Procedures and Guidelines
The Institutional Review Board for the Protection of Human Participants
Murray State University
328 Wells Hall, Murray State University, Murray, KY 42071-3318
Retaining and Storing Signed Informed Consent Documents and Data
Requests for Student Information: The Buckley Amendment (FERPA)
Research Done on the Murray State Campus by non-Murray State Affiliated Personnel or Students
Obtaining Informed Assent from Children and Minors
SAMPLE Assent Document for Activities involving Children or Minors
SAMPLE Alternate Assent Document
SAMPLE Parental/Guardian Permission Document
Section 1: Preface
1.1 Statement of Ethical Principles
Murray State University is committed to excellence in teaching, research, and public service and to the conduct of these activities with the highest possible ethical standards. For activities involving humans, Murray State University is guided by the ethical principles as set forth in the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations will be followed for all applicable Department of Health and Human Services (DHHS) funded research and, except for the requirements for reporting information to DHHS, for all other activity without regard to source of funding.
The Murray State Institutional Review Board (IRB) reviews research protocol applications involving human subjects in order to ensure the rights of subjects are protected, including but not necessarily limited to ensuring that the research conforms to the Code of Federal Regulations.
Section 2: Murray State University Policy on Human Subjects
Safeguarding the rights and welfare of humans in activities is a general institutional policy, with oversight delegated by the President through the Provost to the Institutional Review Board (IRB). Any research involving humans (including pilot studies) which originates at Murray State or is conducted with the assistance of personnel at Murray State University -- whether the investigator is a faculty member, staff member, student, or administrator -- is subject to review and approval by the IRB. Before the IRB will review any protocol, the principal investigator, and if the PI is a student the faculty mentor, must submit certification of current training in the protection of human subjects in research. This training may be done through a web-based training module, through attendance at a training session or in other ways approved by the IRB. (Researchers should contact the IRB Coordinator for more information and for a current list of approved training modules.) To submit an activity to the IRB, the investigator must file a protocol, or a description of the procedure(s) to be used to gather information from human participants. The IRB must approve the protocol prior to the collection of any data or information from the participants. In order to approve proposed protocols, the IRB shall determine that all of the following requirements are satisfied:
Principles that assist the IRB in protecting the rights and welfare of humans include the following existing codes:
Section 3: Definitions
Assent: agreement by an individual not competent to give legally valid informed consent (e.g. a child or cognitively impaired person) to participate in research.
Children: persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. In Kentucky, the legal age is 18.
Faculty Mentor: for research conducted by students, the Murray State University faculty member who instructs the student investigator on appropriate research methodology, who ensures that the student investigator has the knowledge and skills necessary to complete the research, who commits to assisting the student investigator with development of the research protocol, and who accepts responsibility for the conduct of the activity, the supervision of participants, and the maintenance of informed consent documentation as required by the IRB. The faculty mentor must certify that the student(s) will conduct the study in an ethical manner that complies with all relevant Murray State policies and procedures.
IRB or Institutional Review Board: the IRB is an administrative body within Murray State University, established by appointment from the Provost of the University, to protect the rights and welfare of human participants in research who are recruited to participate in research activities conducted under the auspices of Murray State University.
IRB Approval: the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB, the institution, and federal requirements.
Human Research: any systematic investigation using humans, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)). All classroom activities that involve human subjects and that may be published, disseminated, or presented beyond the class must come before the IRB. The terms research and activity are used interchangeably in these guidelines.
Human Participants: living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 CFR 46.102(f)).
Informed Consent: a person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence (45 CFR 46.116; 21 CFR 50.20 and 50.25).
Minimal Risk: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Permission: the agreement of parent(s) or guardian(s) to the participation of their child or ward in research.
Principal Investigator: the lead researcher, suitably qualified by education, training and experience to direct a particular well-defined protocol; the person who takes direct responsibility for the design of and completion of a research project. The Principal Investigator (PI) is directly accountable for protecting the dignity, rights, safety and well being of the research subjects and for ensuring the collection of high quality, accurate data that is obtained in accordance with IRB approval and university procedures and guidelines. The PI may enlist the assistance of other qualified personnel to help with data collection but s/he is ultimately responsible for the conduct of the research project.
Prisoner: any individual involuntarily confined or detained in a penal institution.
Section 4: IRB Structure
The IRB consists of a minimum of five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. All appointments to the IRB shall be in accordance with 45 CFR 46.107 and same is incorporated here in as if copied word for word.
