Human Subject Research and the IRB

In accordance with Meharry’s Federalwide Assurance (FWA#00003675), all research activities involving human subjects, regardless of the funding source for those activities, must be reviewed by the Institutional Review Board (IRB) if the research is sponsored or conducted by Meharry or involves non-public information that can be used to identify human subjects.

 

The IRB has been charged with aligning Meharry Medical College with this mandate. In short, as Meharry’s scientists are translating laboratory findings into patient treatment, the IRB is translating the Assurance into patient protection. Doing so not only ensures safe outcomes for study volunteers; it also means sound investigative practice for Meharry’s scientists. Doing so frees you, the scientist, to conduct your experiment with confidence your regulatory affairs are in order.

 

Effective September 1, 2013, eProtocol (an electronic application submission database) is available to investigators and research staff working with human subjects. All protocols, amendments, annual reviews, and requests for personnel changes must be prepared and submitted in the eProtocol system.

 

Access to e-Protocol

NOTE: Access to the eProtocol system requires valid CITI research education training.

 

To access eProtocol, visit: https://mmc.keyusa.net/

 

Contact the Human Protections Administrator in the Office for Research for any issues logging in with an MMC eProtocol ID (ePID) username and password.

 

eProtocol Assistance
Training assistance or Questions – contact the IRB office at 615-327-6735 or via email at IRB@mmc.edu

The following definitions were established by 45 CFR 46 and are overseen by the Department of Health and Human Services.

 

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

 

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

  1. Data through intervention or interaction with the individual
  2. Identifiable private information.

 

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

 

Interaction includes communication or interpersonal contact between investigator and subject.

 

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 acquisition of the information to constitute research involving human subjects.

 

Minimal risk means 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.

 

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)
The Privacy Rule was issued to implement the requirements of HIPAA. Its standards address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule—called “covered entities,” as well as standards for individuals’ privacy rights to understand and control how their health information is used.

Examples of Human Subject Research

Regulatory requirements to protect human subjects apply to a much broader range of research than many investigators realize. In addition to covering traditional biomedical studies, they also apply to research that uses…

  • Human beings to test devices, products, or materials that have been developed through research.
  • Data collected through intervention or interaction with individuals. Intervention includes not only physical procedures but also manipulation of a subject’s environment and some observations.
  • Private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question. Examples include student records and medical records.
  • Bodily materials such as cells, blood or urine, tissues, organs, hair, and nail clippings, even if the researcher did not collect these materials (such research may be considered exempt if materials are not personally identifiable and if the materials were collected prior to the initiation of the research project).
  • Studies conducted to gain generalizable knowledge about categories or classes of subjects, such as Meharry employees, students, and/or patients. This includes a doctoral dissertation and a master’s thesis.
  • Human beings to evaluate environmental alterations.

 

If you have questions about whether your planned studies constitute human subjects research, please contact the Human Protections Administrator, Shannon Roberson in the Office for Research IRB Office, WBS, Room 2215 on ext 6735.

Decision Charts for Obtaining IRB Approval of a Study

The federal Office for Human Research Protections has provided decision charts to help you decide whether your project meets the definitions for research involving human subjects and whether your project requires full/expedited board review or is exempt from review. The charts, listed together here, were last updated September 2004.

 

From OHRP Guidance Document 45 CFR 46:

 

CHART 1: Is an activity research involving human subjects covered by 45 CFR 46?

 

CHART 2: Is the research involving human subjects eligible for exemption under 45 CFR 45 CFR 46.101(b)?

 

CHART 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) apply?

 

CHART 4: Does Exemption 45 CFR 46.101(b)(2) or (B)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) apply?

 

CHART 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data Documents and Specimens) apply?

 

CHART 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) apply?

 

CHART 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) apply?

 

CHART 8: May the IRB review be done by expedited procedures under 45 CFR 46.110?

 

CHART 9: Can the continuing review be done by expedited procedures under 45 CFR 46.110?

 

CHART 10: Can the informed consent be waived or consent elements be altered under 45 CFR 46.116(c) OR (d)?

