At MSM, the primary purpose of the IRB is to protect the rights and welfare of human research subjects by ensuring that physical, psychological, and/or social risks to subjects are minimized, and when present, justified by the importance of the research, and agreed to by subjects (informed consent).
Secondly, the IRB seeks to protect MSM and researcher(s) from possible adverse consequences of research with human subjects, by assisting the researcher with the design of his/her study so it complies with federal regulations and MSM requirements.
Human Subjects Research at MSM
Research is defined as “a systematic investigation (including research development, testing, and evaluation), designed to develop or contribute to generalized knowledge” [45 CFR 46.102(d)].
Human subjects are defined as “living individual(s) about whom a researcher (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information” [45 CFR 46.102(f)].
All research conducted by MSM agents (faculty, students, and staff) at MSM or elsewhere, or by researchers of other institutions conducting research at MSM, using living humans as research subjects, or using samples or data obtained from living subjects, directly or indirectly, with or without the subjects’ consent, must be reviewed prior to starting by the MSM IRB.
Review and approval by another IRB does not negate the requirement for review and approval by the MSM IRB.
The MSM IRB:
- Reviews all research studies involving human subjects
- Reviews and addresses concerns involving the use of human subjects in research
- Advises faculty, staff and students on the ethical conduct of research involving people
- Conducts appropriate reviews of the Institution’s program and develops guidelines to ensure compliance with federal and state regulations
- Participates in developing, reviewing, and providing educational opportunities for the MSM community on the use and protection of human subjects in research
- Serves in an advisory capacity to the Dean and Senior Vice President for Academic Affairs as well as the Vice President and Senior Associate Dean for Research Affairs.
Before a human subject research project is initiated it must first be reviewed and approved by the IRB and then conducted in full compliance with institutional guidelines and policies. Applications should be made through IRBNet, and can be submitted at any time. The IRB conducts three types of reviews depending on the level of risk the study.
Per federal regulations, the IRB cannot approve a research study ex post facto. Conducting research with human subjects at MSM without IRB approval is a violation of MSM policy. Researchers conducting studies without IRB approval are subject to the sanctions administered by the institution.
Full Board Review
Studies requiring Full Board review present more than minimal risk to subjects, and/or involve vulnerable populations, such as children, prisoners, institutionalized individuals, or persons with diminished capacity to consent (e.g., Alzheimer patients). These studies must be reviewed by the IRB at a convened meeting, and do not qualify for expedited or exempt review.
Common examples of research reviewed at the Full Board level at MSM are studies that include:
- Maximal exercise (VO@) Max) by healthy volunteers
- Children as subjects or participants
- Institutionalized persons (e.g., prisoners, patients in long term care facilities)
- Persons who lack capacity (e.g., persons with severe mental or physical disabilities)
- Sensitive topics (e.g., criminal behavior, sexuality)
- Testing of a new drug or device
- Use of an approved drug or device in a manner not yet approved by the FDA
Actions taken on a study at a convened IRB Meeting.
After review and discussion of a study at a Board meeting, the committee may take 1 of 4 actions on the study:
- Approve: The application package is complete and the consent form is at the appropriate reading level (8th grade or less), the protocol is clear and is accurately described in the consent form, the application for review is thorough and clearly written, and other associated materials are complete.
- Approved contingent upon specific minor modifications or clarifications: This might include fixing of minor consent form errors such as typos, omissions, syntax and/or spelling or could require clarification about minor inconsistencies. Consent forms, applications or protocols that require more than minor corrections will be tabled and reviewed again after the corrections are made.
- Tabled: The Board may decide that the consent form needs modification, that there are too many unanswered questions about the protocol, or the application for review does not adequately outline the study to be conducted. The study is usually reviewed at the next meeting following receipt of adequate revisions.
- Not Approved: A study might be disapproved when the study design does not adequately protect the safety or well-being of the participants, the recruitment goal has little chance of being reached, or continuing non-compliance by the investigator.
To qualify for Expedited review, research must fall into any of nine (9) regulated categories. Expedited categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.
