I. Institutional Commitment
III. Roles and Functions of the IRB
IV. Research Conducted by Researchers not Affiliated with Fordham University
V. Classroom Research Guidelines
VI. Activities Eligible for Exemption from IRB Review
VII. Activities Eligible for Expedited Review
VIII. Initial Full Review of Non-Exempt Research
IX. IRB Considerations in Review of Protocols
X. IRB Report of Action
XI. The Informed Consent Process
XII. Monitoring/Reporting Requirements in On-going Research
XIII. Continuing Review of Non-Exempt Research
XIV. Basic Documents
The Belmont Report
Title 45 CFR Part 46
XV. Oral History Policy
XVI. Waiver of Consent
I. Institutional Commitment
The University is guided in all research with human subjects, whether funded or not, by the principles outlined in The Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979). Briefly, three basic ethical principles are set forth in that Report:
Respect for Persons. The principle of respect for persons...divides into two separate moral requirements: the requirements to acknowledge autonomy and to protect those with diminished autonomy.
Beneficence. Two general rules have been formulated as complementary expressions of beneficent actions: (1) do no harm and (2) maximize possible benefits and minimize possible harms.
Justice. Who ought to receive the benefits of research and bear its burdens? This is a question of justice in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly.
The application of these principles to research requires that appropriate procedures be followed. Respect for persons requires that informed consent be obtained from all research subjects or their legal representatives, unless the research falls within an exempt category. Beneficence requires that the researcher assess risks and benefits to subjects. Justice requires that research subjects be selected in a fair and equitable manner.
The following guidelines and procedures have been established to assist the University community in carrying out its commitment to ethical behavior in human subjects research. They are in compliance with federal regulations (title 45 CFR Part 46) and New York State law (Article 24-A of the Public Health Law).
Listed below are several definitions that help clarify the guidelines.
Assent. Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
. Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
. Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
. A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25].
. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 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, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
An Institutional Review Board established in accord with and for the purposes expressed in Title 45 CFR Part 46. IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.
Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Research. A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of [Federal] policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
III. Role and Functions of the IRB
Fordham University ("Fordham") recognizes its ethical and federally mandated responsibility to safeguard the rights and welfare of human subjects in all research undertaken under its sponsorship. Fordham assigns to the Institutional Review Board for the Protection of Human Subjects ("IRB") the responsibility pf assuring that researchers protect the integrity and dignity of individuals who are the subjects of Fordham-sponsored research.
is defined as any of the following: a) funded or unfunded research conducted by or under the direction of a Fordham University employee in connection with his or her institutional responsibilities; b) research conducted by or under the direction of a Fordham University employee who makes substantial use of any Fordham property, personnel, equipment, or facility; or c) research involving the use of the institution s non-public information to identify or contact human research subjects or prospective subjects.
Members of the IRB are appointed by the Office of the Provost. They will serve for a term of three years with optional renewal. By the nature of their appointment, these terms will be staggered. The Chair will be elected by the Board and also serve a three year term. The IRB ensures that all members of the Fordham community, particularly research investigators, understand their responsibilities for the protection of human subjects at risk whenever research is determined by the IRB to occasion risk to human subjects.
With the assistance of the Associate Vice President for the Office of the Provost, the Director of Research, and the IRB, it is the responsibility of deans, department chairs, program directors, individual investigators, or anyone else engaged in the direction or supervision of research, including research performed by students, to familiarize themselves with the policies and procedures established by Fordham that protect human subjects who may be placed at risk in research.
Research subject to regulation by Fordham and its IRB includes all biological, behavioral, psychological and sociological investigations designed to elicit non-public information about individuals or groups. Such studies may involve adults, children, pre-natal life or dead persons, and other groups defined as vulnerable in Title 45 CFR Part 46. They may utilize organs, tissues or bodily fluids; they may employ graphic, written or recorded information about individuals even when this information has been collected by others. Certain research may be exempt from regulation by Fordham and its IRB. Activities eligible for exemption are listed below. Otherwise, all Fordham-sponsored research, funded or unfunded, involving human subjects at risk must adhere to the policies and procedures promulgated by Fordham through its IRB.
The determination of whether a project is Fordham-sponsored, "involves risk to human subjects," and/or is subject to review procedures, is reserved to Fordham acting through its IRB in accordance with all applicable laws and regulations. Exemptions to the review process will be made whenever appropriate but must not be taken for granted by any investigator, regardless of the source of, or the lack of, funding, the academic status of the investigator, or the nature of research protocols. The authority to approve protocols and exempt projects is reserved exclusively to Fordham acting through its IRB subject to the appropriate delegation of authority as noted below.