 

CHART 11: Can documentation of informed consent be waived under 45 CFR 46.117?

IRB Training

Meharry Medical College requires all principal investigators, key study personnel, and students who are conducting human subjects research to complete the Collaborative IRB Training Initiative (CITI) before research can begin. You will choose your own username and password when you register for the program.  Contact the Human Protections Administrator at IRB@mmc.edu or 615.327.6735 if you need assistance.

 

Please know that the entire educational program and its questions need not be completed in one sitting. You may save your work, log out of the system, and return at your convenience. You will need to re-enter the username and password each time you want to log into the CITI program.

 

Also, for your convenience, save your user name and password in a retrieval place so that you can log into this program multiple times, if desired.

 

The National Institutes of Health also offers online training, which you may complete at any time. However, only the CITI program satisfies the Meharry IRB human subjects training requirement.

IRB Fees

  • Meharry Medical College charges the following fees for IRB reviews of industry-sponsored clinical trials
  • Payment is required prior to IRB approval.
  • No fees are required for government-sponsored or investigator-initiated research.
Initial review, full board $2,000
Initial review, expedited $500
Continuing review, full board $700
Continuing review, expedited $300
Amendment, full board $500
Amendment, expedited $100
Administrative changes $0

Helpful Links

45 CFR 46. The ultimate, comprehensive law that defines federal regulations governing protection of human subjects.

 

Belmont Report
The Belmont Report was issued in 1979 by the Department of Health, Education, and Welfare (now Health and Human Services). It describes the three ethical principles that should be embodied in human subjects research.  These principles are fundamental in IRB review.

 

Health information privacy. The Office of Civil Rights enforces the HIPAA Privacy Rule.

OHRP—Office of Human Research Protections
The OHRP is a federal office that oversees the protection of human subjects in research.  The OHRP interprets and enforces 45 CFR 46.

 

The OHRP Policy and Guidance library can be found here.

 

Frequently Asked Questions submitted to the OHRP.

 

IRB Guidebook. Though still useful, the IRB Guidebook was last updated by the OHRP in 1993 and therefore must be supported with additional documentation when a procedure is in question.

 

OHRP decision charts. These charts will help you know if your research requires IRB approval.

NIH FAQs. NIH FAQs are listed here, and additional FAQs are here.

 

NIH Policies.  The NIH policies page can be found here.

 

Vulnerable populations. These are specific policies protecting women and fetuses, prisoners, and children.

Fda.gov. The FDA, which is housed within Health and Human Services, is the federal office that oversees the safety of the U.S. food supply, medical product safety, and emerging health hazards, as well as bringing new technologies to market.

 

Center for Biologics and Evaluation. CBER is the center within FDA that regulates biological products for human use. https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm

 

Good clinical practice. This office is the regulatory agency for clinical trials.

 

Clinical trials. This question and answer page was designed for consumers.

 

Why volunteer for a clinical trial. This site was also designed for consumers.

 

FDA forms. Form 1571, Investigational New Drug (IND) Application, and Form 1572, Statement of Investigator, can be found here.

Frequently Asked Questions

The IRB is the committee at Meharry that is required by federal regulation to review all research with human subjects to ensure that the rights, safety, and welfare of the subjects are protected. Federal regulations also specify the criteria that the IRB must use to evaluate research that involves human subjects.

45 C.F.R. § 46 was first promulgated in 1974 by the Department of Health and Human Services and has since undergone a number of revisions. FDA regulations also govern research with human subjects: 21 C.F.R. § 50, 21 C.F.R. § 56, 21 C.F.R. § 312, and 21 C.F.R. § 812.

The regulations for the protection of human participants in research apply to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. Meharry, like many other institutions, has stipulated in its Federalwide Assurance (FWA), which is the binding agreement between Meharry and the federal government, that it will comply with these federal regulations regardless of a study’s source of funding. The FWA stipulates the method(s) by which the institution will protect the rights and welfare of research subjects in accordance with the regulations.

