The University of Southern Maine (USM) Human Research Protection Program (HRPP) ensures the protection of the rights and welfare of persons participating in human subject research conducted at or affiliated with USM.
The following section summarizes key elements of USM’s IRB policies and procedures with which you should be familiar for your interview. The source of this information are the Human Research Protection Program (HRPP) standard operating procedures.
The Provost of Academic Affairs serves as the Institutional Official (IO) for USM and is responsible for the overall conduct of research at the Institution.
The duties of the Institutional Official include, but not limited to:
- The Institutional Office is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance.
- The IO is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institutional named in the federal wised Assurance (FWA).
- The IO may delegate the performance of certain oversight and operational duties to one or more individuals. Any delegation of duty must be in writing. Upon designation of the new IO chooses to maintain delegation.
USM’s HRPP and IRB are housed with the Office of Research Integrity and Outreach (ORIO). ORIO is supported by:
- The Social and Behavioral IRB, Biomedical IRB, Regulatory Compliance, Research Service Center, Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Financial Conflicts of Interest Committee (FCOI), Office of General Counsel.
- Academic departments and centers to which faculty, staff, and trainees engage in human.
- Member organizations of the collaborative boards.
USM utilizes the online Collaborative Institutional Training Initiative (CITI) Program. IRB Members must complete the IRB Member Training Modules. HRPP Staff and Research Personnel are required to complete the Biomedical or Social and Behavioral Research modules.
Board Members are provided the latest publication Institutional Review Board Member Handbook by Robert J. Amdur and Elizabeth A. Bankert Fourth Edition.
Continuing education is planned for every Board meeting.
Principle Investigators have primary responsibility for protecting the rights and welfare of humans participating in their research, which should be the primary goal of any research endeavor. It is the policy of the IRB that all research which is reviewed, approved, and conducted under the IRB’s Board jurisdiction will generally conform to the following guidance documents that reflect the basic ethical principles for the conduct of human participant research.
The Nuremberg Code, which contains 10 basic ethical principles that are presented in abbreviated form below:
- Obtain voluntary consent of the participant;
- Design the study to yield results for the good of society, otherwise unobtainable through other means;
- Base studies involving humans on animal experiments;
- Avoid physical and mental suffering and injury to the participant or others;
- Do not conduct the study if death or disabling injury is an expected result;
- The degree of risk should never exceed the humanitarian importance of the problem to be solved by the research;
- Protect the participant from injury, disability, or death;
- Be scientifically qualified to conduct the study. o Allow the participant to voluntarily withdraw at any time;
- Be prepared to stop the study when continuation is likely to result in injury, disability, or death to the participant.
The Belmont Report, which identifies and summarizes three main ethical principles that should govern research with human subjects:
- Respect for persons (autonomy/voluntary participation/adequate information) o Beneficence (risks of research are reasonable in relation to the benefits the research may provide to subjects or science)
- Justice (selection of subjects is equitable and is representative)
The Common Rule (45 CFR 46), which is the federal regulatory framework that governs research with human subjects and codifies the ethical principles of the Belmont Report. Under the Common Rule, research with human subjects is defined as follows:
- Research – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human subject – A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through interaction or intervention, or (2) identifiable private information.
21 CFR 50 and 21 CFR 56, which serve as the regulatory framework for research regulated by the Food and Drug Administration (i.e., research involving drugs, devices, biologics). Please note that there are differences between FDA and HHS regulations.
Other federal and state laws and regulations that apply to research (i.e. Mental Health and Developmental Disabilities Confidentiality Act (MHDDCA), Family Educational Rights and Privacy Act (FERPA), Health Insurance Portability and Accountability Act (HIPAA).
