The video lecture can be also downloaded from here.

1. Standard Operating Procedures for the Ethical Review of Research Involving Human
Subjects, Federal Ministry of Health Khartoum, Sudan, 2023
2. Standards and operational guidance for ethics review of health-related research with
human participants, WHO, https://www.who.int/publications/i/item/9789241502948

6 thoughts on “Module 2”

1. 1- yes its human subject, because its Assessment of Attitudes and Perceptions of such people those whom smoking cigarette.
   2- It is Full Board Review the default procedure for all research projects
   involving human participants.
   •The following are examples of research projects
   that may require a Full Board REC review:
   • Projects involving moderate to serious physical, emotional,
   psychological, legal, social, or economic risk to participants.
   • Projects involving sensitive questions or invasive procedures.
   • Projects involving vulnerable populations
   • Projects where there is a possibility of coercion
   • Projects involving partial disclosure or deception
   • Progress report(s),Annual report(s) and Final report are required.
   my enter point here, which raise question
   Is in n our multi-cultural and multi-ethnic society, investigations involve individuals of
   different ages, gender and social background; investigators may not have
   sufficient knowledge of the implications of any investigations for the
   participants, how researchers avoid any harm which might be caused by carrying
   out or publishing the results of the research project.

   Reply

2. Q1- yes this human subject is considered a research subject because he is a living individual about whom an investigator is conducting research to gain: 1- Data through interaction with the individual. 2- gaining Identifiable private information (obtaining data from living individuals).
   Q2- the level of review for this research
   1- independent Research Ethics Committee (REC)
   type of reviewing:
   1- Expedited review; Applicable for research activities that involve minimal risk to the human participants with no vulnerable population, progress, or annual report(s).
   2- Full Board Review (2 Members assigned as primary and secondary reviewers)
   3- Protocol and consent forms and other documents discussed at the meetings. then the members voting, the voting could conclude the following :
   1- Approving.
   2- Approval with minor changes to research.
   3- Deferral.
   4- Disapprove

   Reply

3. my question is about the legal aspect of the ethical board committee it always ensures the legal rights of human participants in clinical trials especially if globally known companies like Pfizer have very established legal attornies to protect their interests, and if so are they getting compensated and their medical bills paid to respect their dignity as human beings for example the Trovan Case in Nigeria!

   Reply

4. Yes it is a human subject research because it involves interaction with humans.
   Would be an expedited research it involves minimal risk without intervention

   Reply

5. Q1: Yes, collecting data through a questionnaire from specific individuals qualifies as human subjects research because it involves obtaining information from people for research purposes.

   Q2: The study likely fits the exempt category because it poses minimal or no risk to participants, assuming the questionnaire does not collect sensitive information or require procedures that may harm participants.

   Reply

6. 1/ yes this is study on human subjects as it involves collection of personal information
   2/ Expedited review: this is minimal risk study towards participants since it use anonymous quetionnaires it collect sensetive data even though their is need to ensure ethical conduct

   Reply