A. Anne Arundel Community College (“AACC” or “College”) maintains an Institutional Review Board on the Use of Human Subjects in Research (“IRB”) made up of members who represent a range of perspectives and backgrounds from both within and outside of the College.
B. The IRB reviews proposed research projects by College faculty, staff, students, or third parties that utilize human subjects or Identifiable Private Information (as defined below) maintained by the College in accordance with on the guidelines on human protection put forth by the Office of Human Research Protections of the Department of Health and Human Services, 45 C.F.R. § 46, and applicable standards of professional conduct and practice, modern ethical principles, and the consensus of contemporary community standards.
C. The IRB’s role to minimize inherent and potential risks to human subjects as much as is feasible, regardless of projected benefits to individuals or to society.
II. Scope and Applicability
A. This Procedure applies to any College faculty, staff, student, or third party who seeks to conduct research involving Human Subjects, as defined below, including but not limited to surveys, or using Identifiable Private Information, as defined below, of College employees or students maintained by the College.
B. If Research, as defined below, began prior to the Effective Date of these Procedures, the Researcher must stop Research and submit an IRB Application and seek approval before continuing the Research.
C. Requests to access institutional data, including deidentified or aggregate data, are not subject to this Procedure, but rather should be referred to the Associate Vice President of Planning, Research, & Institutional Assessment for approval.
A. Biospecimen means blood, serum, urine, saliva, other bodily fluid, bone marrow, cells, stool, or tissue samples/specimens collected from Human Subjects under this Procedure, including but not limited to, any tangible material derived from such Biospecimens collected under this Procedure from Human Subjects, such as genes, gene fragments, gene sequences, proteins, protein fragments, protein sequences, DNA, RNA, and any subcellular structure, and their unmodified derivatives.
B. Certification means the official notification by the IRB to the supporting Federal department or agency component Research involving Human Subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
C. Deception means that Human Subjects will not be fully informed of the nature of the Research project, its risks, and its benefits before giving consent to participate.
D. DHHS means the U.S. Department of Health and Human Services.
E. Human Subject or Subject means a living individual about whom an Investigator (whether professional or student) conducting research:
1. Obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates Identifiable Private Information or Identifiable Biospecimens.
F. Identifiable Private Information is Private Information for which the identity of the Human Subject is or may readily be ascertained by the Investigator or associated with the information.
G. Identifiable Biospecimen is a biospecimen for which the identity of the Human Subject is or may readily be ascertained by the Investigator or associated with the biospecimen.
H. Interaction includes communication or interpersonal contact between Investigator and Subject.
I. Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
J. Investigator means an individual(s) who submits an IRB Application to conduct Research involving Human Subjects to the IRB.
K. IRB means the College’s Institutional Review Board, which is established in accord with and for the purposes of 45 C.F.R. § 46 et. seq.
L. IRB Administrator means the College employee designated by the Associate Vice President of Planning, Research, & Institutional Assessment to oversee and manage the IRB system and its operations, including working in collaboration with IRB in the development and maintenance of appropriate procedures, processes and records for the IRB.
M. IRB Application is a written request by a College faculty, staff, student, or third party seeking approval from the IRB, using the College’s IRB Forms, to conduct Research involving College faculty, staff, or students to conduct a Research project or activity involving Human Subjects.
N. IRB Co-Chairs means the two (2) member of IRB who preside over IRB meetings.
O. Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
P. 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Q. Representative is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective Human Subject to the Human Subject’s participation in the procedure(s) involved in the Research, which includes a parent or legal guardian of a minor child under the age of 18.
R. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge and does not include scholarly or journalistic activities, public health surveillance activities, activities conducted on behalf of a criminal justice agency or criminal investigative purposes, or authorized operational activities in support of intelligence, homeland security, defense, or other national security missions. This definition includes third party surveys of College employees and/or students.
S. Secondary Research means Research that makes use of existing information, data, or biospecimens collected previously for a different purpose that may have been collected for a non-research purpose or for a different, IRB-approved, research study.
T. Written, or in writing refers to information recorded on a tangible medium (e.g., paper) or in an electronic format.
IV. IRB Membership
A. The IRB will have no less than five (5) members, with varying backgrounds to promote complete review of research activities commonly conducted by the College.
B. The IRB members are selected from within and from outside of the College and from different disciplines.
C. The IRB members must sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, based on characteristics set forth in the College’s Policy on Equal Opportunity and Nondiscrimination, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of Human Subjects.
D. The IRB member must be knowledgeable and be able to ascertain the acceptability of proposed Research in terms of institutional commitments (including policies and resources), applicable law and regulations, and standards of professional conduct.
E. The IRB may not consist entirely of members of one profession or one gender; however, selection must be made on the basis of qualified expertise, not solely on the basis of gender.
F. The IRB members should all be knowledgeable about issues relating to individual civil liberties, be qualified to evaluate the rights of Human Subjects, and be familiar with common protections put in place to ensure the rights of Human Subjects are maintained.
G. The IRB members will include:
1. The Associate Vice President for Continuous Improvement and Innovation Analytics (“AVP”) or designee;
2. One (1) full-time instructional faculty member from physical or natural sciences;
3. Two (2) full-time instructional faculty member from social science;
4. One (1) full-time instructional faculty member from humanities;
5. One (1) full-time instructional faculty member from health sciences;
6. Two (2) staff members from Planning, Research, and Institutional Assessment (“PRIA”) appointed by the AVP, one of which who also serves as IRB administrator, appointed by the AVP;
7. The Special Assistant to the Vice President for Learning;
8. One (1) staff member appointed by the Vice President for Learner Support Services; and
9. One (1) community member appointed by the Provost/Vice President for Learning who is unaffiliated with the College and and who is not a member of the immediate family of a person who is affiliated with the College.
10. Up to two (2) part-time instructional faculty members with any research-oriented disciplines may be appointed by the AVP but are not required to be part of the IRB.
H. Full-time faculty will be selected by the Academic Forum’s Nominating Committee.
I. The Co-Chairs of the IRB will be the AVP and one (1) full-time faculty member, selected by the IRB through a vote.
J. Members serve in staggered three-year terms that may be renewed by re-appointment.
K. Any vacancies that occur during the middle of a term will be filled by appointment as set forth above, except a full-time faculty member will be appointed by the Academic Forum’s Nominating Committee.
