Institutional Review Board

1. At the time of review in a convened meeting a quorum meeting following requirements must be present
   • The IRB must have at least five members.
   • The IRB must include at least one scientist and at least one non-scientist.
   • The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution.
2. The IRB of SKMCH&RC will be composed of at least ten (10) members and each member will be appointed for a minimum period of two years. The IRB will meet monthly or earlier if needed.
3. IRB members who are affiliated with the institution should maintain minimum of 30% collective participation in IRB review activities however, this would not apply to members who are not affiliated with SKMCH&RC, and serving on IRB on voluntary basis. Participation of affiliated members in IRB is assessed as part of their annual appraisal.
4. Nominations for prospective IRB members are invited from colleagues for both scientist and non-scientist members to serve on IRB, at the time of expansion of IRB membership, which are further reviewed by hospital leadership.
5. A clinical research office member will function as the secretary to the IRB and will assist the principal investigator (PI) & the sponsor in obtaining ethical approval from the IRB.
6. The scientific content of all research projects presented to the IRB must have been validated prior to submission to the IRB.
7. All the necessary documents must be completed and submitted to the secretary to the IRB by the concerned parties at least four weeks prior to the proposed date of the meeting.
8. An IRB processing fee must be submitted to the clinical research office before the meeting. The fee is Rs.30,000 for pharmaceutical sponsored trials and Rs.3,000 for external postgraduate student projects. Undergraduate students and investigator-initiated studies by SKMCH&RC staff and are not subjected to an IRB processing fee.
9. The secretary will make sure that final versions of the following documents are sent to all IRB members for review:

IRB application (Online IRB application can be accessed at link:

(https://apps.shaukatkhanum.org.pk:4433/online/irb/index.php)

• A copy of synopsis along with the attached Scientific Review Committee approval and the IRB approval request
• study protocol (and any amendments)
• consent form & subject information sheet both in English & Urdu
• Study questionnaire/data collection form/interview guide as applicable
• A copy of the Investigator Brochure and any other available safety information
• Information about payments and compensation available to subjects
• The Investigator’s current curriculum vitae.
• Any other documents specifically requested by the IRB

10. After reviewing the above documents, the IRB will issue a letter confirming that it has reviewed the concerned documents (adding the dates & version seen) and outlining its decision with regard to the proposal.

11 During a convened meeting, all IRB members will perform the review of each study and will be expected to

• explicitly state that, in his/her opinion, the criteria required for approval have been met, and vote (for/against)
• propose a specific frequency for continuing review
• carefully describe the proposed conditions or basis for requiring changes or in disapproving research, in cases where approval is not granted
• IRB decision will be made by majority vote, and voting information will be recorded in meeting minutes

12. Using the above procedures, the IRB may approve, reject, modify or defer any application, pending further information. The decision of the IRB will be conveyed to the principal investigator (PI) and the sponsor and a copy will be retained in the Investigator’s Study File & IRB folder.

13. Only those IRB members who are independent of the investigator teams and the sponsor of the study/trial can vote/proffer an opinion on a study/trial-related matter.

14. Only those members who actually participate in the IRB review & discussion can cast a vote/provide an opinion or advice

15. In special circumstances, the IRB can invite non-members with particular expertise for assistance.

16. No subject will be enrolled in any study/clinical trial before the IRB issues its written approval of the study protocol.

17. No deviations from, or changes to, the protocol will be initiated without prior written IRB approval of any proposed amendments, except when necessary to eliminate immediate hazards to the subjects or when the change involves only logistical or administrative aspects of the research projects (e.g. change of the investigator).

18. The investigator will be required to continue to report to the IRB as follows:

• • Periodic progress report (at least annually)
  • Deviation from, or changes to, the protocol designed to eliminate immediate hazards to the study/trial subjects.
  • Changes increasing the risk to subjects and/or affecting the conduct of the study/trial significantly.
  • All adverse events that are serious and/or unexpected.
  • New information that may affect the safety of the subjects or the conduct of the study/trial adversely.
  • The investigator will also inform the IRB if there are any changes to the consent document as a result of any new safety concerns as the participants will need to be re-consented in that case. Any amendment to the informed consent document will be submitted to the IRB for its review and approval prior to its implementation.

19. The secretary to the IRB will be responsible for maintaining all relevant records (e.g., written procedures, membership lists, submitted documents, minutes of meetings and correspondence) for a lifetime period after the completion of the study and make them available upon request from any appropriate regulatory authority(ies). The secretary IRB is also responsible for submitting an annual report of research review activities to the clinical executive board (CEBs) for a review of the research review function.

20. Human subject research involving no more than minimal risk qualifies for exemption. It means that the proposed research activity is exempt from full quorum review by IRB, and no further correspondence is required. A review by IRB chairperson and one of the designated IRB members is required, and it is completed in two to four (2-4) weeks of submission. This type of review is applicable when research involves secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects

Investigators should not make final determination that their research is exempt.  IRB is an authorized body to make the final determination of exemption.

