PROCEDURES
IRB Procedures
Conducting Research Involving Human Subjects
The review of research involving human subjects at the University at Albany is a collaborative process intended to result in mutually acceptable research procedures which accomplish the principal investigator’s (PI) scientific objectives while protecting the rights and welfare of the subjects.
The University at Albany has authorized the Institutional Review Board (IRB) to review and approve research involving human subjects. The IRB is a campus-wide committee made up of researchers, administrators, students, at least one non-institutional member, and a non-scientist member.
The IRB sees its role as primarily educational and facilitating. The IRB encourages consultation by PI’s at all stages of the research process.
Applying:
Research involving human subjects conducted by any faculty, staff, or student under the auspices of the University at Albany must be reviewed by the IRB. It is the responsibility of the PI to submit the proposed research to the IRB for approval before the research has begun. The PI should submit a research protocol by completing a human subjects protocol form and sending it to the Office of Regulatory Research Compliance, LCSB 28.
The IRB requires all individuals listed on an IRB protocol to complete the required training before approval will be granted.
(See Training) New Research Protocol Submission Form
Review Procedures:
Once it has been determined that an activity is to be considered human participants research, it will be reviewed under one of two categories, “Expedited Review” or “Full Review”. The review procedures for each of these are described below. Each researcher should make the initial determination regarding the appropriate category of review, although the IRB makes the final determination. The researcher can always request a higher level of review than that required.
When submitting protocols, sufficient time should be allowed for adequate review. You will receive an e-mail from the Office of Regulatory Research Compliance notifying you of receipt of your protocol and signaling the start of the review process. Incomplete applications will be returned to the principal investigator, with deficiencies identified. Once corrected, the application may be resubmitted for review.
The IRB meets weekly during the academic year, and as needed during the summer. For projects requiring full review, refer to
meeting dates and deadlines. Protocols eligible for expedited review may be submitted at any time. The following are the review categories, along with examples of the types of projects included in each category:
A protocol receiving an expedited review is not reviewed at a fully convened meeting of the board. Just one member of the board carries out an expedited review. The reviewer may exercise all of the authority of the full board to approve, require modifications in (to secure approval), or request full board review of the protocol, except the reviewer may not disapprove the research. The reviewer shall refer any project that he/she would have disapproved to the board for a full review. The following activities may be approved under expedited review
-
Anonymous mail or telephone surveys on innocuous topics
-
Anonymous, non-interactive non-participating observation of public behavior
-
Secondary analysis of existing data
-
Educational research involving no interaction with students; e.g., observation of intact classes without modifying or disrupting regular classroom activity
-
Research involving the use of educational records if information taken from these sources is provided to the researcher in such a manner that participants cannot be identified
-
Research on individual or group behavior of normal adults where there is no psychological intervention, physiological intervention or deception
-
Interviews and interactive surveys on non-sensitive topics
-
Meta-Analysis (Refer to “Secondary Analysis of Existing Data Research” section on page 48 of this document.)
-
Continuations and/or modification of proposals initially approved under the full review process, if they present no additional risks to participants
The IRB may require full review of any research submitted or approved under the expedited review process.
A protocol receiving a full review is reviewed and voted on at a fully convened meeting of the board.
The following activities require approval under full review :
-
Research which might put participants at risk, such as research on domestic violence or illegal drug use
-
Research involving psychological or physiological intervention
-
Non-curricular, interactive research in schools
-
Research involving deception
-
Interviews or surveys on sensitive topics
-
Research on special populations (e.g., minors, prisoners, and the mentally incompetent)
-
Research conducted outside the United States, regardless of the procedures involved
Continuations:
The IRB is required to continue to reevaluate research projects at intervals appropriate to the degree of risk, but not less than once a year. For research involving no more than minimal risk, the approval period is generally one year. For research involving greater than minimal risk, the IRB will determine the appropriate approval period. The approval letter from the IRB will indicate the approval period and the date for submitting a request for a continuation.
For projects extending beyond one year, the IRB will send the investigator a courtesy reminder notice, one month prior to the termination date of the project. It is, however, the investigator’s responsibility to request a continuation (even if you do not receive this reminder). Please note: If approval for the project lapses, all research must stop immediately, until IRB review and approval has been obtained.
Continuation Request Form
Modifications:
No changes to an approved protocol can be implemented until the IRB has reviewed and approved the changes. This includes subject recruitment methods, consent form changes, treatment changes, etc.
When submitting modifications, do not resubmit the entire protocol. Submit a memo to the IRB referring to the protocol number and title. Explain the modification, and submit all supporting documents that have been modified; i.e., questionnaires, recruitment flyers, consents, etc. Again, give ample time for review.
As with new protocols, you will be notified in writing of the IRB’s review. Please note that a modification only does not change the approval/termination dates. The modification approval is effective within the approval period of the entire project.
For more in-depth guidance, please refer to the
Investigator Handbook –Human Subjects or
contact the
Office of Regulatory Research Compliance.