L. The IRB membership may invite additional members with competence in special areas to assist as ex-officio, non-voting members of the IRB.
A. All members of the IRB must complete the Human Subjects online training, as determined by the IRB Co-Chairs, before reviewing IRB Applications.
B. The initial IRB training is valid for five (5) years from the date of completion (unless the IRB member’s training certificate expires before this time).
C. Every five (5) years thereafter, the IRB member will be required to complete a continuing/refresher IRB training.
D. IRB member must submit a certificate attesting to completion of the training to the IRB Co-Chairs, who are responsible for maintaining up-to-date certificates for IRB members.
VI. Conflicts of Interest
A. No IRB member may be involved in the review of any IRB Application in which the IRB member has a conflict of interest.
B. A conflict of interest exists if an IRB member or IRB member’s Relative, as defined in the Nepotism Policy or person with whom they have a Personal Relationship, as defined in the Nepotism Policy:
1. Is an Investigator or key personnel on the IRB Application under consideration;
2. Supervises the primary Investigator or key personnel on the IRB Application under consideration;
3. Has direct professional responsibility for the subject matter of the IRB Application;
4. Acts as an officer or a director of the sponsor or an agent of the sponsor of the IRB Application;
5. Is involved in the IRB Application as a coordinator, consultant and/or primary advisor;
6. Has received salary or other payments for services (e.g., consulting fees or honoraria) or equity interests (e.g., stocks, stock options or other ownership interests) from an entity whose financial interests would reasonably appear to be affected by the outcome of the IRB Application;
7. Has a proprietary interested related to the Research, including but not limited to intellectual property rights (e.g., patents, copyrights, trademark, trade secrets, or a licensing agreement or royalties from such rights);
8. Serves on the board or is employed by the entity sponsoring the IRB Application, regardless of compensation; or
9. Has identified any other reason that may cause an appearance of impropriety if the IRB member were to review the IRB Application, such as having a close personal or professional association with the submitting investigator, serving as co-investigator and/or the primary mentor for the investigator or any other reason the IRB member believes they cannot conduct an independent review of the IRB Application.
C. Each IRB member must disclose to the IRB Co-Chairs any conflict of interest in an IRB Application submitted to the IRB and recuse themselves from the review of the IRB Application.
D. If one of the IRB Co-Chairs has a conflict of interest in an IRB Application submitted to the IRB, the IRB Co-Chair who has a conflict must recuse themselves from the review of the IRB Application and inform the IRB, which will select another IRB member for review of that IRB Application from among the remaining IRB members.
E. The recused IRB member may not participate in the discussion for initial or continuing review of any IRB Application or be present during the vote on an IRB Application in which the IRB member has a conflict of interest, except to provide information or answer questions from the IRB regarding the IRB Application as requested during the review process.
F. The IRB Co-Chairs are responsible for enforcing these conflict of interest procedures for the College.
1. The IRB Co-Chairs are responsible for identifying conflict of interest disclosures at IRB meetings before each IRB Application is reviewed and discussed.
2. The IRB Co-Chairs are responsible for documenting all conflicts of interest in the IRB meeting minutes.
3. The IRB Co-Chairs may remove any IRB member who fails to disclose a conflict of interest or recuse themselves from an IRB Application in accordance with these procedures.
4. The IRB may remove an IRB Co-Chairs if the IRB Co-Chair fails to disclose a conflict of interest or recuse themselves from an IRB Application in accordance with these procedures.
G. IRB members are required to be knowledgeable about conflict of interest issues and these procedures pertaining to conflict of interest.
VII. Review of IRB Applications
A. The IRB must review all College Research projects and activities that involve Human Subjects, regardless of the risk foreseen, prior to the initiation of the Research project or activity, including Research projects and activities that are conducted on the College premises, virtually, or elsewhere by College faculty, staff, and/or students or third parties conducting Research involving College faculty, staff, and/or students.
B. Any College faculty, staff, student and/or third party who seeks to conduct a Research project or activity involving Human Subjects must submit an IRB Application to the IRB.
C. College faculty and staff are prohibited from assisting third parties in soliciting College students, faculty, or staff to participate in outside Research, including but not limited to, forwarding links, providing specific information, or otherwise encouraging College students, faculty or staff to participate in an outside Research study.
D. IRB Application forms, including IRB-EXEMPT, IRB-EXPEDITED, IRB-FULL, or IRB-CONTINUING REVIEW, are available online on the College’s IRB webpage or via email from the IRB Administrator at firstname.lastname@example.org. Hard copies can be obtained from the IRB Administrator.
E. The IRB Co-Chairs or designee will appoint two (2) members of the IRB to determine whether the IRB Application is:
1. Exempt from IRB review;
2. Eligible for expedited review;
3. Requires full IRB review; or
4. Requires continuing review or protocol modification.
F. The IRB has the authority to make decisions involving IRB Applications, including but not limited to the following:
1. To determine the level of risk to which Human Subjects may be exposed by the IRB Application;
2. To approve an IRB Application and procedures as submitted;
3. To require modifications to an IRB Application and procedures;
4. To disapprove an IRB Application;
5. To continue review of the Research that the IRB has approved, as determined by the IRB in accordance with the Continuing Review Section below;
6. To determine whether the Research that the IRB has approved will need verification from sources other than the Investigator that no material changes have occurred since previous IRB review;
7. To suspend or terminate IRB approval of Research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to Human Subjects; and
8. To determine whether IRB Applications from third parties have value or benefits to the College in order to consider approval to conduct Research involving College students, faculty, or staff.
G. The IRB Co-Chairs will schedule regular meetings and may schedule additional meetings as needed.
H. Each IRB member is required to exercise independent judgment and conduct reviews in the most objective manner possible.
I. In their evaluations, each IRB member will attempt to ensure that inherent and potential risks to Human Subjects in all IRB Applications are reasonable in relation to anticipated benefits, if any, to the Human Subjects and/or humanity.
