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The role of the Institutional Review Board (IRB) is to review all proposed research involving human subjects to ensure that subjects are treated ethically and that their rights and welfare are adequately protected.
The Lipscomb IRB is guided by the ethical principles set forth in the Belmont Report. Investigators need to be familiar with these principles in designing and implementing their research projects.
For detailed information on policies and procedures related human subjects research, please consult the Lipscomb University Institutional Review Board Policies and Procedures Manual.
The role of the Institutional Review Board (IRB) is to review all proposed research involving human subjects to ensure that subjects are treated ethically and that their rights and welfare are adequately protected.
The Lipscomb IRB is guided by the ethical principles set forth in the Belmont Report. Investigators need to be familiar with these principles in designing and implementing their research projects.
Respect for persons subsumes two ethical beliefs: (1) that individuals should be treated as autonomous agents, and (2) that persons with diminished autonomy are entitled to protection. It is imperative that an individual’s decision to voluntarily participate in a research study is based on his/her ability to make a knowledgeable and informed assessment of the risks and benefits of the research. Investigators can help ensure that this principle is upheld by seeking voluntary, written informed consent with potential participants. The informed consent process should provide adequate information about the study and emphasize the voluntary nature of study participation so that potential participants can intelligently decide whether they wish to be involved in the research. This information should be provided in language that is easy for potential participants to understand.
Respect for persons also means honoring the privacy of individuals and maintaining their confidentiality. Individuals’ privacy rights must also be protected in research conducted at certain heath and mental health organizations involving personally identifiable health information by the federal law, the Health Insurance Portability and Accountability Act of 1996, known as HIPAA or the Privacy Rule.
When individuals have diminished autonomy (e.g., minors, mentally disabled persons) investigators must take special care to protect them in research studies. In some cases this may mean excluding immature or incapacitated individuals from research activities that may harm them. The extent of protection depends on the risk of harm and the likelihood of benefit. Judgments that any individual lacks autonomy should be periodically re-evaluated and will vary in different situations.
The principle of beneficence embodies the idea that research investigators should seek to secure the well being of their study participants by trying to maximize the potential benefits to the participants and minimize the potential risks of harm. If there are risks resulting from participation in a research study research, then there must be benefits. These may be direct benefits to the subjects, or benefits to humanity or the larger society in general.
The principle of justice means that the selection of research participants is fair and that the risks and benefits of research are equitably distributed. Investigators should not select research participants simply because of their ease of availability, their compromised position, their manipulability, or because of social, racial, sexual, economic, or cultural biases institutionalized in society. The selection of research participants should be based on factors that will most effectively address the research problem.
All faculty and staff (both full-time and part-time) using human subjects or identifiable, private information about human subjects to conduct research within the course and scope of their duties are required to have prior approval from the IRB before research is initiated. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds. This policy also applies to students whose research is conducted under the advisement of a faculty member. All research proposals must be reviewed by the IRB and no individual, other than the IRB Chair,or the Chair’s designee, may verify a proposal as a study exempt from federal regulations or outside the regulations’ scope. Research that is conducted without IRB approval is not in compliance with Lipscomb University policy and federal regulations. In these circumstances a non-compliance report will be sent to the Provost for further action.
Please refer to this website for the most current policies, procedures, forms and IRB meeting times.
The IRB (members listed below) is composed primarily of faculty members from disciplines in which research involving human subjects is integral to that discipline's work, researchers whose primary interests are non-scientific, as well as members from the community. The human subjects review process is administered through the Office of Research.
Any research activity involving human subjects conducted by faculty, staff, and students must be reviewed and approved for compliance with regulatory and ethical requirements before the study or activity begins. These activities include a wide variety of procedures from collection of data through surveys or observation and interventions in school classrooms all the way across the spectrum to use of investigational drugs or devices and/or randomized clinical trials. Other examples of studies include research on medical records, research using existing pathological specimens, discarded tissue or secretions, and research requiring standardized tests from the fields of education, psychology or human performance.
Certain studies involving human subjects may be exempt from IRB review. Exempt projects fall into defined categories (see, Categories for Exempt Research) set forth in the Code of Federal Regulation, part 43, 45. Verification of a project’s exempt status must be verified by a designated official of the IRB.
Most federally funded research with human subjects is governed by federal regulations embodied in Title 45 Code of Federal Regulations Part 46 (45 CFR 46). It should be noted that Lipscomb’s IRB follows federal and state regulations to review all University affiliated human subject research, regardless of funding, to ensure the rights, welfare, and protection of all participants and subjects. Thus, investigators should understand the federal definitions of “research” and “human subjects” in order to help determine whether their proposed studies require IRB review. These regulations define research and human subjects as follows:
The regulatory definition of human subjects research is as follows: “A systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge, or work that is intended to fulfill requirements for a master’s thesis, doctoral dissertation, or other research requirement of the University.”
