Research Ethical Review Checklist

Research Ethical Review Checklist

Institutional Research Ethics Checklist

This checklist must be completed and submitted through email (oric@cmhlahore.edu.pk) along with the research synopsis to the ORIC-CMH LMC & IOD.

Undergraduate Student ?

Postgraduate Resident: ?

Faculty: ?

Other: ? _______________________________

For office use only

ORIC No: _______________________________

ERC No: _______________________________

Department/School/Other Unit:

Program of study (if applicable):

Name of Principal investigator:

Name of Supervisor:

Corresponding E-mail:

Name/s of all co-investigators:

Project Title:

Start date:

End date (cannot be retrospective):

Number of participants (if applicable):

Funding Source (if any):

1. Participant Information and Consent

Are you gathering data from people?

If yes:

(a) Have you attached a participant information sheet explaining your approach to their involvement in your research and maintaining the confidentiality of their data?

(b) Have you attached a consent form?

YES ? NO ?

2. Data Source and Protection

Are you gathering data from secondary sources such as websites, archive material, and research datasets?

Have you read the data protection guidelines? (https://www.isaca.org/resources/news-and-trends/industry-news/2024/achieving-ethical-protection-of-data-privacy#f6)

(a) Have you considered and addressed data protection issues relating to storing and disposing of data?

(b) Is this an auditable form (can you trace the use of the data from collection to disposal)?

Have you planned to share data with third parties, have you obtained appropriate consent and safeguards?

YES ? NO ?

3. Vulnerable Participants

Are you gathering data from people who are considered vulnerable participants (e.g., children, pregnant women, prisoners)?

If yes:

Have you read the guidelines for proceeding with research and obtaining consent from vulnerable participants (e.g., children, people with learning disabilities, your students)? (http://nbcpakistan.org.pk/assets/national-guidelines-for-collection%2c-usage%2c-storage-and-export-of-human-biological-materials-20202.pdf)

YES ? NO ?

4. Sensitive Data and Study Protocol

Have you read the Helsinki – Ethical Principles for Medical Research Involving Human Participants (https://www.wma.net/policies-post/wma-declaration-of-helsinki/)
Will the study involve using participants' images or sensitive data (e.g., personal details stored electronically, image capture techniques)?

Did the participants specifically consent to the related images or sensitive data?

Will the study involve discussion of sensitive topics (e.g., sexual activity, drug use)?

Could the study induce psychological stress or anxiety in participants or those associated with the research, however unlikely you think that risk is?

Have you ensured that your research is culturally sensitive and respectful of diverse perspectives?

YES ? NO ?

5. Biological Samples and Invasive Procedures

Will blood or tissue samples be obtained from participants?

Is your research governed by the Ionizing Radiation (Medical Exposure) Regulations (IRMER) 2000?

Are drugs, placebos, or other substances (e.g., food substances, vitamins) to be administered to the study participants, or will the study involve invasive, intrusive, or potentially harmful procedures of any kind?

Is pain or more than mild discomfort likely to result from the study? Please attach the pain assessment tool you will be using.

Will the study involve prolonged or repetitive testing or does it include a physical intervention?

Are you gathering data from laboratory animals?

Have you read ethical guidelines for using laboratory animals for medical research purposes? (https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf)

YES ? NO ?

6. Incentives and Risk Assessments

Will financial inducements (other than reasonable expenses and compensation for time) be offered to participants?

Have you undertaken Risk Assessments for each of the procedures that you are undertaking?

YES ? NO ?

7. Researcher-Participant Relationship and Conflicts of Interest

Is there an existing relationship between the researcher(s) and the participant(s) that needs to be considered? For instance, a lecturer researching his/her students, or a manager interviewing her/his staff, if yes, please declare.

Will there be transparency regarding funding sources and potential conflicts of interest?

YES ? NO ?

8. Ethical Guidelines and Dissemination

Is the research compliant with national ethical guidelines and regulations? (http://nbcpakistan.org.pk/assets/hbm-nbc-guidelines-final-18june-2016.pdf)

Is there a plan to disseminate findings to participants and the wider community?

YES ? NO ?

9. Contact for Ethical Reporting

Have contact details been included for reporting and addressing ethical issues that may arise during the research?

YES ? NO ?

10. Collaboration and Partnership:

Are you collaborating with other researchers or institutions?

If yes, then mention the details of collaboration in the research synopsis.

Do you have clear ethical guidelines and expectations established for your collaborators?

Have you considered involving the community in the research process to ensure that it is relevant and beneficial to their needs?

Is any of the research activity taking place outside of Pakistan?

YES ? NO ?

11. Security-Sensitive Research

Does your research fit into any of the following security-sensitive categories?
1. Commissioned by the military
2. Involves the acquisition of security clearances
3. Concerns terrorist or extreme groups

YES ? NO ?