J. If an IRB Application is approved and the Research is supported by a Federal department or agency component, the IRB will issue a Certification and the IRB Co-Chairs will provide any assurance required by the Federal department or agency.
VIII. Research Excluded from Review by the IRB
A. Research that does not involve the use of Human Subjects does not need to be presented to IRB in any form.
B. Data collection conducted by a faculty member, in a classroom setting, as part of a course curriculum, including activities designed for demonstration purposes as part of the educational experience for students, does not need to be presented to the IRB in any form.
C. If the faculty member plans to disseminate research findings beyond the classroom, the faculty member must submit an IRB Application to the IRB using one of the processes set forth below.
IX. Research Exempt from Full Review by the IRB
A. The following categories of Research involving Human Subjects are exempt from this full IRB review:
1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction, including most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods;
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording, subject to the Section below on Audio and Video Recording) or research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording (subject to the Section below on Audio and Visual Recording) if the Subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
a. The information obtained is recorded by the Investigator in such a manner that the identity of the Human Subjects cannot readily be ascertained, directly or through identifiers linked to the Subjects;
b. Any disclosure of the Human Subjects’ responses outside the Research would not reasonably place the Subjects at risk of criminal or civil liability or be damaging to the Subjects’ financial standing, employability, educational advancement, or reputation; or
c. The information obtained is recorded by the Investigator in such a manner that the identity of the Human Subjects can readily be ascertained, directly or through identifiers linked to the Subjects, and an IRB conducts a limited IRB review to make the determination required by § 46.111(a)(7).
d. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the Subjects, and the Investigator has no reason to think the Subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the Subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
e. If the Research involves deceiving the Subjects regarding the nature or purposes of the Research, this exemption is not applicable unless the Subject authorizes the deception through a prospective agreement to participate in Research in circumstances in which the Subject is informed that the Subject will be unaware of or misled regarding the nature or purposes of the Research.
3. Secondary Research or storage or maintenance of Identifiable Private Information or Identifiable Biospecimens for potential Secondary Research use, subject to the Section on Consent for Secondary Research;
4. Research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. Research subject to this exemption must meet the following criteria:
a. Each federal department or agency conducting or supporting the Research and demonstration projects must establish, on a publicly accessible federal website or in such other manner as the department or agency head may determine, a list of the Research and demonstration projects that the federal department or agency conducts or supports under this provision; and
b. The Research or demonstration project must be published on this list prior to commencing the Research involving Human Subjects.
5. Taste and food quality evaluation and consumer acceptance studies:
a. If wholesome foods without additives are consumed; or
b. 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.
B. An IRB Application may be exempt from full review by the IRB if it does not use living Human Subjects or presents little or no risk of harm to Human Subjects if it meets one (1) or more of the following:
1. Social, economic, and educational research if the involvement of Human Subjects is limited to one (1) or more of the following categories:
a. The use of survey and interview procedures;
b. The observation of public behavior; or
c. The study of existing data, documents, records, or specimens.
2. Research undertaken without the intention of involving living Human Subjects;
3. Research in which the involvement of Human Subjects is limited to one (1) or more of the following categories:
a. Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators that provide instruction, such as:
i. Research on regular and special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods; or
ii. Research involving survey procedures, interview procedures, educational testing, or observation of public behavior unless:
1) The information obtained will be recorded in such a manner that the Human Subjects can be identified, either directly or through identifiers linked to the Human Subjects; and
2) The Human Subject’s responses, if they became known outside the research, could reasonably place the Human Subject at risk of criminal or civil liability or be damaging to the Human Subject’s financial standing, employability, or reputation (e.g., when the research deals with the Human Subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol);
b. Research involving survey procedures, interview procedures, educational testing, or observation of public behavior, and the Human Subjects are elected or appointed public officials or candidates for public office, or when federal statutes require without exception, maintenance of confidentiality of personally identifiable information, throughout the research and thereafter;
c. 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 will be recorded by the Investigator in such a manner that Human Subjects cannot be identified, directly or through identifiers linked to the Human Subjects.
C. If an Investigator believes that the project or activities the Investigator intends to conduct qualifies for an exemption, the Investigator must submit an IRB-EXEMPT Form to the IRB Co-Chairs or designee in writing, describing the project and explaining why the Investigator believes the proposed project or activities qualifies for exemption.
D. Upon receipt of an IRB-EXEMPT Form, the IRB Co-Chairs will appoint two (2) IRB members, which may include the IRB Co-Chairs to review the information provided and make the determination of whether or not the project or activities are exempt and submit the determination to the IRB Co-Chairs.
E. One (1) of the IRB Co-Chairs or designee send a written decision, physically or digitally signed by one (1) of the IRB Co-Chairs or designee, to the Investigator via email within ten (10) Business Days regarding whether the proposed Research is exempt.
1. If the Research is not exempt, the IRB Co-Chairs or designee will include in the written decision how to submit the appropriate forms to request a full review and will maintain a copy of the written decision.
2. If the Research is exempt, the IRB Co-Chairs or designee will maintain a copy of the written decision.
X. Research Qualifying for Expedited Review by the IRB
A. An IRB Application may qualify for expedited review if it involves no more than Minimal Risk and involve only procedures listed in one (1) or more of the following categories:
1. Clinical studies of drugs and medical devices, only when it meets the conditions described by DHHS;
2. Collections of blood samples by finger stick, heel stick, ear stick or venipuncture, under the conditions described by DHHS;
3. Prospective collection of Biospecimens for research by noninvasive means (e.g., hair and nail clippings, teeth, saliva);
4. Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving general anesthesia, sedation, x-rays, and microwaves (e.g., physical sensors applied to the body that do not involve significant amounts of energy, moderate exercise, muscular strength testing, body composition measures, etc.);
5. Research involving materials (data, documents, records or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis);
6. Collection of data from voice, video, digital or image recordings made for research purposes (see Section below on Audio and Video Recording);
7. Research on individual or group characteristics or behavior, such as Research of perception, cognition, motivation, identity, language, communication, cultural benefits or practices, and social behavior;
8. Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies;
9. Continuing review of Research previously approved by the convened IRB, where:
a. The Research is permanently closed to the enrollment of new Subjects, all Subjects have completed all Research-related interventions, and the Research remains active only for long-term follow-up of the Human Subjects;
b. No subjects have been enrolled and no additional risks have been identified; or
c. The remaining Research activities are limited to data analysis.