21. IRB review also ensures that informed consent in research is documented as per GCP requirements and hospital policy on informed consent. A template document outlining requirements for consent in research is available with the clinical research office for investigator use. The investigator should ensure that the following is covered during the process of informed consent for research studies

• • an explanation of the research, duration of patient participation, and procedures to be followed by patients;
  • expected benefits;
  • potential discomforts and risks;
  • alternative treatments and procedures that might also be beneficial;
  • the extent to which confidentiality of records will be maintained;
  • compensation or medical treatments available if an injury occurs;
  • a statement that participation is voluntary;
  • assurance that refusal to participate or withdrawal from participation will not compromise care or access to the hospital’s services; and who to contact with questions about the research.

22. A sub-set of research activities may qualify for a waiver of informed consent if it meets following criteria:

• The research involves no more than minimal risk to subject and involves no procedures for which informed consent is normally required outside of the research context.
• The waiver or alteration will not adversely affect the rights and welfare of the subjects.
• The research could not practically be carried out without the waiver or alteration.
• Whenever appropriate, the subjects will be provided with additional information after participation

23. Review of application during Pandemics & Public Health Emergencies

IRB will use its best efforts to continue to function during a pandemic. It will provide a rapid but robust review. IRB will adapt to meet by video conferencing and accept online reviews (in place of signed forms)

IRB will further ensure that practical and meaningful consent process is in place for patients affected by diseases outbreak. If appropriate, alterations in the informed consent process, including waiver of informed consent and verbal consent can be approved by IRB.

24. To obtain an application template, guidelines for IRB approval and for any further information regarding IRB approval, please contact:

Clinical Research Administrator

Shaukat Khanum Memorial Cancer Hospital & Research Centre

7 – A, Block R – 3, Muhammad Ali Johar Town, Lahore

Tel: +92 (0)42 35905000 Ext. 4280

Fax: +92 (0)42 35945209

E-mail: [email protected] 

Criteria for IRB Approval of Research

Institutional Review Board (IRB) is responsible for reviewing and approving all Clinical Research Projects undertaken in the hospital or involving the hospital’s patients or patient data.

The principal duty of the IRB is to safeguard the welfare of patients who participates in research (participants). It primarily evaluates the ethical aspects of the planned study.

The IRB judges that the investigator is suitable to conduct this research (sufficiently qualified and experienced), and ensures that the rights of study participants are protected from possible risks of research.

In order to approve research under review, IRB should determine that all of the following requirements are satisfied

1. Risks to subjects are minimized by using:

i) procedures consistent with sound scientific design and which do not unnecessarily expose subjects to risk

ii) whenever appropriate by using procedures already being performed on subjects for diagnostic or treatment purposes

2. Risks to subjects are reasonable in relation to the anticipated benefits

3. Selection of subjects is equitable (Are these participants appropriate to the research question)

4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative

5. Informed consent will be appropriately documented

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects

7. When appropriate, there are adequate protections to protect the privacy of subjects and to maintain the confidentiality of data.

Note: When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as hospital staff, children, prisoners, pregnant women, mentally disabled, or economically or educationally disadvantaged persons, IRB should ensure that appropriate safeguards have been included in the study to protect the rights and welfare of these subjects. In cases where research involves the participation of hospital employees, IRB should ensure that mechanisms are in place to obtain voluntary participation and appropriate confidentiality. Informed consent must state that refusal to participate will not result in any loss of privileges or negative impact on evaluation.

As per ICH-GCP, all researchers involved in research must ensure the following as part of responsible conduct of research

• The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the research
• The investigator should be thoroughly familiar with the research protocol, should be aware of, and should comply with, GCP and the applicable regulatory requirements.
• The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority (ies) where applicable.
• The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties
• The investigator should ensure availability of adequate resources for conducting a research study such as adequate time allocation to research activities, qualified and trained staff as members of research team and other logistics as per study need.
• The principal investigator of a study has ultimate responsibility for maintaining study oversight (including but not limited to ensuring protocol compliance, investigational products accountability) and for supervising any individual or party to whom the investigator delegates trial-related duties and functions.
• A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.
• During and following a subject’s participation in a trial, the investigator should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial.
• The investigator is responsible for ongoing ethics and regulatory communication as applicable with relevant committees following initial approval of the study.
• Investigators are responsible for obtaining and documenting informed consent from research participants as per approved protocol consent procedures. In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki. Neither the investigator nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial. Once consent has been obtained, research participation should be clearly recorded in the research subjects’ hospital records, and a copy of the signed consent must be retained in the research files.
• The investigator should maintain adequate and accurate source documents and research related records.
• The investigator should submit written summaries of the trial status to the IRB at least annually, or more frequently, if requested by the IRB.
• All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator’s Brochure) identifies as not needing immediate reporting.
• If a clinical trial is prematurely terminated or suspended for any reason, the investigator should promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects, and, where required by the applicable regulatory requirement(s), should inform the regulatory authority (ies).
• Upon completion of the research study, the investigator, where applicable, should inform the IRB with a summary of the trial’s outcome, and the regulatory authority (ies) with any reports required.
• For research projects undertaken as part of training requirements, following are the supervisor responsibilities for oversight of such research activities
  • Supervisor to only allow project initiation once IRB approval is confirmed and should conduct regular project update meetings
  • Promptly notify the institution in case of any research misconduct which may lead to suspension of the study or termination of ethics approval for that study.