GUIDE FOR COMPLETING THE
Institutional Review Board (IRB)
POST-APPROVAL MONITORING SELF-ASSESSMENT FORM
The purpose of the Post-Approval Monitoring (PAM) program is to review and evaluate research activities involving human subjects conducted under the auspices of UAlbany. Investigators should be aware of certain specific responsibilities that are required when conducting research.
PAM information – overview and procedure [LINK] ORRC Post-Approval Monitoring (PAM)
Please refer this guidance when completing the Post Approval Monitoring Self-Assessment. If you need additional assistance, please do not hesitate to contact the Office of Regulatory Research Compliance (ORRC) at 518-442-9050
or by e-mail at
APPROVAL AND RECORD KEEPINGStudy File: Investigators are required to maintain study file and related documentation. A study file may consist of paper documents or electronic/digital or other media. The study file provides the investigator's documentation of adherence to proper conduct of the study.
The study fileshould include: a copy of the approved protocol and research materials, approval letter(s), all correspondence with the IRB and the sponsor (if applicable), a copy of the approved, IRB-stamped informed consent information, CITI human subjects protections training completion reports, research logs, the completed data collection tools, etc.
Record-keeping requirement: All study records must be kept for at least three yearsaftercompletion of the research.
All modifications or amendments to approved research must be reviewed and approved prior to implementation. Investigators submit their requests for modifications into the ORRC and include, as appropriate, the revised protocol, consent form, recruitment materials, etc.
RESEARCH PROTOCOL
PI can only use the IRB-approved project description, procedures and all data collection instruments while s/he conducts research
All modifications or amendments to approved research must be reviewed and approved prior to implementation. Investigators submit their requests for modifications into the ORRC and include, as appropriate, the revised protocol, consent form, recruitment materials, etc.
If there are ANY changes to the approved protocol, PI must submit a request for modification to the IRB and include, as appropriate, the revised protocol documents (e.g., consent information, recruitment materials) for review and approval.
Investigators are required to report any unanticipated/adverse event that occurs during the protocol approval period to the IRB. Situations that require reporting those that are:
1-Unexpected AND
2-Related or possibly related to participation in research AND
3-Research places subjects or others at greater risk of harm than previously known or recognized, OR
-- Incident was unexpected and serious (e.g., protocol deviations, exceptions, breaches of confidentiality, side effects, deaths, serious or continuing noncompliance, or other problems).
RECRUITMENT
Recruitment:Only IRB-approved scripts and flyers may be used in study.The advertising or recruitment materials such as flyers or posters must the IRB stamp. Recruitment efforts and materials (advertisements, flyers, announcements, telephone scripts, newspaper ads, bulletin board tear-offs, Internet postings, and posters) are part of the informed consent process and the participant selection process. Consequently, the IRB must review and approve all recruitment procedures and materials before use.
INFORMED CONSENT PROCESS
Informed Consent: As described in the Belmont Report, consent must be (1) informed, (2) understood, and (3) voluntary. These are the hallmarks of consent and provide respect for research subjects by honoring their autonomy. Informed consent is not just a form or a signature, but a process of information exchange that includes subject recruitment materials, verbal instructions, written materials, and question and answer sessions.
The IRB and investigators share responsibility for ensuring that the informed consent process is adequate. Rather than an endpoint, the Consent Form should be the basis for a meaningful exchange between the investigator and the subject.Consent is not a single event; rather, it is a process. Since subjects always retain the right to withdraw from a research project, their continuing consent is important.
Consent documents are stamped by the IRB when approved. The original stamped document should be used to make copies.
Federal law defines children as "persons who have not attained the legal age for consent process under the applicable law of the jurisdiction." In New York, the legal age for consent is 18. When a child is the subject of research, the IRB must determine whether adequate provisions are made for soliciting the assent of the child, as well as the permission of the child’s parent or court-appointed guardian.
Assent—a child’s affirmative agreement to participate in research. Failure to object, absent affirmative agreement, should not be construed as assent. In general, children under the age of 7 are considered incapable of providing assent. Children between the ages of 7 and 12 are generally considered capable of providing assent, depending on the nature of the research and the individual child’s maturity and psychological state. The assent process for children in this age group should be simplified so it is comprehensible to the children. Children who are at least 13 years old can generally provide assent in a full and meaningful way.
Parental permission—Current regulations tend to avoid the term "consent" when one person grants approval for another to participate in research. Parents or legal guardians therefore grant "permission" for children to participate in research(45 CFR 46.408). The "permission" form is, in essence, a consent document and should follow all applicable requirements for informed consent.
PRIVACY, DATA STORAGE & CONFIDENTIALITY
Confidentiality refers to the agreement made with subjects, through the consent process, about what, how, or if information provided by the subjects will shared or protected from disclosure. The conditions for maintaining confidentiality of the subjects and the research records are required for the life of the data. During the study, all documents, electronic files, videotapes, etc., that contain the subject’s personal identifiers must be kept in locked storage with access restricted to the investigator and/or designee(s).
The more sensitive the research, the greater the care required in obtaining, handling, and storing the data.
QUALITY IMPROVEMENT
The purpose of PAM includes improvement of UAlbany regulatory research compliance programs. The information gathered during PAM is for the ORRC and for the IRB and is used to monitor the implementation of approved protocols, identify areas that need improvement, to correct or target opportunities for education, to gather information for continuous quality improvement of ORRC procedures and processes, and improve our customer service. Please feel free to provide any concerns, recommendations, or suggestions.
CONTINUING EDUCATION AND TRAINING
ORRC strives to provide information and assistance to investigators, research staff, and students in several ways, and may hold formal seminars to help educate the research community about IRB and human research topics. Arrangements can be made to have ORRC staff present informational sessions for small groups which can be tailored for the needs of a specific group (e.g., department, course, undergraduate, graduate, etc.)
Office of Regulatory Research Compliancestaff is always available to answer your questions about the IRB processes and to provide assistance and consultation to investigators planning human subjects activities.
Office of Regulatory Research Compliance, LCSB28, Phone 518-442-9050, Fax 518-442-9997