Section 5: Time Needed For Review
The full IRB meets monthly during the academic year. Meeting dates for each semester are available at the beginning of each semester from the Office of Sponsored Programs. IRB applications (new or updated) for the full board (Level 3 review) must be submitted for review by the published due date prior to the scheduled board meeting for consideration by the Full Board Review process. The IRB’s disposition of the application is forwarded to the applicant within 1 to 2 weeks of the IRB meeting. Any required revisions must be submitted and approved by the IRB. The initial review will determine whether revisions need to go to the full Board or whether they may be reviewed by a subcommittee.
New or continuing projects considered under the Level 1 or 2 categories will be considered as they are received. Level 1 and 2 projects generally require 1-2 weeks for review and notification from the date of receipt. Any required revisions must be submitted and approved and are generally acted upon within 1 to 2 weeks.
The IRB cannot and will not review protocols for projects that are already in progress or that have been completed.
Section 6: Types of IRB Review and Approval
It is the policy of Murray State University that the IRB will utilize Department of Health and Human Services (DHHS) criteria for all activities involving humans. According to DHHS, research can be categorized into three types of activities, and there are three types of review. The Murray State University IRB has affirmed the letter and spirit of the DHHS criteria by requiring that review of research from the DHHS Level 1 category be handled by the IRB Coordinator or the IRB Chair. For this level of review, the research must belong to one or more of the activities defined under Section 6.1 below. For activities to be considered for Level 2 review, the research must belong to one or more of the activities defined under Section 6.2 below or be a minor change to a previously approved protocol. Minor change is defined as a change that does not increase or alter the risks to the subject as determined during the initial approval process. An example would be a change to a data collection tool or the addition of a data collection process in which no additional procedures are required of the participant and the level of risk is not increased. Level 2 research is reviewed by a subcommittee of the IRB. Research that does not fall within the scope of the Level 1 or Level 2 categories must be reviewed by the full Board as a Level 3 study. The investigator is responsible for identifying the category s/he feels is appropriate. The IRB must concur with that selection. It is the researcher’s responsibility to contact the IRB Coordinator if help is needed in making this determination. Final determination of the correct category for a research activity will be made by the IRB.
6.1 Activities Considered under the Level 1 Category
Activities involving no more than minimal risk to participants and in which the only involvement of humans will be in one or more of the following categories will be reviewed by the IRB as Level 1 application. This category does not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization. In order to establish an individual activity as Level 1, the principal investigator must complete the Application for Approval of Investigations Involving Human Participants. Final determination of the correct category for a research activity will be made by the IRB.
The following six categories of activities are to be considered within the Level 1 review category process. The investigator must select one of the following activities that fits his/her research and submit an application for Level 1 approval to the IRB for review.
For research that is not funded by a federal agency, the following categories of Level 1 review are also available for studies with no greater than minimal risk activities:
Research where activity is limited to study of existing or prospective identifiable data:
6.2 Activities Considered under the Level 2 Category
Activities involving no more than minimal risk to participants and in which the only involvement of humans will be in one or more of the following categories, will be reviewed by the IRB as a Level 2 application. In order to establish an individual activity as Level 2, the principal investigator must complete the Application for Approval of Investigations Involving Human Participants. Final determination of the correct category for a research activity will be made by the IRB.
The following nine categories of activities are to be considered within the Level 2 review category process. The investigator must select one of the following activities that fits his/her research and submit an application for Level 2 approval to the IRB for review.
6.3 Activities Considered under the Level 3 Category
Any research or training project involving the use of humans which does not fall into the Level 1 or Level 2 Review categories must be submitted to the IRB for a Level 3,Full Board evaluation. For new activities, the principal investigator must complete and submit the Application for Approval of Investigations Involving Human Participants. For continuing activities, investigators should use the Project Update and Closure Form.
6.4 Continuing Activities
Level 1, 2, and 3 activities may only be approved for a maximum of a twelve-month period. Any such activities that continue beyond the approval period must be submitted to the IRB for continuing review. Federal regulations (45 CFR 46) require this review to occur on or before the approval end date of the previous IRB review. All activities that were submitted for IRB review, whether Level 1, 2 or 3, must be reported on at least annually to the IRB until the research is completed. The IRB may require that a protocol be reviewed more often than annually if, for example, it determines that the research involves more than minimal risk or if there is concern that initial results of the research may change the risk/benefit analysis (45 CFR 46.103(b)(4)(ii)). Each year (or more frequently if required by the IRB) for the duration of the project, a Project Update and Closure form must be submitted to and processed by the IRB no later than the anniversary of the latest approval date. The Project Update and Closure Form must be processed in sufficient time for review and approval to occur. If ongoing research is not approved for continuation by the end of the approval period, then all data collection and subject recruitment must immediately stop and the entire protocol will need to be submitted as a new application for review. Failure to submit the Project Update and Closure Form within the stated time frame will result in the closure of the study due to noncompliance and the Murray State IRB will no longer accept responsibility for oversight of the research. Refer to Section 8 for additional information on continuing review of projects.
