Institutional Review Board
for the Protection of Human Participants in Research (IRB)
Policies and Procedures
Institutional Review Board
for the Protection of Human Participants in Research (IRB)
Policies and Procedures
Table of Contents
I.
INSTITUTIONAL REVIEW AND APPROVAL
II. IRB
ADMINISTRATION
III.
DEFINITIONS
IV. MANDATORY TRAINING
V. GENERAL APPLICATION PROCEDURES
Forms Page
VI. INFORMED
CONSENT AND ASSENT
VII. REVIEW AND
APPROVAL
VIII.
RESPONSIBILITIES OF INVESTIGATORS
IX. RECORDS RETENTION
X. REPORTING
MISCONDUCT AND NON COMPLIANCE
XI.
ADDENDUM
I. INSTITUTIONAL REVIEW AND APPROVAL
The Policies and Procedures of Marywood University's Institutional Review Board for the Protection of Human Participants (also referred to as "subjects") in research are grounded in the University's self imposed commitment to safeguard the rights and welfare of human participants in all research under its sponsorship and to serve as their protector on behalf of the community of persons of which the University is a part. The University seeks to comply with all federal regulations requiring the establishment and operation of such a board. (See Office for Human Research Protections, "Code of Federal Regulations," 45 CFR 46 and the Food and Drug Administration, 21 CFR 50 and 21 CFR 56. Links to further information on ethical standards and regulation may be found on our links page.)
Forms of research involving human participants, as defined in this document, and conducted at Marywood University, or conducted by students, staff or administration under its sponsorship at another location, must be reviewed and approved by the Institutional Review Board for the Protection of Human Participants (IRB).
If research is eligible and qualifies for Exempted status, it may be submitted for review and approval to the appropriate School or Departmental Review Board (DRB), of which there are currently three:
Nursing and Public
Administration
Psychology and Counseling
School of Social Work
The IRB has made provisions for school and departmental review and approval of those research activities, which can be deemed no more than minimal risk (not beyond the risks of ordinary life) for the human participants. A School or department wishing to establish a review system must submit for review and approval a set of written guidelines, which will fully describe how the obligations of the IRB will be met, and under what School, departmental or professional standards the activities will be reviewed (please see XI. ADDENDUM).
If a School or department does not have a DRB, the researcher must apply directly to the IRB. All doctoral dissertation applications and research involving children must be reviewed by the IRB, regardless of the research type (Full, Exempt or Expedited). However, Doctoral Exempted studies may be reviewed by the Psychology DRB if they qualify. Review is also required of research carried out under the sponsorship of an institution other than Marywood University, but which is performed on the premises of Marywood University, even if the research has already been approved by the IRB at the sponsoring institution or elsewhere.
Activities Excluded from School or Departmental Review which Require IRB Review:
4. Any research involving more than minimal risk to human participants.
5. Any research involving human participants carried out by an individual or agency outside of but involving Marywood University.
6. Any research involving human participants, which do not fall within the approved, written school or departmental guidelines.
7. Any research involving human participants which is carried out by a member of a school or department where there is no IRB approved school or departmental reviewing system.
8. Any research involving human participants for which the IRB provides notice to the investigator, school or department that the IRB is exercising its oversight responsibility and requires IRB review and approval.
The IRB is to provide an independent determination concerning:
1. The safeguarding of the rights and welfare of individual research participants.
2. Whether these participants are placed at risk; and, if risk is involved, whether:a) the risks to the participant are so outweighed by the sum of the benefit to the participant and the importance of the knowledge to be gained as to warrant a decision to allow the participant to accept such risks;b) the rights and welfare of participants are protected;
c) informed consent will be obtained by adequate and appropriate means;
d) the conduct of the activity will be reviewed at timely intervals.
Research covered by this policy that has been approved by the IRB may be subject to further review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by the IRB.
NOTE: No research may begin, including recruiting subjects or initiating the informed consent process, until IRB or DRB approval has been granted!
1. Membership
Members of the IRB are appointed by Marywood University's Vice-President for Academic Affairs to represent the interests of the University and the community. IRB members are ordinarily appointed for a three-year term and may be reappointed when this initial term expires. There are at least seven voting members of the IRB, with various backgrounds and fields of expertise, including at least one member whose primary concerns are in a scientific area, one member whose primary concerns are in non-scientific area, and one representative from outside of the University. Appointment of members to the IRB will be made to ensure, where possible, equal opportunity diversity as well as professional and academic discipline variety.
