Human Research Protections & Institutional Review Board
To open a new study in OneAegis, please register at phs.oneaegis.com. Contact the IRB Office for a user manual for the new system and please check the IRB website for updates: www.phs.org/IRB.
The Presbyterian Healthcare Services’ (PHS) Human Research Protections Program (HRPP) exists to promote high quality, ethical research. The HRPP does this by serving as the advocate for the rights and welfare of persons who participate in research programs conducted under the auspices of PHS. Research oversight at PHS is the responsibility of the Institutional Review Board.
Human Research Protections
The Human Research Protections Program at Presbyterian Healthcare Services (PHS)
Presbyterian Healthcare Services (PHS) has established a human research protections program which (in partnership with its research community) is responsible for ensuring the ethical and equitable treatment of human subjects in research conducted under the auspices of PHS. Research under the auspices of the organization includes research conducted at PHS, conducted by or under the direction of any affiliated investigator (including students or residents) in connection with his or her organizational responsibilities, conducted by or under the direction of any approved unaffiliated investigator proposing to use any PHS property, facility, patient/employee population, or non-public information for research purposes
PHS fosters a research environment that promotes respect for the rights and welfare of individuals participating in research. In reviewing and conducting research, PHS adheres to the principles described in the Ethical Principles and Guidelines for the Protection of Human Subjects in Research (commonly known as the "Belmont Report") by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. In addition to upholding these principles, PHS research activities conform to all applicable federal, state, and local laws and regulations, as well as PHS organizational policy.
The PHS Human Research Protections Office is responsible for implementing and managing the human research protections program.
Human Research Protections Office
The mission of the PHS Human Research Protections Office (HRPO) is to advance the ethical treatment of research participants and ensure the responsible conduct of research by (1) safeguarding the rights, privacy, and welfare of human participants in research projects conducted under the auspices of PHS; and (2) facilitating a culture of respect, integrity, responsibility, and trust; and (3) providing timely and high quality education, review, and monitoring for human research projects.
The PHS HRPO provides administrative and technical support to researchers, and to the PHS Institutional Review Board (IRB). Learn more about the IRB
Regulatory/Institutional Authority
Regulatory and Institutional Authority
The Presbyterian Healthcare Services (PHS) human research protections program derives its regulatory authority from the following:
Code of Federal Regulations (CFR) Title 45 Part 46 (45 CFR 46): "Protection of Human Subjects" (aka the "Common Rule")
21 CFR Part 56: "Institutional Review Boards"
21 CFR Part 50: "Protection of Human Subjects"
The Presbyterian Healthcare Services (PHS) human research protections program operates under the organizational authority of two policies: "Human Research Protections Program" (IRB.PHS-E.002), and "Human Research Protections and Institutional Review Board Policies and Standard Operating Procedures" (IRB.PHS-E.001). These policies can also be accessed from IRBNet.
Institutional Review Board (IRB)
Institutional Review Board
The Presbyterian Healthcare Services' (PHS) Institutional Review Board approves, monitors, and reviews all research involving human participants that is conducted under the auspices of PHS.
What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. PHS has established an on-site IRB to ensure the protection of the rights and welfare of human research subjects through review and oversight of safe and ethical research. The IRB discharges this duty by complying with the requirements of federal and state regulations, the FWA, and organizational policies. All non-exempt research conducted under the auspices of PHS must be reviewed and approved by the PHS IRB or another designated IRB prior to the initiation of the research unless it has been determined that PHS is not engaged in the research.
The PHS IRB derives its authority from federal regulatory sources (45 CFR 46.107).
IRBs have the authority to:
Approve, require modifications to secure approval, or disapprove all human subjects research activities overseen and conducted under the auspices of the PHS;
Require that informed consent be obtained and documented in accordance with regulatory requirements unless the criteria for the waiver or alteration of such requirements has been satisfied and approved by the IRB. The IRB may require that information, in addition to that specifically mentioned in the regulations, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects;
Conduct continuing review of research at intervals appropriate to the degree of risk of the research, but not less than once per year;
Suspend or terminate approval of research not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants;
Observe, or have a third party observe, the consent process; and
Observe, or have a third party observe, the conduct of the research.