Non-Research Activities ---IRB Review is Not Required
Examples of activities that typically are considered non-research activities by the IRB include:
Class Projects and Coursework: class research assignments that involve the use of human subjects do not require IRB review if they are not going to be published and have no connection with research conducted or presented outside the classroom. Course instructors are responsible for ensuring that class projects do not propose more than a minimal risk to participants and must make sure their students understand and abide by ethical obligations in carrying out their class research assignments. We suggest that, at a minimum, students be required to complete the training modules available through the Collaborative Institutional Training Initiative.
Additionally, instructors are responsible for reviewing student class research assignment proposals and should review research methods and procedures to ensure they are ethical and appropriate. Course instructors are responsible for monitoring student research activities to ensure the rights and welfare of human subjects are adequately protected. Instructors who have any questions are encouraged to consult with the IRB Chair.
The information provided in the category descriptions below is based on the federal regulations and is meant to help you determine whether you should apply for exempt status determination. You may also want to review the exact wording of the federal regulations at 45 CFR 46.101(b) and 21 CFR 56.104.
An important aspect of applying for exempt status is that all of the research procedures must fall within one or more of the six categories. If you believe that your research project qualifies for exempt status, after reading over these general guidelines and the information about the six different categories of research that qualify for exemption, you may submit one of the exempt project applications. Otherwise, please complete an expedited application.
CATEGORIES OF RESEARCH THAT QUALIFY FOR EXEMPTION
Please Note: The Lipscomb IRB will not allow research to be exempt when any of the following apply:
Category 1 – Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular or special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Approval under this category requires that two criteria be met. Your research project must involve collecting data in established or commonly accepted educational settings, including but not limited to, schools and colleges. This could include other sites where the type of educational activity you are investigating regularly occurs; and
The research must involve only normal education practices. This exemption would not include research involving randomization of participants or research on experimental methods, unless these are considered normal education practices for the discipline.
Faculty in the Department of Education may be consulted for guidance on whether the research involves “normal educational practices.”
There are no age restrictions for participants and no restrictions on research methods in this category
Category 2 – Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior; unless: (i) information obtained is recorded in such a manner that human participants’ responses outside the research could reasonably place participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
Age restrictions apply: Survey or interview procedures cannot involve children.
Observation of public behavior cannot involve children, if the investigator will interact with them.
Note that data collected under this category may be identifiable as long as questions are not of a sensitive nature. Likewise, sensitive data may be obtained, if data are recorded in a completely anonymous manner.
Focus groups are considered an interview procedure and will qualify for exemption under this category, as long as the issues discussed are not of a sensitive nature such that participants would be at risk, if a breach in confidentiality should occur. Likewise, data recorded by use of recording devices would qualify for exemption as long as the information collected is benign in nature.
Category 3 – Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category 2, if: (i) the human participants are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
This category can be confusing and actually applies to two very different criteria.
Item (i) of this category includes the research procedures previously identified in category 2 (i.e., use of educational tests, survey procedures, interview procedures, and observation of public behavior). However, this category differs from the previous one in the situations to which it applies. If the population targeted for the research activities is elected or appointed officials or candidates running for public office, the research qualifies for exempt review. The key difference between this category and category 2 is that public officials or candidates running for public office give up their right to confidentiality in lieu of the public’s “right to know.”
OHRP has provided guidance on what constitutes public officials. Public officials could include mayors, governors, school superintendent, school board members, police chief and others appointed by a state official. Public officials would not include public employees such as teachers or police officers.
The second part of this category (ii) addresses the use of educational tests, surveys, interviews, or observation of public behavior to collect data for specific federal programs conducted or supported by the Department of Justice or data collected for the Institute of Education Sciences which includes the National Center for Education Statistics of the United States Department of Education. These agencies have specific programs that create data bases which are then protected by law from ever being accessed by anyone other than those federal agencies. No officer or employee of the Federal Government, and no recipient of assistance under the provisions of this category is allowed to use or reveal any research or statistical information furnished under this category by any person and identifiable to any specific private person for any purpose other than the purpose for which it was obtained. Data collected for these programs will be immune from legal process and cannot, without the consent of the individual concerned, be admitted as evidence or used for any purpose in any action, suit or other judicial or administration proceeding.
The only circumstance in which an exemption application would be submitted to the IRB for consideration under part (ii) of this category would be if Lipscomb University was awarded a grant to conduct research involving specific programs of the Department of Justice or the National Center for Education Statistics.
Category 4 – Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Clarification of Existing Data
According to the Office for Human Research Protections (OHRP), to qualify for this exemption criterion, the data, documents, records, or specimens must be in existence at the time of IRB review. OHRP interprets the term “existing” to mean that all of the data, documents, records, or specimens to be used in the research are in existence prior to IRB review and were collected for purposes other than the proposed research. The principle behind this requirement is that the rights of individuals should be respected; participants should provide permission for their individually identifiable information to be used for research purposes. The investigator must clearly demonstrate that all of the data to be collected under this category are currently in existence at the time of IRB review and the source(s) from which data will be obtained.
