VII. Informed Consent
VIII. Review and Approval
Procedures for the Stonehill College Institutional Review Board (IRB) on research involving human participants are meant to safeguard the rights and welfare of human participants in all research under the College’s sponsorship. The College seeks to comply with all federal regulations requiring the establishment and operation of such a board.
Forms of research involving human participants, as defined in this document and conducted at Stonehill College or under its sponsorship at another location, must be reviewed and approved by the College’s IRB.
Research that the IRB approved may be subject to further review and approval or disapproval by College officials. However, those officials may not approve research if the IRB has not approved it.
The ultimate responsibility for treatment of human research participants rests with the researcher and with Stonehill College. The Stonehill College IRB exists as a safeguard to promote ethical and responsible treatment of participants in research. Stonehill College and federal policies require that each project involving studies with human participants be reviewed to consider:
- The rights and welfare of the participants involved,
- The appropriate guidelines for the selection of human participants,
- The appropriateness of methods used to secure informed consent,
- The review of the research at timely intervals, and
- The balance of risks and potential benefits of the investigation.
Membership: The IRB is appointed by the Academic Vice President. IRB members are ordinarily appointed for a three-year term and may be reappointed. There are at least seven members of the IRB with various backgrounds and fields of expertise, including at least one representative from outside of the College. Appointment of members to the IRB will be made to ensure, where possible, a variety of professional and academic disciplines.
If the IRB reviews research that involves a vulnerable category of participants, such as children, prisoners, pregnant women, or mentally disabled persons, it will consider including one or more people who are knowledgeable about and experienced in working with these persons. These invited members do not vote.
The IRB may invite people competent in special areas to assist them in their review of issues that require expertise beyond or in addition to that available on the IRB. These invited members do not vote.
Meetings: The IRB meets once a month in formal session during the academic year. The times of these monthly meetings are announced.
Who must submit a proposal for review: The IRB reviews research proposals sponsored by members of the faculty, staff, or administration of Stonehill College. When individuals from an institution other than Stonehill College wish to conduct research on its campus, a faculty member of the College must sponsor the application to the IRB.
Student research: Stonehill College students are bound by the same IRB policies and procedures as the faculty and staff. The IRB will not review any student-submitted application unless the application is sponsored by a faculty or staff member familiar with the student and the proposed research. Policies included later in this document specify which student research is exempt from IRB review.
Deadline for submission of applications: Applications must be submitted by the deadline indicated on the IRB calendar. Late applications will be deferred until the next meeting. Individuals who in some cases cannot meet this deadline should contact the chairperson of the IRB.
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 and the deceased. 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, Stonehill College stipulates the following definitions:
Research: Any systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to the well-being of participants and to general knowledge. Activities that meet this definition constitute "research" for the IRB, whether or not they are considered research in other contexts.
Excluded from this definition are activities whose sole purpose is instructional; also excluded are activities whose purpose is related to routine course or program development. However, when such research involves students outside of the course, the investigator should apply for exemption or IRB approval.
This definition applies to:
- Persons or programs requesting extramural (federal, state, or private) funds for research or training
- Faculty, staff, and administration engaged in research as part of their professional role within the College or as part of their job assignment
- Students conducting research as part of an independent study or the Honors Program
- Individuals from outside the College conducting research at Stonehill College.
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 must request a clarification from the IRB regarding activities or procedures that are seen by the investigator as questionable in terms of their inclusion in this description.
Children: Children are "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).
IRB approval: Means that the IRB has reviewed the research and that the research will be conducted within the policies and procedures outlined in this booklet and within the constraints of other institutional and federal requirements. IRB approval does not necessarily include approbation of the research itself.
In conformity with Federal Regulations and Stonehill policy,there are three separate avenues for review of research involving human participants. All three types use the same application form with the appropriate boxed checked off.
Full IRB Review: Research involving more than minimal risk to the participant requires review by the full IRB using risk/benefit analysis. Research using children or vulnerable populations requires review by the full IRB.
Expedited Review: Research involving no more than minimal risk and in which the only involvement of participants will be in one or more of the categories defined by Federal Policy 46.110 requires review by the chair and selected members of the IRB. See below for eligibility criteria.
Exempt Review: Research of minimal or no risk as defined by Federal Policy 46.101b requires review by the IRB chair only. See pages below for eligibility criteria.