6.5 Project Closure
When the research study has been completed, the Project Update and Closure form must be submitted to the IRB Coordinator. Failure to do so will result in the closure of the study due to noncompliance and the Murray State IRB will no longer accept responsibility for oversight of the research. The Project Update and Closure Form is due for review by the IRB by the closing date stated in the most recent approval letter.
6.6 Special Regulations
Special regulations apply to activities involving fetuses, pregnant women, human in vitro fertilization, prisoners, and children. Any activities involving these populations may have specific regulations governing their conduct. Investigators should refer to the specific federal regulations (45 CFR 46 Subparts B, C, D) or contact the Murray State IRB Coordinator.
6.7 Changes to Proposed Research
No changes may be made to an approved protocol without the prior approval of the IRB except when the change is necessary to eliminate immediate hazards to the participants (45 CFR 46.103(b)(4)(ii)). If changes are required, the researcher must submit an Application for an Amendment to a Previously Approved Protocol form to the IRB and the change must be approved at the appropriate level before it may be implemented. Minor changes to a previously approved Level 3 protocol may be reviewed by the IRB subcommittee. Minor change is defined as a change that does not increase or alter the risks to the subjects as determined during the initial approval process. An example would be a change to a data collection tool or the addition of a data collection process in which no additional procedures are required of the participant and the level of risk is not increased. In the case where change is necessary to eliminate immediate hazards to the participants, the researcher must notify the IRB immediately and submit the Application for an Amendment to a Previously Approved Protocol form within 3 calendar days of the change. The IRB will then review the change and make a decision on whether to allow the project to continue and whether further changes to the protocol are required to protect the rights and welfare of the subjects.
Section 7: Initial IRB Review Process
The signed protocol form must be submitted as a pdf document and all attachments must be submitted as editable Word documents to firstname.lastname@example.org.
Section 8: Procedure for Continuing Review of Projects
All research that has been approved by the IRB must be reviewed at least annually regardless of whether the research was classified as Level 1 or Level 2 or Level 3. NOTE: The IRB may require that a protocol be reviewed more often than annually if, for example, it determines that the research involves more than minimal risk or if there is concern that initial results of the research may change the risk/benefit analysis.
If the approved research activity or data analysis will continue beyond the end date as stated in the most recent approval letter, an application for continuing review of the project must be submitted to the IRB (using the Project Update and Closure Form) at least one week before the expiration date for Level 1 or Level 2 protocols or by the deadline for the next full Board meeting before the expiration date for Level 3 protocols. The principal investigator should complete this application. If the investigator is a student, the student’s faculty sponsor must approve the application. The application for continuing review should be filled out on the IRB website and then saved and printed. One signed paper copy of the form must be submitted to the IRB for inclusion in the file and one pdf copy of the signed form and one copy of the attachments as Word files must be submitted to the IRB via email for dispersal to the appropriate reviewers. A Word file copy of the latest approved consent form or cover letter, if required for the research, must also be submitted for updating.
The IRB disposition of the application for continuing review is forwarded to the applicant by the IRB Coordinator within two weeks following the IRB meeting. If the applicant is a student, communication will be sent only to the faculty mentor, who has the responsibility to transmit the IRB response to, and work with, the student. NOTE: If the research approval expires before the application for Project Update and Closure is processed, the principal investigator and/or the faculty sponsor must resubmit the entire protocol for the review and approval process. Adverse events must be reported to the IRB in writing immediately following any such occurrence; reporting of such events cannot be delayed until application for continuing review. Continuing review is handled in the same manner as the initial IRB review. Refer to Section 7 for more information.
Failure to complete the Project Update and Closure Form in the stated time frame will result in the closure of the study due to noncompliance and the Murray State IRB will no longer accept any responsibility for oversight of the research. All subject recruitment and data collection on the study must stop immediately and cannot resume until the principal investigator has completed and submitted to the IRB a new Application for Approval of Investigations Involving Human Participants and that application has been reviewed and approved.
The IRB may choose to conduct targeted audits of studies to insure that no material changes have occurred since previous IRB review (45 CFR 46.103(b)(4)(ii)). In such cases, the IRB Coordinator will notify the Principal Investigator (or the faculty mentor if the PI is a student), by official letter of the upcoming audit and request that necessary records be made available for review. A report of the audit findings will be presented to the IRB at the next full Board meeting or sooner if deemed appropriate by the IRB Coordinator should the audit indicate the need to take immediate actions to address any issues that could affect the subjects’ informed choice to participate in the research.