IRB members are volunteers who represent the specialty areas that encompass most of the research performed at the PHS, as well as the interests of the community. In addition to regular and alternate members, the PHS IRB has two elected officers: Chair and Vice Chair. The IRB functions independently of, but in coordination with, other organizational committees and officials and must remain free from the influence of financial and other organizational interests. However, the IRB makes its independent determination to approve or disapprove a research plan based upon whether or not human subjects are adequately protected.
Membership on the IRB
The PHS Human Research Protections Office (HRPO) accepts nominations and applications on a continuous basis from individuals interested in serving on the IRB. HRPO staff, along with the IRB Chair, review all completed applications with consideration for maintaining the diversity and specialty requirements as mandated by federal regulations. Recommended applications are then sent for formal institutional approval. Members are appointed to a two-year renewable term.
If you are interested in serving on the PHS IRB as a scientific, non-scientific, or community member, please complete the IRB member application form and submit to IRB@phs.org.
Attending IRB Meetings as a Guest
Guests wishing to attend IRB meetings must request permission in advance from the HRPO, and must complete a confidentiality agreement.
Quality Improvement vs. Research
Quality Improvement vs. Research
There is no regulatory definition but often QA/QI is described as "systematic, data-guided activities designed to bring about immediate (or nearly immediate) improvements in health care delivery." Quality improvement activities are an important component of hospital operations. Because QI activities are data-driven and involve human participants, it is not surprising that there can be overlap with research methodologies common to human subjects research. Where overlap exists between QI and research methodologies, the federal regulations that protect human research participants may apply. Whether the QI activity is human subjects research or not, it is vital that it be executed in a manner that is ethical and respects the rights and welfare of the human participants.
How does QI differ from research?
Both research and quality improvement are systematic investigations that may involve human participants but they differ in important ways.
When is IRB approval needed for QI activities?
IRB approval may be required when the activity involves some of the following characteristics:
seeks to develop new knowledge or validate new treatments rather than to assess the implementation of existing knowledge;
when the methodology employs a standard research design, such as randomization;
when the protocol is fixed with a rigid goal, methodology, population, time period, etc.;
when the funding for the activity comes from the outside organizations such as the NIH or those with a commercial interest in the results;
when there will be a delay in the implementation of results;
when the risks from the intervention to participants are greater than minima
Worksheet for Assessing Whether a QI Activity is Also Research
The worksheet should help QI investigators to ascertain whether or not the IRB needs to be consulted or not.
Can QI studies be published without prior IRB approval?
QI projects are generally in-house activities that aim to determine if a particular treatment or procedure at an institution is meeting expected standards. If deficiencies are detected changes might be made to clinical practice, local guidelines updated or staff training provided. QI findings are typically specific to the institution in which the activity was conducted and so the results are usually only disseminated within that institution or health service. Data from a QI project may be published. When QA/QI is published or presented, the intent is usually to discuss potentially effective models, strategies, assessment tools or to provide benchmarks, rather than to develop or contribute to 'generalizable' knowledge. The intent to publish is an 'insufficient criterion' for determining whether a quality improvement activity involves research, according to OHRP. At PHS all Student/ Resident are responsible for submitting a Student / Resident Application in order for a IRB reviewer to determine if their project constitutes as QI or human subject researcher.
Can a project be both QA/QI and HSR?
Yes. The following characteristics make it more likely that a project involves both QA/QI and research and would fall under the jurisdiction of both the Hospital and IRB. Consult with the IRB if you are uncertain.
Randomization of patients into different intervention groups in order to enhance confidence in differences that might be obscured by nonrandom selection (but not to achieve equitable allocation of a scarce resource).
Testing issues that are beyond current science and experience, such as new treatments
The involvement in key project roles of researchers who have no ongoing commitment to improvement of the local care situation.
Delayed or ineffective feedback of data, especially if feedback is delayed or altered in order to avoid biasing the interpretation of results.
Funding from an outside research organization with an interest in the use of the results.
If a study includes randomization, is it always considered HSR?
No. An example of a QA/QI study that involved medication compliance included the randomization of patients to one of three arms:
in one arm patients were given a cell phone and a reminder call when it was time to take their medication.
patients in a second arm were given a reminder call but no cell phone.
patients in a third arm took their medication while being directly observed by staff (direct observation therapy--DOT).
What if I am getting funding for my project?
Outside external funding may make a difference in distinguishing between QA/QI and research. An NIH research grant to support a project would often be considered research. Internal funding to improve a program may not
What if I need to access PHI?