Requirements for studies sponsored by federal departments and agencies such as the DoD, EPA, etc
Minimizing risks to participants and ensuring participants’’ rights and welfare are key components of human subjects protections. Below are some strategies through which these goals can be accomplished:
- Design and implement protocols that comply with applicable regulatory and institutional policies, as well as the principles of the Belmont Report
- Verify procedures are consistent with sound research design by ensuring that the research is reasonably expected to answer the proposed question and that the resulting knowledge is expected to be sufficiently important to justify the research
- Ensure that recruitment procedures foster the equitable selection of participants
- Utilize procedures already being performed for diagnostic or treatment purposes, when possible
- Ensure that appropriate resources are available to conduct the research (e.g., personnel, facilities, equipment, etc.)
- Keep in mind that “minimal risk” to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests.
- Establish adequate provisions for monitoring participants to identify adverse events and to review data collected to ensure participant safety, when appropriate
- Develop plans for protecting participant privacy and the confidentiality of data.
- Privacy – Relates to an individual having control over the extent, timing, and circumstances regarding the sharing of information about themselves with others.
- Confidentiality – Relates to the protection of a participant’s data that has been shared with the researcher with the expectation that it will be protected and not disclosed.
- Ensure enhanced protection for participants vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or those economically or educationally disadvantaged).
These determinations informed by the guidance provided by the US Department of Health and Human Services Human Subject Regulations Decision Charts and in consultation with IRB administrators or chairs, as appropriate. If the research:
- Involves activities or data subject to other rules or regulations (i.e. HIPPA, HITECH, FERPA, etc.), the review ensures compliance with these external regulations or rules.
- Is not regulated, a designated IRB staff member may issue a “non-human research” determination through eProtocol when the Principle Investigator submits a Human Subjects Research Determination Form.
- Is exempt, an IRB staff member ensures that the application indicates the request for an exempt determination.
Note that USM may conduct FDA regulated Investigational New Drug (IND) research. If USM does conduct FDA regulated IND research, the USM IRB will ensure appropriate expertise in the Board is present to review the research. If the USM IRB does not have appropriate expertise to review the FDA IND regulated research, it will not conduct the review.
The IRB must obtain sufficient information prior to review of applications for initial or continuing review so that it can apply and satisfy the requirements for approval of research.
The IRB considers the following with respect to each application for initial, continuing, or modification review:
- Does the activity described in the eProtocol application meet the definition of human research as defined in the “Common Rule?”
- Is the activity human research as defined in FDA regulations?
- Is USM engaged in the proposed research?
- Is the research exempt from IRB review?
Principle Investigators, research staff, and the IRB Board have a responsibility for ensuring research is conducted in compliance with the IRB, as well as other institutional and regulatory requirements. Below are examples of some of these requirements:
- All research with human participants must obtain IRB review and approval or a determination of exemption before work can begin.
- The requirements of the IRB (i.e., initial review, continuing review, modifications, and reporting of adverse events and unanticipated problems) must be met.
- Research must be conducted as specified in the IRB-approved protocol.
- All proposed changes to the research, no matter how minor, must be approved by the IRB prior to implementation unless necessary to eliminate immediate hazard to participants.
- Materials must be submitted to the IRB in a timely fashion (e.g., requests for changes, continuing review applications, etc.).
- Information regarding reportable events is available in USM’s HRPP Policies and Procedures HRPP 006 Unanticipated Problems & Adverse Events (pdf).
- Unanticipated problems involving risks to subjects or others (UPIRSO) refer to any incident, experience, or outcome that meets all of the following criteria:
- is unexpected (in terms of nature, severity, or frequency) given that (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- is related or possibly related to participation in the research; and
- suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
- Events that satisfy all three criteria are reportable to the IRB.
- Events that meet the criteria for an Unanticipated problems involving risks to subjects or others (UPIRSO) and are also serious Adverse Event (AE)s should be reported to the IRB within one (1) week of the investigator becoming aware of the event.
- Adverse Events (AE) are any untoward or unfavorable occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. AEs encompass both physical and psychological harm and occur most frequently in the context of biomedical research, although they can occur in the context of social and behavioral research.
- AEs that are a UPIRSO are reportable to the IRB. If investigators are unsure whether an AE is a UPIRSO, the event should be reported. The IRB will review the report and make a final determination as to whether the event constitutes a UPIRSO.