Data, documents, etc. must be either available to the public (e.g., court records, telephone directory information) or the data must be stripped of any direct identifiers (e.g., names, addresses, telephone numbers, social security numbers) and any indirect identifiers (e.g., codes that can be used to link data to participants).
It is important that the IRB understands the investigators’ plans for recording the data. Temporarily recording a name or other identifiers that allow individual subjects to be identified will exclude this type of research activity from meeting the exempt 4 criteria.
Definition of Human Subject and Coded Private Information/Data or Coded Specimens
Exemption Category 4 is difficult to apply because in some cases the activities do not technically meet the category but still do not require expedited or full review because they do not meet the federal definition of “human subject” (i.e. identity of the subject is not readily ascertainable by the PI).
For example, if the research involves only coded private information/data or coded specimens, OHRP does not consider the research to involve human subjects as defined under the HHS Protection of Human Subjects Regulations (45 CFR Part 46.102(f)) if the following conditions are both met:
(a) the key to decipher the code is destroyed before the research begins;
(b) the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;
(c) there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased
(d) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
Category 5 – Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
This category is limited to very specific types of research or demonstration projects that are conducted by or subject to the approval of federal Department or Agency heads. The following criteria must be satisfied to invoke the exemption under this category:
Category 6 – Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the Food & Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
This category addresses two different types of research activity.
1. First, if the taste test involves wholesome food without any additives it is then eligible for exemption. The IRB reviewer must make sure that the food product to be researched is “wholesome” (no additives).
An example of such a research project would be a taste-test conducted on different types of apples to determine consumer preference. The apples are those normally grown in different sections of the country, using normal agricultural practices, and do not involve the addition of food additives or chemicals. The subjects merely indicate which of the apples they prefer.
2. The second item (ii) is more difficult to understand. Research conducted on human subjects who consume plants or animals raised for food products may qualify for exempt review.
The Food and Drug Administration has determined levels of safety for various agricultural chemicals, referred to as GRAS (FDA generally recognized as safe) and GRAE (generally recognized as effective) additives which are fed to animals raised for food production. If these agricultural additives are given to animals at or below the levels found to be safe by FDA, the research can receive exempt review.
An example of such research would be taste-testing pork products where the swine have been fed corn and a chemical additive at a level designated below FDA guidelines that make the animal gain weight more quickly. The objective of the study is to determine whether the addition of the chemical changes the flavor of the pork.
There are also approved levels for environmental contaminants set forth by the Food and Drug Administration, the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) that may affect the grass or grain consumed by grazing food animals such as chemicals sprayed on a field to combat chickweed. If the research involves taste-testing of food products that come from animals exposed to environmental contaminants and the investigator can show that the use of these contaminants was at or below those approved levels, the research can receive exempt review.
In all of these situations, the investigator should provide some documentation that the alterations, either chemical, environmental or agricultural, have been found to be safe by FDA, USDA, and/or EPA. 9
However, if there have been food and color additives incorporated into the food product and these additives are used in research with the intent to apply to FDA for marketing that additive, the research would not qualify for exemption. Even if the procedures are preliminary in nature, if the research would eventually lead to FDA approval for marketing the food or color additive, it would not qualify for exempt review. The additives are viewed as investigational by FDA and, therefore, do meet the exemption criteria.
This category applies to Food and Drug Administration (FDA) regulated research.
45 CFR 46
OHRP Policy & Guidance
University of Kentucky, Office of Research Integrity, Issues to be Addressed When Conducting Exempt Review 8/19/09
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the federal requirements. All of the authorities of the IRB may be exercised, except the reviewers may not disapprove the research, that being reserved for a full committee action. Expedited review is appropriate for research that involves no more than minimal risk or for review of minor changes to previously approved research projects and protocols. The research proposal and protocols must be submitted to the University IRB to determine that all of the following requirements are satisfied:
Below is a list of types of research with human subjects that may be eligible for an expedited review:
1. Collection of hair and nail clippings in a non-disfiguring manner.
2. Collection of excreta and external secretions.
3. Collection of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice.
4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
5. Anonymous voice recordings made for research purposes, such as investigations of speech defects.
6. Moderate exercise by healthy volunteers age 18 to 60.
7. Study of existing data, documents, records, pathological specimens or diagnostic specimens.
8. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate the subject's behavior and the research will not involve stress to subjects.
9. Research involving manipulation of the subject's behavior which does not involve stress or risk.
Expedited review may also be appropriate for minor changes or requests for extensions in previously approved research during the period (one year or less) for which approval is authorized.