Section 9: Advertising for Human Participants
Advertising for prospective participants must receive prior approval of the IRB. Coercive statements or grossly liberal compensation must be avoided and risks and benefits must be mentioned.
Recruitment materials must include:
When appropriately worded, the following items should be included:
Recruitment materials for studies involving remuneration cannot include emphasis on compensation (e.g., bold type, larger font, etc.)
Once approved by the IRB, recruitment material cannot be altered or manipulated in any way without subsequent IRB approval.
Recruitment using social media ads that are size limited (e.g Facebook, Twitter, etc.) must be linked to a page or document that contains all required recruitment elements.
Section 10: Activities Involving Other Sites
Some research activities collect data from other sites or in collaboration with other organizations. In the instances when this occurs, the IRB must have a letter of approval from the cooperating institution(s). The approval letter must include the following items:
The IRB expects the permission letter to be included as part of the application. Research may not begin at a site until the investigator places a copy of the site permission letter on file with the IRB Coordinator.
Section 11: Internet Research
Safeguarding the rights and welfare of humans in activities is a general Institutional policy, with oversight delegated by the President through the Provost to the Institutional Review Board (IRB). Any research involving humans that originates at Murray State University -- whether the investigator is a faculty member, staff member, student, or administrator -- is subject to review and approval by the IRB. This restriction applies to all activities that include the collection of data for research purposes, even when this collection occurs via the Internet. To submit an activity to the IRB, the investigator must use the Application for Approval of Investigations Involving Human Participants to file a protocol containing a description of the procedure(s) to be used to gather information from human participants. The IRB must then approve the protocol prior to the collection of any data or information from the participants. In order to use the programs provided by the Center for Teaching, Learning and Technology (CTLT) office which facilitate survey research, an applicant must provide CTLT with an approval statement from the IRB. Compliance with University regulations is a matter of professional ethics.
The use of the Internet as a medium for research continues to increase. While it provides many advantages, it can also complicate the process of human subjects protection. Research using electronic communication cannot be promoted as anonymous, even if attempts are made to secure the transmission of data. In addition to interception of data, there exists the possibility of spyware that can track keystrokes on computers and/or electronic surveillance of employee computer use. Please contact the IRB to discuss how to best handle the process of informed consent for internet research. In most cases, written documentation of informed consent can be waived, but it should be recognized that no guarantees can be made regarding the tracking or interception of subject responses by third parties.
11.1 Required Statement for Internet Research
All consent statements for online survey research which involves sensitive information or for which disclosure of the participants’ responses could place them at any risk must include the following information:
All responses from online participants will be treated confidentially and stored on [state how stored (e.g., secure server, encrypted hard drive, encrypted file, unencrypted hard drive, etc.)]. However, we are unable to guarantee the security of the computer on which you choose to enter your responses. Information (or data) you enter, and websites you visit online can be tracked, captured, corrupted, lost, or otherwise misused.
Section 12: Conflict of Interest
As a part of the informed consent process, a researcher is ethically responsible for notifying the IRB and potential research subjects of any possible conflict of interest. Conflict of interest may occur where 1) the researcher has a personal economic interest in the outcome of the study, 2) the researcher acts as an officer or a director of any outside entity that has financial interests in the outcome of the research study or 3) the researcher is recruiting potential subjects from persons over whom the investigator holds significant influence or power (i.e., students within the researcher’s own classroom, employees in the researcher’s workplace where the researcher is in a position of administration, etc.)
Section 13: The Informed Consent Process
Every person (faculty, staff, student, or administrator) at Murray State University must obtain the informed consent of any participant. Obtaining the informed consent of participants is a matter of professional ethics in every discipline at the University. A sample consent document is included in these Procedures and Guidelines. The IRB strongly suggests that investigators use the sample as the structure for their consent forms.
The investigator must ensure that the circumstances under which consent is sought will provide the participants (or their representative) with sufficient opportunity to consider whether or not to participate. The circumstances must also minimize the possibility of coercion or undue influence that might be experienced by the participants. Many times the situation of the participants may be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, their age, associations with certain groups, or their mental or physical capacities. Restriction of freedom of choice may also occur due to confinement in a mental hospital or in a jail, penitentiary, or correctional institution. Participants in any of these categories are not excluded; rather, the investigator must make special efforts to ensure that potential participants are given every opportunity to exercise free choices in consenting to participate.