If the IRB reviews research that involves a vulnerable category of participants, such as children, prisoners, pregnant women or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these persons.
The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues, which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
2. Meetings
The IRB meets once a month in formal session during the academic year. Meetings are also held during the summer sessions, as needed. The times of these monthly meetings are announced on the IRB Meeting Schedule page. Changes in time and/or date of the meetings or cancellation of the meeting are communicated to all concerned. At the discretion of the chairperson, the Board may conduct business via telephone, e-mail or campus mail.
3. Required Sponsorship
A review and approval of research activities will be made by the IRB or DRB only for studies sponsored by members of the faculty, staff or administration of Marywood University. In those instances where individuals from an institution other than Marywood University wish to conduct research on its campus, a faculty member of the University must sponsor the application to the IRB.
4. Student Research
Students attending Marywood University (undergraduate, graduate and doctoral) are bound by the same procedures and policies as the faculty and staff. Moreover, no applications to the IRB or DRB from either an undergraduate, graduate, or doctoral student will be reviewed unless sponsored by a faculty or staff member familiar with the student and the proposed activity.
Students wishing to graduate in a given semester need to apply to the IRB by the end of the semester prior to the one in which they plan to graduate (i.e. by the end of the fall for a planned spring graduation).
5. Submission of Applications
Any individual intending to conduct research involving human participants, whether or not the research is supported by a grant, contract, or fellowship from any public or private agency, has the responsibility to at least file an application for exemption from formal review (discussed below), in order to determine whether the activities proposed require formal IRB review. If a grant or contract application is involved, this application should be sent directly to the IRB, and sufficiently in advance of the due date of the application in order to allow time for the review process, should it be deemed necessary. All research involving more than minimal risk (as defined below) must be reviewed by the IRB; such projects should not be sent to a DRB. All research involving children must be submitted to the IRB. Doctoral dissertation research must also be submitted to the IRB (exception: Doctoral studies eligible for Exempt review by the Psychology DRB).
6. Deadline for Submission of Applications and ModificationsFull applications to the IRB must be submitted at least 2 calendar weeks prior to the date of the IRB meeting. Applications received too late to permit proper review will be held until the next regularly scheduled meeting. Expedited and exempt applications are accepted weekly according to our administrative schedule. Please see our meeting and application submission schedule for more information.
If the IRB has reviewed a researcher's applicaton and grants him/her a "minor modification" or "deferred" status, the researcher must submit the modifications within 6 months, otherwise the IRB will automatically withdraw the application and the researcher must reapply if he/she plans to continue.
The respective DRB chairperson will determine deadlines for DRB submission.
7. Approval of Research
Once approved, researchers will be sent notification via the IRBNet system, at which time a determination letter will be made available. The approval letter will communicate the approval and expiration dates for the research project. Approved consent/parental consent/assent/ scripts and any advertisements will be stamped an uploaded to IRBNet as 'board documents', so that researchers will have a record of the approved forms. A
IRB approval expires at one (1) year from the original approval date. Status reports are due for all approved projects every six (6) months.
For all three categories of research (full, exempt and expedited), if research will continue beyond the one year approval period, the researcher must reapply to the IRB prior to the expiration date. Renewals should be submitted on the annual/continuing review form and should include all pertinent information about the study, particularly updates or changes (if applicable). Research that initially required a full review may be resubmitted as expedited if the research fits specific criteria for an expedited review (see Expedited Review, below). IRBNet will send automatic reminders to researchers, and anyone else who has been granted full access to a study, based on the study's expiration date. Please note that it is ultimately the researcher's responsibility to know when his/her approval is set to expire, and to reapply.
Activities within the scope of the IRB's responsibilities include research, development, and related activities, which would normally be construed as biomedical or behavioral investigations involving human participants. Included are studies involving not only adults and children, but also investigations of prenatal life. Studies or procedures utilizing organs, tissues, or bodily fluids of a human being are also included, as are the use of graphic, written, or recorded information about individuals even when other institutions or investigators have collected this information.
For the purposes of IRB review, Marywood University stipulates the following definitions:
1. Research - Any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to the well-being of participants and to generalizable knowledge. Activities that meet this definition constitute "research" for the IRB, whether or not they are considered research in other contexts.