HIPAA makes an exception for QA/QI activities, including outcomes evaluation and development of clinical guidelines or protocols. These activities fall under the category of 'health care operations' for which no HIPAA Authorization or Waiver of Authorization needs to be sought. The hospital's Privacy Office can authorize the use of PHI for QA/QI projects.
Required Training and Education
Required Training and Education
Anyone who is significantly involved in the design, conduct, or publishing of research (e.g., investigators, study coordinators, study nurses, etc.) is considered an investigator and must complete required training, including the Collaborative Institutional Training Initiative (CITI) course in the ethical use of human subjects in research.
Individuals who are assisting with the study in an administrative capacity or who are ancillary to the study (e.g., data entry clerks, phlebotomists, technicians, etc.) are not considered to be co-investigators and are not required to take CITI training.
Collaborative Institutional Training Initiative (CITI) Web Page
Investigators should choose the appropriate CITI curriculum depending on their research focus (social-behavioral or biomedical). New study applications and requests for continuing review will not be processed until all key study personnel have completed CITI training. Re-training is required every three years and requires completion of CITI refresher modules.
Types of Review
Types of Review
The federal regulations, Title 45 CFR Part 46, describe three levels of IRB review (see below). Please note that the Presbyterian Healthcare Services (PHS) Institutional Review Board (IRB) will make the final determination whether your application is appropriate for full, expedited, or exempt review. The IRB may request additional information or revision of materials or procedures before approval. A quicker response time is dependent, in part, on whether the application is neatly and completely filled out, avoids the use of jargon, and includes copies of all pertinent materials attached in a logical order.
Exempt Studies
All research using human subjects must be approved by the PHS IRB. However, under federal regulations (45 CFR 46.101(b)), certain categories of human subject research are exempt from IRB approval. Exempt research is subject to review for determination of exemption status, and exemptions are determined or granted, rather than approved. Although exempt research is not covered by the Common Rule [45 CFR 46], this research is not exempt from ethical considerations, such as honoring the principles described in "The Belmont Report." The IRB does not conduct continuing reviews of exempt research but any changes to the exempted project should be reviewed by the IRB to ensure the exemption still applies.
In order to obtain an exemption determination, investigators must submit a completed "Request for Determination of Exempt Status" form (available for download from IRBNet). The IRB Chair or designee review all requests for exemptions and determine whether the request meets the criteria for exempt research. Exempt determination letters do not include a termination date. However, studies receiving an Exempt classification by the IRB will be required to submit a one-page "Study Update Form Exempt/Ceded Review" each year in order to keep the study open. It is the responsibility of the Principal Investigator to inform the PHS IRB of any changes in the study scope or design prior to implementation of the changes to ensure that the study continues to meet the exempt criteria. Investigators must also notify the Human Research Protections Office (HRPO) when an exempt research project is complete so that the organization can maintain an accurate database of active research.
Expedited Review
Expedited review is a process by which certain types of minimal risk research may be reviewed and approved without convening a meeting of the IRB. Expedited reviews are not "quicker" or conducted with less rigor, but fewer reviewers are required for approval. There are several types of research that may be reviewed in an expedited manner. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the categories listed in and authorized by 45 CFR 46.110 and 21 CFR 56.110 may be reviewed by the expedited review procedure.
Full Review
All research that poses greater than minimal risk to research participants will be reviewed at a convened meeting of the IRB.
All studies submitted for Expedited and Full Board review will first be pre-reviewed by the HRPO/IRB Coordinator who will check for completeness and accuracy. Only complete submissions will be placed on the IRB agenda for review. The investigator will be informed either by e-mail, phone, or in person of missing materials and the necessary date of receipt for inclusion on the agenda.
If an investigator is submitting for the first time or is not well-versed in the submission procedures, a consultation can be arranged with HRPO/IRB staff.
Study activities may not begin until notification of approval from the IRB has been received.
Educational Opportunities
Educational Opportunities
We offer outreach presentations at your meeting, class, or other gathering. We will prepare a presentation specific to your needs. Popular topics may include:
IRB submission process
Regulatory updates and how they affect researchers
Navigating OneAegis
To schedule an individual consultation with an IRB Coordinator or to schedule an outreach event, email IRB@phs.org or call 505-841-1436.