The consent document is not meant to be merely a legal record of the consent process, nor is it meant to be the only communication between the investigator and the prospective participant. On the contrary, the document should be one part of the total process. Broadly, the informed consent document communicates to the prospective participant:
If applicable, the alternative treatments available will be explained. The individual will also be given the opportunity to obtain further information and answers to questions related to the study. The consent form should serve as a written summary of the exact information that was presented to the prospective participants before their agreement to participate in the study. As such, it will provide a useful reference for both the subject and the investigator. Participants agreeing to the study sign the consent form. If the consent form is multiple pages, participants must initial each page. Participants must be given a copy of the consent form to keep. It is the responsibility of the researcher to ensure that informed consent documents are written with vocabulary and a reading level comprehensible to the researcher’s target population.
13.1 Waivers to Obtaining Written Informed Consent
Under certain circumstances, the use of written consent documents may be waived by the IRB. Requests for waiver must be fully justified by the investigator when submitting an application to the IRB. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects if it finds either:
Waiver of written consent procedures does not imply waiver of the investigator’s responsibility to obtain consent from the participant. In all cases, the investigator must provide the participant with a statement of the study that includes all relevant elements of informed consent. It is the recommendation of the Murray State IRB that, wherever practicable, when written documentation of consent is waived, a cover letter be submitted to participants which outlines the purpose and procedures of the project with a statement such as “completion of the survey and/or return of the questionnaire indicates consent to participate in the study.” A sample cover letter may be found at the end of this document.
13.2 Obtaining Oral Consent by Oral Presentation
If oral presentation is necessary due to limited literacy or language comprehension, the participant or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. It is the researcher’s responsibility to ensure that the language used in the short consent form and the oral presentation is comprehensible to the target population. A witness must also be present for this presentation and must sign both the short form and a written summary of the oral presentation as does the investigator. The participant or his/her legal representative must be furnished with a copy of both signed documents.
13.3 Alterations to the Informed Consent Process
13.4 Categories of Participants Receiving Informed Consent
Except as otherwise determined by the IRB, every participant who is a physically and mentally able adult must provide consent to participate in the activity prior to the start of that activity. The ideas of mental and physical normalcy revolve around the ability of the participant to provide truly informed and voluntary consent. Variations from this norm may be a function of age or the circumstances of the participant.
Obtaining permission to conduct research involving children -- that is, persons under 18 years old -- requires special attention to the child’s age, his/her ability to understand what is asked of him/her, and his/her relationship to parents or guardians. In all cases, the investigator must demonstrate respect for the rights of the subject within the proposed consent procedures, which should be developmentally appropriate to the age and circumstances of the subject. Unless waived by the IRB, if the participant is a minor then written parental/guardian permission must first be obtained. A sample parental/guardian permission form is found in the Tips for Informed Consent Section. For children with parental permission, an assent form must be signed by those child participants capable of reading and understanding a simplified version of the permission form signed by the parent or guardian. The child's assent form must be separate from the parental permission form. As part of the IRB protocol application, the researcher must submit a copy of both the intended assent form and the parental permission form. For those participants who are too young to read an assent form, but who would be capable of understanding an oral explanation of the procedures, a copy of the oral explanation to be given must accompany the request for IRB approval, and be signed by the individual responsible for the oral explanation. The age, maturity, and psychological state of the participants must be taken into account by the principal investigator when creating an assent form or an oral presentation to obtain oral assent from such participants. Investigators should carefully review 45 CFR 46.408 for additional specific requirements for permission by parents or guardians and for assent by children. View sample assent forms.
Parental Permission: Parental (or legal guardian) permission in writing is required for all minors, under the age of 18, who participate in research activity.
Adolescent’s Written Assent: A child’s written assent is needed (in addition to parental permission) when the child is considered old enough to read and comprehend a well-constructed assent form. However, the investigator should use supplementary verbal explanations wherever needed.
Child’s Assent: For children who can read but may not comprehend an assent form, the investigator should provide an explanation in a form the child can understand (in addition to parental permission). A conversational question-and-answer setting is often necessary to achieve this goal. In addition, the child’s assent should be positive, that is, not merely lacking in dissent. If the child is old enough to render a signature, investigators are required to obtain a signed assent form.
Very Young Children: For children who cannot read (e.g., infants, toddlers, or preschoolers) the investigator should give explanations that match the level of understanding. In many instances, the children’s nonresistant behavior may be interpreted as assent, but the investigator must use special care to discontinue the participation of children who appear to experience undue stress from the activities procedures. A verbal script must be submitted as part of the protocol.
Wards of the State: Children who are wards of the state may participate in activities only under very limited circumstances with the appointment of an advocate for the child for the duration of the activity.
