigators who intend to involve human research subjects will not make the final determination of exemption from applicable Federal regulations or provisions of this Assurance.
E. Research investigators and faculty advisors will make the preliminary assessment of whether research which involves human subjects may be exempt from coverage under 45 CFR 46.101 and institution policy. When the research investigators are students or non-faculty members, the preliminary assessments as to the possible exempt status of the research activity will be made by faculty advisors or others designated by the IRB. Any research involving human subjects that is conducted by or under the direction of any employee or agent of the institution using any property or facility of the institution, must be referred to the IRB to determine the exempt status of the proposed research. The IRB will serve as the final review authority.
F. Research investigators will prepare protocols giving complete descriptions of the proposed research involving human subjects. In the protocols, research investigators will make provision for the adequate protection of the rights and welfare of prospective research subjects and ensure that pertinent laws and regulations are observed. This requirement is applicable even in cases where the research is exempt under 45 CFR 46.101.
G. Research investigators and faculty advisors, through appropriate procedures established within their respective departments, are responsible for reviewing research protocols for ethical considerations and scientific merit.
H. Research investigators and faculty advisors, as appropriate, will be responsible for ensuring that all research involving human subjects is submitted to the IRB.
I. Research investigators are responsible for obtaining informed consent in accordance with 45 CFR 45.116 and IRB requirements, and for ensuring that no human subject will be involved in the research before consent is obtained where such requirements are applicable.
J. Unless otherwise authorized by the IRB, research investigators are responsible for ensuring that legally effective informed consent:
1. is obtained from the subject or the subject’s legally authorized representative;
2. is in language understandable to the subject or representative;
3. is obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate; and
4. does not include exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the research investigator, the sponsor, the Institution, or its agents from liability for negligence.
K. Unless otherwise authorized by the IRB, research investigators at a minimum will provide the following information to each subject:
1. a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
2. a description of any reasonably foreseeable risks or discomforts to the subject;
3. a description of any benefits to the subject or to others which may reasonably be expected from the research;
4. a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. for research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
8. a statement that participation is voluntary, and that neither a refusal to participate nor a decision to discontinue participation will involve any penalty or loss of benefits to which the subject is otherwise entitled.
L. When required by the IRB committee, the research investigator will provide one or more of the following additional elements of information to each subject:
1. a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
2. anticipated circumstances under which the subject’s participation may be terminated by the research investigator without regard to the subject’s consent;
3. any additional costs to the subject that may result from participation in the research;
4. the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. a statement that significant new findings developed during the course of willingness to continue participation will be provided to the subject; and
6. the approximate number of subjects involved in the study.
M. Research investigators and faculty advisors (when the investigators are students) will be responsible for ensuring that informed consent is documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative, unless this requirement is specifically waived by the IRB.
N. Research investigators may use a consent form which is either:
1. a written consent document that embodies the elements of informed consent required by 45 CFR 46.116. This form may be read to the subject or the subject’s legally authorized representative, but in any event, the research investigator shall give either the subject or the representative adequate opportunity to read the form before signing it;
2. a “short form” written consent document stating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject’s legally authorized representative. When the “short form” is used, research investigators shall ensure that:
a. a witness is present at the oral presentation; b. the short form is signed by the subject or the representative; c. the witness signs both the short form and a copy of the written summary of the oral presentation; d. the person obtaining consent signs a copy of the summary; e. a copy of both the short form and summary is given to the subject or the representative; and f. the written summary of what is to be said to the subject or the representative receives the prior approval of the IRB.
O. Research investigators will include samples of proposed informed consent forms with the protocol.
P. Research investigators are responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement. All signed consent documents are to be retained in a manner approved by the IRB.
Q. Research investigators are responsible for placing the consent documents signed by human research subjects in a repository until three years after the termination of the last approval period.
R. Research investigators will promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects. Research investigators will be responsible for submitting a supplement to the original protocol to the IRB (and, in the case of DHHS-funded protocols, to submit a certificate to DHHS) when:
1. it is proposed to involve human subjects, and the activity previously had only indefinite plans for the involvement of human subjects, or
2. it is proposed to involve human subjects, and the activity previously had no plans for the involvement of human subjects, or
3. it is proposed to change the involvement of human subjects and the new involvement is significantly different from that which was initially approved.