Helpful Resources
Helpful Resources
Federal Regulations
Code of Federal Regulations (CFR) Title 45 Part 46: "Protection of Human Subjects" (OHRP)
Code of Federal Regulations (CFR) Title 21 Part 50: "Protection of Human Subjects" (FDA)
Code of Federal Regulations (CFR) Title 21 Part 56: "Institutional Review Boards"
Governmental Agencies
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention
Department of Health and Human Services (DHHS)
Secretary's Advisory Committee on Human Research Protections (SACHRP)
Food and Drug Administration (FDA)
Office for Civil Rights – HIPAA
National Bioethics Advisory Commission (NBAC)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Office for Human Research Protections (OHRP)
Office for Human Research Protections (OHRP) Human Subjects Research Decision Charts
Office of Human Subject Research (NIH)
Ethics Documents for Human Subject Participants in Research
Universal Declaration of Human Rights (1948)
International Conference on Harmonization
Important Organizations
Public Responsibility in Medicine and Research
Association for the Accreditation of Human Research Protection Programs (AAHRPP)
Association of Clinical Research Professionals (ACRP)
Miscellaneous
Collaborative Institutional Training Initiative (CITI) Web Page
Contact Us
Contact Us
If you have questions about conducting research at Presbyterian, please contact the Human Research Protections and IRB Office.
Phone: 505-841-1436 Email: IRB@phs.org Hours: Monday – Friday, 8:00 a.m. to 5:00 p.m.
If you have questions about financial information or patient billing related to research activities, please contact: Lori Galves, Manger Clinical Research Financial Administration Phone: 505-923-8518 Email: lgalves@phs.org
Federal Wide Assurance
Federal Wide Assurance
The federal regulations require that federally-funded human subject research only be conducted at facilities covered by a Federal Wide Assurance (FWA) approved by the U.S. Department of Health and Human Services' (DHHS) Office for Human Research Protections (OHRP). An FWA is an organization's assurance to the federal government that human subject research conducted at that site is in compliance with federal regulations pertaining to the protection of human subjects. The FWA designates the Institutional Review Board (IRB) that will review and oversee the research, specifies the ethical principles under which the research will be conducted, and names the individuals who will be responsible for the proper conduct of the research.
Presbyterian Healthcare Services (PHS) has an OHRP-approved FWA (#00006178), and has designated one IRB (registration # IRB00001091) to review all human research plans. In its FWA, PHS has opted to limit the application of the FWA to non-exempt human subject research conducted or supported by DHHS or federal agencies that have adopted the Common Rule.
Policies, Procedures, and Guidelines
Policies, Procedures, and Guidelines
The Presbyterian Healthcare Services (PHS) human research protections program operates under the organizational authority of two policies: "Human Research Protections Program" (IRB.PHS-E.002), and "Human Research Protections and Institutional Review Board Policies and Standard Operating Procedures" (IRB.PHS-E.001). These policies can also be accessed from IRBNet.
Applicable regulatory guidance and standard operating procedures specific to the PHS human research protections program are available below, and may also be found on IRBNet.
Does My Project Need IRB Review?
Does My Project Need IRB Review?
Step One: Is it Research?
The federal regulations and PHS IRB policy define research as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge".
A Systematic Investigation follows a predetermined plan for looking at a particular issue, testing a hypothesis or research question, or developing a new theory that may include:
Collection of quantitative or qualitative data
Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups
Collection of data using experimental designs such as clinical trials
Observation of individual or group behavior
Contribute to Generalizable Knowledge means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. This may include one or more of the following:
Presentation of the data at meetings, conferences, seminars, poster presentations, etc.
The knowledge contributes to an already established body of knowledge
Other investigators, scholars, and practitioners may benefit from this knowledge
Publications including journals, papers, dissertations, and master's theses
Step Two: Does it Involve Human Subjects?
The federal regulations define a human subject as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information".
"Living individual" refers to data (information or specimens) collected from living subjects.
"About whom" refers to the fact that the information collected must be personal information about an individual.
"Intervention" includes physical procedures, manipulations of the subject or the subject's environment for research purposes.
"Interaction" refers to communication between the investigator and the subject. This includes face-to face, mail, internet and phone interactions, as well as other modes of communication.
"Individually identifiable" means the identity of the subject is or may be readily ascertained by the investigator or others.
"Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Examples of private information include medical or academic records or personal journals.