13.4.2 Vulnerable and Special Populations
Besides children, numerous other types of subjects require special attention when obtaining informed consent. In all cases, the guiding principle is respect for the rights of the potential participant. The Belmont Report contains an important section on the application of its standards to informed consent. Every investigator should carefully examine this material.
Among the types of participants for which the investigator should have special concern in obtaining informed consent are the following:
Obtaining the informed consent of prisoners to participate in an activity requires attention to their circumstances. The activity should not provide the prisoners with advantages that would outweigh their ability to weigh the risks involved in the activity. Moreover, the consent form should make it clear to prisoners that participation will have no effect upon their parole or treatment. Investigators proposing research that involves prisoners should allow additional time for the review process in order that a prisoner representative can be included in the IRB review (as required by 45 CFR 46.304).
220.127.116.11 Cognitively Disabled
The use of patient advocates appointed or approved by the IRB is necessary to guard patient interests. For research involving adults who have been determined to have or are suspected of having a limited capacity to provide informed consent (which may include, but is not limited to, the elderly), a process for determining the competency of the research subject will be required. For research that meets the IRB standards for Level 1 or 2 review, the IRB may allow competency to be determined by the researcher through a series of question and answer discussions with the potential research participant. However, for research that requires Level 3 review or for Level 1 or 2 research that the IRB determines involves a population in which competency to consent is of particular concern (e.g., including but not limited to nursing home residents, Alzheimer’s patients, elderly patients in a Veterans Administration hospital), and/or the nature of the study is believed to be such as to indicate that an independent investigation of competency is warranted, a qualified third party, such as a speech pathologist, physician or psychologist who is not a member of the research team, may be required to determine competency for informed consent.
It is the responsibility of the researcher to determine if a potential participant has been declared legally incompetent. If this has been done, permission to enroll the potential participant in a research study must be sought from the legal guardian.
In cases where a potential participant has not been declared legally incompetent but said person displays signs of incompetency, consent/assent must be obtained from that person (unless comatose or otherwise totally mentally incapacitated) and must also be obtained from the person(s) who normally make decisions concerning the care and well-being of the potential participant, such as next of kin, health care surrogate, if applicable, or person with Power of Attorney for such decisions. If after obtaining what was believed by the researcher at the time to be informed consent from the participant, information gleaned during the course of the research indicates an issue as to the individual’s mental capacity such that informed consent is not obtainable from the participant, the researcher must obtain consent from the person(s) who normally make decisions concerning the care and well-being of the potential participant, such as next of kin, health care surrogate, if applicable, or person with Power of Attorney for such decisions.
If the potential participant refuses his/her consent/assent, it is ethically unacceptable to enroll this person in a research study regardless of the consent of a care-giver, health care surrogate or person with Power of Attorney.
In any case wherein informed consent has been obtained from one other than the potential participant, a copy of the document indicating legal guardianship, Power of Attorney, health care surrogate, or other such documentation granting authority to the individual providing consent to make such decisions for the participant shall be retained by the researcher and placed in the research file.\
18.104.22.168 Fetuses, pregnant women, and human in vitro fertilization
Regulations require additional safeguards for the conduct of activities involving fetuses, pregnant women, and human in vitro fertilization. Among the recommendations are systems for monitoring the acquisition of informed consent as well as other aspects of the activity.
Universities, and the association of investigators with them, provide investigators with a ready pool of research subjects: students. To protect students against coercion when research is conducted in the classroom setting, the Murray State IRB has determined that there must be a defined break between when the class period finishes and when the research begins. During the class time, the researcher and/or faculty member may announce that the study will take place, give potential subjects information about the study, including purpose and time commitment, and answer any questions that the potential participants might have. However, the research itself can only be conducted at the end of the class period. At the end of the class period, students must be given a short break (for example, 2-5 minutes) to allow uninterested persons time to leave. At the designated time, the researcher may return to the classroom to administer the study to those students who have voluntarily chosen to return/remain and to participate. (Please note: Faculty members may not specifically recruit members of their own classes to participate in their research projects unless special measures are taken to avoid coercion. Someone other than the faculty member must obtain the informed consent of the students if the faculty member intends to use his/her own students as research subjects and/or the identity of those who choose not to participate must be protected until such time as the teacher/student class relationship has been completed. The person who will invite the students to participate in the study must have certification of training in the protection of human subjects in research on file in the IRB office and must be identified on the protocol approval form. In all cases, the IRB will work with the researcher(s) to design a recruitment and informed consent process that provides adequate protection for participants in human subjects in research.)