10. Continuing review of Research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through nine (9) above 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.
B. In addition, minor changes to a previously approved IRB Application may be acceptable for expedited review during the period for which approval is authorized.
C. If an Investigator believes that the project or activities the Investigator intends to conduct qualifies for expedited review, the Investigator must submit an IRB-EXPEDITED Form to the IRB Co-Chairs or designee in writing, describing the project and explaining why the Investigator believes the proposed project or activities qualifies for expedited review.
D. Upon receipt of an IRB-EXPEDITED Form, the IRB Co-Chairs will appoint two (2) IRB members, which may include the IRB Co-Chairs to review the information provided and determine whether or not the project or activities are eligible for expedited review and submit the determination to the IRB Co-Chairs.
E. The IRB members appointed to make this determination may require the Investigator to discuss the IRB Application before making a decision regarding whether expedited review is appropriate.
F. One (1) of the IRB Co-Chairs or designee will send a written decision, physically or digitally signed by one (1) of the IRB Co-Chairs or designee, to the Investigator via email within ten (10) Business Days regarding whether the proposed Research will receive expedited review.
1. If the Research is not eligible for expedited review, the IRB Co-Chairs or designee will include in the written decision how to submit the appropriate forms to request a full review and will maintain a copy of the written decision.
2. If the Research will receive expedited review, the IRB Co-Chairs or designee will notify the IRB that an IRB Application was approved for expedited review and will maintain a copy of the written decision.
G. A research activity may only be disapproved after a full review by the IRB.
XI. Research that Requires Full Review by the IRB
A. An IRB Application that is not subject to exemption or expedited review must undergo a full review by the IRB.
B. To approve the IRB Application, the IRB must determine that all of the following requirements are satisfied:
1. Risks to Human Subjects are minimized by:
a. Using procedures that are consistent with sound research design and which do not unnecessarily expose Human Subjects to risk; and
b. Using procedures already being performed on the Human Subjects for diagnostic or treatment purposes, whenever appropriate;
2. Risks to Human Subjects are reasonable in relation to anticipated benefits, if any, to Human Subjects, and the importance of the knowledge that may reasonably be expected to result;
3. Selection of Human Subjects is equitable, taking into account the purpose of the proposed Research and the setting in which the Research will be conducted;
4. Informed consent will be obtained from each prospective Human Subject or Representative and will be appropriately documented unless waived in accordance with the Informed Consent Section below;
5. Where appropriate, the IRB Application makes adequate provisions for monitoring the data collected to ensure the safety of the Human Subjects;
6. Where appropriate, the IRB Application makes adequate provisions to protect the privacy of the Human Subjects and to maintain the confidentiality of data;
7. Where some or all of the Human Subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, appropriate additional safeguards have been included in the IRB Application to protect the rights and welfare of such Human Subjects;
8. Research will be performed by scientifically or otherwise qualified persons with adequate supervision by professional personnel; and
9. The general procedures to be employed are legal and acceptable by both national and local standards of practice.
C. The Investigator must submit an IRB-FULL Form to the IRB Co-Chairs or designee, and the Investigator may submit supporting documents as well.
D. The IRB Co-Chairs or designee will assess the completeness and compliance of the application with these Procedures.
1. After this initial review, the IRB-FULL Form and/or IRB Application may be returned to the Investigator with a request for more details or suggestions for change.
2. Upon acceptance by the IRB Co-Chairs or designee, the IRB Co-Chairs or designee will send the IRB-FULL Form and IRB Application to the IRB member and will put it on the agenda for review at the next scheduled IRB meeting.
3. The IRB Co-Chairs or designee, in their sole discretion, may invite the Investigator to attend the IRB meeting to clarify the IRB Application and/or respond to questions by IRB members.
E. The IRB may only conduct a full review if a majority of the IRB members are present during the IRB meeting, including at least one (1) member whose primary concerns are in non-scientific areas.
F. During the review of an IRB Application, the IRB, in its discretion, may consult with outside sources of expertise beyond or in addition to that available on the IRB, including but not limited to legal counsel or members of the Institutional Review Boards of other institutions.
G. The outside sources may not vote on matters before the IRB.
H. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the Research (as distinguished from risks and benefits of therapies Subjects would receive even if not participating in the Research).
I. The IRB should not consider possible long-range effects of applying knowledge gained in the Research (e.g., the possible effects of the Research on public policy) as among those Research risks that fall within the purview of its responsibility.
J. In making the assessment of the whether the selection of Subjects is equitable, the IRB should take into account the purposes of the Research and the setting in which the Research will be conducted.
K. The IRB should be particularly cognizant of the special problems of Research that involves a category of Subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
L. For IRB Applications from third parties, the IRB may consider the value or benefits to the College to conduct Research involving College students, faculty, or staff in determining whether to approve the IRB Application.
M. The IRB will reach a consensus as to whether to approve, disapprove, or suggest modifications to an IRB Application.
N. If a consensus cannot be reached, the IRB members will conduct a vote and the decision will be made by a simple majority of the IRB members present at the IRB meeting.
O. The IRB will send a written decision to the Investigator regarding whether the IRB has approved or disapproved the IRB Application or will require modifications to secure IRB approval within twenty-five (25) Business Days of receipt of the IRB Application.
1. If IRB Review will take more than twenty-five (25) Business Days, the IRB Co-Chairs or designee will notify the Investigator in writing and provide an estimate for when a decision will be made.
2. If the IRB decides to disapprove an IRB Application, the written decision will include a statement of the reasons for its decision and give the Investigator an opportunity to respond in person or in writing.
3. If the IRB requires modifications, the written decision will include instructions on how to resubmit the IRB Application for reconsideration once modifications are made.