S. Research investigators will be responsible for complying with all IRB decisions, conditions, and requirements. Appropriate sanctions will be administered by the institution in case of failure to comply.
T. Research investigators are responsible for reporting the progress of IRB-approved research to the IRB at least once per year or as often as requested by and in the manner prescribed by the approving IRB on the basis of risks to subjects.
U. Research investigators (in the case of student investigators, through their faculty advisors) will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects or others.
V. Research investigators and faculty advisors are responsible for reporting promptly to the IRB any serious or continuing noncompliance with the requirements of this assurance or the determinations of the IRB or to Board or committee meetings.
W. To facilitate the review of research and the protection of the rights and welfare of human subjects, research investigators and faculty advisors are encouraged to attend IRB meetings when invited by the IRB.
X. The research investigators will be responsible for notifying the Food and Drug Administration (FDA) and the IRB whenever it is anticipated that an investigational new drug or device exemption will be required.
Y. When the proposal involves a test article involving an investigational new drug or device:
1. The principal investigator will identify the test article in the certification to DHHS and state whether the 30-day interval required for test articles has elapsed or was waived by the FDA.
2. If the 30-day interval has expired, the principal investigator will state in the certification to DHHS whether the FDA has requested that the sponsor continue to withhold or restrict the use of the test article for application in human subjects.
3. If the 30-day interval has not expired and a waiver has not been issued, the principal investigator will send a statement to DHHS upon expiration of the interval.
4. In addition, the principal investigator will ensure that no human subjects are involved in research projects for which the filing of a supplement is required by DHHS, prior to review of the submitted supplement and approval by appropriate DHHS officials.
Z. No research investigator who is obligated by the provisions of this Assurance, any associated Inter-Institutional Amendment, or Noninstitutional Investigator Agreement will seek to obtain research credit for, or use data from, patient interventions that constitute the provision of emergency medical care without prior IRB approval. A physician may provide emergency medical care to a patient without prior IRB review and approval, to the extent permitted by law (see Section 116[F]). However, such activities will not be counted as research nor the data used in support of research.
AA. Research investigators will advise the IRB and the appropriate officials of other involved institutions of the intent to admit hospital patients as human subjects involved in research protocols for which this Assurance or any related Inter-Institutional Amendment or Noninstitutional Investigator Agreement applies. When such hospital admission is planned, those institutions in which the research will be conducted must possess an applicable OHRP – approved Assurance prior to involvement of such persons as human subjects in those research protocols.
IV. IRB Procedures
A. The chairperson(s) and membership of the IRB are appointed by the Vice President of Academic Affairs. All appointments and reappointments will be for terms of three years.
B. Departmental Human Subjects Review (HSR) committees should be established by the department chairpersons and approved by the Vice President of Academic Affairs, where there are substantial research activities pertaining to human subjects. The HSR committees should be established at the departmental level for the preliminary review of research conducted in their appropriate departments and other “allied” departments which have occasional human subject activity prior to IRB review. It is suggested that all departments which review three or more research activities per month establish an HSR committee.
C. IRB membership requirements:
1. The IRB is comprised of members from diverse backgrounds to promote complete and adequate review of research activities covered by this Assurance, and has the professional competence necessary to review the specific research activities which will be assigned to it.
2. The IRB is sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of the race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
3. When research is reviewed involving a category of vulnerable subjects (such as children, prisoners, pregnant women, or handicapped or mentally disabled persons), the IRB will include in its reviewing body one or more individuals who are knowledgeable about and experienced in working with these subjects.
4. The IRB includes both male and female members.
5. The IRB includes members representing a variety of professions.
6. The IRB includes at least one member whose primary expertise is in a non-scientific area.
7. The IRB includes at least one member who is not otherwise affiliated with the institution and who is not a part of the immediate family of a person affiliated with the institution.
D. HSR committee membership lists and qualifications.
1. The names and qualifications of the members of the HSR committees should be reviewed and approved by the IRB chairperson and the Vice President of Academic Affairs. Lists of these names will be maintained by the chairperson of the IRB.
2. The HSR committees should be composed of a minimum of three faculty members. To the extent possible, HSR committees are encouraged to include members from diverse backgrounds as well as members from other departments.