Fordham regards an infringement of its established policies and procedures as a serious breach of professional standards and cautions investigators and others who violate these standards that they will be subject to sanctions as outlined in the University Policy for Responding to Allegations of Scientific Misconduct, which also provides for due process. Procedures applicable to faculty discipline are contained in the University Statutes, Chapter Seven,Part II. Violations by investigators who do not hold faculty rank are handled through the established processes applicable to their employment or student status. Fordham also reserves the right not to defend investigators should litigation result from violations in connection with their research activities in circumstances where the investigator has failed to submit a research protocol for the required IRB approval, or, having submitted such a protocol, the investigator departs substantially from the approved research protocols or fails to implement the required emendations and/or alternative procedures. During the pendency of possible disciplinary action against an investigator, Fordham and its IRB reserve the right to suspend, take possession of, or destroy research that does not, in its judgment, conform to IRB requirements, guidelines or regulations.
IV. Research Conducted by Researchers not Affiliated with Fordham University
The Fordham University Institutional Review Board (IRB) reviews all human subject research conducted by faculty, staff, and students, regardless of the location of the research activity, source of funding, and whether the research is exempt under the Code of Federal Regulations for Protection of Human Subjects (45 CFR 46). The IRB is also required to review research that is conducted by researchers who are not affiliated with the University when their research proposes to make use of University facilities or recruit University students, staff or faculty as research participants.
The purpose of this policy is to provide the same protections to students and staff of Fordham University who are recruited on campus to participate in investigative studies performed by researchers who are not affiliated with the as the protections afforded to human subjects in research performed by researchers affiliated with the University. Implementation of this policy will assure that the highest standards of ethics, practice, and conduct will be employed in such studies in which University students and/or staff may become involved.The following criteria apply to this situation:
o Researchers should first receive IRB approval from their own educational institution. In this instance, the researcher will likely have to provide the Board with a copy of the IRB application and approval letter.
o Student and faculty researchers without off-site IRB approval will need to go through the Fordham IRB process.
o In addition, human subject researchers who are not Fordham students, faculty or staff, must obtain a Fordham University research sponsor (faculty or staff) who will assume responsibility for the proposed research activity at Fordham.
V. Classroom Research Guidelines
Research, as defined in Federal Regulations 45 CFR 46 and conducted by undergraduate and graduate students, is subject to federal regulations that require that all research protocols involving human subjects be reviewed by an Institutional Review Board.
However, a number of schools and departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwiseserve as participants. The purposes of these course projects are to train students and to provide them with an opportunity to practice various research methods. These projects do not generally result in generalizable knowledge or publications and are not undertaken with these goals in mind. Therefore, the IRB does not consider them to be research and IRB review is not required. Such projects are considered "classroom exercises" and are typically quite limited in scope.However,
Any data collected under these circumstances cannot be used for future theses or publications. If the student might want to use these data for a future thesis or publication, the project requires IRB review and approval before the data are collected.
Any student-initiated and/or student-conducted research that is not a research practicum or internship, that uses human subjects, and that is undertaken with the intent to contribute to generalizable knowledge, requires IRB review and approval. This includes, but is not limited to, undergraduate and graduate honors, thesis, and dissertation research.
All class research projects that involve protected groups as defined in Title 45 Code of Federal Regulations Part 46 (such as, but not limited to pregnant women, children, prisoners, institutionalized mentally ill patients) require IRB review even if there is no intention to publish results.
Faculty and/or students are urged to contact the IRB if in doubt about whether a project requires review.
University divisions and/or departments may establish additional criteria based on their particular needs and preferences, as long as they meet these minimum Fordham University Institutional Review Board guidelines.
VI. Research Eligible for Exemption from IRB Review
All research with human subjects conducted by faculty members, administratorsor students, whether funded or not, must be reviewed and approved by the IRB. After review, the IRB may determine that a project meets one or more of the following criterion and therefore may be Exempt from full Board review:
EXEMPT CATEGORIES: (There are 6 categories)
Category 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Category 3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b) (2) of this section, if: the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s)without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Category 4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Category 5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Category 6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
VII. Research Eligible for Expedited Review
The following research activities may be eligible for expedited review:
In order for a study to be eligible for exepedited it must meet items A - F below and be included in one the 9 categories below:
(A) 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 following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
(D) The expedited review procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review-expedited or convened-utilized by the IRB.
(F) Categories one (1) through seven (7) pertain to both initial and continuing IR review.
Expedited Categories: (There are 9 categories)
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drags that significantly increase the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Category 3 Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner, (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; fi) sputum collected after saline mist nebulization.