The following types of activities are not intended to fall under IRB review: Non-intrusive observation of participants in public settings; data-gathering from class members solely for classroom purposes; and needs assessment or evaluation data intended to remain within the Stonehill College community.
For informed consent, see below.
The final determination of level for review is made by the Chair of the IRB in conjunction with the IRB. Allow at least ten days for review. No research may be initiated prior to formal written approval from the IRB.
The following categories are exempt from full IRB review, but must be reviewed by the chair of the IRB (Federal Policy 46.101b):
Instructional strategies in educational settings: Research conducted in established or commonly accepted educational settings are exempt from full IRB review if they involve normal educational practices such as:
- research on regular and special educational instructional strategies, or
- research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
- This category may be applied to research involving children. All other research on children requires full review.
Surveys/interviews; standardized educational tests; observation of public behavior: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, are exempt from full IRB review if:
- Information obtained is recorded in such a manner that human participants cannot be identified, directly or through identifiers linked to the participants, and
- disclosure of the human participants’ responses outside the research could not reasonably place the participants at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability, or reputation, or
- needs assessment or evaluation data intended to remain within the Stonehill community and not circulated on the website, in written documents, or in public presentations.
Surveys or interviews on sensitive or personal topics which may cause stress to study participants are not exempt from IRB review.
Surveys or interviews with children are not exempt.
Public officials; surveys/interviews; educational tests; observation of public behavior: Research involving the use of educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures, or observation of public behavior if:
- the human participants are elected officials or candidates for public office; or
- federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Existing data; records reviews; pathological specimens: Research involving the collection or study of existing data, documents, records, and pathological specimens are exempt from full IRB review, if these sources are publicly available or if the information is recorded in such a manner that participants cannot be identified directly or through identifiers linked to the participants.
Records considered private based on federal and state statute, including medical records and education records, require written release by the study participant or by the custodian of the record. Researchers are cautioned that review of private records involving access to and/or recording of identifiable information is not exempt from IRB review and requires written consent of the study participant. Existing public records do not require prior consent of participants to review the records.
Pathological or diagnostic specimens which are considered waste and are destined to be destroyed can be used in research and are considered exempt from IRB review if there are no patient identifiers linked to the specimen and if the data is not intended to be used in the diagnosis or treatment of a patient. (If either of these conditions apply, consent of the research participant is required and a higher level of IRB review is required.) Specimens retrieved as extra during a clinical procedure require review at a higher level and require written consent from the participant.
Inclusion of fetal tissue in the pathological specimens category of exempt research is prohibited by regulation.
Public service programs; demonstration projects: Research and demonstration projects are exempt from full IRB review if they are conducted by, or participant to, the approval of department or agency heads, and which are designed to study, evaluate or otherwise examine:
- public benefit or service programs;
- procedures for obtaining benefits or services under those programs;
- possible changes in, or alternatives to, those programs or procedures; or
- possible changes in the methods or levels of payment for benefits or services under those programs.
Taste testing and food quality evaluation: Taste and food quality evaluation and consumer acceptance studies:
- if wholesome foods without additives are consumed (all food tested must be GRAS, or Generally Recognized As Safe); or
- 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 Inspection Service or the U.S. Department of Agriculture.
This category may be applied to research involving children; however, written parental consent to include children in taste testing studies is required.
Research in the following (minimal risk) categories are eligible for approval on the basis of a review by the IRB Chair and selected IRB members (Federal Policy 46.110).
Applicability: Research activities that present no more than minimal risk to human participants, and 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 participants.
The categories in this list apply regardless of the age of participants, except as noted.
The expedited review procedure may not be used where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ 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.
The expedited review procedure may not be used for classified research involving human participants.
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.Research categories one through seven pertain to both initial and continuing IRB review.
- Clinical studies of drugs and medical devices only when condition i) or ii) is met.
- 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.)
- Research on medical devices for which an investigational device exemption application (21 CFR Part 812) is not required; or 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:
i) from healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, 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
ii) from other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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.
- Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: i) hair and nail clippings in a nondisfiguring manner; ii) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; iii) permanent teeth if routine patient care indicates a need for extraction; iv) excreta and external secretions (including sweat); v) 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;vi) placenta removed at delivery; vii) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; viii) 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; ix) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; x) sputum collected after saline mist nebulization.