If your activity is research but does not involve human subjects as defined in the regulations your activity does not fall under the purview of the IRB. You do not need to submit an application to the IRB but will still need operational approval.
If you have determined that your research does meet the federal definition for human subjects research, you will need to apply for IRB review and approval before you begin (the IRB will not review projects retrospectively).
You may submit it to the IRB if you would like consultation or assistance in making the determinations.
Who Can Conduct Research?
Who Can Conduct Research?
In order for a study to be eligible for review by the Presbyterian Healthcare Services (PHS) Institutional Review Board (IRB), the principal investigator (PI) or a co-investigator must be affiliated with PHS.
An Affiliated investigator is any individual who is qualified by experience, education, and training to conduct research at PHS, and who falls into one of the following categories:
A physician or advanced-practice clinician with clinical privileges at a PHS facility;
A private-practice physician on the PHS medical staff who does not have clinical privileges;
A paid employee of PHS, including an employee currently enrolled as a student in an academic program related to the study;
An employee of a PHS-contracted service (e.g., Tricore Labs, Radiology Associates of Albuquerque); or
A resident who is participating in a program which has a clinical affiliation agreement with PHS.
An Unaffiliated investigator is any individual who
Does not meet the above affiliation criteria (for example, a resident participating in a program which does not have a clinical affiliation agreement program with PHS or a private-practice physician without clinical privileges); and
Proposes to conduct research using any PHS property, facility, patient/employee population, or non-public information.
Approval is required when a PI is not affiliated with PHS or is not covered under the IRB of another institution. Any human research activities being proposed by an unaffiliated PI may be covered under the PHS FWA only in accordance with a formal, written agreement stating a commitment to abide by PHS's policies/procedures and IRB oversight.
Principal Investigator
Conducting research with humans is a privilege and carries with it ethical and legal responsibilities. The PI is the individual responsible for writing an accurate protocol to utilize human subjects. Ultimately, the PI assumes the responsibility for the ethical conduct of the project and for the welfare of the human subjects. This responsibility includes the intellectual conduct of the project, fiscal accountability, administrative aspects, and the project's adherence to relevant policies and regulations.
Student Investigators
Student investigators must be paid PHS employees in order to be the PI and to initiate a research project at PHS. Student investigators have to obtain educational institutional IRB approval/acknowledgement before submitting to PHS IRB. Students also must identify a PHS study mentor who will provide guidance and oversight of the proposal development/submission process and the conduct of the research. Study mentors must formally approve and sign off on student/resident application and "Roles and Responsibilities form".
Students who are unaffiliated with PHS must service as a CO-I and are required to have a mentor/precentor who is employed with PHS and who will serve as the PI. Study mentors must formally approve and sign off on student/resident application and "Roles and Responsibilities form". To conduct research under the auspices of PHS, a resident must be participating in a program which has a clinical affiliation agreement with PHS.
Submitting a Project for IRB Review
Submitting a Research Project to the IRB? Here's Where to Start.
Two different types of approval may be required.
IRB Approval
Principal Investigators (along with at least one other member of the study team) who are seeking IRB review of research projects are required to register with OneAegis, PHS's web-based electronic submission system.
Investigators must submit completed study applications along with ALL relevant materials via OneAegis. No hard copy or email attachments will be accepted.
Operational Approval
To determine if Operational Approval is needed, please complete the operational approval determination form.
If Operational Approval is needed for an interventional study, please complete the following forms.
If Operational Approval is needed for an observational/data study, please complete the following forms.
Study activities may not begin until notification of operational approval (if required) and IRB approval have been received.
Important Dates and Deadlines
What Dates/Deadlines Should I Be Aware Of?
All new study submissions need to be complete and received in the Human Research Protections Office (HRPO) by the 10th day of the month to be considered for inclusion on the next IRB agenda. The workload of the HRPO necessitates that all study submissions received after midnight on the 10th will be assigned to the next month's agenda. The IRB meets on a regular basis throughout the year (typically on the fourth Tuesday of the month). The schedule for the IRB may vary due to holidays or lack of quorum.
News and Announcements
News and Announcements
March 2019
Clinical Trial Informed Consent Form Posting Common Rule Requirement
The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision.
Read more about the revised Common Rule
At this time, two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified:
A docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021)
HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.