The IRB can review research at a meeting of the full committee, or via expedited review. The IRB may also determine that a study with human subjects fits under one of the categories of exempt research that are specified in 45 C.F.R. § 46. Research that involves greater than minimal risk to subjects is reviewed at a meeting of the full committee. Research with vulnerable populations may also be reviewed by the full committee. Research that poses minimal risk to subjects is eligible for expedited review.

Yes. A research project involving human subjects cannot be initiated until the IRB reviews and approves it or determines that it is exempt. Meharry’s IRB procedures state that researchers may not determine for themselves whether research with human subjects is exempt. This rule is not designed to hinder the progress of research but to protect human subjects from harm and is consistent with federal regulations and guidance pertaining to research with human subjects.

The IRB meets on the first and third Tuesday of every month. If you submit the completed Human Subjects Review Form by the second or fourth Tuesday of that month, the project should be reviewed at a meeting that month. However, if necessary and/or required protocol materials are not submitted, this may delay review. The IRB reviews the applications at the meetings of the full committee and decides to approve, disapprove, or approve with corrections. You will be notified of the IRB’s decision no later than three days following the IRB meeting. If you receive an approval letter, you are ready to start; if you receive a letter requiring modifications to your protocol, you may not begin your work until the corrections have been submitted and you receive a final approval letter. In some circumstances, so many revisions may be required that you will be asked to revise the protocol and resubmit it for review at another IRB meeting.

Any investigator who wants to conduct research with human subjects must submit the necessary application materials to the IRB and receive IRB approval prior to beginning any activities with human subjects, including recruiting people to participate in the study. Additionally, any time an investigator wants to make a change to an IRB-approved study, the investigator must submit that change to the IRB and receive approval for the change prior to implementing it. This change is called a “modification” and the Meharry IRB has a modification form for investigators to submit. Investigators must also submit a continuing review form to the IRB at least annually in order to be able to continue to work on the study. The IRB will let the investigator know if review must take place more frequently than once per year.

No. If the project ended, the IRB closed the records. If the project is modified and started again, it is considered a new project by the IRB. You must submit a new Human Subjects Review Form and other necessary accompanying materials so the review process can begin again.

Yes. So long as data are being collected for a research project, the IRB must continue to review the status of the protocols and the details of the continuing data gathering activity. If the continued research meets the requirements for expedited review, the expedited review process may be used, if desired by the IRB.

Yes, if there is a clear intent before treating the patient to use systematically collected data that would not ordinarily be collected in the course of clinical practice in reporting and publishing a case study. Treating with the intent of conducting research should be distinguished from the use of innovative treatment practices.

Yes. All projects involving human subjects must be reviewed by the IRB. On the Human Subjects Review Form, you should indicate to the IRB that it is a submission based on a previously approved protocol. Please provide the title and study number of the previously approved protocol.

Cooperative protocol requirements may be standard, but the research setting is not standard across institutions. In addition, one should not assume that because a protocol or informed consent document has been reviewed by another entity it necessarily conforms to pertinent regulations, local laws, or the local research setting. For example, local laws, institutional policies and constraints, professional and community standards, and population differences are all factors that can influence the research setting. (See 45 CFR 46.103(d), 46.107(a), and 46.111(a)(3), noting the relevance of the particular setting in which the research is to take place.)

The proper approach is for the independent investigator to seek permission from OHRP (and the institution) to rely upon the IRB of a local institution with an OHRP-approved Assurance for the research in question. If no such local institution is available or permission is denied, the independent investigator must identify another IRB that holds an appropriate Assurance for reviewing the research. It will be important for the investigator to ensure that the IRB he or she selects can evaluate the research in accordance with the needs of the research setting (e.g., local laws, professional and community standards, and cultural differences due to different geographical or research settings).

Contact Administration

Institutional Review Board
Harold D. West Basic Sciences Building, Room 2215
Meharry Medical College
1005 Dr. D. B. Todd Jr. Boulevard
Nashville, Tennessee 37208
irb@mmc.edu
615.327.6735