Proposed research studies involving human subjects that do not qualify for Exempt or Expedited level review must be reviewed by the IRB at a convened meeting (Full Board level review). Studies requiring Full Board review present more than minimal risk to subjects, and/or involve vulnerable populations, such as prisoners, institutionalized individuals, or persons with diminished capacity to consent (e.g., Alzheimer patients).
Full Board studies are reviewed on a first come, first served basis by the IRB at scheduled meetings. Common examples of research reviewed at the Full Board level at Lipscomb are studies that include:
Determining when to submit a proposal depends upon when a researcher would like to begin data collection. To improve the chances that a project receives IRB approval by the planned data collection start date, researchers should submit their research proposal form and all required materials and documents as early as possible. The more time between the date that a research proposal is submitted and the planned data collection start date, the greater the chances the project will not be delayed by the IRB review process.
Usually, exempt and expedited proposals are approved in 2-4 weeks. The approval timeline for exempt and expedited reviews could be longer if research proposal materials are missing (e.g., letters of cooperation, informed consent forms, etc.) or if proposals are submitted over the summer or holiday breaks.
When a research proposal requires a full committee review, the approval timelines are longer. The IRB recommends that researchers consider the following timeline when submitting research proposals requiring full committee review:
The following is a step by step guide on how to submit your completed research proposal and supporting documents electronically as an IRB Packet. Submit through the IRB Google Group.
A student named John Doe is advised by Roger Wiemers and is submitting on July 8, 2016. John would create a document with the name IRB-Doe-Wiemers-07-08-16.
Save a copy of the Research Proposal Form for your records.
Investigators not affiliated with Lipscomb University must first partner with a Lipscomb faculty researcher before submitting a research proposal form (note: partnerships between Lipscomb faculty members and outside researchers need to be approved by the Lipscomb faculty member’s dean). If a researcher is unable to form a partnership with a Lipscomb faculty member for whatever reason, he or she may contact the IRB Chair directly to discuss possible alternative paths to submitting a research proposal.
Research that involves living human beings as research subjects is fundamentally different from all other kinds of research. When conducting such research we are morally and ethically bound to love our brothers and sisters, whom we are using as research subjects, as we love ourselves. We must protect their privacy and treat them with respect and dignity, seeking only what is best for them, not what is best for our own research. Informed consent is the concept under which care and concern lives itself out. Much has been written on the need for informed consent and its origins in modern ethical thought. The following gives some idea of the background and urgency of the issue.
“All modern codes of ethics concerning research with human subjects affirm the moral importance of a principle of informed consent. It is a principle born of outrage at the atrocities committed by German physicians and scientists under the Hitler regime. As is well known, thousands of concentration camp prisoners were used as human guinea pigs against their will in experiments that were typically excruciatingly painful and generally led to death or permanent disfigurement. As a part of its written decision, the war crimes tribunal that convicted several of the notorious “Nazi Doctors” produced what has since become known as the Nuremberg Code (1), widely regarded as the first international code of human experimentation ethics. The code begins simply, with one statement set apart from all the rest:
‘The voluntary consent of the human subject is absolutely essential.’ “
A note to student researchers: A well thought out and carefully constructed consent document is a vital part of any research involving human subjects. This web page is intended to give you a very basic introduction to the informed consent concept and the required elements of the consent form. We recommend working closely with your faculty advisor as you compose the consent form for your research project and have written an informed consent template that can be modified to meet the specifications of your research project.
The Lipscomb IRB has two tools designed to help researchers with informed consent.
The Department of Health and Human Services requires all researchers conducting human subjects research to provide prospective subjects with informed consent. In most cases, federal regulations require written informed consent. Informed consent is a process, not a document. The first part of the process consists of you informing prospective research volunteers about the research. This is commonly done through an “information sheet”. The majority of this document addresses this part of informed consent.
The consent form (information sheet) should be written in clear, everyday language that prospective volunteers can easily understand. Ordinary language should replace technical terms. The Readability Scoring feature of Word can be used to determine the reading level of your document. A 7th to 8th grade reading level is commonly used. See the instructions for measuring readability in this web site.
In the special case of an informed assent document, the wording must be age appropriate. For pre-literate children, illiterate adults or non-English readers, the information sheet must be read to the research volunteer and a second person, who has no connection to the research project, must provide a signed statement that the volunteer has been informed and has indicated understanding of the information.
Introductory Statement: In the first paragraph of the consent form, provide a brief statement which includes the general topic of investigation and identifies the sponsoring agency (if any) and the Principal Investigator(s).
Background Information/Purpose of Study: State the purpose of your research. The principle of respect for persons requires researchers to clearly inform prospective participants of research objectives in an honest and forthcoming manner (if research involves deception this must be justified in your IRB application). The statement of purpose should be concise, but must provide sufficient information to allow the individual to make an informed decision about whether or not to participate.
Explanation of Procedures to be Followed: Clearly state the nature and duration of the subject's participation in the research study. Describe the procedures employed by the study, state any physical requirements and indicate as accurately as possible the volunteer's anticipated time commitment to the project.