Category 4 Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.). Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of thesubject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electoretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Category 5 Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. This listing refers only to research that is not exempt.)
Category 6 Collection of data from voice, video, digital, or image recordings made forresearch purposes.
Category 7 Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
Category 8 Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
Category 9 Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
VIII. Initial Full Review of Non-Exempt Research
Scheduled meetings of the full IRB will be published on Fordham's IRB website at the beginning of the academic year (see Schedule of Meetings page). Application for full IRB review is made by e-mailing a protocol (see IRB Forms page) and any letters of consent or statements of assent to the IRB (IRB@fordham.edu). Send two copies of supporting materials to: Institutional Review Board, Room 203-C, Fordham University, 113 West 60th Street, New York, NY 10023. These materials should include copies of questionnaires or other research instruments, advertisements for subjects, and the full proposals for research approved for funding.
IX . IRB Considerations in Review of Protocols
The IRB will pay special attention to the following:
- Identification and Assessment of Risks. These may be of a physical, psychological, social or economic nature. In behavioral, social, and some biomedical research, the methods for gathering information may pose the added risk of invasion of privacy and possible violations of confidentiality.
- Determination that Risks are Minimized. Precautions, safeguards, and alternatives should be incorporated into the research design where warranted to reduce the probability of harm.
- Assessment of Anticipated Benefits. Benefits may be to subjects and to society. The IRB will look for a clear statement of benefits to subject, as well as identification of the knowledge researchers expect to gain.
- Determination that Risks are Reasonable in Relation to Anticipated Benefits. Evaluation of the risk/benefit ratio is the major ethical judgment IRBs must make. In reaching this judgment the IRB will take into account the subject population (e.g., children, pregnant women, terminally ill). In research where no direct benefits to the subject are anticipated, the IRB must evaluate whether the risks presented by procedures performed solely to obtain generalizable knowledge are ethically acceptable.
- Informed Consent. Because of the centrality of informed consent to research with human subjects, a separate section below lists the basic elements of the consent document and process. The IRB will evaluate the information to be presented to subjects in light of the risks and benefits of the proposed research procedures.
- Privacy and Confidentiality. Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. For example, in recruiting subjects through a clinic, institution, or doctor, it is important that potential subjects have an opportunity to refuse participation before their identity or means of contacting them is revealed to a researcher. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.
The IRB will seek to determine whether an invasion of privacy is involved. It will also examine the research design to assure that information linked to individuals is adequately protected from breaches of confidentiality. There are specialized security measures developed for this purpose. These include the use of codes, storage of date under lock and key, and certificates of confidentiality.
X. Report of IRB Action
The Office of Research will send a written IRB Report of Action to the investigator shortly after IRB review, whether full or expedited. The Report will indicate one of the following: (1) the protocolwas approved as submitted; (2) specific revisions requiring simple concurrence by the investigator are required (with the IRB Chairperson or designated reviewer delegated to approve revisions on behalf of the IRB); (3) approval of the protocol is deferred due to IRB requests for substantive clarifications, protocol modifications, or informed consent document revisions (with subsequent review of the responsive materials by a convened IRB).
Any revisions to the human subjects protocol requested by the IRB should be incorporated into the written protocol, withrevision dates on each revised page and on the protocol itself, so that the operative protocol is clearly marked.
The Office of Research will certify IRB review and approval to funding agencies, as required.
XI. The Informed Consent Process
Informed consent is central to the ethical conduct of research with human subjects. Researchers must obtain fully informed consent in all non-exempt research with human subjects. The informed consent document must be signed by the subject before any research is initiated. This principle precludes the use of incomplete disclosure of the nature of the research, deception, and so-called "passive consent."
When subjects are children (under 18) or not competent to consent the parent or legal guardian must sign the consent form. Investigators should be guided by the elements of informed consent, as outlined by the Federal government:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact, together with phone numbers, for answers to pertinent questions about the research and research subjects' rights, and whom to contactin the event of a research-related injury to the subject. (The investigator should be the contact for questions about the research and the University Director of Research should be the contact for questions about the rights of subjects);
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
The following conditions should govern the consent process:
· Prospective subjects should be free to consider whether to participate (i.e., they should not be rushed, excessive payments should not be offered, nor should other undue influence or coercion be exerted).
· The informed consent document should be written in language understandable to the subjects. If the subjects are non-English-speaking, the document should be translated.· Where the potential need to report illegal activity to the authorities exists (e.g., child abuse, drug and alcohol abuse by minors), the subjects should be so informed before agreeing to participate.
· Where there is reason for special concern (e.g., regarding pressure on potential subjects), the IRB may require monitoring (such as a third party observer).