Modification Request Form
Institutional Animal Care and Use Committee
Research Involving Animal Subjects
The primary function of the University at Albany Institutional Animal Care and Use Committee (IACUC) is to assist faculty, students, and staff in upholding the university’s assurance of providing the best care and most humane treatment of our laboratory animals.
The IACUC reviews all projects involving animals to ensure that they are justified by their benefits and minimize any animal pain or suffering that might occur.
The IACUC meets monthly to review all research or educational use of laboratory animals at the university. This may include work with animals that is performed at other institutions by University at Albany faculty, students, and staff. No use of animals may begin without the written approval of the IACUC.
Applying:
Research involving Animal subjects conducted by any faculty, student, or staff under the auspices of the University at Albany must be reviewed by the IACUC. It is the responsibility of the researcher to submit the proposed project to the IACUC for approval before research has begun. The researcher must submit an animal research protocol buy completing the combined protocol form and sending it to the Office of Research Compliance. The IACUC requires all individuals listed on an IACUC protocol to complete the required training before approval will be granted. (
See Training)
Primary IACUC/IBC Review Form (Word) (RTF)
Review Procedures:
The IACUC will review the proposed activity under one of the following categories:
EXPEDITED REVIEW:
The following activities may be approved under expedited review by two reviewers (one of which must be the Chair or the Consulting Veterinarian and the other is designated by the Chair.)
-
Activities expected to cause only negligible pain or suffering;
-
Activities performed on anesthetized animals to be sacrificed while still under anesthesia;
-
Activities performed on unanesthetized animals involving no more than slight, short-lasting pain or suffering;
-
Operations performed under anesthesia or some other painkiller in which the animal will recover and receive postoperative painkillers (as necessary.)
FULL REVIEW:
-
The following activities are not eligible for expedited review and, therefore, shall be reviewed and approved at a convened meeting of the IACUC:
-
Activities involving more than minimal pain or suffering to subjects;
-
Activities involving mammals other than laboratory rats and mice, regardless of the nature of the activity;
-
Activities involving the use of primate tissues or bodily fluids (must also be reviewed and approved by the Biosafety Committee).
Continuations:
Approval of an activity is valid for one year only. If an individual wishes to continue the activity beyond this period, he/she must request a continuation of approval, and a new proposal every three years.
Please note: If approval for a project lapses, all research must stop immediately, until IACUC review and approval has been obtained.
Modifications:
Approval of an activity applies to those procedures described on the IACUC Protocol Form. If a researcher wishes to modify those procedures, he/she must submit the revisions for appropriate review and approval. Modifications containing significant changes such as major survival surgery, death as an endpoint, and/or unrelieved pain and distress are automatically assigned for full committee review without receiving a preliminary evaluation. Please note that a modification only does not change the approval/termination dates. The modification approval is effective within the approval period of the entire project.
For more in-depth guidance, please refer to the
Investigator Handbook –Animal Subjects or
contact the
Office of Regulatory Research Compliance.
IBC Procedures
Research Involving Hazardous Material
The primary function of the University at Albany Institutional Biosafety Committee (IBC) is to assist faculty, students, and staff in upholding the University’s policy that any possession of and/or activity involving known or potential biohazardous materials be reviewed and approved by the IBC. Biohazardous materials subject to review by the IBC include, but are not limited, to the following:
Biological Agents
Biohazards are infectious agents or biologically derived infectious materials, which present or may present a risk to other living things, including humans. Biohazards invade the body through similar portals of entry as chemical hazards; e.g., eyes, mouth, lungs, etc. However, unlike hazardous chemicals, biological hazards can reproduce and spread the infection in a relatively short amount of time.
-
Human, animal and plant pathogens: bacteria, fungi, viruses, parasites;
-
All human blood, blood products, tissues and certain body fluids;
-
Cultured cells (all human or certain animal) and potentially infectious agents these cells may contain;
-
Allergens
-
Toxins
Recombinant DNA
The NIH Guidelines define Recombinant DNA molecules as either (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above. In addition, synthetic DNA segments which are likely to yield a potentially harmful polynucleotide or polypeptide (e.g., a toxin or a pharmacologically active agent) are considered as equivalent to their natural DNA counterpart.
Select Agents
Under federal regulation the University at Albany must report all specified biological "select agents" in its possession to the government. These "select agents" are identified on a
list provided by the Centers for Disease Control (CDC).
Radioactive Material
All research involving radioactive materials or machines and equipment that emit ionizing radiation must receive approval from the Radiation Safety Committee for the purchase, possession, use, transportation, and disposal of such material or equipment. Application forms are available from the Radiation Safety Officer. Since approval of a protocol usually takes at least two weeks from the receipt of an application, the Investigator should consider this timeframe in planning the research.
The procedures involved in purchasing, possessing, using, transporting and disposing of radioactive material are detailed in the University manual, "Required Procedures for Radiation Protection." Investigators are advised to consult this manual when planning to use radioactive materials.
Contact the
Office of Environmental Health and Safety at (518) 442-3495 for more information.