Examples of systematic investigations include:
Research activity would normally include the following:
a. Persons or programs requesting extramural (federal, state, or private) funds for research or training.b. Individual faculty members (as well as members of the staff and administration) engaged in research as part of their professional role within the University or as part of their job assignment.
c. Graduate and doctoral students doing research, which is of the nature of a thesis or dissertation and is part of a degree program.
d. Students performing research as part of an independent study or the Honors Program.
e. Individuals (including students or persons from outside the University other than faculty, staff, or administration) conducting research at Marywood University.
2. Human Participant (or Subject) - a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.
Intervention includes both physical procedures by which data are gathered (e.g., 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.
3. Minimal Risk - The probability of 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. Investigators have the obligation to request a clarification by the IRB regarding activities or procedures that are seen by the investigator as questionable in terms of their inclusion in this description.
4. IRB Approval - Means that the IRB has reviewed the research and that the research will be conducted within the policies and procedures outlined in these policies and within the constraints of other institutional and federal requirements. IRB approval does not necessarily include approbation of the research itself.
Marywood University has an IRB training policy for investigators, sponsors, IRB members and IRB administrative personnel. All persons must complete the Collaborative Institutional Training Initiative (CITI) program and supply a completion certificate. Please see our Training Policies page. For specific information on the CITI Program, please see our CITI FAQs page.
V. GENERAL APPLICATION PROCEDURES
No research may begin, including recruiting subjects or initiating the informed consent process, until IRB or DRB approval has been granted!
FULL REVIEW - RESEARCH FOR FORMAL REVIEW
A researcher must apply for full review, unless the he or she believes the proposed research meets the criteria for expedited review or exemption from formal review. An application form may be found on the IRB forms page. A new application for review is required for each research project that differs significantly in terms of procedures or subject populations from a previously approved application. Small changes to approved research may be made via the "Revisions/Changes to IRB Approved Research" form, also found on the IRB forms page.
The ultimate determination of whether participants are at risk can be made only by the IRB or the appropriate DRB. If participants will be placed at more than MINIMAL RISK (as defined above), then the IRB must approve the research and the informed consent/assent form(s) to be used via a convened meeting. The IRB must approve both the form and the procedure by which consent is to be obtained. It is the policy of the IRB to require an informed consent, as well as assent, for any study involving children (under 18 years of age) and other vulnerable populations, no matter what the condition of risk. The procedures necessary for a proper informed consent are described below.
When reviewing research proposals, the IRB or DRB is primarily interested in safeguarding the rights and well being of the human participants and in assessing the ethical implications of the proposed procedures. In this context, the IRB or DRB may pass judgment on "research design," but only to the extent that such design affects the rights or well being of human participants. In analyzing the risk/benefit ratio of a research activity, both the stated goals and the scientific merit of the research will be considered.
Therefore, the research must be described to the IRB or DRB in a manner that allows adequate review of all these aspects of the research. The IRB recommends that research descriptions and applications adhere to the following narrative outline:
- OVERVIEW: Describe the research planned and the rationale for the project, including: (a) research questions(s) or hypothesis(es), (b) most recent relevant research in the area of inquiry, and (c) purpose of the study. Be specific with your research question(s) or hypothesis(es).
- PARTICIPANTS: Include characteristics and recruitment, specifying: (a) the expected number of participants, (b) characteristics of the population, e.g. age, minority population, special group whose ability to give consent is compromised, pregnant women, fetuses, prisoners, (c) inclusion and exclusion criteria, (d) where you will recruit participants, (e) how you will advertise the research, submitting any flyers, posters, or email scripts to be used; If using a flyer, state how it will be used, such as posting, distributing via email, naming list-servs to be used, etc. and (f) if an institution or other entity is providing access to data or participants, supply a permission letter on their letterhead, signed by an official representative. (See permission letter template.)
- BENEFITS/RISKS: Address both potential benefits and risks to participants. Risks relate to the possibility of harm as a result of participating and can be physical, psychological, financial, social and legal or may result from breaches of confidentiality. State: (a) what the potential risks are to participants, (b) if risks are minimal; specifically, no grater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination/testing, (c) how potential risks will be minimized, (d) if risks are reasonable when compared to benefits available and (e) what the potential benefits are to participants and/or the field of study.