13.4.3 Other Groups
Other groups, such as the elderly, the economically disadvantaged, the very sick, and the institutionalized are described as vulnerable populations by the Belmont Report and are therefore provided similar protection when used as participants. (See Section 13.4.2 above.)
13.5 Notable Risk Projects
When an activity involves greater than minimal risk, the participant needs a reasonable enumeration of the risks in order to decide whether or not to participate. The list should not be constructed either to minimize real risks or to overstate them. Projects with risks should also list protection measures used to lower the risk potential or to ensure safety while the subject encounters the risks. If a project presents one or more risks, an injury clause needs to be included in the consent document.
Although the regulations specifically mention only the preceding special categories of participants, the overall intent is clear. Whenever the potential participants of research have special features or circumstances that might alter their ability to render informed and voluntary consent to participate in activities, the investigator has special responsibilities. There is no way to anticipate every situation. Therefore, investigators must use extreme care to respect the rights of potential participants in developing the means of obtaining their informed consent. The IRB may choose to conduct targeted audits of studies to insure that no material changes have occurred since previous IRB review (45 CFR 46.103(b)(4)(ii)). In such cases, the IRB Coordinator will notify the researcher (or the faculty mentor if the researcher is a student) by official letter of the upcoming audit and request that necessary records be made available for review. A report of the audit findings will be presented to the IRB at the next full Board meeting or sooner if deemed appropriate by the IRB Coordinator should the audit indicate the need to take immediate actions to address any issues that could affect the subjects’ informed choice to participate in the research
Voice recordings are considered identifiable information; therefore, an investigator cannot promise anonymity to subjects participating in a project where they will be audiotaped. In addition to any signed consent documents, it is also recommended that the audiotape record both verbal permission of the participant and information advising the participant that his/her identity will be associated with the information he/she provides. Oral history and ethnography provide good examples of interview methods holding generally minimal risk but which also may make use of audiotapes that will not be erased at the conclusion of the immediate activity.
13.7 Anonymous Questionnaires
Many types of survey research use anonymous questionnaires returned by mail or placed in drop-box locations. A participant is anonymous only if his/her identity remains individually unknown to the investigator. Where the identity is known but held secure from being known by others, the investigator is said to be maintaining the confidentiality of the identity. With anonymous questionnaires, the investigator may fulfill the requirements of informed consent by providing the participant with a cover letter or set of instructions that includes the following items, as applicable:
13.8 Focus Groups
Research using focus groups may fall into any of the three levels of review conducted by the IRB (i.e., Level 1, Level 2, Level 3). In all cases, it must be clear that each member of the focus group has been given adequate information on the project in order to make an informed decision on his/her choice to be part of the discussion. Because the very nature of the group setting does not allow for anonymity of responses in the focus group, if the topic to be discussed is sensitive or can in any way cause harm to the participants (including, but not limited to emotional harm or loss of reputation or standing in the community), it may be necessary to ask each participant to sign a certificate of confidentiality. If the meeting is to be audiotaped or videotaped, the guidelines under Section 13.6 must be followed.
Section 14: Retaining and Storing Signed Informed Consent Documents and Data
Signed informed consent forms are legal documents, and the researcher has legal responsibilities in handling them. They should be stored in a secure location at Murray State University that is accessible to the University in the event that an inquiry should require an examination of them. The specific location (including room and building) of the documents must be explained in the IRB application. Data that can be linked to a subject should be treated in the same manner as a signed informed consent form. Access to these documents should be limited to those persons who have a need to know their contents, ordinarily the investigator (and co-investigators), a representative of the IRB (usually the Chair), the IRB Coordinator on behalf of the University, and authorized federal officials. In compliance with federal regulations consent documents must be retained for a period of three (3) years following the completion of the research. It is required that any parental permission and assent forms from minors are retained until one (1) year after the minor reaches legal age.
Consent documents become part of the IRB file of a project and, as such, are subject to Federal audit. Therefore, the IRB will review carefully both the content of and the storage provisions for all consent forms.
Data collected from subjects that cannot be linked to a subject do not require the same secured handling as those documents that contain identifying information or which could be linked to a particular individual. This type of data is not required to be stored in a locked location within Murray State University, but the data shall be available for review and certification at any time during the period that the identifying information is held.
An investigator who leaves the University prior to the end of the three-year retention period for consent forms should notify the IRB of this fact, specifying the new location of the consent documents. If consent documents are maintained by a graduate student or research assistant during data collection, they must be turned over to the responsible faculty member after data collection is completed. A change of location within the University that results in a new storage place for consent forms must also be reported to the IRB.
