Dr. Saima Pervaiz Iqbal
Professor Family Medicine
Word count: 1200 words
Read time: 6 minutes

               “Calamity is the test of integrity.”

                                                                        Samuel Richardson (English novelist)

Pakistan and its scientific community is unfortunately not generally recognized for its research output on a global scale. This is evident by the limited number of Pakistani universities making their mark internationally as centers for productive research. The reasons for poor output are numerous including lack of critical thinking and creativity, poor infrastructure, lack of role models in academic centers, limited resources, etc. I will not dwell on these because by no means would I want the readers to undermine the importance of generating new knowledge due to constricted circumstances. However, in these Corona times importance of research related to this pandemic is recognized more emphatically. Whether it is to determine risk factors for contracting Covid-19,  or establish the efficacy of possible treatments or determine the burden of psychosocial impacts on a quarantined population the possibilities of research are endless and very much needed for us to move forward and combat the existing circumstances. The Higher Education Commission (HEC) of Pakistan announced funding opportunities for research projects related to Covid-19 and many researchers in Pakistan have grabbed the opportunity and applied for funding. As Chairperson of the Research Ethics Committee of the National Bioethics Committee (NBC-REC) our group has and is, in the process of reviewing these proposals with our Rapid Turnaround Review (RTR) process. We have learned several lessons after going through this exercise and I would like to present some salient points for future researchers to keep in mind before submission of their projects for Ethics Review.

1. Robust science

High standards of ethics constitute the basics of good quality research. Bad science cannot be compatible with ethical research. Therefore, scientists and researchers need to keep this in mind while developing their proposals.  Pandemic situations like the present cannot be used as an excuse for establishing poor scientific practices.

2. Rationale of the research

Conducting research for the sake of research and quick publication is not desirable. If a project is worth doing it is worth doing well. Scientists should weigh the efforts they put into a research project with the desired outcome and impact it will have on scientific knowledge and the community at large. The researcher should ask him/herself, “If I do this research… so what?” Many research projects get stuck in ethical reviews because the Principal Investigator (PI) has not presented a valid case for the conduct of their research.

3. Crisp and clear objectives with measurable endpoints

This is a no-brainer for established scientists. What do you want to achieve and measure? Using the SMART objectives guide is recommended while writing up your proposals to make it easier for the reviewer to understand what is being done. PIs may subdivide their research objectives into Primary outcomes and Secondary outcomes for a clearer picture.

4. Appropriate study design

Select the appropriate study design according to the question being addressed. Monitored Emergency Use of Unregistered Interventions (MEURI) is a recognized study design used in public health emergencies which evaluates the potential use of experimental drugs or treatments. Such studies were conducted during the Ebola outbreak in 2014 and are being conducted even now for COVID 19. MEURIs are used in severe and desperate situations when other options are not available. Use of Convalescent Plasma for Severe cases of COVID 19 is one example of a MEURI.

Other study designs are to be employed according to the study objectives be it an observational study or interventional one like a trial.

5. Selection of appropriate participants

Be careful when developing your inclusion criteria for research participation. It is safer and sound to include adults of both genders but be mindful of vulnerable populations. Vulnerable are those people whose rights can be easily victimized and would be unlikely to protect themselves from anticipated harms and risks from their involvement in research. These include orphan children, pregnant women, terminally ill persons, marginalized groups, ethnic or religious minorities, prisoners and refugees.

6. Therapeutic misconception and informed consent

Therapeutic misconception as the name implies is a term used in research ethics in situations where participants are under the false impression that they will be receiving therapy rather than being enrolled for research in a clinical study. Doctors in Pakistan inculcate a feeling of trust and competence in their patients. When doctors are also researchers the patient or research subject may not be able to distinguish whether they are being provided definitive treatment or are they being involved in research. Therefore, the informed consent form (ICF) must be designed with care for a potential risk of therapeutic misconception. Ideally, the attending physician and researcher should NOT be administering the consent form which could influence or coerce patients to join unwittingly. A third person to administer the ICF would be more appropriate for the participant to make an informed choice. Details of whom to contact in case of emergency is also an essential part of the ICF. Maintaining the privacy of data and confidentiality of research subjects is a given for any ethical research.

7. Safety of participants

The safety of research subjects is of paramount importance in the eyes of the reviewer.  Please provide details as to how this will be secured and the mechanisms in place should a circumstance like an adverse event arise. Researchers have also mentioned follow-up plans for research subjects but how would that be possible if the subject is in quarantine or isolation?

8. Approval from local IRBs

As we receive projects for ethical approval from a National Committee, this does not override the approval from individual institutional review boards (IRBs).  Approval from the NBC-REC may carry clout but IRBs of institutions hosting the research have to be taken on board for approval and acceptance.

9. Data Safety and Monitoring Board (DSMB)/Committee

Research involving potential risks to participants will require to be supervised by an independent board or committee to do interim analysis and assess the data generated. Details about this committee and its members is appreciated in the RTR process.

10. Study team with defined roles

As it is a requirement to define the contribution of authors in a manuscript before submission for publication in a scientific journal, the Ethics review committee also appreciates this information. Quite often we have witnessed esteemed professionals being involved in a high-profile research project without information on their academic contribution.  Who is responsible for conducting research on the ground to ensure that the protocol is being followed and securing patient safety? Who are the data collectors and how will they collect the data given the restrictions on movement? In qualitative study designs, how will interviews and focus groups be conducted?  Have qualified personnel been assigned the jobs and have appropriate roles been given to them? Robust research requires mature and reliable team members as the PI cannot do it alone.

11. Interaction with media

Researchers and scientists shouldn’t interact with media pre-maturely. This has the potential for inducing therapeutic misconception and questioning the integrity of the research and researcher. The intent to generate “hope” in the public quite often morphs into “hype”.

12. Declaration of conflict of interest (COI)

A COI is defined as a situation in which financial or personal considerations or gains may compromise a researcher’s professional judgment in conducting or reporting of the research results. It involves one person (the PI) who has multiple interests. Pharmaceutical companies sponsoring a trial and providing reimbursement or rewards to researchers are one example. The researcher must identify, disclose and manage potential COI.

13. Safety of the researcher and their team

Doctors and health care professionals are being hailed as frontline warriors in the Corona pandemic. Researchers should also be acknowledged for their efforts and the safety of researchers and their teams is of importance. They may need personal protective equipment in some situations requiring data collection. Their involvement in research rather than patient care and actively saving lives should not compromise their health and safety. There is a possibility that the PI or co-PI may develop the disease and may need to go into isolation. Such a situation warrants a backup plan for the smooth conduct of the project and the involvement of other team members.