- Any other events that meet the criteria for a UPIRSO should be reported to the IRB within two (2) weeks of the investigator becoming aware of the problem.
- Unanticipated problems involving risks to subjects or others (UPIRSO) refer to any incident, experience, or outcome that meets all of the following criteria:
- Potential non-compliance with laws, regulations, or IRB requirements by the research team or others must be reported, even if this non-compliance was unintentional or discovered during the course of quality assurance activities. Participants being exposed to unnecessary risk may also be reported as potential noncompliance.
- Protocol deviations, participant complaints, or loss of research data must be reported to the IRB.
The informed consent process emphasizes that the participant is competent to understand the purpose and requirement of the research, is volunteering to participate in the research study, and has the ability to withdraw from the study at any time without any adverse effect. Informed consent is not a single event or document, but rather an ongoing process involving the investigator (or designees) and research participant.
The process starts with the exchange of information about the study. The setting and the tone of the study must be non-coercive. Informed consent requires full disclosure of the nature of the research, the participant’s role in that research, an understanding of that role, and the participant’s voluntary choice to join the study. A thorough explanation of the study along with all risks, benefits, and alternatives to participation is essential.
The individual must be given an opportunity to ask questions and have those questions satisfactorily answered. The participant must be fully informed in order for consent to be truly voluntary choice to join the study. For more information on obtaining and documenting informed consent, please visit the IRB Consent forms.
Investigators are responsible for obtaining and documenting informed consent before the research begins unless the IRB waives this requirement. Informed consent should include the following:
Informed Consent/Parental Permission/Child Assent
- The investigators are responsible for ensuring proper informed consent is obtained and documented before the research begins, unless the IRB waives this requirement.
- The Common Rule (45 CFR 46.116 (a)) outlines the required elements of the informed consent. A Checklist and description of types of consent can be found on the USM’s IRB website.
- Consent is documented by use of a consent form approved by the IRB unless a waiver of informed consent or a waiver of documentation of informed consent is granted.
- Informed consent must be conveyed in language that is understandable to participants or their legally authorized representative. (e.g.; eighth grade reading level, English and foreign language versions for a multi-cultural study).
- The recruitment and consent process will take place in an area in which it is possible to maintain privacy and confidentiality.
- The recruitment and consent process will not promise participants a certainty of cure or benefit beyond what is outlined in the informed consent document/informed consent script.
- Consent must be sought under circumstances that minimize potential for coercion or undue influence.
- A clear and concise explanation of the research to be conducted and the procedures to be employed, including language detailing all potential risks or discomfort and procedures to minimize such risks, duration of participation, and benefits of participation.
- It must be made clear to participants that their participation is voluntary and that they may withdraw at any time with no penalty.
- A statement describing alternatives to the proposed research activity, if any exist. Such as, receiving course credit for participation. Offer another activity someone may participate in to earn course credit.
- A statement that the data/information will be kept confidential, how confidentiality will be maintained, and for how long records will be kept.
- Minimum Retention Period for Human Subject Research:
|Record Type||Period of Retention|
|IRB Records||3 years after study completion|
|Federal Grants||3 years after expiration of grant period|
|HIPAA Authorization||6 years after completion of study|
|HIPAA Waiver||6 years after completion of study|
|FDA||2 years after last marketing approval|
|DoD-conducted or supported||3 years after the completion of the research|
- A statement of whom to contact for answers to pertinent questions about the research and research participants’ rights (e.g. how to contact the IRB), and whom to contact in the event of a research-related injury to the participant.
- A signature line with a statement that the participant is fully informed and agrees to participate on a purely voluntary basis.
- The participant (or their legally authorized representative) must be provided with a copy of the consent document at the time of consent unless this requirement is waived by the IRB.