For more information and instructions for uploading a clinical trial informed Consent form
January 21, 2019
No more delays. Compliance with revised Common Rule started January 21, 2019. The revised regulations apply to new studies approved or determined exempt on or after January 21, 2019. Key changes in the revised Common Rule include:
Revisions and additions to the exempt review categories and the addition of a limited IRB review process for some exempt research
Changes to continuing review requirements
Changes to the informed consent process and form, including a new requirement for presenting key information and a new requirement for clinical trials to post the informed consent form on a public website
Additional provisions for handling, storage and maintenance of identifiable information and biospecimens
Requirements for single-IRB oversight starting in 2020 for most collaborative research projects. Note: NIH has separate single-IRB requirements for multi-center studies that went into effect in late January 2018.
Please look out for revised applications and forms available in IRBNet. If you have any questions, please contact PHS IRB at 505-841-1436.
June 19, 2018
On June 19, the Office of Human Research Protections (OHRP) within the U.S. Department of Health and Human Services issued a final rule adopting a proposal released in April to delay the compliance date for revisions to the Common Rule (the set of regulations governing research involving human participants) by six months. The new compliance date for the majority of the new regulations is now January 21, 2019. However, beginning on July 19, 2018, institutions may choose to adopt three "burden-reducing" provisions early. The burden-reducing provisions include: the revised definition of research; the elimination of requiring annual continuing review for certain categories of research; and elimination of requiring IRBs to review grant applications and funding proposals.
January 17, 2018
The U.S. Department of Health and Human Services and 15 other federal departments and agencies announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the Common Rule, originally published in the Federal Register on January 19, 2017. While most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018, this has now been delayed to July 19, 2018 in order to provide regulated entities additional time to prepare to implement the changes. Until July 19, 2018, regulated entities (the PHS IRB) will be required to comply with the pre-2018 Common Rule. The IFR is available for review in the Federal Register.
April 2018
Under the NPRM proposal, the compliance date would be changed from July 19, 2018, to January 21, 2019. In addition, regulated entities would be required to comply with all pre-2018 Requirements during the period that the general compliance date is delayed, except if an institution chooses to substitute the three burden-reducing provisions of the 2018 Requirements for the comparable provisions of the pre-2018 Requirements. As proposed, if institutions choose to implement these three burden-reducing provisions for particular studies, such studies would be subject to the 2018 Requirements beginning on January 21, 2019.
The NPRM has been put on public display by the Office of the Federal Register.
FAQs
General Information
How do I know if I am conducting research with human participants?
Read more in the "Does my project need IRB Review?" section.
Does my project need IRB Review?
Read more in the "Does my project need IRB Review?" section.
Who can conduct research?
Read more in the "Who can conduct research?" section.
What is an IRB?
Read more in the "Institutional Review Board" section.
What is the OneAegis?
OneAegis is PHS's web-based electronic submission system. Principal Investigators (along with at least one other member of the study team) who are seeking IRB review of research projects are required to register with OneAegis. All study applications and study related materials must be submitted via OneAegis. No hard copy or email attachments will be accepted.
What are the IRB meeting dates and deadlines?
Read more in the "What Dates/Deadlines Should I Be Aware of?" section.
I am developing a case study; do I need to submit my proposal to the IRB?
Case studies generally involve the description of medical treatment in a single patient or a few patients with a unique treatment, disease course, or outcome based on a retrospective review of medical records, or they can involve a description of a unique diagnostic finding or uncommon presentation. No predetermined hypothesis or research question guides case studies and publication of the information about the patients' medical care is not planned prior to or during the patients' treatment. In addition, case studies are usually prepared by clinicians who have personally provided care to those patients.
Case studies should be uploaded to the PHS IRB for review.
I am not collecting any identifying information in my human participant research project. Do I need to submit my proposal to the IRB for review?
Yes, if your research project involves active data collection. Federal regulations and PHS policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review. Please contact the HRPO staff for further guidance.
If my research qualifies as exempt, does this mean that I don't have to submit a protocol for review?
Under federal regulations [45 CFR 46.101(b)], certain categories of human subject research are exempt from IRB approval. Exemptions are determined or granted, rather than approved. The significance of exempt status is that the research activity is not monitored by the IRB (assuming the project does not change). However, even though exempt studies are not covered by the federal regulations, such research is not exempt from ethical considerations, such as honoring the principles described in The Belmont Report.
