Office of Research

The mission of Dysphagia Management Services LLC is to improve the comfort, care and quality of life in America’s aging population. The mission of the Office of Research is to support the clinical research endeavors of the Dysphagia Management Services LLC qualified research team. Lead by the Director of Clinical Education, Training & Research, Jeanna Winchester PhD, and her research team, the Office of Research works foster an environment for research and activity that facilitates the discovery and dissemination of knowledge.

The Office of Research provides administrative support for Dysphagia Management Systems LLC’s research programs. The Office of Research is the office of record for extramural proposals and awards supporting research, education and public service activities of Dysphagia Management Systems LLC and research team. Our staff members are expert resources for policy and program information and act as administrative contacts with external regulatory agencies, higher education organizations and professional societies, and other appropriate entities to discuss regulatory changes, institutional policy developments and overall awareness of regulatory requirements and enhancements. The Office of Research provides coordination and support in the development of research grant proposals to federal and state government agencies and corporate and foundation entities.

 

For information on the use of human subjects in research at Dysphagia Management Systems LLC, please contact Research@DysphagiaMgmtsys.com for information, an application and application instructions for new human research protocols for Internal Review Board (IRB) review.

 

Dysphagia Management Services LLC is looking to expand its membership to our IRB. We are looking for community members who are interested in contributing directly to the facilitation of human subjects clinical research at Dysphagia Management Systems LLC. We are looking for members who enjoy reading, learning about new topics and have good analytical or problem solving skills. We are seeking community members who are not affiliated with Dysphagia Management Systems LLC. Employees and their immediate family members are (spouse, domestic partner or dependent children) are considered affiliated. For more information, please email Research@DysphagiaMgmtSys.com.

 

An IRB is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subjects research be conducted in accordance with all federal, institutional and ethical guidelines. This committee meets regularly on the schedule shown below.

2016

January 8^th, February 19^th, March 11^th, April 29^th, May 20^th, June 17^th, July 8^th, August 5^th, September 2^nd, October 21^st, November 18^th, December 9^th

 

2017

January 6^th, February 10^th, March 17^th, April 28^th, May 26^th, June 23^rd, July 14^th, August 18^th, September 15^nd, October 13^st, November 10^th, December 8^th

 

Human Research FAQ:

1. All human subjects research, and all other activities, which in part involve human subject research, regardless of sponsorship, must be reviewed and approved by the Dysphagia Management Services LLC IRB. This includes all interventions and interactions with human subjects for research, including advertising, recruiting and/or screening of potential subjects. Additionally, use of state death data records must be reviewed and approved by the Dysphagia Management Systems LLC IRB prior to initiation.
2. Human subjects research is any research or clinical investigation that involves human subjects.
   1. Human Subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; (2) identifiable private information.
      1. Intervention includes both physical procedures by which data are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes
      2. Interaction includes communication or interpersonal contact between investigator and subject.
   2. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects).
   3. FDA regulations define a clinical investigation as any experiment that involves a test article and one or more human subjects and that either is: (1) subject to requirements for submission to the FDA; (2) not subject to requirements for prior submission to the FDA under appropriate sections of the Federal Food, Drug and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
3. Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable. When considering whether an activity meets the definition of human subjects research per DHHS regulations, one must consider the federal definitions of research and human subject:
   1. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
      1. A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. Examples include: surveys, questionnaires, interviews, focus groups, analyses of existing data or biological specimens, epidemiological studies, evaluations of social or educational programs, cognitive and perceptual experiments, medical chart review studies, etc.
      2. Investigations designed toe develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g. publications or presentations). However, research results do not have to be published or presented to quality the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that is never published is still considered research. Participants in research studies deserve protection whether or not the research is published.
4. Review of existing data is a research activity requiring IRB review. To be considered existing data, the data must be “on the shelf” at the time the research is proposed. The research activity may be determined to be exempt (still subject to expedited IRB review by Dysphagia Management System LLC’s Office of Research). Some existing data studies that utilize a source that is publically available, as recognized by the IRB, are excluding from the definition of research and do not require any IRB review.
5. Studies involving vulnerable populations, as determined by the federal regulations to be children, prisoners, fetuses, neonates, pregnant women, and the decisionally impaired, require special protections for their research participation and voluntariness. The IRB will review additional factors as set out in the federal regulations and make additional findings in order for research to proceed with particular vulnerable populations.
6. Federal regulations divide human subjects research into three categories according to the level of risk posed to subjects. For all projects involving human subjects, researchers must submit an application for IRB review. The categories of review are as follows:
   1. Exempt: To qualify for this category, the research must fall into one of six exemption categories as defined by 45 CFR 46 (http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html).
   2. Expedited review: To qualify for this category, research must fall into one of the nine federal defined categories of research that may be reviewed through an expedited review process. (http://www.hhs.gov/ohrp/policy/exprev.html) These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risks to subjects. Some examples qualifying for expedited review are (but are not limited to): (1) Studies involving collection of hair, saliva, or dental plaque samples; (2) Studies of blood samples from healthy volunteers; (3) Analysis of voice recordings; (4) Studies of existing pathological specimens with personal identifiers
      1. This type of review process involves a subset of the full committee membership, delegated this authority by the Chair, to independently evaluate the protocol, and when all reviewers concur, the protocol is approval. At Dysphagia Management Systems LLC, expedited review is performed by two IRB Committee members, and the Chair. Note: Reviews via the expedited process usually take approximately three weeks.
   3. Full Committee Review: this category of review is reserved for research proposals that involve greater than minimal risk or a particular vulnerable population as defined in the regulations. Examples include (but are not limited to): (1) Invasive physiological or medical research; (2) Research where there is a risk that confidentiality could be violated and if breached could result in potential criminal or civil liability or damage to a subject’s financial standing, employability, or reputation; (3) Research involving prisoners. Full committee meetings are held at regular intervals (see above calendar for dates) at a time and location that is subject to change from meeting to meeting. Information regarding the time and place of meetings may be obtained by contacting Research@DysphagiaMgmtSys.com.
7. Protocols the require review at a convened full committee meeting must be received by Dysphagia Management System LLC’s Office of Research by no later than 5:00pmEST on the deadline day. Principal Investigators and staff may attend the full committee meeting if requested by the primary reviewer for a protocol, and may provide information to the members; however, they may not be present during the final discussion and vote. IRB members may not participate in the review and approval process of their own protocols.
8. Full committee review process takes approximately six weeks.
