Policies, Procedures and Guidance For Human Subject Research
Institutional Review Board
Office of the Vice President for Research
Approved: December 2014
Updated: July 2015
IRB Registration # IRB00000388
Federalwide Assurance # 00009470
Institutional Review Board 1
Office of the Vice President for Research 1
I. Introduction 3
A. Ethical Principles Governing Human Subjects Research 3
B. Purpose 4
C. Scope 4
D. Applicability 4
E. Assurance 5
F. Definitions and Operational Concepts 5
II. The Institutional Review Board (IRB) 10
A. The Role of the IRB 11
B. Institutional Review Board Responsibilities 11
C. IRB Authorized Powers 13
D. Categories of Review 14
E. Withdrawal or Termination of Research 18
F. Foreign Research 18
G. Collaborative Research 18
H. Application Requirements for Research Involving Human Subjects 18
I. Informed Consent: General Requirements 19
J. Informed Consent in Vulnerable Populations 20
K. Documentation of Informed Consent 24
L. Policy on Self-Experimentation 26
M. Rensselaer Finance Policy for Selecting and Paying Human Subjects 27
N. IRB Procedure for Protocol Violations 27
O. Procedure for Adverse Research Events 29
P. IRB Membership 30
Q. IRB Meetings 31
R. Meeting Minutes 31
S. IRB Policy Updates, Changes and Additions 32
III. The Office of Research Compliance 33
A. Compliance Specialist: Administrative Support 33
B. Compliance Specialist: Operational Responsibilities 33
C. Record Keeping, File Retention and File Destruction 34
D. Office of Research Granted Powers 34
E. IRB Annual Report 35
F. Complaints, Adverse Events, Privacy Breaches, and Allegations of Research Misconduct 35
I. Introduction Rensselaer Polytechnic Institute requires that researchers respect and protect the rights, privacy and welfare of individuals recruited for and participating in research. In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This Commission in turn published The Belmont Report which articulated the ethical principles that guide human subjects research and served as the foundation for Title 45, Code of Federal Regulations, Part 46 (hereafter 45 CFR 46). Rensselaers policies, procedures and guidance involving human subject research are designed to comply with the Code of Federal Regulations and state and local laws to protect individuals from harm, provide equitable selection of subjects, and maximize the benefits and minimize the risks of research participation. Rensselaer and its faculty, staff and students share in the collective responsibility for the protection of human research participants and, more broadly, for the ethical conduct of research. This collaboration must operate in a culture of trust, mutual assurance, and integrity by upholding the highest ethical principles in the conduct of research and the pursuit of knowledge. A. Ethical Principles Governing Human Subjects Research
1. Respect for Persons All researchers are required to seek and obtain, whenever possible, voluntary, written informed consent from all potential human subject participants. Informed consent must provide potential participants with sufficient information to Understand what they are participating in; Understand the voluntary nature of their involvement; Understand that they are not under duress; and Provide sufficient information to allow the person to decide if they wish to participate or
not. The consent process must be written or explained in an easy-to-understand/easy-to-read nature. Respect for persons also includes honoring the privacy of individuals and maintaining their confidentiality.
This guiding principle requires that researchers maximize the potential benefits to the participants or to society, while minimizing the potential risks of harm. The extent of protection depends on the risks and benefits of the proposed research to the participants and to society. All participants should be treated in an ethical manner. Ideally, direct benefits to the subjects should always outweigh the risks of participating in the research. At a minimum, proposed research must present sufficient benefits to society at large to outweigh the risks the research presents to the research participants.
This guiding principle requires that participants be selected fairly and that both the risks and benefits of research are distributed evenly among the subjects. Researchers should always take
precautions not to select participants simply because of convenient availability, manipulability, compromised positions, or based on social, racial, sexual, economic, or cultural biases institutionalized in society.
The Policies, Procedures and Guidance for Human Subjects Research manual is designed as an official policy manual and reference guide for IRB personnel and researchers. This manual details the policies, procedures, regulations and protocol submission requirements governing human subject research at Rensselaer.
This Manual and the ethical principles governing human subject research will apply to all research: 1. Sponsored by Rensselaer Polytechnic Institute; 2. Conducted by or under the direction of any employee or agent of Rensselaer, including any
faculty, staff or administration members, and students, in connection with their responsibilities; 3. Conducted by or under the direction of any employee or agent of Rensselaer, including any
faculty, staff or administration members, and students, using any property or facility of this University;
4. Involving the use of Rensselaers non-public information to identify or contact human research subjects or prospective subjects;
5. Conducted by students and includes, but is not limited to: a) Student classroom projects involving human subjects or information protected under other
applicable laws (such as HIPAA); b) Undergraduate or Graduate level thesis, dissertation, capstone project; or c) Any project that would normally be treated as reviewable research in a non-class setting.
6. Presented by an outside entity, not otherwise covered, to the Rensselaer IRB for review under the terms of an External Review Agreement as set forth in the Rensselaer Policy on IRB External Review of Non-Rensselaer Research Protocols. The Rensselaer Policy on IRB External Review of Non-Rensselaer Research Protocols is incorporated herein by reference.
When applying the definition of research and determining the applicability of human subject protections to a research protocol, the Office of Research, and the IRB will consider: 1. The intent of the investigation; 2. The subject population; 3. Type of information being used or sought; 4. The source of information being used or sought; 5. The source of funding, if any; 6. The researchers relationship to the participants; 7. The researchers status (e.g., student, faculty, employee of a state agency, etc.); 8. The interaction with other federal or state laws or regulations (e.g. HIPAA); 9. The primary or intended use of the data; 10. Secondary beneficiaries of the research results; 11. The dispensation of the data at the protocols conclusion; and 12. Privacy, confidentiality and security measures being utilized.
E. Assurance Rensselaer entered into a legally binding agreement with DHHS concerning research involving human subjects. This Assurance (Federalwide Assurance # 00009470) is administered by DHHSs Office of Human Research Protections (OHRP) and governs all human subject research receiving, or eligible to receive, federal (DHHS) funds. This agreement is guided by the ethical principles of the Belmont Report and requires, at a minimum, compliance with 45 CFR 46 (The Common Rule). In addition, the following Federal Agencies have adopted the requirements of the DHHS Common Rule and as such any research that complies with the OHRP Federalwide Assurance, will also meet their requirements.
Department of Agriculture 7 CFR 1c Department of Energy 10 CFR 745 National Aeronautics and Space Administration 14 CFR 1230 Department of Commerce 15 CFR 27 Consumer Product Safety Commission 16 CFR 1028 Agency for International Development 22 CFR 225 Department of Housing and Urban Development 24 CFR 60 Department of Justice 28 CFR 46 Department of Defense 32 CFR 219 Department of Education 34 CFR 97 Department of Veterans Affairs 38 CFR 16 Environmental Protection Agency 40 CFR 26 National Science Foundation 45 CFR 690 Department of Transportation 49 CFR 11 Central Intelligence Agency By Executive Order 12333 Department of Agriculture By Statute
In addition, Rensselaer has voluntarily agreed to apply all the Common Rule requirements and all subparts found under 45 CFR 46 (The Common Rule) to all human subjects research regardless of funds, funding source or governing Federal Agency. Furthermore, Rensselaer has voluntarily agreed to apply heightened standards to all human subject research involving pregnant women, neonates, prisoners, and/or children.
F. Definitions and Operational Concepts
Adverse Event, Serious: Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious Adverse Events include those that: 1. Are fatal or life threatening;