Applying:
Research involving the use of hazardous materials conducted by any faculty, student, or staff under the auspices of the University at Albany must be reviewed by the IBC. It is the responsibility of the researcher to submit the proposed project to the IBC for approval before research has begun. The researcher must submit a protocol for all activities or modifications of activities involving recombinant DNA, potentially pathogenic substances, toxins, and/or human tissue/body fluids and obtain approval of the IBC prior to initiation of the activities.
The IBC requires all individuals listed on an IBC protocol to complete the required training before approval will be granted. (
See Training)
Primary IACUC/IBC Review Form (Word) (RTF)
Review Procedures:
The IBC will review the proposed activity under one of two categories: full or expedited. A protocol that receives a full review is discussed and voted on at a convened meeting of the IBC. A protocol receiving an expedited review is reviewed by two primary reviewers from the Committee (as designated by the Chair based on their knowledge and experience with the particular type of research. The reviewers may exercise all of the authority of the full board to approve, require modifications in (to secure approval), or request full board review of the protocol, except a reviewer may not disapprove the research. The reviewer shall refer any project that he/she would have disapproved to the board for a full review.
Most new protocols will receive a full IBC review. However, under certain circumstances an expedited review may be conducted by at least two designated reviewers from the appropriate Committee(s) in accordance with the NIH Guidelines and/or other federal regulations. Expedited review may not be used for protocols involving BL2/BL3 or BL3 containment.
Ongoing projects must be reviewed at least annually, and the IBC has the right to require more frequent monitoring if necessary
. If there is a significant change in the experiment (i.e. in the containment level, etc.), a new and complete protocol form must be submitted; minor changes can be granted expedited review.
The IBC requires all individuals listed on an IBC protocol to provide their curriculum vitae as evidence that they are properly trained in microbiological and biosafety practices or to complete the required training before approval will be granted. (
See Training)
Investigators are also required to develop a Laboratory Safety Plan, including an emergency action plan for accidents and spills, as an addendum to the university emergency safety plan. Contact the
Office of Environmental Health and Safety at (518)-442-3495 for more information.
For more in-depth guidance, please refer to the
Bio Safety Handbook – Hazardous Materials Or
Contact the
Office of Research Compliance.
Research Misconduct Procedures
Maintenance of high ethical standards in research and scholarship is a central and critical responsibility of the University. In keeping with the commitment to integrity in the pursuit of truth, and in compliance with federal regulations, the University at Albany will immediately review reports of suspected misconduct or other evidence of misconduct; thoroughly investigate such instances if the initial inquiry concludes that an investigation is warranted; take appropriate action following the investigation, including imposition of sanctions if allegations of misconduct are substantiated; and fulfill reporting and other federal requirements in the case of sponsored research.
Misconduct, in the context of University at Albany policy means:
-
misrepresentation of academic credentials or scholarship;
-
fabrication, falsification, or plagiarism in proposing, conducting, or reviewing research or in research results; or
-
other practices involving violations of academic integrity that significantly deviate from practices commonly accepted within the academic community in research and scholarship and in artistic performance and expression.
This includes, but is not limited to, material failure to comply with regulatory requirements affecting specific aspects of the conduct of research such as the protection of human subjects and the welfare of laboratory animals, or the failure to meet other material legal requirements governing research. It does not include honest error or differences of opinion.
Summary of Procedures
The institutional response to reports of suspected misconduct includes the following steps:
A. Initial Assessment of Suspected Misconduct
Suspected misconduct is reported to the Vice President for Research who informs the Chair of the Committee on Ethics in Research and Scholarship (CERS).
B. Inquiry
If either the Vice President for Research or the CERS Chair concludes that an inquiry should be conducted, an Inquiry Committee will make a recommendation to the President as to whether the allegation of misconduct warrants a formal investigation.
C. Investigation
If the President authorizes an investigation, an Investigation Committee formally examines and evaluates the evidence and other relevant information to determine if misconduct has occurred.
D. Institutional Actions
The President reviews the investigation report and the recommendation of the Vice President for Research, makes the final determination whether misconduct has occurred, and imposes appropriate institutional sanctions.
Additionally, if an individual has been found to have committed scientific misconduct, sanctions can be imposed by the relevant agency, the legal process, and professional society. Federal agencies finding scientific misconduct have subjected researchers to a variety sanctions from a letter of reprimand to debarment from receiving federal funding for a number of years. Once debarred or excluded, a person may not receive any form of assistance, financial or nonfinancial, from the Federal government for a set period of time, usually three years. D ebarred persons may not receive any Federal assistance or contracts, financial or nonfinancial, under Federal programs and activities of Executive Branch agencies. This includes, but is not limited to, grants, cooperative agreements, subsidies, contracts, subcontracts, student loans, and other forms of Federal funding.
To make a confidential report of noncompliant conduct, call the Office of the Vice President for Research at (518) 437-4560 or
contact the
Office of Regulatory Research Compliance at (800)-365-9139.
For more in depth guidance, please refer to the [
Investigator Handbook – Research Integrity ]