9. HIPAA and the Privacy Rule: the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) took effect April 14, 2003. HIPAA regulates the protection of private health information for individuals. The law’s Privacy Rule provides standards for the use and disclosure of all individually identifiable health information obtained from a covered entity. Health Information that contains any of the 18 identifiers defined by HIPAA are considered to be protected health information (“PHI”) subject to HIPAA regulations. To access this information, all researchers must obtain either an individual’s written authorization to access their protected health information, or obtain an approval of a waiver of authorization from an IRB/HSC or Privacy Board.
10. When the IRB review process is complete, investigators will receive written notification of the Committee’s action. Please read all correspondence carefully because it may request additional information or describe conditions associated with the Committee’s action. The approval period for a protocol can be for no longer than 12 months (365 days) from the date of the review, but may be less than 12 months, depending on the perceived risks to the research subjects.
11. An adverse event is a serious, undesirable, and unintended result involving risks to research participants or others. Adverse events must be promptly reported in writing to the IRB Chair, and a form is provided on this webpage. The Investigator must provide a description of the adverse event and state whether or not changes are needed in the protocol and the informed consent process. These revisions must be reviewed by the full committee. If the events are determined to place participants at increased risks, the Chair may request resubmission of the protocol for full committee review. If the committee determines that the research participant may be placed at an immediate risk, the Committee has the authority to suspend or terminate approval of a protocol, requiring the immediate cessation of data collection from research participants. The Investigator will be notified of the Committee action, and the Chair shall contact the appropriate officials, sponsors, and/or OHRP or FDA as required.
12. Amendments or Changes to the Protocol: When an Investigator desires to amend or change a protocol, he or she should contact the Office of Research prior to implementation of any amendments or changes for review and approval. A protocol change may affect the risks involved with a study, in addition to adverse events, unanticipated problems, or complaints about the research – all of which should be reported to the IRB. A written description of proposed changes to the protocol, informed consent process and/or research instruments must be submitted to the IRB for review and approval.
    1. Minor changes proposed to previously approved protocols (i.e. number of participants) must be reviewed by the IRB Chair. All other proposed modifications (major changes) will be reviewed using the same process used for the review of the original protocol. Only when it is necessary to eliminate apparent immediate hazards to research participants, may, according to the federal regulations, an Investigator be permitted to modify an approved protocol without the prior review and approval of the IRB; however, the IRB must be promptly informed of the change upon implementation.
13. Continuing Review (Renewals): All protocols approved by the IRB are subject to continuing review at intervals appropriate to the degree of risk, but not less than once in the 12 months following approval. At Dysphagia Management Systems LLC, this is called the Renewal  If the Principal Investigator does not receive a form for request for continuing review (renewal) within one month prior to the expiration date of the current Dysphagia Management System LLC’s Office of Research/IRB approval, a request for the form should be made by contacting the Office of Research at Research@DysphagiaMgmtSys.com.
    1. If the IRB approval of a protocol expires before it has been re-reviewed, the protocol shall be suspended. While in a suspended status, new subject recruitment must cease, and interventions under the research protocol must be halted. The only exception to this requirement is when there are concerns for the safety or well-being of the research subjects. In such a case, the Investigator must contact the Office of Research, promptly. The suspension will be removed when and if the protocol is re-approved by the IRB.
14. The Office of Research/IRB, as a courtesy, sends out a written reminder to the Principal Investigator that the approval date is approaching expiration, and a renewal form is attached to the notice. However, it is the responsibility of the Principal Investigator to apply for renewal prior to the expiration date of the IRB approval. If the protocol has not been re-approved, then the approval expires and data collection must cease. The Principal Investigator will receive a written notification of the IRB’s review and decision for continuing a research protocol when the review process is complete. If the protocol has been re- approved, the notice will be labeled as “Re-Approval”.
15. Closing a Study at Dysphagia Management Systems LLC: If an Investigator desires to close or terminate a study on or before the approval expiration date, he/she must submit a Study Closure Report Form to be received by the IRB staff.
16. The following techniques are recommended for assuring confidentiality on a continuum according to the degree of prospective harm that may occur:
    1. Substitute codes for personal identifies and store the key in a different physical location;
    2. Remove the face sheet, which typically contains personal identifying information such as name, telephone, addresses;
    3. Data with personal identifies should be kept in locked files, access to the data should be controlled by the researchers with specified procedures;
    4. Research assistants should be educated in the importance of confidentiality and the potential risks of harm to subjects. In situations of serious risk, assistants could be asked to sign confidentiality agreements;
    5. Access to data can be controlled electronically, perhaps by storing very sensitive data on computers not attached to a network, where hackers could penetrate the files. Electronic files can be protected with key words, and portable computers should be appropriately secured;
    6. The data can be manipulated electronically, for example by encrypting data files;
    7. The data can also be recorded to eliminate identifiers by collapsing it into categories;
    8. Research involving many data files on the same person can use anonymous linkage systems;
    9. Researcher may apply for a Certificate of Confidentiality to protect sensitive information from subpoena or other legal processes or governmental agencies