Description of Risks/Discomforts & Benefits: In lay terms, describe any foreseeable risks or discomforts to the volunteer. Individuals who may be placed at increased risk of physical discomfort or psychological distress must be clearly warned of the nature of their risk and informed of precautionary measures employed by the investigator to minimize risks and ameliorate negative effects. Also describe any benefits to the participant or others which may be reasonably expected from the research.
Compensation: If the participant is to receive compensation for participation, state the nature and amount of compensation and the terms of payment.
Confidentiality/Anonymity: Describe the extent to which the project will maintain the privacy of information. Confidentiality means the researcher will maintain records with personal identifiers but will not release information to unauthorized personnel. Anonymity means that records will not include any personal identifiers or code numbers that may link a participant to specific information.
Voluntary Nature of the Study: Include the following statement: Participation in this study is completely voluntary; refusal to participate involves no penalty or loss of benefits to which I am otherwise entitled. I understand that I may discontinue participation without penalty or loss of benefits to which I am entitled. I also understand the investigator has the right to withdraw me from the study at any time.
Contact Information: Provide the name and telephone number of the person available to answer questions about the research. This is usually the Principal Investigator. Also include the following statement: "If you have other questions or concerns regarding the study and would like to talk to someone other than the researcher(s), you may also contact Dr. Roger Wiemers, Chair of the Lipscomb University Institutional Review Board, at firstname.lastname@example.org."
Signed Consent to Participate: Include the following statement: "You are making a decision whether or not to participate. Your signature indicates that you have read this information and your questions have been answered." Include a line for the participant to sign and date the form.
(1) A minor, anyone under the age of 18 years, is not a legal person and cannot give consent. For research involving minors a parent or legal guardian must sign the Informed Consent Form. The participating child must sign a corresponding Informed Assent Form. This detail of the regulations increases the amount of work a researcher must do if children are the subjects of the research in order to provide them the full protection the law gives.
(2) The wording of the Informed Assent Form may have to be substantially different from that of the Informed Consent Form in order to be “age appropriate”.
(3) Research involving pre-literate children, infants and adults or children with limited cognitive ability present additional challenges in complying with the regulations. Your research advisor is responsible for guiding you to information on best practices in all of these cases.
Deadlines for submission depend on the level of review. Applications for Exempt and Expedited Review are accepted whenever you complete them, with the exception of the time period December 6 – January 7, and are reviewed on a rolling basis.
Applications for Full Review are due as shown below. It is very important that you plan your proposal submission so as not to encounter a long delay (that is, one month or more) by submitting the proposal one or two days late. All dates are subject to change.
Applications that are not complete will be returned for correction and may cause a delay.
Full Review Applications Due
IRB meeting date*
Review Results e-Mailed to Researchers
|Sept. 3, 2019||Sept. 12, 2019||Sept. 19, 2019|
|Sept. 30, 2019||Oct. 10, 2019||Oct. 17, 2019|
|Oct. 28, 2019||Nov. 7, 2019||Nov. 14, 2019|
|Nov. 25, 2019||Dec. 5, 2019||Dec. 12, 2019|
|Jan. 6, 2020||Jan 16, 2020||Jan 23, 2020|
|Feb. 6, 2020||Feb. 13, 2020||Feb 20, 2020|
|Mar. 2, 2020||March 12, 2020||March 19, 2020|
|March 30, 2020||April 9, 2020||April 16, 2020|
|April 27, 2020||May 7, 2020||May 14, 2020|
* Meetings at 10:55 in Ezell 345 Conference Room. All dates are subject to change.
An unintended, but not necessarily unexpected, result of therapy or other intervention that is unpleasant or dangerous.
Refers to information or data where identifiers (and codes that are linked to identifiers) have been removed, as well as other values that would enable individuals to be identified by inference. Close correlation with values in additional datasets, or unique values, or cells containing few data points, for instance, could support such inferences. A dataset, therefore, must at least have been thoroughly de-identified in order to be anonymized. For all practical purposes, anonymized data cannot be linked to the individual. Examples of anonymized data are public use files made available by the Bureau of the Census.
Health Services Research is a field of inquiry using quantitative or qualitative methodology to examine the impact of the organization, financing, and management of health care services on the access to, delivery, cost, outcomes, and quality of services.
An agreement or contract between an institution and the Office of Human Research Protections (OHRP), on behalf of the Secretary of Health and Human Services; the assurance stipulates the methods by which the institution will protect the rights and welfare of research subjects in accordance with the regulations.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978
The official notification to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB
A person who has not attained the legal age for consent to treatments or procedures involved in the research
Any experiment that involves a test article and one or more human subjects
The central federal policy adopted "in common" by 16 federal departments and agencies (and concurred, with some modifications, by the FDA) that support and/or conduct research involving human subjects. The adoption of the federal policy in 1991 implements a recommendation of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research that all federal departments and agencies "adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (codified at 45 CFR 46, Subpart A), as periodically amended or revised, while permitting additions by any department or agency that are not inconsistent with these core provisions" (OPRR Guidebook, Chapter 2).
Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research
The manner of treating private information, which has been disclosed by the individual subject of the information to a particular person or persons for a specific purpose, such that further disclosure of the information will not be allowed to occur without authorization
Research that has been approved will undergo review until the completion or termination of the research, including scheduled continual reviews of research that will occur at least annually
Those projects normally supported through grants, contracts, or similar arrangements, which involve institutions in addition to the grantee or prime contractor (such as a contractor with the grantee, or a subcontractor with the prime contractor)
Refers to information that is collected for analysis or used to reason or make a decision
Informational privacy especially when the information in question is stored in a database
Refers to information or data where direct identifiers such as name and address have been removed. In common use, the term refers to data where it may still be possible to identify individuals by inference or through codes held by the investigator or a third party. Therefore data that is de-identified may not be anonymized because it may still permit at least probabilistic re-identification when analyzed in conjunction with other datasets.
The head of any federal department or employee of any department or agency to whom authority has been delegated
Therapeutic, diagnostic or prosthetic articles, which do not interact chemically with the body (e.g., pacemakers, intrauterine contraceptive devices, diagnostic test kits, crutches, and artificial joints)
An individual who is considered to have reached maturity by: 1) the appointment by a court of a guardian; 2) upon marriage; or 3) upon attaining majority
The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval
The Common Rule codified in 45 CFR 46.101(b) specifies that research activities may be exempt from the policy if human subjects involvement is limited to one of the listed scenarios, including studies involving the collection or study of existing data when those data either are publicly available or are not personally identifiable. As detailed in the text, however, some IRBs request to see the studies that may be exempt, and open files on them for tracking.
The Common Rule codified in 45 CFR 46.110 specifies that research activities may be eligible for expedited review if the protocol involves only minimal risk or a previously reviewed protocol is receiving modifications that are only minor. Expedited review is carried out by the IRB Chair or by one or more experienced reviewers designated by the chair. Such expedited reviews have the force of full reviews, except that if the protocol is found not acceptable, then it must receive review by the full committee; the chair or designee alone cannot reject a proposal.
Regulations are the rules that departments or agencies issue to provide specific guidance to themselves and others about how they will implement pertinent laws. In this particular report, "regulations" refers to federal regulations on human subjects protection to the Department of Health and Human Services' regulations, since that agency sponsors most of the relevant research and this project, but the report applies similarly to other departments and agencies.
An individual who is authorized under applicable state or local law to consent on behalf of another person (e.g., children) to general medical care
Informational privacy especially when the information in question pertains to the health or medical condition of the individual in question
Individuals about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information
A proposition (or set of propositions) proposed as an explanation for the occurrence of some specified group of phenomena to be tested by research
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.
The right of individuals to control access to, and the use of, information about themselves.
The knowing, legally effective consent of any individual or the individual's legally authorized representative; such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence
Health services is a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations.
Any public or private entity or agency (including federal, state, and other agencies)
A committee formed to ensure the protection of human subjects in research
Includes communication or interpersonal contact between investigator and subject
Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulation of the subject or the subject's environment that are performed for research purposes
The determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirement
An individual or judicial or other body authorized under North Dakota law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research
That 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
A child's biological or adoptive parent
The agreement of parent(s) or guardian to the participation of their child or ward in research
Health or medical data or information that can be linked manifestly or inferentially to an individual
The individual with primary responsibility for the design and conduct of a research project
Information about behavior that occurs in a context in which the 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 (e.g., medical record).”
The formal design or plan of an experiment or research activity
Payment for participation in research
Studies undertaken to contribute to the body of generalizable knowledge
Any drug/biological product/medical device for human use, human food additive, color additive, electronic product, or any other article subject to FDA regulations
The Common Rule codified in 45 CFR 46.116(d) specifies that an IRB can alter or waive the requirement to obtain informed consent if it finds and documents that the research involves no more than minimal risk to the subjects, the waiver or alteration will not adversely affect the rights and welfare of the subjects, the research could not practicably be carried out without the waiver or alteration, and whenever appropriate, the subjects will be provided with additional pertinent information after participation.
FDA regulations at 21 CFR 56.105 permit the agency to waive any of its requirements including the requirement of IRB review. Since this report addresses human subject research, not product safety and effectiveness, this provision is unlikely to apply (OPRR 1993, Chapter 2).
The above compilation is taken from http://www.nd.gov/dhs/info/research/definitions.html.
A CITI Training Certificate of Completion (i.e., the “Human Subjects Research” training) is required for each researcher & faculty advisor involved in the proposed research study (Training course available at www.citiprogram.org; Lipscomb has a subscription to CITI trainings). If a study includes data from medical records or other health-related data, CITI’s “Information Privacy and Security” training is also required.