4. The IRB Co-Chairs or designee will maintain a copy of the written decision.
XII. Continuing Review
1. If the IRB approves an IRB Application, the IRB will conduct continuing review of the Research at intervals appropriate to the degree of risk, but not less than once per year, unless one (1) of the following circumstances applies:
a. The IRB Application was eligible for expedited review;
b. The IRB Application was exempt from full review;
c. The Research has progressed to the point that it involves only one or both of the following, which are part of the IRB–approved study:
i. Data analysis, including analysis of Identifiable Private Information or Identifiable Biospecimens, or
ii. Accessing follow-up clinical data from procedures that Human Subjects would undergo as part of clinical care.
2. The IRB will conduct continuing review of Research projects and activities that are conducted, supported or otherwise subject to regulation by any federal department or agency at least annually.
3. The IRB shall have authority to observe or have a third party observe the consent process and the Research.
XIII. Review of IRB Applications Approved by Other IRBs
A. An Investigator who seeks approval for Research projects or activities using Human Subjects who are College students, faculty, or staff or will be conducting Research on College premises that has been approved by an IRB outside of the College (“Outside IRB”) that also adheres to the regulations set forth in 45 C.F.R. § 46 must submit a College IRB-EXEMPT Form, other materials originally submitted to the Outside IRB to obtain approval, and the Outside IRB’s decision in writing to the IRB Co-Chairs or designee.
B. The IRB Co-Chairs or designee may determine if these materials are sufficient for the IRB to give its approval (secondary concurrence), or if more information (e.g., an IRB Application using the College IRB Application forms) is required, in which case the submission will be reviewed according to the procedures for IRB-EXEMPT review.
C. If the IRB Co-Chairs or designee approves the Research project or activities based on the materials submitted to the Outside IRB and the Outside IRB’s decision to approve the Research project or activities, the Investigator must keep the IRB Co-Chairs or designee apprised of all continuing reviews and addenda submitted to the Outside IRB.
D. The IRB Co-Chairs or designee may request further information from the Investigator to continue its approval at any time.
XIV. Human Subjects Data Collected the College’s Students for Classroom Assignments
A. Many class assignments using Human Subjects do not meet the definition of research in 45 C.F.R. § 46(d) and may not require IRB approval.
B. To minimize administrative burdens on faculty and students, the IRB does not require students to submit an IRB Application unless one (1) or more of the conditions are met:
1. Involves Human Subjects who are minors (individual under the age of 18) or within vulnerable populations, including but not limited to, prisoners, persons lacking the capacity to give informed consent, pregnant women, or other vulnerable populations as defined by 45 C.F.R. § 46;
2. Uses the data obtained for publication or presentation outside of the College, thesis research, dissemination to media outlets, or any other type of public dissemination;
3. Involves sensitive topics or confidential information that could place a Human Subject at risk if disclosed, including the following:
a. Any interview, survey, or questionnaire that proposes to investigate opinions, behaviors, and/or experiences regarding, but not limited to, any of the following sensitive topics:
i. Sexual orientation and gender identity;
ii. Incest, rape, sexual molestation, deviant sexual behaviors, or attitudes regarding sexual conduct (such as pedophilia, bestiality, etc.);
iii. Practices of contraception, abortion, and/or pregnancy;
iv. Substance use and/or abuse, including, but not limited to, alcohol, marijuana, steroids, amphetamines, narcotics, and any prescription medication legally or illegally obtained;
v. Mental health of the Human Subject or of others (such as, suicide, depression, or obsessive-compulsive behaviors, including, but not limited to, gambling, smoking, eating, etc.);
vi. Traumatic experiences of a Human Subject, including, but not limited to, war or combat experiences of veterans; or
vii. Any activity that could put the Human Subject or others at risk of criminal or civil liability.
4. Involves more than Minimal Risk;
5. Involves the use of any kind of Deception; or
6. Involves video recording or photography of Human Subjects.
C. Use of audio recording does not trigger the requirement for IRB review if the recording will be erased by the end of the semester; however, Maryland law requires that the Investigator obtain consent to record from the Human Subject in order to record audio of the Human Subject.
D. Faculty whose students are conducting Research that does not require IRB approval must accept primary responsibility for ensuring the rights and welfare of the Human Subjects.
E. If the faculty member will use data collected from the students in the class or data collected by students from other Human Subjects in the faculty member’s own research, the faculty member must submit an IRB Application to the IRB for approval.
XV. Informed Consent
A. General Requirements
1. Before involving a Human Subject in Research, an Investigator must obtain the legally effective informed consent of the Human Subject or Representative.
2. The Investigator must seek informed consent only under circumstances that provide the prospective Human Subject or Representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
3. The information that is given to the Human Subject or Representative shall be in language understandable to the Human Subject or Representative.
a. Research may involve children, persons with limited educational backgrounds, or persons for whom English is not their native language.
b. The language used in the consent form must be appropriate for the age, education and intellectual levels of the persons who are to be Human Subjects or their Representative, and in the native language of the Human Subject or Representative.
4. The Investigator or designee must provide the prospective Human Subject or Representative with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.
5. Except in accordance with the Broad Consent Section below, informed consent must:
a. Begin with a concise and focused presentation of the key information that is most likely to assist a prospective Human Subject or Representative in understanding the reasons why one might or might not want to participate in the Research (“Key Information”) and must be organized and presented in a way that facilitates comprehension; and
b. Present information as a whole in sufficient detail relating to the Research and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective Human Subject’s or Representative’s understanding of the reasons why one might or might not want to participate.
6. No informed consent may include any exculpatory language through which the Human Subject or Representative is made to waive or appear to waive any of the Human Subject’s legal rights, or releases or appears to release the Investigator, the sponsor, the College, or its agents from liability for negligence.
B. Except in accordance with the Broad Consent Section or Waiver or Alteration of Consent below, in seeking informed consent the following information shall be provided to each Human Subject or Representative:
1. A statement that the study involves Research, an explanation of the purposes of the Research and the expected duration of the Human Subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the Human Subject;
3. A description of any benefits to the Human Subject or to others that may reasonably be expected from the Research;
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the Human Subject;
5. A statement describing the extent, if any, to which confidentiality of records identifying the Human Subject will be maintained;
6. For Research involving more than Minimal Risk, an explanation as to whether any compensation and/or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
7. A statement of the person(s) to contact for answers to pertinent questions about the Research, the Human Subjects’ rights, and/or in the event of a Research-related injury to the Human Subject;
8. A statement that participation is voluntary and refusal to participate will involve no penalty or loss of benefits to which the Human Subject is otherwise entitled;
9. A statement that the Human Subject may discontinue participation at any time without penalty or loss of benefits to which the Human Subject is otherwise entitled; and
10. One of the following statements about any Research that involves the collection of Identifiable Private Information or Identifiable Biospecimens:
a. A statement that identifiers might be removed from the Identifiable Private Information or Identifiable Biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another Investigator for future research studies without additional informed consent from the Human Subject or Representative, if this might be a possibility; or
b. A statement that the Human Subject’s information or biospecimens collected as part of the Research, even if identifiers are removed, will not be used or distributed for future research studies.
