Research involving biological samples can vary depending on the source and identifiability of the material. Below are the categories commonly used to classify such studies.

• a) In Vitro using Anonymous or Unidentified Samples: Studies conducted outside a living organism using biological materials where the source cannot be linked back to a specific individual.
  Example: A dental researcher analyzing the efficacy of a new disinfectant on commercially available biofilms with no patient identifiers.
• b) In Vitro using Anonymized Samples (Coded or Reversibly Anonymized): Studies using samples that have a reversible code that could potentially allow re-identification.
  Example: A nursing student analyzing cytokine levels in leftover blood samples from a hospital biobank, labeled with a code linked to patient demographics but not direct identifiers.
• c) In Vitro using Anonymized Samples (Irreversibly Anonymized): Samples from which all identifiers have been permanently removed, making re-identification impossible.
  Example: A medical researcher studying gene expression in archived FFPE tissue samples where patient identifiers were permanently removed.

• d) In Vitro using Identifiable Samples: Samples that can be directly linked to an individual.
  Example: A dental resident investigating mouthwashes on bacteria cultured from consenting patients' samples.
• e) In Vivo: Studies conducted within living organisms (humans or animals).
  Example: A clinical trial evaluating a new wound dressing on patients with diabetic ulcers.
• f) Both In Vitro and In Vivo: Studies combining lab-based and in-body research components.
  Example: A researcher analyzing stress biomarkers in saliva (in vitro) and administering stress questionnaires (in vivo).

Research projects can be categorized based on their core objectives and the contexts in which they are conducted. Below is a classification of common study types along with practical examples.

• a) Social and Behavioral Research: Studies exploring behaviors, responses, and interactions within various social contexts.
  Example: A nursing study on how educational interventions affect medication adherence, or a dental study on the influence of social media on teen oral hygiene.
• b) Clinical Trial: Systematic studies to assess safety/efficacy of drugs, devices, or interventions in humans.
  Example: Testing a new drug for hypertension or comparing two dental implant techniques.
• c) Academic Clinical Trial: Trials run for academic inquiry using approved drugs in new ways (indications, doses, methods).
  Example: Evaluating a lower painkiller dose for chronic pain, or studying a new dental sealant application technique.

• d) Epidemiological/Public Health Research: Studies on disease distribution, determinants, and control within populations.
  Example: Dental caries prevalence and risk factor analysis in a community, or tracking hospital-acquired infections.
• e) Program Evaluation Research: Research assessing program design, implementation, and outcomes.
  Example: Evaluating a medical school curriculum or a community oral health education program.
• f) Implementation Research: Studies focusing on integrating and scaling evidence-based practices.
  Example: Nursing research on fall prevention protocol adoption, or teledentistry integration in clinics.
• g) Human Genetic Testing Research: Research involving analysis of genes, proteins, or chromosomes for health-related insights.
  Example: Studying genetic cancer susceptibility or genetic links to dental anomalies.
• h) Research on Disaster and Conflict Context: Studies focusing on populations impacted by crises, disasters, or conflicts.
  Example: Assessing displaced persons' mental health post-disaster or evaluating emergency medical services in conflict zones.

Research involving biological samples can be classified depending on their source and whether the materials are identifiable or not. Below are the common categories with explanations and examples.

• a) In Vitro Study – Anonymous or Unidentified Samples: Uses biological materials outside a living organism (in vitro) where the source cannot be linked back to an individual, and no identifiers were ever collected or were permanently removed.
  Example: Analyzing the efficacy of a new disinfectant on commercially available biofilms with no patient identifiers; studying gene expression in archived tissue samples where all patient identifiers were permanently removed during initial archiving.
• b) In Vitro Study – Anonymized Samples (Coded or Reversibly Anonymized): Uses biological materials outside a living organism (in vitro) that have been coded or linked to an existing dataset, allowing potential re-identification by a third party with access to the code/link.
  Example: Analyzing cytokine levels in leftover blood samples from a hospital biobank, labeled with a code linked to patient demographics but not direct identifiers, where the link could be unencrypted by the biobank.
• c) In Vitro Study – Identifiable Samples: Uses biological materials outside a living organism (in vitro) where the source can be directly linked to a specific individual by the research team.
  Example: Investigating the effect of different mouthwashes on oral bacteria cultured from samples collected directly from consenting patients in your clinic.
• d) In Vivo Study (Directly within Living Organisms): Involves direct interventions, observations, or measurements within living organisms (e.g., humans, animals). Biological samples may be collected, but the primary research focuses on the living subject.
  Example: A clinical trial evaluating the effectiveness of a new wound dressing on patients with diabetic ulcers; assessing drug metabolism in an animal model; collecting saliva samples from participants to analyze stress biomarkers while also assessing their perceived stress levels through questionnaires.