· Subjects should be given a copy of the consent form as a reminder of the information conveyed.
· Consent forms must be retained for at least three years following the conclusion of a research project.· The IRB may sometimes approve the use of a "short form" consent document, which means that the information is presented without benefit of a written version of the consent document. However, the IRB must first review and approve a written summary of what will be presented. Each oral presentation must be witnessed by a third person, who must sign both the consent form and a copy of the written summary of the presentation. A copy of the summary must be presented to those who sign the consent form for future reference.
· If vulnerable populations are involved, additional safeguards are generally required. In the case of children, in addition to the required parental/guardian consent, an "assent" document should be prepared, written in language the child will understand.
· When the Informed Consent document has IRB approval, the Office of Research will stamp the form approved and insert the approval and expiration dates. This stamped document is the official one that should be given to subjects, signed, and returned to the investigator for safekeeping. The investigator must retain signed consent forms for at least three years past completion of the research activity and should inform the Office of Research in writing of where the forms are kept. IRB approval of the research together with the informed consent document expires one year from the date of initial approval. It is the responsibility of the researcher to insure timely application for continuing IRBreview and approval as necessary. The IRB has the authority to observe or have a third party observe the consent process.
Please contact the Chairperson of the IRB or the Director of Research if you have any questions regarding informed consent.
XII. Monitoring/Reporting Requirements in Ongoing Research
The Principal Investigator is responsible for reporting promptly to the IRB on the following situations:
· Adverse Events. A report, in writing, should be made as soon as possible regarding any unanticipated injuries or other problems involving risks to subjects and others.
· Changes in Protocol. Any changes in the approved research protocol with respect to human subjects should be communicated in writing. Proposed changes should not be initiated without IRB review and approval.
Report should be made to the IRB via the Office of Research.
XIII. Continuing Review of Non-Exempt Research
Research that is ongoing requires review at least once every twelve months. (The IRB may require more frequent review, as appropriate to the degree of risk to subjects.) The IRB has the authority to suspend or terminate previously approved research that is not being conducted in accordance with IRB requirements, or that has been associated with unexpected serious harm to subjects.
The Investigator should supply an electronic copy of the completed Annual Review Form to the IRB office via email at IRB@fordham.edu. This information should be provided with sufficient time for review and response before expiration of the current approval date, at least one month before the expiration date.
Please note investigators will receive notification that their approval will be expiring soon. It is the investigator's responsibility to submit their renewal application in order to avoid a lapse in approval. If a lapse occurs, all human subjects activity should halt until approval has been renewed. If approval lapses, the investigator will have to submit a new submission for review and approval by the IRB committee.
XV. Oral History Policy
The U.S. Office for Human Research Protection (OHRP), part of the Department of Health and Human Services (HHS), working in conjunction with the American Historical Association and the Oral History Association, has determined that oral history interviewing projects in general do not involve the type of research defined by HHS regulations and are, therefore, excluded from Institutional Review Board oversight. The Fordham IRB concurs with that decision.
As described in the memo (12.01.03) of Michael Carome of OHRP on the field of oral history: "A decision whether oral history or other activities...are subject to the policies and regulations oulined in FWA and HHS regulations for the protection of human subjects (45 CFR 46) is based on the prospective intent of the investigator and the definition of 'research' under HHS regulations at 45 CFR 46.102(d): 'a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.'... Oral history activities, such as open-ended interviews, that ONLY document a specific historical event or the experiences of individuals without an intent to draw conclusions or generalize findings would NOT constitute 'research' as defined by HHS regulations 45 CFR part 46."
a) Oral history activities, in general, are designed to create a record of specific historical events and, as such, are not intended to contribute to generalizable knowledge. Only those oral history projects that conform to that regulatory definition of research need to submit their research protocols for IRB review.
b) Faculty and/or students are urged to contact the IRB if in doubt about whether a project requires review.
c) Some oral history interviewing projects may meet the definition of research. Other activities involving open-ended interview that have similar characteristics can involve research as defined by the HHS regulations when the activities are part of a systematic investigation designed to develop or contribute to generalizable knowledge. See Michael Carome memo cited above.
d) The evaluation of whether oral history activities require IRB review hinges upon whether the person is engaged in the creation of "generalizable knowledge." In other words, does the activity represent a systematic investigation in which the historian intends to develop or contribute to generalizable knowledge?
XVI. Waiver of Consent
(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
(Approved by the Office of Management and Budget under Control Number 0990-0260.)
(45 CFR 46.116 & 46.117; 21 CFR 50.23 & 50.24; 21 CFR 56.109 (2001 and 2006).