3. The names and qualifications of HSR committee chairpersons and members are forwarded to the IRB chairperson for review.
E. IRB and HSR Committee Authorities and Responsibilities.
1. The IRB and HSR committees, as appropriate, are responsible for reviewing, approving, requiring modifications in, and disapproving all activities or proposed changes in previously approved activities covered by this Assurance. The HSR committees provide preliminary review of all activities involving human subjects (including continuing and expedited review) for subsequent final review and approval by the IRB. HSR committees serve only to provide preliminary review services for the IRB.
2. The IRB and HSR committees will approve research based on their determinations that the following requirements are satisfied:
a. risks to subjects are minimized:
(1) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
(2) whenever appropriate by using procedures already being performed on the subjects for diagnostic or treatment purposes.
b. risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result. In evaluating risks and benefits that may result from the research, the IRB will not consider long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility.
c. selection of subjects is equitable. In making this assessment, the IRB shall take into account the purposes of the research, the setting in which the research will be conducted, and the population from which subjects will be recruited.
d. 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 45 CFR 46.116.
e. informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
f. where appropriate, the research plan makes adequate provision for monitoring the data to ensure the safety of subjects.
g. where appropriate, there are adequate provisions to protect confidentiality of data.
3. In accordance with 45 CFR 46.117, and University policy, the IRB (and HSR committees, as appropriate) will require documentation of informed consent by means of a written consent form, or may waive the requirement for some or all subjects if the IRB determines that:
a. the only record linking the subject and the research would be the consent document, and the principal risk would be the potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern. Or
b. the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
4. When the requirement for documented consent is waived, the IRB (and HSR, where appropriate) may require the research investigator to provide subjects with a written statement describing the research.
5. The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in 45 CFR 46.116(C), if the IRB finds and documents that:
a. the research is to be conducted for the purpose of demonstrating or evaluating:
(1) federal, state or local benefit, or service programs which are not themselves research programs;
(2) procedures for obtaining benefits or services under these programs; or
(3) possible changes in or alternatives to these programs or procedures; and
b. the research could not practicably be carried out without the waiver or alteration.
6. The IRB, as appropriate, may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in 45 CFR 46.116 (a) and (b), or waive the requirement to obtain informed consent provided the IRB finds and documents that:
a. the research involves no more than minimal risk to the subjects;
b. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
c. the research could not practicably be carried out without the waiver or alteration; and
d. whenever appropriate, the subjects will be provided with additional pertinent information after participation.
7. The IRB (and HSR committees, as appropriate) will have the authority to observe or have a third party observe the consent process and the research.
8. The IRB (and HSR committees, as appropriate) will determine in its review of research protocols which projects will require review more often than annually and will notify researchers in the letter of approval where applicable.
9. All convened IRB and HSR committee meetings will be conducted under and pursuant to Robert’s Rules of Order, or other procedures as determined by the IRB.
10. Convened meetings of the IRB and HSR committees will occur:
a. monthly or as frequently as needed to review research protocols;
b. at the call of the Chairperson when the Chairperson judges the meeting to be necessary or advantageous; and
c. at the call of the Chairperson upon the receipt of a joint written request of three or more members for the HSR committees.
11. The IRB will conduct continuing review of research at intervals appropriate to the degree of risk, but no less than once per year.
12. The IRB (and HSR committees, as appropriate) is authorized to seek confirmation from sources other than the research investigators that no material changes have occurred since previous review.
13. The IRB will have authority to suspend or terminate approval of research that is not being conducted in accordance with its decisions, conditions, and requirements or that has been associated with unexpected serious harm to subjects.
14. Research investigators, faculty advisors, department chairpersons, and other University staff are responsible for promptly reporting information to the IRB on a variety of issues. In conjunction with this requirement, the IRB and HSR committees must be prepared to receive and act on information received from a variety of sources, such as human subjects, research investigators, or other University staff. (See Part 2, VI, F, below.)
