Departments

Rational of RDRC

The Research development and Review Cell (RDRC) is to enhance oral health by transferring basic and applied research knowledge and new technical advances into patient-oriented research Project. The purpose of the department is to give dental students a chance to experience both basic and clinical research from a hands-on perspective by participation in an ongoing research investigation that to promote research culture in students and faculty. Enhance research capabilities of AIDM. Produce potential researchers and add scientific knowledge in national and international databases.

Extending Research Opportunities

In addition to building oral health research capacity by training more and better researchers and policymakers should also explore creative strategies to extend traditional avenues for acquiring clinical knowledge and to make use of untapped faculty resources. Such strategies will also help college to respond to patient and purchaser pressure for more and quicker information about the effectiveness of different clinical strategies.

Focus of Research and Research Training

To build clinical and basic science research opportunities for undergraduate to enrich their education in the research capacity and resources as well as foster relationships with other researchers, that they can take advantage of the statistical, data base, communications, measurement, and other research techniques and protocols that are emerging from the growing field of outcomes research.

Expanding Research Capacity and Accomplishments

The student conduct research within the dental college and also collaborate with other colleges. The students who are involved in research have opportunities to author manuscripts, present their results at national and international conferences’, and successfully compete for awards and grants inside and outside of the dental college and also to published in AJDMS journal.

Benefits of Research Development and Review Cell

• Support a research program that includes clinical research, evaluation and dissemination of new scientific and clinical findings, and research on outcomes, health services, and behavior related to oral health
• Enhance its research program, when feasible, to the basic sciences and to the transformation of new scientific knowledge into clinically useful applications.
• Look forward to all faculty to be critically knowledgeable about scientific advances in oral health and to stay current in their teaching and practice and encourage all faculty to participate in research.
• Continue to evaluate and improve its extramural training and development programs.
• Focus more resources on those extramural programs with greater demonstrated productivity in strengthening the oral health research capacity of dental schools and faculties
• Preserve some funding for short-term training programs intended primarily to increase research understanding and appreciation among clinical teaching faculty and future practitioners.

The AIDM-RDRC is composed of a minimum of the following members:

1. Chairperson
2. Deputy Chair
3. Senior Medical Academics/Senior Health Professionals
4. Continue to evaluate and improve its extramural training and development programs.
   a) Medical (at least one)
   b) Dental (at least one)
   c) Health (at least one)
5. Statistician (at least one)
6. Non Institutional Members (at least one)
7. Social/Behavioral Scientist (meaning not in medical, dental or any allied health sciences) (at least one)
8. Female Member (at least one if not represented in any of the above group)
9. Member Secretary (at least one)

Chairperson:

• Recommends committee members
• Recommends policy amendments and changes
• Supervises meetings
• Represents AIDM-RDRC in national and international ethics forum
• Coordinates with stakeholders outside AIDM
• Classify the review (full board, expedited or exempted) for initial protocol submissions
• Oversees the operations of the AIDM-RDRC and all subcommittees
• Supervises the management of the AIDM-RDRC Office
• Acts on suggestions, complaints, and queries from stakeholders
• Ensures AIDM-RDRC compliance with international, national and institutional policies governing human subject research
• Ensures budget adequacy for AIDM-RDRC operations and activities

Deputy Chair:

• Chairs meetings when the Chair is absent or unable to perform the duties of the Chair.
• Assume the responsibilities of the Chair in his absence.

Member Secretary:

• Oversee preparation and accuracy of the agenda of the meeting.
• Supervise the preparation of the minutes of the meeting and approved the minutes of the meeting
• Familiarize him/herself with the international and national guidelines on research ethics
• Participate actively in the Full Board Review meetings and other AIDM-RDRC meetings.
• It is expected that a member secretary will have at least 50% attendance during the period of appointment
• Perform other AIDM-RDRC related tasks that may be assigned to him/her by the
  Chairperson

Secretary

• Prepares and issues the schedule of every AIDM-RDRC meetings
• Prepares the meeting agenda and ensure all necessary documents are attached to the agenda
• Makes prior review of the applications to ensure their completeness
• Distributes the agenda and papers
• Sends out invitation to Principal Investigator(s) notifying the date to attend the meeting atleast five (5) working days in advance
• Prepares the venue of the meetings
• Takes minutes of the meeting
• Is not eligible for voting or giving opinion in the meeting
• Destroys the copies of the proposals which have been reviewed immediately after the meeting leaving the master copy for archiving
• Ensures the minute of the meeting which is tabled is checked by the chairperson prior the next meeting.
• Notifies applicants on decisions taken at the meeting and taking other follow-up action as necessary
• Archives the meeting records