- PROCEDURES: Describe the methods and procedures to be used with the participants in the research, in non-technical language. State: (a) exactly what participants will be asked to do, (b) where research will take place, (c) what standardized tests, tools, or measures will be used, submitting instrumentation or questions, discussing reliability and validity; if tools are older than 10 years, discuss rationale for choice, (d) if research-developed tool is used, provide documentation that tool has been piloted, pre-tested or reviewed by 3 professionals in the field of study (Master's degree or higher). If using professionals, supply names, degrees held and contact information. Professionals must also provide a statement of why they endorse tool. Professionals may be faculty or thesis/dissertation committee members, (e) what data/information will be collected, (f) how data will be analyzed, (g) approximate duration of research, (h) if participants will be compensated. If so, please disclose method and rationale (not considered a benefit).
- INFORMED CONSENT: (See templates on Forms Page) Describe the process of obtaining consent from participants. State: (a) how informed consent will be obtained and (b) how informed consent will be documented (oral or written).
Informed consent should convey purpose of study, how participants were selected, procedures, length of study and time required of participants, risks/benefits of participation, voluntariness of participation, procedure for withdrawal and what happens to data, confidentiality of data, data destruction, investigator and sponsor (if applicable) contact information and contact information concerning research integrity. Please see Informed Consent, below.
- RECORDS MANAGEMENT: Records must be kept for as long as the applicable regulations require (at LEAST 3 years; See Records Retention). Please state: (a) the length of retention, (b) that records will be kept in a locked file, (c) who will have access to the records (i.e. researcher, sponsor, transcriptionist, research assistant) and (d) that records will be destroyed and how. If records will not be destroyed, please state that in this section.
EXEMPT FROM FORMAL REVIEW
Any investigator who intends to conduct research involving human participants, and who on the basis of the categories described below judges that research to be exempt from formal review, must file an application for exemption from formal review with either the IRB or the appropriate DRB for approval. Please note that the IRB or DRB makes the final determination regarding whether a protocol is eligible for exemption.
Exempt applications should follow the above narrative format, only instead of a consent form, they should include a "participant letter". The participant letter must contain the same information as an informed consent form, only it does not include a signature line.
The term exempt does not mean exempt from review. An exempt review is not conducted by the entire Committee, but may be carried out by the IRB chairperson, director or by one or more experienced reviewers designated by the chairperson from among members of the IRB. The reviewer(s) may exercise all of the authorities of the IRB.
Categories for exemption from formal review include:
(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.(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.
(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 (2) of this section, if:
(i) 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.(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.
(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:
(i) 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.(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.
NOTE: Children are considered a vulnerable population and receive additional protections in the Federal regulations. Where children will be involved as research subjects, the use of survey or interview procedures is eliminated from the above exemptions. The only research activities involving children that may fall under exemption are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed. (Please see Subpart D of 45 CFR 46.)
Other vulnerable populations, such as pregnant women and prisoners, also receive additional protections under various subparts of 45 CFR 46. (Please see Subparts B and C.)
Any investigator who intends to conduct
research involving human participants, and who
on the basis of the categories described below judges that research
to be eligible for expedited review, must file an expedited application with the IRB for approval. Please note that the IRB makes the final determination regarding whether a protocol is eligible for expedited review.
The expedited review procedure may be used for
research that involves no more than minimal risk, but does not
qualify for exemption (does not fit into one or more of the above exemption categories).
Expedited review applies to one or more of the following categories:
(1) 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 drugs that significantly increases 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.
(2) 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 children2, 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.
(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; (j) sputum collected after saline mist nebulization.
(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 the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, 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.
(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. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(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.)
(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.
(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.
Expedited applications should follow the above narrative format.
An expedited review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. The reviewer(s) may exercise all of the authorities of the IRB.
Are you confused over which type of review to request?
Please see the Full, Expedited or Exempt Decision Charts.
You may also contact our office for help in determining which form would be best to use.
VI. INFORMED CONSENT AND ASSENT
In most research activities, the investigator
must obtain informed consent from each of the participants; or, in
the case of those not able to give informed consent (e.g., children,
mentally challenged), informed consent must be obtained from their
parents, guardians or legal representatives.