15. The IRB and HSR committees will prepare and maintain adequate documentation of activities, including the following:
a. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by research investigators and reports of injuries to subjects.
b. Minutes of meetings which are in sufficient detail to show the names of attendees at the meetings; actions taken by the committee; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; a written summary of the discussion of problematic issues and their resolution; and dissenting reports and opinions. If a member in attendance has a conflicting interest regarding any project, minutes shall show that this member did not participate in the review, except to provide information requested by the IRB or HSR committee.
c. Records of continuing review activities.
d. Copies of all correspondence between the IRB, HSR committees, and the research investigators.
e. A list of IRB members as required by 45 CFR 46.103(b)(3).
f. Written procedures for the IRB as required by 45 CFR 46.103(b)(4).
g. Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).
16. The IRB and HSR committees will provide for the maintenance of records relating to a specific research activity for at least 3 years after termination of the last approval period for the activity.
17. IRB and HSR committee records will be accessible for inspection and copying by authorized representatives of the chairpersons of the IRB or DHHS officials when it concerns work sponsored by DHHS or other federal agencies.
18. When the IRB of this institution accepts responsibility for review of research which is subject to this Assurance and conducted by any independent investigator who is not otherwise subject to the provisions of this Assurance, the IRB will obtain and retain a Noninstitutional Investigator Agreement (NIA) to document the investigator’s commitment to abide:
a. by the same requirements for the protection of human research subjects as does this institution, and
b. by the determinations of the IRB.
19. The IRB and HSR determine whether research is exempt. HSR committees may make a preliminary determination as to whether research which is submitted for federal funding is exempt from coverage under 45 CFR 46.101. These preliminary determinations will be submitted to the IRB for final determination. If a department does not have an HSR committee, it may make arrangements with an “allied” department’s HSR committee for this initial review, or it may elect to send the protocol directly to the IRB for this review.
20. If the research protocol is non-exempt, the IRB Chairperson(s) determine(s) whether the research protocol meets the criteria for an expedited review.
21. The IRB chairperson(s), as appropriate, either refers all research protocols directly to the IRB, or initiates an expedited review process.
22. The eligibility of some research for review through the expedited procedure does not negate or modify the policies of this Institution or the other requirements of 45 CFR 46.
23. The IRB may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized.
24. The only other research for which the IRB may use an expedited review procedure is that which involves no more than minimal risk to the subjects and in which the only involvement of human subjects will be in one or more of the following categories:
a. Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
b. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
c. Recording of data from subjects 18 years or age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amount of energy into the subject or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
d. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
e. Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
f. Voice recordings made for research purposes such as investigations of speech defects.
g. Moderate exercise by healthy volunteers.
h. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
i. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the research investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects.
j. Research on drugs or devices for which an investigational new drug exemption is not required.
k. Any other category specifically added to this list by DHHS and published in the Federal Register.
25. Expedited review will be conducted by the IRB chairperson and by one or more of the experienced members designated by the chairperson to conduct the review.
26. The IRB member(s) conducting the expedited review may exercise all of the authorities of the IRB, except that the reviewer(s) will refer any research protocol which the reviewer(s) would have disapproved to the IRB for review. The reviewer(s) may also refer other research protocols to the IRB whenever the reviewer(s) believes that IRB review is warranted.
27. When the expedited review procedure is used, the IRB chairperson will inform the IRB members of the research protocols which have been approved under the procedure.
28. At a convened meeting, any member may request that an activity which has been approved under the expedited procedure be reviewed by the IRB in accordance with non-expedited procedures. A vote of the members will be taken concerning the request and the majority shall decide the issue.
29. Research protocols scheduled for review will be distributed to all members of the IRB prior to the meeting.
30. When it is determined that consultants or experts will be required to advise the IRB in its review of a protocol, the research protocol will be distributed to the consultants or experts prior to the meeting.
31. All IRB initial reviews and continuing reviews will be conducted at convened meetings and at timely intervals.
32. A majority of the membership of the IRB and HSR committees will constitute a quorum in their meetings, and is required in order to convene a meeting for the review of research protocols.
33. An IRB member whose concerns are primarily in non-scientific areas must be present at the convened meeting before the IRB can conduct its review of research.
34. For a research protocol to be approved, it must receive the approval of a majority of those members present at the convened meeting.
35. No IRB or HSR committee may have a member participating in the IRB or HSR committee initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB or HSR committee.
36. In cases where research activities were initially approved under expedited procedures and subsequently reviewed by non-expedited procedures, the decisions reached at the convened meeting will supersede any decisions made through the expedited review.