Expedited reviews are conducted by one or two IRB members. Common examples of Expedited research at MSM are:
- Studies including blood samples taken from healthy volunteers
- Studies involving moderate exercise by healthy volunteers
- Analyses of data collected via recordings (such as those taken in the investigation of speech defects)
- Studies of existing data or pathological specimens that include identifying information
- Linguistic and ethnographic studies
- Studies involving focus groups.
To qualify for Exempt level review, the research study must fall into any of six (6) categories delineated in the federal regulations.
Exempt DOES NOT mean the study is exempt from IRB review. The categories represent studies that present minimal risk to subjects. Risk is reduced through anonymity of responses, use of data from human subjects that is existing or publicly available, or through the use of non-invasive paradigms that will not harm subjects.
Exempt reviews are conducted by one IRB member. Common examples of Exempt research at MSM are:
- Anonymous surveys
- Educational tests
- Studies using human subject data or information that is publicly available (such as that from a data repository or purchasable data set)
- Observation of public behavior that does not put subjects at risk.
Special guidelines apply to children included in research classified as Exempt.
IRB Membership and Meeting Schedule
The full Board meets on the 3rd Wednesday of every month except November and December. A combined meeting for November and December is held the 1st or 2nd week of December. This schedule is subject to change depending on the business to be conducted.
Applications may be submitted at anytime on IRBNet. Those studies to be reviewed by the full Board usually need to be submitted 6 weeks before the meeting date. This allows time for screening of the application in the IRB Office, a pre-review by a primary reviewer Board member, initial corrections by the investigator, a thorough review by a Board member, additional corrections by the investigator, and review by all Board members for deliberation at a convened meeting.
The IRB is constituted according to federal regulations. It includes scientists (with clinical, basic, and behavioral/social science research backgrounds), non-scientists, community members and prisoner research advocates. The current committee (2009-2010) consists of 20 members plus 2 alternates.
Raymond J. Barreras, Ph.D.
Phone: (404) 892-7219
Rhonda Conerly-Holiday, Ph.D.
Assistant Professor, Department of Community Health & Preventative Medicine
Phone: (404) 756-5042
JoAnn Cross, RN
Morehouse Medical Associates
Phone: (404) 756-1420
Elvan Daniels, MD
IRB Vice Chair
Assistant Professor, Department of Community Health & Preventive Medicine
Phone: (404) 756-6713
Yvonne Fry-Johnson, MD
Assistant Professor, Department of Pediatrics
Phone: (404) 756-5761
Russ Havlak, MPA
Phone: (404) 639-0338
Brenda Hayes, DSW, MPH
Assistant Professor, Department of SRA
Phone: (404) 756-5794
Jacqueline Hibbert, Ph.D.
Associate Professor, Department of MBI
Phone: (404) 752-1737
Kisha Braithwaite Holden, Ph.D.
Assistant Professor, Department of Psychiatry
Phone: (404) 756-8923
Priscilla Igho-Pemu, MD
Assistant Professor, Department of Medicine/CRC
Lilly H. Immergluck, MD
Associate Professor, Department of Pediatrics
Priscilla Johnson, Ph.D.
Research Administrator, CRC
Brenda Klement, Ph.D.
Assistant Professor, Department of Medical Education
Phone: (404) 752-1637
Sandra Moore, MD
Assistant Professor, Department of Pediatrics
Phone: (404) 756-1371
Julian Menter, Ph.D.
Professor, Department of Medicine
Phone: (404) 752-1700
Carlos Pavao, MPA
Dekalb Board of Health
Phone: (404) 918-4850
Christopher Phillips, MD
Assistant Professor, Department of Medicine
Phone: (404) 616-0735
Quarshie Alexander, MD
Assistant Professor, CRC
Phone: (404) 752-8681
Karen Russell-Randall, Ph.D.
Assistant Professor, Department of Pharmacology & Toxicology
Phone: (404) 752-1875
George Rust, MD
Professor, Department of Medicine
Phone: (404) 752-1236
John C. Smith, MSW
Department of SRA
Phone: (404) 752-1973
Kevin Stein, Ph.D.
American Cancer Society
Phone: (404) 982-3640