For research involving
children
aged seven (7) to seventeen (17), an assent form should be used in
addition to
parental consent. Research involving children under the age of seven
(7) should include an assent script in addition to parental consent.
Assent forms or scripts should include age-appropriate
language. Readability levels may be checked using some word processing
software. Please contact the IRB office for further information.
When parental permission is to be obtained, the
IRB may find that the permission of one parent
is sufficient if the research does not involve greater than minimal
risk or if the research involves greater than minimal risk but
presents the prospect of direct benefit to the individual child
participants. Where research involves greater than minimal
risk with no prospect of direct benefit to individual child
participants, but is likely to yield generalizable knowledge
about the participant's disorder or condition, both
parents must give their permission unless one parent is deceased, unknown,
incompetent, or not reasonably available, or when only one parent has legal
responsibility for the care and custody of the child. When research is not
otherwise approvable but presents an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of children, both
parents must give their permission unless one parent is deceased, unknown,
incompetent, or not reasonably available, or when only one parent has legal
responsibility for the care and custody of the child.
A copy of the informed consent form should be given to the person signing the form, and the researcher should retain the original. The IRB or DRB must approve all informed consent/assent documents.
Informed consent and assent templates may be found on the IRB Forms page.
In clear, non technical and age-appropriate language, participants must be informed of:1. The fact that the study is research.2. The purpose of the research.
3. The expected duration of the participant's participation.
4. The procedures to be followed.
5. Any reasonably foreseeable risks or discomforts.
6. The benefits to the subject or to others, which may reasonably be expected from the research.
7. Appropriate alternative procedures or course of treatment, if any that might be advantageous to the participant.
8. The extent, if any, to which confidentiality of data and privacy of participants will be maintained.
9. For research involving more than minimal risk, whether any compensation and whether any medical treatments are available if injury occurs.
10. Whom to contact for answers to pertinent questions about the research, participants' rights, and research related injury to the participant.
11. The fact that participation is voluntary and that the participant may withdraw his or her consent at any time without penalty or loss of benefits.
12. How long records will be maintained by the researcher (at least 3 years; See Records Retention), who will have access to the records, where records will be stored (i.e. locked file), and if and when data will be destroyed.
There are two procedures, which may be used to obtain informed consent:
1. The participant or a legal representative signs a written informed consent document, which embodies the elements above.2. The participant or a legal representative signs a document indicating that the subject had the above elements explained to him/her orally and that he/she understands this oral description and he/she agrees to participate in the activity described.
In this case, however, an auditor witness to the oral presentation must be present. A written summary of the oral presentation must be submitted to and approved by the IRB. A copy of this presentation is to be retained by the IRB.
Waivers of Informed Consent
With expedited research, if you propose to obtain informed consent for the research activity without obtaining the participant's signature on a consent form, you must request a waiver of documentation of consent (signature). Waiving the requirement for a signed form does not eliminate the requirement for informed consent via verbal communication or written "participant letter". This type of waiver is useful in situations where a signed consent document could have a negative consequence for the participants, or for some telephone or Internet survey procedures [45 CFR 46.117(c)]. If you wish to request a waiver of the documentation requirement, please submit a Waiver of Documentation of Informed Consent form to the IRB.
With expedited and exempt research, if you propose to waive the requirement to obtain informed consent completely, or to alter some of the elements of informed consent, you must submit a Waiver or Alteration of Informed Consent form to the IRB. You must provide a response to all of the following points [45 CFR 46.116(d)].
If you
2. The waiver or alteration of consent will not adversely affect the rights and welfare of the subjects.
3. The research could not practicably be carried out without the waiver or alteration.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Parental/guardian consent will not be waived in Internet research involving minors.
Please note that passive consent, whereby consent is assumed unless a participant/parent/guardian "opts out", is not an acceptable form of consent. Instead, a waiver of consent, meeting the above criteria, must be requested.
Please note that requests for waivers do not apply to FDA regulated studies.
Specific review and approval procedures of the IRB are as follows:
1. Upon receipt of the research application packet, the staff of the IRB checks to insure that the properly completed accompanying forms and attachments are present and that the necessary description of the research is provided. The materials are electronically shared with the appropriate members of the IRB.
Note: If required application pieces are missing, review may be delayed.2. Upon request of the IRB, the investigator may be asked to provide additional information or to appear in person before the committee to present a full explanation of risks and protection for the human participants. Any investigator may ask to appear before the Board to describe the proposed research.