Section 15: Deceptive Research
Research activities that do not fully disclose the purpose of the research to the subjects are those that are said to be deceptive. Any deceptive research should be carefully weighed in terms of the justification for the need to deceive the subject and alternative methods for conducting the research that do not involve deception. The IRB will decide if the information being withheld from the subjects is an important element in the subject’s decision to participate. If the IRB decides that the information being withheld is an important element, then the research will not be approved. At a minimum, subjects must be informed in a consent form that full information is not being disclosed to them. Any research involving deception must involve a full debriefing.
Section 16: Requests for Student Information: The Buckley Amendment(FERPA)
The Family Educational Rights and Privacy Act (FERPA) more commonly known as the Buckley Amendment, deals with primary rights of students. Basically, these rights are 1) the students’ right to inspect and review educational records, 2) their right to seek to amend educational records and 3) their right to have some control of the disclosure of information from educational records. The FERPA officer on the Murray State campus must review any research using Murray State University student information before that research is submitted to the IRB for approval. A statement from the FERPA officer outlining precisely which information the researcher may obtain from the student records and how this information may be obtained must be submitted with the protocol for review by the IRB.
Section 17: Research Performed on the Murray State Campus by non-Murray State Affiliated Personnel or Students
The Murray State IRB has no control over research that is accomplished by off-campus (not affiliated with Murray State) researchers through direct collection of data from Murray State personnel or students. However, if a non-Murray State researcher involves any Murray State personnel or students in the contacting of potential participants, gathering of data, or dissemination of forms, then the research must come before the Murray State IRB for approval. The IRB cautions subjects who choose to participate in research conducted by non-Murray State affiliated researchers to be sure that the research meets all of the requirements of informed consent so that they can be certain that their rights as a research subject are protected.
Section 18: Adverse Event
Federal Policy requires IRBs to have and follow written procedures for “prompt reporting to the IRB of any unanticipated problems involving risks to human subjects or others” (45 CFR 46.103 (b) (5)). Investigators carry the responsibility for timely reporting of adverse events to the IRB to ensure that the IRB is cognizant of any new information that might affect its assessment of the benefit-to-risk ratio of research study participation and/or the adequacy of research protocol provisions for protecting the welfare of research subjects. To report an adverse event, the IRB investigator must complete the Adverse Event Form and submit it to the IRB Administrator as a signed pdf document, within three (3) calendar days of identifying the adverse event. The IRB Administrator will immediately share the information with the IRB Chair for review and consideration of next steps. A copy of the Adverse Event Form will be sent to the department head or office director of the investigator, to the Murray State Provost, and to the University General Counsel.
Section 19: Problems Reported to the IRB
In the course of protecting human subjects involved in research, the IRB will respond to any problem or complaints raised directly or by third party reporting, to any member of the Board. When notified of a problem or complaint, the IRB Chair and IRB Coordinator will review the issue and determine appropriate action. If warranted, the Murray State General Counsel may be involved in the investigation and the research may be suspended. Targeted audits of the research may be undertaken if deemed appropriate by the IRB Chair and/or the majority of the IRB.
Section 20: Misconduct in Human Participants Research
It is the ethical responsibility of all Murray State University personnel to obtain the approval of the IRB when undertaking any research which involves the use of human participants. Any desired changes to the protocol approved by the IRB shall be resubmitted to the IRB for approval. Moreover, it is unethical and a violation of the IRB’s policies and guidelines to deviate from the protocol as approved by the IRB in conducting research or to misrepresent information or omit any material information regarding a protocol. In the event that the IRB policies and guidelines are not adhered to and the research is completed, the following procedure has been approved by the Provost:
20.1 Thesis Research
20.2 Faculty, Staff, and/or Student Research – Failure to Obtain IRB Approval
20.3 Faculty, Staff, and/or Student Research – Deviation from Approved Protocol
Section 21: Reporting Requirement
The IRB Coordinator shall promptly report to the IRB, the Provost and the University General Counsel any unanticipated problems involving risks to subjects or others, any serious or continuing non-compliance, and any suspension or termination of IRB approval. As required by the federal regulations (45 CFR 46.103(b)(5)), the Office for Human Research Protections (OHRP) will be notified of such issues involving research studies that are funded by any agency of the Department of Health and Human Services as required in OHRP's Guidance on Reporting Incidents to OHRP and Guidance on Reviewing and Reporting Unanticipated Problems. Other funding agencies will be notified as required in their guidance documents. If the report is the result of serious or continuing non-compliance, the IRB reserves the right to treat such as a basis to pursue an inquiry under Murray State University’s Policies and Procedures to Deal with Misconduct in Research as outlined in section 20.3.2 above.
Section 22: Examples
22.1 SAMPLE Cover Letter