11. When appropriate, one (1) or more of the following:
a. A statement that the particular treatment or procedure may involve risks to the Human Subject (or to the embryo or fetus, if the Human Subject is or may become pregnant) that are currently unforeseeable;
b. Anticipated circumstances under which the Human Subject’s participation may be terminated by the Investigator without regard to the Human Subject’s or Representative’s consent;
c. Any additional costs to the Human Subject that may result from participation in the Research;
d. The consequences of a Human Subject’s decision to withdraw from the Research and procedures for orderly termination of participation by the Human Subject;
e. A statement that significant new findings developed during the course of the Research that may relate to the Human Subject’s willingness to continue participation will be provided to the Human Subject;
f. The approximate number of Human Subjects involved in the study;
g. A statement that the Human Subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the Human Subject will or will not share in this commercial profit;
h. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to Human Subjects, and if so, under what conditions; and
i. For Research involving biospecimens, whether the Research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
C. Broad Consent
1. Broad consent may be obtained in lieu of informed consent only with respect to the storage, maintenance, and secondary research uses of Identifiable Private Information and Identifiable Biospecimens.
2. Broad consent for the storage, maintenance, and secondary research use of Identifiable Private Information or Identifiable Biospecimens (collected for either research studies other than the proposed research or nonresearch purposes) is permitted as an alternative to the informed consent requirements described in the Sections above.
3. If the Human Subject or Representative is asked to provide broad consent, the following shall be provided to each Human Subject or Representative:
a. A description of any reasonably foreseeable risks or discomforts to the Human Subject;
b. A description of any benefits to the Human Subject or to others that may reasonably be expected from the Research;
c. A statement describing the extent, if any, to which confidentiality of records identifying the Human Subject will be maintained;
d. A statement of the person(s) to contact for answers to pertinent questions about the Research, the Human Subjects’ rights, storage and use of the Human Subject’s Identifiable Private Information or Identifiable Biospecimens, and/or in the event of a research-related injury to the Human Subject or a research-related harm.
e. A general description of the types of research that may be conducted with the Identifiable Private Information or Identifiable Biospecimens, including sufficient information such that a reasonable person would expect that the broad consent would permit the types of research conducted;
f. A description of the Identifiable Private Information or Identifiable Biospecimens that might be used in research, whether sharing of Identifiable Private Information or Identifiable Biospecimens might occur, and the types of institutions or researchers that might conduct research with the Identifiable Private Information or Identifiable Biospecimens;
g. A description of the period of time that the Identifiable Private Information or Identifiable Biospecimens may be stored and maintained (which period of time could be indefinite), and a description of the period of time that the Identifiable Private Information or Identifiable Biospecimens may be used for research purposes (which period of time could be indefinite);
h. Unless the Human Subject or Representative will be provided details about specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the Human Subject’s Identifiable Private Information or Identifiable Biospecimens, including the purposes of the research, and that they might have chosen not to consent to some of those specific research studies;
i. Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the Human Subject in all circumstances, a statement that such results may not be disclosed to the Human Subject; and
j. When appropriate, one (1) or more of the following:
i. A statement that the Human Subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the Human Subject will or will not share in this commercial profit;
ii. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to Human Subjects, and if so, under what conditions; and
iii. For Research involving biospecimens, whether the Research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).
D. Waiver or Alteration of Consent
1. Waiver or Alteration of Consent in Research Involving Public Benefit and Service Programs Conducted by or Subject to the Approval of State or Local Officials
a. In order for an IRB to waive or alter consent, the IRB must find and document that:
i. The Research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
1) Public benefit or service programs;
2) Procedures for obtaining benefits or services under those programs;
3) Possible changes in or alternatives to those programs or procedures; or
4) Possible changes in methods or levels of payment for benefits or services under those programs; and
ii. The Research could not practicably be carried out without the waiver or alteration.
2. General Waiver or Alteration of Consent
a. In order for an IRB to waive or alter consent under this Section, the IRB must find and document that:
i. The Research involves no more than Minimal Risk to the Human Subjects;
ii. The Research could not practicably be carried out without the requested waiver or alteration;
iii. If the Research involves using Identifiable Private Information or Identifiable Biospecimens, the Research could not practicably be carried out without using such information or biospecimens in an identifiable format;
iv. The waiver or alteration will not adversely affect the rights and welfare of the Human Subjects; and
v. Whenever appropriate, the Human Subjects or Representatives will be provided with additional pertinent information after participation.
3. If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of Identifiable Private Information or Identifiable Biospecimens in accordance with the Broad Consent Section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the Identifiable Private Information or Identifiable Biospecimens.
4. If an IRB determines that the requirements to alter consent set forth above are satisfied, an IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed consent set forth above.
a. An IRB may not omit or alter any of the General Requirements set forth above.
b. If a broad consent procedure is used, an IRB may not omit or alter any of the elements required in the Broad Consent Section.
E. Screening, Recruiting, or Determining Eligibility
1. An IRB may approve an IRB Application in which an Investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective Human Subjects without the informed consent of the prospective Human Subject or Representative, if either of the following conditions are met:
a. The Investigator will obtain information through oral or written communication with the prospective Human Subject or Representative; or
b. The Investigator will obtain Identifiable Private Information or Identifiable Biospecimens by accessing records or stored Identifiable Biospecimens.
F. If the IRB approves a clinical trial conducted or supported by a Federal department or agency, the Investigator will post the informed consent form in accordance with 45 C.F.R. § 46.116.