As a researcher, it is essential to carefully consider any potential risks that participants may face in your study. You should evaluate the likelihood and severity of these risks and weigh them against the potential benefits or knowledge the research may generate. The expected benefits should always outweigh any possible risks.

• Risk–Benefit Assessment: Researchers are expected to briefly summarize their assessment of potential risks and benefits of the study. This ensures transparency and demonstrates that risks have been considered in relation to anticipated knowledge or participant benefits.
• Managing Potential Risks: If the study involves risks greater than those encountered in daily life (e.g., minor discomfort, psychological sensitivity, physical procedures), researchers must describe the measures they will take to minimize risks and protect participants.
• Examples of Risk Management Strategies:
  • Blood Draw Studies: Conducted by trained professionals using sterile equipment, with participants monitored for immediate reactions.
  • Sensitive Personal Questions: Ensuring privacy and confidentiality through anonymous surveys, secure data storage, and restricted access.
  • Exercise Program Studies: Pre-screening participants for health conditions and supervision by qualified instructors to ensure safety.

This question aims to understand your plan for monitoring and reporting any unexpected and unfavourable medical occurrences that a research participant might experience during your study. It's crucial to have a clear process in place to ensure participant safety and the integrity of the research data.

• What are Adverse Events (AEs)?

  An adverse event is any untoward medical occurrence in a research participant which does not necessarily have to have a causal relationship with the treatment. This can include any unfavourable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the participant's involvement in the research.

• What are Serious Adverse Events (SAEs)?

  An adverse event is considered serious when it results in: death, life-threatening injury requiring hospitalization, prolongation of hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to prevent permanent impairment or damage.

• Procedures to Describe
  • Monitoring for AEs and SAEs: How will you actively or passively monitor participants throughout the study (e.g., check-ups, questionnaires, lab tests, participant self-reporting)?
  • Documenting AEs and SAEs: What methods will you use to record events, including severity, participant experience, and actions taken?
  • Reporting SAEs: Specify timelines and procedures for reporting SAEs to the Ethics Committee, regulatory authorities (if applicable), and sponsors. Clarify who is responsible and the reporting channels.
  • Assessing Causality: How will you determine whether an AE or SAE is related to the study intervention or procedures?
  • Managing AEs and SAEs: What steps will you take to manage AEs/SAEs, including medical care and participant follow-up?

By clearly outlining your AE and SAE reporting plan, you demonstrate your commitment to participant safety and ethical research conduct.

Researchers may apply to the Ethics Committee (EC) for a waiver of the requirement to obtain informed consent from participants under specific circumstances, provided the research involves less than minimal risk and the waiver will not negatively impact participants' rights.

Grounds for Consent Waiver

• A. When the research cannot be practically conducted without the waiver and there is a sound scientific justification.
• B. For retrospective studies where participants are de-identified or cannot be contacted.
• C. For research using anonymized biological samples or data.
• D. For certain public health studies, surveillance programs, or program evaluation studies.
• E. For research utilizing data available in the public domain.
• F. During humanitarian emergencies and disasters when participants may not be able to provide consent (with attempts to obtain consent later if feasible).

Specific Considerations for Public Health Research

Consent may be waived in situations such as:

• Research involving routinely collected, anonymized data.
• When obtaining consent is impractical for stored samples/data or surveillance activities.
• Evaluations of national public health policies and programs.
• Program improvement studies.
• Authorized health registries.
• Cluster randomized trials where individual consent is not practical.

EC Approval is Mandatory

Researchers cannot independently decide if their study qualifies for a consent waiver. A formal application with appropriate justification must be submitted to the EC, whose decision will be made on a case-by-case basis. For anonymized samples/data, approval from the institution's EC or the repository's EC for a waiver is required.