- 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: i) 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 participant or an invasion of the participant’s privacy; ii) weighing or testing sensory acuity; iii) magnetic resonance imaging; iv) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; v) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- 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 participants. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- 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 participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.).
- Continuing review of research previously approved by the convened IRB as follows:
- where the research is permanently closed to the enrollment of new participants; all participants have completed all research-related interventions; and the research remains active only for long-term follow-up of participants; or
- where no participants have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two through eight 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.
In most research, 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 guardians or legal representatives. A copy of the informed consent form should be given to the person signing the form.
In clear and non technical language, participants must be informed that:
- The fact that the study is research.
- The purpose of the research.
- The expected duration of the participant's participation.
- The procedures to be followed.
- Any reasonably foreseeable risks or discomforts.
- Appropriate alternative procedures or course of treatment, if any that might be advantageous to the participant.
- The extent, if any, to which confidentiality of data and privacy of participants will be maintained.
- For research involving more than minimal risk, whether any compensation and whether any medical treatments are available if injury occurs.
- Whom to contact for answers to pertinent questions about the research, subjects' rights, and research related injury to the participant.
- 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.
There are two procedures, which may be used to obtain informed consent:
- The participant or a legal representative signs a written informed consent document, which embodies the ten elements above.
- The participant or a legal representative signs a document indicating that the subject had the above representative sign a document indicating that the participant had the above eleven elements explained to him/her orally and that he/she understand 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.
There may be cases in which the use of either of these procedures for obtaining informed consent may be considered inappropriate by the investigator because they would adversely affect the experimental design or procurement of valid results. Accordingly, modifications to the above informed consent procedures can be recommended to the IRB. However, all modifications must be approved prior to implementation of the proposed research. This approval must be recorded in the IRB’s minutes.
No such modification will be approved unless and until the IRB determines:
- That the risk to any human participant is, in fact, minimal, justifying a less full disclosure in the informed consent procedures than would normally be required; or,
- That the use of either informed consent procedure would, in fact, invalidate objectives of considerable immediate consequence, and that the use of any reasonable alternative means for attaining these objectives would be less advantageous to the participant.
Specific review and approval procedures of the IRB are as follows:
- Upon receipt of the necessary number of copies of the research protocol, the Chairperson of the IRB or checks to insure that the properly completed accompanying forms are present and that the necessary description of the research is provided. Copies are then distributed to members of the IRB.
- Upon request of the IRB, the principal 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.
- In cases where it is deemed necessary by the Board, consultants to the IRB may be asked to comment on a proposed research activity.
- A quorum for the IRB to conduct business is a majority of the total membership. The IRB may not have a member participate in the its initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
- The IRB will decide by a majority of the members present:
- To approve the proposal.
- To approve the proposal with restrictions or conditions.
- To defer the proposal, pending changes in the application or receipt of additional information from the investigator or consultants to the IRB.
- To disapprove the proposal.
- Minutes are kept of all IRB meetings. Records will be retained by the IRB for a period of three years.
- The IRB chairperson will inform the principal investigator of the decision of the Board.
- If changes are recommended by the Board, the IRB chairperson or designated member will communicate these through the minutes to the investigator.
- The IRB chairperson or designated member will be responsible for review and approval of the investigator's submitted changes.
- If the investigator deems it necessary to make further changes, these can be submitted to the chairperson or designated IRB member for review and approval.
- If there are changes in the study which the chairperson or designated board member 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.
- Adverse decisions may be appealed by re-review of the proposal. Appeals will be heard when the principal investigator has revised the proposal or provides additional information.
- The IRB has the 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 and all appropriate department heads and deans.
- Familiarize themselves with these guidelines and to discuss with members of the IRB any questions regarding proposed research activities.
- Submit either an adequately prepared IRB form for each research project involving human participants.
- Notify the IRB of any physical, psychological, or social injury suffered by a research participant because of his or her participation in a research activity.
- Make provisions to keep records, documents, and informed consent forms normally for at least three years following the completion of the project or activity, or for a longer period as judged necessary.
- Take proper measures to insure confidentiality and security of all information obtained from the subjects.
- Retain adequate records relating to IRB-approved research for a period of three years following completion of the research.
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.
 See Office of Science and Technology Policy, "Federal Policy for the Protection of Human Participants," Federal Register, Vol. 56, No. 117, June 18, 1991, and “Protection of Human Participants,” 45CFR46.101.