G. The informed consent requirements in this Procedure is not intended to preempt any applicable Federal, state, or local laws that require additional information to be disclosed in order for informed consent to be legally effective.
H. Nothing in the Procedure is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or local law.
I. Documentation of Informed Consent
1. Unless the IRB waives the requirement to obtain a signed informed consent form in accordance with the Waiver Section above, informed consent must be documented using a written informed consent form (“Consent Form”) that meets the requirements set forth above, is approved by the IRB, and is signed, including in an electronic format, by the Human Subject or Representative.
2. The Investigator or designee must provide a written copy of the signed Consent Form to the person who signed the Consent Form.
3. The Investigator must either give the Human Subject or Representative an adequate opportunity to read the Consent Form before it is signed or may read to the Consent Form to the Human Subject or Representative.
4. Short Form
a. A short form written informed consent (“Short Form”) stating that the elements of informed consent required as set forth above have been presented orally to the Human Subject or Representative, and that the Key Information was presented first, before other information, if any, was provided.
b. The IRB must approve a written summary of the oral statement that will be made to the Human Subject or Representative.
c. When a Short Form is used, there must be a witness to the presentation of the oral statement.
d. The Human Subject or Representative must sign the Short Form.
e. The witness must sign the Short Form and a copy of the summary.
f. The Investigator or designee who obtained consent must sign the Short Form and a copy of the summary.
g. The Investigator or designee who obtained consent must provide a copy of the Short Form and the summary to the Human Subject or Representative.
J. In no case shall an Investigator propose, or the IRB approve, an informed consent procedure in which any possible or potential risk is knowingly or purposely minimized, misrepresented, or otherwise distorted.
K. The IRB Co-Chairs will retain all approved consent procedures.
L. The Investigator or designee will retain all signed consent forms.
M. Waiver of Requirement to Obtain a Signed Consent Form
1. The IRB may waive the requirement for the Investigator to obtain a signed Consent Form or Short Form for some or all Human Subjects if it finds any of the following:
a. That the only record linking the Human Subject and the Research would be the Consent Form and the principal risk would be potential harm resulting from a breach of confidentiality and each Human Subject or Representative will be asked whether the Human Subject wants documentation linking the Human Subject with the Research, and the Subject’s wishes will govern;
b. That the Research presents no more than Minimal Risk of harm to Human Subjects and involves no procedures for which written consent is normally required outside of the research context; or
c. If the Human Subjects or Representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the Research presents no more than Minimal Risk of harm to Human Subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
2. In cases in which the documentation requirement is waived, the IRB may require the Investigator to provide Human Subjects or Representatives with a written statement regarding the Research.
N. Consent for Secondary Research
1. Consent is not required for Secondary Research that uses Identifiable Private Information or Identifiable Biospecimens, if at least one of the following criteria is met:
a. The Identifiable Private Information or Identifiable Biospecimens are publicly available;
b. Information, which may include information about Biospecimens, is recorded by the Investigator in such a manner that the identity of the Human Subjects cannot readily be ascertained directly or through identifiers linked to the Subjects, the Investigator does not contact the Subjects, and the Investigator will not re-identify Subjects;
c. The Research involves only information collection and analysis involving the Investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
d. The Research is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities, if the Research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E–Government Act of 2002, 44 U.S.C. 3501 note, if all of the Identifiable Private Information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the Research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
2. Broad Consent is required for Secondary Research involving the use of Identifiable Private Information or Identifiable Biospecimens for secondary Research use, if the following criteria are met:
a. Broad consent for the storage, maintenance, and Secondary Research use of the Identifiable Private Information or Identifiable Biospecimens was obtained in accordance with § 46.116(a)(1) through (4), (a)(6), and (d);
b. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with § 46.117;
c. An IRB conducts a limited IRB review and makes the determination required by § 46.111(a)(7) and makes the determination that the Research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
d. The Investigator does not include returning individual Research results to Subjects as part of the study plan. This provision does not prevent an Investigator from abiding by any legal requirements to return individual Research results.
3. Broad Consent is required for storage or maintenance of Identifiable Private Information or Identifiable Biospecimens for potential Secondary Research use if an IRB conducts a limited IRB review and makes the determinations required by § 46.111(a)(8).
A. The Investigator and all employees, students, or others engaged in Research involving the use of Human Subjects will ensure that confidentiality is maintained with respect to the collection, storage, security, use, and destruction of all data involving Human Subjects.
B. The Investigator must include the measures that will be taken to protect confidentiality in the IRB Application, regardless of risks to Human Subjects involved or of consent procedures used.
C. The IRB will only grant exceptions to confidentiality of the data associated with individual Human Subjects if the disclosure is required by law or judicial authority or if the Human Subject gives prior written approval for disclosure.
D. General information, such as descriptions of consent procedures and outcomes of the review process and minutes of IRB meetings are public information and are not subject to confidentiality.
XVII. IRB Records
A. The IRB Co-Chairs or designee will take minutes of each IRB meeting and circulate them to all IRB members.
B. Minutes of IRB meetings will contain sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote of each IRB member (for, against, or abstain) on each action taken; the basis for requiring changes in or disapproving an IRB Application; and a written summary of the discussion of disputed issues and their resolution.
C. The College authorizes the IRB Co-Chairs or designee to provide written assurance, if required by a federal agency or department, that the College complies with the requirements under 45 C.F.R. § 46 or to register the IRB with DHHS, if appropriate, and renew registrations, if required.
1. If registration is required, the IRB Co-Chairs or designee must renew the registration every three (3) years.
2. If registration is required, the IRB Co-Chairs or designee must update the registration information within ninety (90) days after changes occur regarding the contact person who provided the IRB registration information or the IRB Co-Chairs.