If you have never registered before (you do not have a CITI Program username) please go to www.citiprogram.org and register an account in the system by clicking on "Register" button under "Create an account" from the homepage. After typing and selecting "Lipscomb University" from the dynamic drop down list, follow the prompts to create your account.
If you already have a CITI Program username, please log into your account, go to Main Menu, and follow the "Click here to affiliate with another institution" link. Type and locate Lipscomb University via the dynamic drop down list.
The various training modules are split into different "Learner Groups." Lipscomb researchers will most often be members of the "Faculty, Staff, & Students" learner group. The "Clinicians" learner group under the "Information Privacy & Security" training module is designed for those who work with patients/clients and contribute directly to the collection and documentation of identifiable medical information (e.g., master's in marriage and family therapy and mental health counseling students).
Anyone who would like to submit a research proposal to the IRB needs to take part in the "Human Subjects Research" training curriculum. Before taking part in the "Human Subjects Research" training, researchers should select the learner group that best fits their research context (i.e., Faculty, Staff, & Students). It may be the case that a research project requires the completion of multiple training modules (e.g., Human Subjects Research and Information Privacy and Security). Additional training modules include:
Investigators must report unanticipated problems and adverse events that occur during the course of their research with human subjects to the IRB in a timely fashion. An adverse event, as defined by the Department of Health and Human Services, is “an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).” An adverse event in non-medical research can include an undesirable and unintended consequence of, or reaction to, procedures. An unanticipated adverse event can also be defined as any adverse experience whose nature, severity, and frequency of risk were not described in the information provided for IRB review or in the consent form.
Adverse events/experiences include, but are not limited to:
Unanticipated adverse events that are associated with a research intervention must be reported to the IRB. An unanticipated adverse event is considered to be associated with a research intervention if there is a reasonable possibility that the reaction may have been caused by the research intervention (i.e., a causal relationship between the reaction and research intervention cannot be ruled out by the investigator(s)).
All unanticipated problems should be reported as soon as possible to the IRB Chairperson (via email at email@example.com) no later than 96 hours from the time the investigator became aware of the issue. All fatal or life-threatening events, regardless of whether they were unexpected or not (e.g., a critically ill patient in a cancer study dies during a procedure), MUST be reported to the IRB within 48 hours after discovery. Investigators should file such reports in writing, using the “Adverse Event Report Form” available online and contained in the appendices of the Lipscomb IRB Manual. All relevant documents and supporting material should be included with the Adverse Event Report Form. When attaching supporting material and consent forms, participants' personal identifiers (e.g., name, social security number) should not be included.
In some instances, a serious or unexpected adverse event may necessitate an immediate change in protocol to relieve an apparent immediate hazard to research participants. In such situations, the principal investigator may implement a change in protocol in order to protect the welfare of the research participants. Investigators should be certain to describe such changes in protocol in the Adverse Event Report Form.
When the IRB receives an Adverse Event Report Form, the information will be reviewed to determine:
The investigator will be informed in writing of the findings of the IRB review. When necessary, the IRB will also promptly report to appropriate institutional officials, any supporting agency or department heads, and the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) any
How do I seek funding?
The Office of Research supports faculty interested in pursuing funding for their research and academic initiatives. There are a number of internal and external opportunities available, and we would be happy to meet with you to explore these funding options and help you begin the grant-seeking process.
How do I get started?
A Grant Approval Form must be submitted for each project for which you plan to seek external funding. The grant approval form serves as the official notification of your intentions to seek external funding and must be approved by your Department Chair and Dean or Institute Director before you can continue in the process.
Complete your Grant Approval Form well enough in advance to ensure its successful approval for submission. We recommend filling out the form as soon as you are certain of your intentions to pursue external funding and have begun to formulate your ideas. It is not unusual for it to take 4-6 months or even a year to develop an idea, search for funding agencies and prepare a grant application for submission. Please note that many funders have only one or two deadlines each year, so you may have to wait until the next year's cycle to apply. The earlier you fill out the Grant Approval Form, the better we will be able to assist you through each stage of the process.
Where can I get help developing my proposal?
You have filled out the Grant Proposal Form, received notice of its approval and met with OSP to identify potential funding sources. It's time to start developing your proposal.
The OSP is happy to assist as you develop your proposal and will help you to proofread and perfect your proposal and make sure everything is complete for your application. We will also work with you to develop your budget.
Here are some tips to help you get started as you develop your proposal. Please contact OSP with questions and concerns.
STEP #1: Get in the "proposal" mindset
Before you begin writing your proposal, be sure you understand what it is you are writing. Remember that a grant proposal is distinctive from other types of scholarly writing and may require you to adjust your mindset.