The criteria and processes for determining "exemption" from IRB review are outlined in the Human Research Protections Program Policies and Standard Operating Procedures manual.
In order to have a research project recognized as exempt, investigators will need to submit a "Request for Exempt Determination" form (available for download from OneAegis), along with other study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.) via OneAegis.
I will be collaborating with another institution; do I need to submit to PHS's IRB and the other institution?
If you are affiliated with PHS and you are the person responsible for the conduct of the study (PI), you must get PHS IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Reliance Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.
When may I begin data collection for my study?
You must receive written approval from the PHS IRB before beginning participant recruitment, data collection, or data analysis. An e-mail will be sent to you via OneAegis when your project has IRB approval.
How long will it take for me to obtain approval to do my study?
That depends on the nature of your study and the characteristics of the people you intend to recruit. Research projects that involve only minimal risks are eligible for expedited review, for which you should allow at least 3 weeks for IRB review.
All new study submissions need to be complete and received in the Human Research Protections Office (HRPO) by the 10th day of the month to be considered for inclusion on the next IRB agenda. The workload of the HRPO necessitates that all study submissions received after midnight on the 10th will be assigned to the next month's agenda. The IRB meets on a regular basis throughout the year (typically on the fourth Tuesday of the month). The schedule for the IRB may vary due to holidays or lack of quorum.
Please consult the current year's IRB meeting calendar for exact meeting dates.
Can the IRB approve a project retroactively?
No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research, IRB approval can be sought for the data analysis going forward.
Who can I talk to if I have a question about my research project involving human participants?
Read more in the "Contact Us" section.
Can I serve on the IRB?
Read more in the "Membership on the IRB" topic under IRB section.
Human Subjects Training
What training do I need?
Read more in the "Required Training and Education" section.
What is CITI?
Read more in the "Required Training and Education" section.
Fees
Am I required to pay a fee for IRB review?
The Application Process
I don't know where to start to submit an application. What needs to be included?
Every new study application submitted to the IRB must include a protocol and a completed application form, along with all required materials. For more information about the submission process and the types of documents that need to accompany your application form, please consult the Human Research Protections Program Policies and Standard Operating Procedures manual.
What is a research protocol? Are there "sample" protocols available for me to use?
A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. Every application submitted for review by the PHS IRB must be accompanied by a protocol.
The IRB also encourages researchers to consult with colleagues and other professionals in their field who have done research for advice on preparing research protocols.
What is informed consent?
No investigator conducting research under the auspices of PHS may involve a human being as a subject in research without obtaining the legally effective, written informed consent of the subject or the subject's legally authorized representative unless a waiver of consent has been approved by the PHS IRB. The IRB will evaluate both the consent process and the procedures for documenting informed consent to ensure that adequate informed consent is obtained from participants. Consent forms must comply with federal regulatory requirements. The Office for Human Research Protections (OHRP) provides guidance on developing informed consent processes and documents.
How do I write an informed consent document?
The Office for Human Research Protections (OHRP) provides guidance on how to develop informed consent processes and documents.
The PHS Human Research Protections Office provides additional guidance on how to ensure readability when writing for a general audience.
A consent form template is also available for download from OneAegis.
How do I know if my project requires operational approval?
In order to evaluate and mitigate certain legal and compliance risks, as well as resource utilization and financial impact, operational review and approval is required for certain studies. Review the clinical research operational approval determination form.
If my project involves billable patient services, who do I contact?
Lori Galves, Manager Clinical Research Financial Administration Phone: 505-923-8518 Email: lgalves@phs.org
If I need help negotiating a study budget, who do I contact?
Lori Galves, Manager Clinical Research Financial Administration Phone: 505-923-8518 Email: lgalves@phs.org
What level of IRB review is right for my project? What if I pick the wrong level?
The level of IRB review is regulated by the level of risk to participants. Final determination of the applicable level of review will be conducted by the IRB.
Full board reviews are conducted when more than "minimal risk" is present to subjects.
Expedited reviews are conducted when no more than minimal risk is present to subjects and the research fits one of the expedited review categories.
Exempt designation is granted if there is less than minimal risk to subjects and it fits one of the exemption categories.
Continuing Review
After my study has been approved what do I have to do?