- Child Informed Assent: Investigators must obtain the affirmative agreement of children, in addition to parental permission. In the United States the legal age of adulthood is a matter of state and local law. Assent forms should be written at a level understandable to the child. If the study includes a broad age range of children, more than one assent form may be needed (i.e., an assent form suitable for a 17 year old is not usually suitable for a 7 year old child).
- Waiver of Consent: In order to waive or alter consent, the IRB must find and document:
- The research involves no more than minimal risk to the subjects;
- The research could not practicably be carried out without the requested waiver or alternation;
- If the research involves using identifiable private information or indefinable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
- Waiver of Documentation of Informed Consent (no signature): The IRB may waive the requirement for the investigator to obtain signed (documented) informed consent for some or all participants [45 CFR 46.117(c)] if it finds that:
- The only record linking the participant to the research would be the consent form, and the principle risk to the participant is the potential harm resulting from the breach of confidentiality. In that event, each participant (or legally authorized representative) should be asked if he/she wishes to have documentation liking the participant with the research. The participant’s wishes will govern.
- The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context (e.g., drawing a blood sample, or asking shoppers about the ambient lighting or temperature of the store).
- If the participant (or legally authorized representative) is a member of a distinct cultural group in which signing forms is not the norm, that the research presents no more than minimal risk of harm, and there is an appropriate alternative for documenting that informed consent was obtained.
Where documentation of informed consent has been waived, the IRB may require investigators to provide participants with a written statement regarding the research; the informed consent without a signature.
- Broad Consent: One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers might be removed from the indefinable private information or indefinable biolspecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or legally authorized representative, if this might be a possibility; or
- A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
A Conflict of Interest (COI) is a situation in which financial or other personal considerations compromise, or have the appearance of compromising, an individual’s professional judgment in proposing, conducting, supervising or reporting of funded research. Conflicts of interest include non-financial as well as financial conflicts, because non-financial interests can also come into conflict with a researcher’s primary commitment to maintain scientific objectivity.
The following relationships are examples of situations that may raise questions regarding an apparent or actual conflict of interest in research:
- An investigator has a consulting or other relationship with a company sponsoring a research project, or a company that manufactures or markets a product under evaluation in the research
- An investigator has intellectual property interests in a product or method under evaluation in the research
- An investigator is a founder and has equity interests in a start-up company that owns intellectual property under evaluation in the research
Potential conflicts of interest are identified through annual and continual disclosure requirements for investigators, as well as, through eProtocol’s conflict of interest section. Investigators applying for federal funding and awarded external funding also complete the Conflict of Interest online CITI training every four years.
If a COI exists with any investigator or key personnel, the Financial Conflict of Interest Board will work with the IRB Chair/Board to determine how the perceived, potential or real COI will be reduced, managed, or eliminated in the interest, preserving research objectivity and protecting the rights and welfare of human research participants. For research involving human participants for which a COI determination is made, a management plan is developed with strategies adequately protect the rights and welfare of human research participants.
Please take some time to review the following website and policy: Financial Conflicts of Interest
Principle investigators must perform or delegate to authorized research staff all necessary research tasks, including specifically:
- Obtaining IRB approval before research begins;
- Obtaining informed consent of participants prior to study enrollment;
- Conducting continuing review in a timely manner;
- Informing the IRB of any disapprovals, suspensions, or terminations to active research studies; and
- Creating and maintaining accurate records; and
- that sufficient resources are available to meet the needs of study.
The Principle Investigator is ultimately responsible for proper conduct of the study and fulfillment of related obligations, including specifically:
- Appropriate training for all research staff on protocol and safety issues;
- Cooperating with investigations/inspections by authorized internal oversight activities as well as external reviews; and
- Supporting student researchers and the protection of human participants in the students’ research, if applicable.
The negotiations of research contracts and management of grants takes place through the Research Service Center (RSC).
Assistance with research development, services and support can be obtained from the Office of Research.
Researchers may contact the Institutional Official – Provost for Academic Affairs or Ross Hickey, Assistant Provost for Research, to obtain answers to questions, express concerns, or share suggestions regarding the HRPP.