STEP #2 Put together your proposal
Your proposal should provide answers to several important questions:
A strong proposal contains several key sections:
STEP #3 Prepare necessary attachments
You will often be required to submit additional materials along with your proposal narrative such as CVs, project summaries, letters of support, tax exempt certificates, etc. Be sure to include all necessary attachments. Pay attention to details such as consistent formatting and proof the attachments as carefully as the core narrative.
STEP #4 Peer review
It is often helpful to ask your colleagues to read over your proposal at various stages of development. Colleagues within your department may offer concrete feedback on your methodology, your objectives, the significance of your study, your literature review, etc. Colleagues outside your discipline often have a different perspective, and can offer feedback on whether your proposal is easy to understand, free of jargon and clear to a "lay person." The OSP can help you connect to faculty willing to read your proposal. If you are interested in becoming a peer reviewer, please contact us.
OSP will also review and proofread your entire proposal before submission, and is more than happy to read drafts at any stage of the process.
STEP #5 Submission
Once you feel comfortable with your proposal, the OSP will submit it to the funding agency along with all necessary attachments. Most government funding agencies now require electronic submission of proposals, thus, submitting your final proposal to OSP at least 7-10 days in advance of the application deadline will allow OSP staff time to address potential problems caused by electronic submission. While the government is working to fix the "bugs" in the electronic submission system, occasional delays are inevitable and the government's electronic systems are not always reliable. Submitting early provides time to address any complications should they arise.
Where can I get help developing my grant budget?
Purpose of the Grant Budget
Grant budgets are designed to accurately reflect the costs of the project. There are a number of misperceptions and myths surrounding grant budgets. Keep in mind that funding agencies review the grant budget to make sure that the project is feasible given the budget request. They do not look more favorably on projects that promise "more for less." Instead, funding agencies favor projects that demonstrate that the Principal Investigator has paid careful attention to the time and effort required on the project and is fully aware of how much this time and effort ACTUALLY COSTS.
Most government funding agencies recognize that externally-funded projects have other costs that are not easily identifiable within a project. These costs are known as "Facilities and Administrative" (F & A) costs (also know as Indirect Costs) for the host institution. For example, if a project coordinator is hired for a grant, Human Resources must spend time and effort processing new hire paperwork. If copies are to be made, Document Services must first set up a copy code. If work is to take place in a campus space, there will be costs associated with lighting, maintenance, etc. Rather than account for each of these items individually within a grant budget, most funding agencies allow us to request F & A costs based on a negotiated rate. Requesting F & A costs does not impact whether the proposal receives funding or the amount of Direct Costs available for the project.
Funding agencies sometimes require a "Cost Share," meaning that the college covers some of the costs for the project. Many corporate and foundation funding agencies will not accept requests for F & A rates, but will consider these costs as part of the Lipscomb University Cost Share. It is sometimes helpful to outline Lipscomb’s contributions, whether or not a Cost Share is required, on corporate or foundation funding requests. If a government agency does not require a cost share, then none should be listed in the budget.
Where can I get help managing my grant?
Congratulations! You have just received an official Notice of Award Letter. Your hard work has paid off and your project is going to be funded.
For many of those who seeking external funding, the submission of a grant application becomes a major focus and it is hard to think beyond the application deadline to the reality of managing the grant once it is awarded. After your first feeling of elation wears off, you may begin to feel a bit overwhelmed by the thought of managing the grant
As Principal Investigator, you are responsible for managing your grant award. However, the OSP is always happy to help answer your questions and will provide guidance and assistance at every stage of the process. Please consult the Faculty Research Handbook that outlines the management process and provides information on a wide variety of issues that you may encounter as you manage your grant. Explore the handbook, but please do not hesitate to contact OSP with questions and concerns! We are happy to help you.
Will I need to go through the IRB before applying for a grant?
Are you engaged in research with human subjects? Don’t forget the IRB.
The Institutional Review Board (IRB) is a committee that reviews all research that involves human subjects. Its primary purpose is to ensure that human research subjects are protected. This includes protecting the privacy of subjects, respecting the autonomy of subjects, preserving the dignity of subjects, minimizing risks while maximizing benefits to subjects, and providing adequate information for subjects to make informed decisions about their involvement in a research project.
Investigators cannot begin research involving human subjects until a complete application has been submitted, reviewed, and approved by the IRB.
Determining whether your work is research that involves human subjects can be surprisingly complicated and depends on a variety of factors. There are a number of questions to think about as you determine whether you will need IRB approval:
If the answer to any of these questions is "yes," your work may require IRB review.
What are some examples of Human Subjects Research?
Examples of human subjects research include collecting survey data, conducting interviews or focus groups for research purposes, using existing records (such as medical or academic records) for research, collecting biological specimens for research, or engaging in evaluation and assessment activities that involve human subjects interactions (i.e. surveys). Research at the undergraduate or graduate level such as thesis, honors, or seminar projects may also be considered human subjects research and may require review.
What are indirect costs?
Review an explanation of indirect costs.