D. The IRB Co-Chairs or designee shall prepare and retain documentation of its activities, including the following:
1. Copies of all IRB Applications reviewed, scientific evaluations, if any, that accompany the IRB Applications, approved sample consent forms, progress reports submitted by Investigators, and reports of injuries to any Human Subject;
2. IRB meeting minutes;
3. Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review;
4. Copies of all correspondence between the IRB and Investigators;
5. A list of the IRB members, including name, earned degrees, representative capacity, indications of experience, such as board certifications or licenses, sufficient to describe anticipated contributions to IRB deliberations, and any employment or other relationship with the College;
6. Statements of significant new findings regarding risk factors for Human Subjects that appear during the course of the Research;
7. Documentation specifying the responsibilities that the College and another organization operating an IRB each will undertake to ensure compliance with the requirements under the law and these Procedures; and
8. Written assurances, registrations, or renewals.
E. All IRB records will be retained for at least three (3) years after completion of the Research.
F. Records relating to the Research that is conducted will be retained by the Investigator for three (3) years after completion of the Research.
1. All IRB records are public information once the IRB has ascertained that no data pertaining to individual Human Subjects is present in those records.
G. IRB records will be made available for inspection and copying by authorized persons, including representatives of DHHS, at a reasonable time, place, and manner.
XVIII. Research Undertaken without the Intention of Involving Human Subjects
A. In the event that Research is undertaken without the intention of involving Human Subjects but it is later proposed to involve Human Subjects, the Investigator must submit an IRB Application to IRB prior to beginning to conduct the Research with Human Subjects.
B. The IRB will consider the IRB Application in accordance with this Procedure before involvement of Human Subjects occurs.
XIX. Proposed Changes to Research
A. If an Investigator proposes to make changes to IRB-approved Research, the Investigator must promptly report any proposed changes to the IRB and may not initiate changes without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the Human Subjects.
B. An Investigator who proposes changes to Research must submit a detailed written description of any substantive changes to the Research and any modifications that change the risk to the Human Subject(s) (“Revised Proposal”).
C. The Revised Proposal must refer specifically to appropriate sections of the IRB Application submitted with the original IRB form.
D. The IRB will review the Revised Proposal at the next scheduled IRB meeting or may hold a special meeting to review the Revised Proposal, in the discretion of the IRB Co-Chairs.
XX. Procedure for Reporting Unanticipated Problems Involving Risks
A. The Investigator must promptly report any unanticipated problems involving risks to Human Subjects or others or any serious or continuing noncompliance with the requirements or determinations of the IRB with respect to IRB-approved Research to the IRB Co-Chairs and the Provost/Vice President of Learning (“VPL”).
B. The IRB must promptly report any suspension or termination of approval, including a statement of the reasons for the IRB’s action, to the Investigator, the VPL, and any other College officials, in the discretion of the IRB Co-Chairs.
C. A Human Subject may also report concerns regarding noncompliance or risks to Human Subjects to the IRB Co-Chairs and the VPL.
D. The VPL, in consultation with the IRB Co-Chairs, will investigate any concerns regarding noncompliance or risks to Human Subjects and determine if any action should be taken, including up to termination of approval of the Research.
E. The VPL or the IRB Co-Chairs may consult with College counsel, as needed.
XXI. Additional Requirements for Certain Types of Research
A. Special Populations
The IRB will follow the guidelines for research involving prisoners, pregnant women, fetuses, placenta (after delivery), neonates, and children under the age of 18 under 45 C.F.R. § 46.
B. Longitudinal Research
The IRB may request that the Investigator for any Research that extends beyond one (1) year to obtain consent from Human Subjects or their Representatives on a yearly basis.
1. The IRB recognizes that it may be impossible to study some psychological processes without withholding information about the true object of the study or deliberately misleading the Human Subjects.
2. In rare circumstances, the use of Deception may be a material part of the Research.
3. If an Investigator would like to use Deception in the Research, the Investigator must specifically address the use of Deception in the IRB Application and must demonstrate to the satisfaction of the IRB that:
a. The potential benefits of the experiment exceed the risks to the Human Subjects of using Deception;
b. Alternative procedures avoiding Deception are not available; and
c. The Investigator has considered the way that withholding information or engaging in deliberate Deception will affect the Human Subjects.
4. The IRB must specifically approve the use of Deception prior to the start of any Research.
5. If Deception is approved to be used in the Research by the IRB, the consent form may be provided to the Human Subject or Representative during the Research or following the completion of the Research.
D. Observational Research
1. Studies based upon observation must respect the privacy and psychological well-being of the Human Subjects studied.
2. The IRB may require that the Human Subjects who will be observed give their consent to being observed and be made aware that they may be observed by strangers, unless the Research has been approved to use Deception as a material condition of the Research, in accordance with the Sections above.
3. The IRB may require assurance that the Investigator has taken into account local cultural values and the possibility of intruding upon the privacy of Human Subjects who, even while in a normally public space, may believe they are unobserved.
XXII. Audio and Video Recording
A. Under Maryland law, it is illegal to record audio of a person without their consent, and the Investigator must obtain written consent to take an audio recording of a Human Subject prior to taking an audio recording.
B. Audio and video recording of Human Subjects is a form of research that does not protect the anonymity of the Human Subject.
C. Certain precautions must be taken whether or not the Research is exempted from review as described in the Sections above.
D. Human Subjects must be informed that they will be recorded by audio or video for research purposes only.
E. The Investigator and/or department may not use any recordings for purposes other than those specified in the IRB Application.
F. The Investigator must store all recordings in a password-protected folder on a password-protected computer.
G. In some cases, the IRB may require encryption of the file as a further protection.
H. In some cases, the IRB may prohibit use of recording devices that are connected to the Internet (e.g., cell phones, laptops), and such recordings may not be stored on devices connected to the Internet until after the appropriate password-protection and encryption has taken place.
I. Only the Investigator and, where appropriate, the Investigator’s advisor(s) or supervisor(s) may listen to or view the recording.
J. All recordings must be destroyed or erased as soon as possible (e.g., upon transcription), but in no case later than the completion of the Research.
Procedure Title: Procedure on the Use of Human Subjects in Research
Policy Category: General
Policy Owner: Provost/Vice President of Learning
Policy Administrator: Associate Vice President for Continuous Improvement and Innovation Analytics
Contact Information: Dr. Shuang Liu; 410-777-1868; email@example.com
Approval Date: July 20, 2022
Effective Date: August 16, 2022
Applies to: All members of the College community
Related Policies: N/A
Related Procedures: N/A
Relevant Laws: 45 C.F.R. § 46 et. seq.