 

Florida Law and Human Subjects

There are State of Florida laws that intersect with the federal regulations governing the protections of human subjects, that researchers working with human subject need to be aware of, depending on the nature of the researcher’s proposed research. These laws are shown below:

1. Legal Age of Consent– In Florida, the legal age of consent is 18 years of age. All under the age of 18 are considered children or minors. Note the following exceptions: Emancipated Minors – In Florida, the following categories of children are legally authorized to consent to participation in research on their own behalf:
   1. Children who have had the “disability of nonage”(e.g. considered a child) removed by a circuit court. (See Chapter 743, Florida Statutes).
   2. Children who are married or have been married may consent to medical care and treatment, including participation in experimental procedures.
   3. An unwed pregnant child may consent to the performance of medical or surgical care of services relating to her pregnancy by a hospital or clinic or by a licensed physician. This category includes research relating to her pregnancy.
   4. Except for emancipated minors, Dysphagia Management System LLC’s IRB will not approve the enrollment in research of persons under the age of 18 without parental permission unless the investigator can demonstrate that enrollment is permissible under and consistent with Florida law and meets the requirements set forth in 45 CFR 46, Subpart D and 21 CFR 50 Subpart D.
2. Genetic Testing– State law (Section 760.40) provides that informed consent must always be obtained prior to DNA testing and notice given whenever the results are received.
3. Diagnosis and/or treatment of STDs (including HIV and AIDS) – State law (Section 384.25, F.S.) requires that practitioners report evidence of sexually transmitted diseases, including HIV and AIDS, to the county health department.
4. HIV Testing– State law (Section 381.004) governs informed consent requirements for HIV testing and disclosure of HIV testing and results to third parties.
5. Treatment of persons who are developmentally disabled – State law (Section 393.13(6)) provides certain rights to individuals who are developmentally disabled. Prior to instituting a plan of experimental medical treatment, express and informed consent shall be obtained from a developmentally disabled individual, if competent, or the individual’s parent or legal guardian.
6. Rights of persons determined to be incapacitated– State law (Section 744.3215) provides that persons determined to be incapacitated retain protected rights; however, a guardian may consent on behalf of a ward to the performance on the ward of any experimental biomedical or behavioral procedures or to the participation by the ward in any biomedical or behavioral experiment.
7. Foster Children– Children in foster care may not have had parental rights legally severed. Thus, while State law is clear regarding consent for medical treatment, it is silent regarding consent for biomedical or behavioral research. The Department of Health has informally opined that it will not approve research involving foster children without parental permission, unless the parental rights have been severed. Any researchers considering research with this vulnerable population should consult with the Florida Department of Health for more specific guidance.
8. When the Subject Cannot Consent (incapacitated/incompetent adults)– Florida recognizes that the following individuals (in order presented) may consent to the enrollment of an individual in medical research that has been approved by an IRB:
   1. Surrogate (competent adult expressly designated by the patient/individual to make health care decisions on behalf of the patient). Designation should be in writing.
   2. Court Appointed Guardian (in the absence of a Surrogate, or where a court revokes the authority of the Surrogate). All persons who have been adjudged incompetent should have a judicially appointed guardian.
   3. A person holding a valid power of attorney (durable POA) which contains language giving the right to make health care decisions from a patient:
   4. A proxy (in the event the patient is incompetent or incapacitated) Pursuant to Section 765.401 a proxy may consent (where the patient has not executed an advance directive, or designated a Surrogate to make heath care decisions) to experimental treatment, provided, the experimental treatment has been approved by and IRB, and the proxy reasonably believes that the patient would have made the decision under the circumstances.
      1. What is a proxy? A substitute, competent decision maker in the following order of priority:
         • Patient’s spouse
         • An adult child, or if the patient has more than 1 child, a majority of the adult children reasonably available for consultation
         • A parent of the patient
         • The adult sibling of the patient (if more than 1, then a majority of such adult siblings)
         • An adult relative of the patient who has exhibited special care and concern for the patient and maintained regular contact with the patient
         • A close friend of the patient
         • A clinical social worker
9. Researchers working with confidential governmental records: Please be advised that there are Florida Statutes that mandate that certain records be kept confidential and exempt from Chapter 119, Public Records Law, such as reports of abuse, neglect, or exploitation of a vulnerable adult. However, for example, in Section 415.107, F.S. there is an exemption for any person engaged in bona fide research or auditing; however, information identifying the subjects of the report must not be made available to the researcher.
10. It is very important to determine with a governmental agency whether certain information that the researcher is seeking is confidential by law, and whether there are any exemptions or exceptions that would permit the researcher to lawfully access the information, the manner of de-identification, and any other requirements that the governmental agency must comply with in order for the researcher to lawfully access and utilize confidential information or data.
11. Many records maintained by the Florida Department of Health, or Department of Children and Families are confidential and exempt from Chapter 119. Some of those confidentiality clauses contain specific research exemptions, but it is key that the researcher determine the agency requirements, whether confidentiality agreements or data use agreements must be in place, and any other requirements that the Florida Department of Health may impose prior to releasing any information for bona fide research use.
12. Educational/School records – Section 1002.22, Florida Statutes protects the rights of students and their parents in respect to student records and reports as created, maintained, and used by public educational institutions in the state. In general, student records are confidential and may not be released without parental consent. However, once a child reaches the age of 18, or is attending a postsecondary educational institution, the permission or consent of the parent is accorded to the student. This right to privacy with respect to educational records is protected by Chapter 119.07(1). Any personally identifiable information is confidential and exempt from the Public Records Laws of Chapter 119, Florida Statutes. However, the information may be released without the consent of the student or the student’s parent in certain circumstances, such as individuals or organizations conducting studies for or on behalf of an institution or a board of education for the purpose of developing, validating, or administering predictive tests, administering student aid programs, or improving instruction, if such studies are conducted in such a manner as will not permit the personal identification of the students and their parents by persons other than representatives of such organizations and if such information will be destroyed when no longer needed for the purpose of conducting such studies. See Section 1002.(3)(d), F.S. for more detail and other exceptions.
13. Fetal research restriction – Section 390.0111(6), Florida Statutes provides that no personal shall use any live fetus, or live, premature infant for any type of scientific, research, laboratory, or other kind of experimentation either prior to or subsequent to any termination of pregnancy procedures except as necessary to protect or preserve the life and health of such fetus or premature infant.
14. Experimental Research– Section 381.026(4)(e), Florida Statutes provides that a patient has the right to know if medical treatment is for purposes of experimental research and to consent prior to participation in such experimental research. The participation must be a voluntary matter, and a patient has the right to refuse to participate. The patient’s consent or refusal must be documented in the patient’s care records.

Note: That information contained herein is offered for informal guidance purposes only, and should not be considered as legal advice on a particular matter.