AIDM-RDRC Members

• Make a timely and thorough review and decision regarding protocols given to them for evaluation
• Familiarize themselves with the SOPs and the international and national guidelines on research ethics
• Participate actively in meetings of AIDM-RDRC. In the event of multiple absences without valid reason, the member can be recommended to be replaced.
• Participate in decision making
• Participate in the review of the progress reports, final reports and other amendments presented during the meeting
• Maintain confidentiality of the documents and meeting
• Declare any conflict of interest in general and for specific protocols for review
• Participate in required training with proof of attendances
• Submit an updated and signed CV at the start of each term of appointment
• Refer to the Chair for any suggestions, complaints or grievances of research participants, PIs, and/or sponsors.
• Do other AIDM-RDRC related duties that maybe requested of him/her by the Chair when necessary

Principles

Principles that govern research with human subjects:

• Human subject should provide voluntary consent and know the risks of participation.
• The experimental results should be for the greater good of society.
• Experiment should be based on previous animal experimentation.
• Experiment should avoid unnecessary physical/mental suffering.
• No experiments should be conducted if it is believed to cause death/disability.
• Benefits must always outweigh the risks.
• Adequate facilities should be used to protect subjects.
• Experiment should be conducted only by qualified scientists.
• Subject should always be at liberty to stop at any time.
• Scientist in charge must be prepared to terminate the experiment when injury, disability or death is likely to occur.

Basic Principles:
The fundamental principle is respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research, both initially and during the course of the research.

• The investigator’s duty is solely to the patient or volunteer, and while there is always a need for research, the subject’s welfare must always take precedence over the interests of science and society, and ethical considerations must always take precedence over laws and regulations.
• The recognition of the increased vulnerability of individuals and groups calls for special vigilance. It is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor, then allowance should be considered for surrogate consent by an individual acting in the subject’s best interest, although their
  consent should still be obtained if at all possible.

Operational Principles:

• Research should be based on a thorough knowledge of the scientific background, a careful assessment of risks and benefits, have a reasonable likelihood of benefit to the population studied and be conducted by suitably trained investigators using approved protocols, subject to independent ethical review and oversight by a properly convened committee.
• The protocol should address the ethical issues.
• Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied.
• Information regarding the study should be publicly available.
• Ethical publications extend to publication of the results and consideration of any potential conflict of interest.
• Experimental investigations should always be compared against the best methods, but under certain circumstances a placebo or no treatment group may be utilized.

Full Board Review:

Full Board
If the project involves more than minimal risk to participants, project requires a Full Board review. Protocols involving any of the following will
also require Full Board review:
1. Minor subjects (children 17 years of age or younger)
2. Special populations (prisoners, pregnant women, individuals with disabilities)
3. The use of video- or audiotape to record subjects
4. Asking questions that may be highly embarrassing or compromising (e.g., sexual behavior, sexual orientation, alcohol consumption, illegal
drug use, medical conditions, violations of the law, personal finances, problems in the workplace, etc.)
5. Inflicting physical pain upon, attaching electrodes to, or injecting any substance into subjects
6. Creating high levels of stress, fear, discomfort, or tension
7. Threatening subjects in any way
8. Causing subjects to violate laws or official university regulations
9. Providing some subjects with benefits denied to others (this includes payments or rewards for participation, e.g., offering extra credit to
participants, etc.)
10. Causing physical or mental exhaustion or engaging subjects in intense exercise
11. Placing individuals in confining physical settings or attaching other devices
12. Exposing subjects to extreme conditions (e.g., bright lights, loud noise, intense pressure, strong odors, complete darkness, extreme heat or
cold, sudden movement, etc.)
13. Leaving subjects alone for periods of time longer than 20 minutes
14. Taking hair samples or nail clippings from subjects
15. Taking human tissue samples, drawing blood, or sampling any other bodily fluid

Exempt
Research that is classified as Exempt will not require any further review after the initial approval and only needs to be reviewed by the chair of the IRB.
Categories of Research that qualify as Exempt:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(i) research on regular and special education strategies, or
(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures [if minors are involved, Full Board review is
required], interview procedures [if minors are involved, Full Board review is required], or observation of public behavior UNLESS
(i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and
(ii) Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public
behavior that is NOT already Exempt under #2 if:
(i) The human subjects are elected or appointed public officials or candidates for public office, or
(ii) Federal statute(s) require(s) without exception that confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, or pathological 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.
5. Research and demonstration projects which are conducted by or subject to the approval of [Federal] 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 these programs,
(iii) possible changes in or alternatives to those programs or procedures, or
(iv) payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies,
(i) If wholesome foods without additives are consumed or
(ii) 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 and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited
Research that is classified as Expedited only needs to be reviewed by the chair or by a qualified member of the IRB that has been designated by
the chair. It is, however, subject to annual review.
A research project is appropriate for Expedited review if it involves only minimal risk, but is not classified as Exempt. Minimal risk is defined as risk that is not greater than what one encounters in ordinary daily life or during the performance of routine physical or psychological examinations or tests.