3. In cases where it is deemed necessary by the Board, consultants to the IRB may be asked to comment on a proposed research activity.
4. A necessary quorum for the IRB to consider a proposal is a majority of the total membership. The IRB may not have a member participate in the Board's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
5. The IRB will decide by a majority of the members present:
a) To approve the proposal.b) To approve the proposal after modifications and/or specific conditions have been met.
c) To defer the proposal, pending changes in the application or receipt of additional information from the investigator or consultants to the IRB.
d) To disapprove the proposal.
6. Minutes will be taken at all IRB meetings. Applications will be retained by the IRB for a period of three years after research completion. See the IRB Retention Schedule.
7. The IRB staff will send the principal investigator and sponsor a determination letter informing him or her of the decision of the Board.
a) If changes are recommended by the Board, IRB staff will communicate these via the letter.b) The IRB chairperson, director or designated member(s) will be responsible for review and approval of the investigator's submitted modifications.
c) If the investigator deems it necessary to make further changes, these can be submitted to the IRB for review and approval.
d) If there are changes in the study which the chairperson, director or designated board member(s) feels may change the level of risk to human participants, the investigator will be requested in writing to submit the proposal to the full Board for further review.
8. Adverse decisions may be appealed by re-review of the proposal. Appeals will be heard when the proposal has been revised and/or provides additional information.
9. The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected harm to participants. A list of the reasons for any suspension or termination will be provided to the investigator, all appropriate department heads and deans.
VIII. RESPONSIBILITIES OF INVESTIGATORS
1 . Familiarize themselves with these guidelines and discuss with members of the IRB or appropriate DRB any questions regarding proposed research activities.2. Submit an adequately prepared IRB application to the IRB or appropriate DRB for each research project involving human participants.
3. Notify the IRB and the dean or departmental chairperson of any injury physical, psychological, or social suffered by a research participant because of his or her participation in a research activity.
4. Take proper measures to insure confidentiality and security of all information obtained from the participants.
5. Submit status reports to the IRB or DRB in a timely manner (every 6 months). Forms may be found on the IRB Forms page.
6. Participate in required IRB training through the CITI program.
7. If research continues beyond one (1) year from the original approval date, reapply prior to the expiration using the IRB's Annual/Continuing Review form, which may be found on the IRB Forms page.
8. If the IRB determines that your application will be granted minor modification or deferred status, submit your modifications within 6 months, or your application will automatically be withdrawn.
8. Understand that all research is bound by Federal Regulations and must be kept for the longest applicable period (3 years or longer, see Records Retention, below).
Regulations require each investigator to retain research data not only while the research is being conducted, but also after the research is completed. How long must the investigator retain records after the completion of the research? Unfortunately, there are several different regulations, each of which has different requirements. As a result, researchers must retain their records for as long as the applicable regulations require.
X. REPORTING MISCONDUCT AND NON COMPLIANCE
Research investigators are responsible for reporting to the IRB any instance of serious or continuing non-compliance with the IRB policies and procedures or the requirements or determinations of the IRB.
If inadvertently or intentionally, an approved
research protocol was not followed, the researcher must submit a
Deviation/Violation report to the IRB promptly.
Procedure for Establishing a DRB:
Anyone wishing to establish a DRB must first apply to the Assistant to the Vice President for Academic Affairs for Research and Community Collaboration. This person should submit:
1. A description of the types of research involving human participants which would normally be undertaken in a School or department, and for which there is sufficient experience to be able to review as minimal risk.
2. A statement of the ethical standards with which such activities must comply.
3. A description of the reviewing process at the school or departmental level and the mechanisms for forwarding to the IRB those applications which involve more than minimal risk to the human participants. This description must include an identification of the School or departmental members involved in the reviewing committee, and a description of the forms and/or other materials used by the investigators.
4. Assurance that participation of human participants is voluntary.
5. Assurance that the anonymity of participants will be protected and that appropriate procedures for maintaining confidentiality of participants' responses have been made.
6. Assurance that records will be maintained, allowing the IRB to perform periodic review of the school or department's experiences in the reviewing process.
7. Assurance that the board will consist of an appropriate number of persons as deemed by the IRB.
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Direct comments to the IRB staff here: IRB@marywood.edu
Last update
January 6, 2009
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