37. The IRB will notify the research investigator(s) in writing of its decisions, conditions, and requirements. The approvals will be reviewed at least annually by the chairperson of the IRB.
38. The IRB will provide to the research investigator(s) reasons for the decision to disapprove a research protocol and an opportunity for the research investigator(s) to respond.
V. IRB and HSR Committee Chairpersons
A. The chairpersons are responsible for reviewing the preliminary assessments of research investigators and faculty advisors and for determining whether research protocols qualify for exemption from coverage under 45 CFR 46.101 and University policy. The HSR committee chairpersons will forward to the IRB chairperson(s) for approval and notify the investigator of the HSR committee’s preliminary decision.
B. The HSR committee chairpersons will forward to the IRB chairperson(s) all research protocols received by the HSR committee for research involving risks to subjects or other participants, and any research funded by a federal department or agency.
C. When the IRB approves a protocol on condition that the research investigator make modifications to the protocol, the chairperson(s), in consultation with relevant members (as appropriate), will determine when such modifications are made satisfactorily. As appropriate, the IRB and HSR committee may negotiate protocol modifications with the research investigator. Each protocol submitted to DHHS must include:
1. certification (including the identification number of this Assurance) that the research was reviewed and approved by the IRB, established under this Assurance; or
2. certification (including the identification number of this Assurance and a copy of the signed agreement stipulated in Part 1, II, G, above): that the research was reviewed and approved by the IRB established under another assurance; or
3. notification that the research was determined to be exempt from coverage under 45 CFR 46 or that coverage was waived. The principal investigator is responsible for forwarding certification of IRB approval of proposed research to the appropriate Federal agency or department.
A. The chairpersons will keep research investigators aware of decisions and administrative processes affecting their respective protocols and shall return all disapproved protocols to the research investigators.
B. The chairpersons of the IRB will receive from research investigators any appeals of HSR committee preliminary decisions; the appeal documents must included copies of the relevant protocols. Such appeals will be referred to the IRB for review as the final authority.
C. The chairpersons will be responsible for promptly reporting information to the IRB or HSR members, research investigators and faculty advisors, appropriate institutional officials, and OHRP on a variety of issues. Information may originate from sources such as human subjects, research investigators, IRB or HSR members, or other institutional staff. Specifically, The IRB chairperson will report to the IRB information received in each of the following cases:
1. Any serious or continuing noncompliance by research investigators with the requirements of the IRB.
2. Injuries to human subjects.
3. Unanticipated problems involving risks to subjects or others.
In addition, the IRB chairperson(s) will report to the IRB and to OHRP information related to suspension or termination of IRB or HSR committee approval. The IRB and the HSR committees have the authority to suspend or terminate approval of research that is not being conducted in accordance with their respective requirements or that has been associated with unexpected serious harm to subjects. Any IRB or HSR suspension or termination of approval will include a statement of the reasons for the action and shall report the action promptly to the research investigator, appropriate institutional officials, and the OHRP.
VI. Affiliated Institutions and Investigators (i.e., all performance sites, with or without IIAs)
A. Each performance site to this institution that is involved in federally sponsored research activities must provide to the Office of Sponsored Programs an appropriate written assurance of compliance with the Belmont Report and the Federal Policy, to include Subparts B, C, and D or 45 CFR 46 where appropriate (or equivalent protections if a foreign site), for review and approval, as specified by the sponsoring Federal department or agency (e.g., by OHRP for DHHS), prior to involvement of human subjects or expenditure of funds or other support to do so.
B. Each institutional performance site must respond to a request by the Office of Sponsored Programs of this institution for an Inter-Institutional Amendment or FWA (as appropriate), whichever is most suited to the circumstances.
C. Each non-institutional performance site (e.g., a private practice physician not otherwise an employee of this institution or who otherwise would not ordinarily be bound by the provisions of this Assurance or any other applicable institutional Assurance) who is involved in human subject research of this institution must respond to a request by the Office of Sponsored Programs or IRB of this institution for either an Agreement for an Independent Investigator or a Noninstitutional Investigator Agreement, as appropriate, depending on the nature of the research activity.
D. Performance sites that are legally separable from this institution (whether an institutional or non-institutional performance site) are not authorized to cite this Assurance.