The IRB will conduct a continuing review of ongoing research at intervals that are appropriate to the level of risk for each research plan, but not less than once per year. At the time of initial review and at continuing review, the IRB will make a determination regarding the frequency of review of the research study. If IRB approval of the human research expires, all study procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. IRB approval is considered to have lapsed at midnight on the expiration date of the approval (i.e., the expiration date is the last day research can be conducted). Continuing human research procedures is a violation of federal regulations. You need to receive continued approval from the IRB in order to continue research
.It is the responsibility of the principal investigator to ensure continued approval of his or her human participant research study. As a courtesy, the Human Research Protections Office will send reminder emails to the principal investigator 60, 30, and 14 days in advance of project expiration. If no response is received to the reminders, a notice indicating the approval for the study expired may be sent after the approval expiration date.
The approval date and approval expiration date are clearly noted on IRB determination letters and must be strictly adhered to. Investigators should allow sufficient time for development and review of continuing review submissions.
"Continuing Review Report" forms are available for download from OneAegis.
For more information about the continuing review process, please consult the Human Research Protections Program Policies and Standard Operating Procedures manual.
Closing a Study
When should I close a study? What is the process for study closure?
Studies may be closed when the involvement of human subjects ceases (interventions, interactions, observations, and the gathering, use, study, and analysis of identifiable private information, including specimens, are all complete). Studies may be closed when the only remaining research activity involves the analysis of unidentifiable individual level data, or aggregate data sets.
Investigators should submit study closures to the IRB on a "Study Closure Report" form (available for download from OneAegis). With closure submissions, the investigator must provide a summary of the research activity and any findings available at that time.
Students/Resident Researchers
Students/Resident Researchers
Do student research projects conducted by PHS employees need IRB approval?
Student / Resident are responsible for submitting a Student / Resident Application in order for a reviewer to determine if their project constitutes as human subject researcher.
Students / Residents also are required to identify a PHS employee who will take on the role as their study mentor to oversee study activities.
What are my responsibilities as a student investigator?
An affiliated student investigator, under the guidance of the PHS employed mentor, serves as the principal investigator for their research project and has primary responsibility for ethical conduct of the research. The student investigator is responsible for preparing and submitting the IRB application and for ensuring that the study adheres to relevant policies and regulation.
Students who are unaffiliated with PHS must service as a CO-I and are required to have a PHS employed mentor/precentor who will serve as the PI for their research project. The PI is responsible for preparing and submitting the IRB application and for ensuring that the study adheres to relevant policies and regulation.
Under the mentorship of your PHS Mentor, you must:
Complete the CITI "Human Subjects" Training module (if your project constitutes as human subject research) at: https://about.citiprogram.org/en/homepage/
All key members of the study team (principal investigator, co-investigators, faculty advisors, and project manager/study coordinators) must complete CITI. The IRB recommends that you complete this training before beginning the IRB Student/Resident application, as it will help prepare you for the questions asked in the application.
Submit an accurate and complete Student/Resident application to the IRB, allowing adequate time for review
Obtain IRB approval or an exemption prior to the initiation of research including subject screening and recruitment
Conduct the research in accordance with the approved protocol
Submit amendments to inform the IRB of any proposed changes or additions to the previously approved study protocol before implementing those changes.
Submit scheduled continuing review applications to the IRB if required
Manage research data carefully to ensure subject confidentiality.
Consult with your PHS mentor when problems are encountered
Report all unanticipated problems or serious adverse events involving risk to human subjects to the IRB as soon as possible.
What are my responsibilities as a student investigator?
The PI/study team must conduct the study in accordance with the PHS IRB-approved protocol and PHS IRB policies. Please be aware of reporting requirements post IRB approval. The following activities require further submission to the IRB:
Amendments: Any modifications to the study must be approved by the IRB prior to implementation.
Continuing Review: IRB review is required at least annually for all non-exempt research, unless a shorter approval period was determined by the IRB.
Reportable Events: Serious Adverse Events, Unanticipated Problems, Protocol Deviations and other events must be reported as detailed in the following HRPP Policies:
Study Closure: Studies should be closed in accordance with the HRPP Closure Guidelines
What do I do when I have completed my study?
By submitting a Study Closure (via the IRBNet), you confirm that the study is finished and that there will be no further interaction with subjects or their data. Once the IRB receives and acknowledges the Study Closure, the study is terminated in the IRBNet.
