Top 10 problems that can delay the review of an ethics application ... and solutions | Research

Click on the problem for recommended solutions.

Stage 1: Application completeness problem	Stage 2: Ethics review feedback problem
Missing supporting documentation Vague description of objectives and processes Generic and formulaic information-consent letter Term confusion Inconsistent and inaccurate information	Failure to fully disclose magnitude and probability of risks Failure to consider social and economic vulnerability Failure to consider undue influence Failure to secure permission from organization or group pre-approval Failure to consider need to re-consent

Stage 1: Application completeness problem
Reason for delay	Why it might occur	TCPS2 principles	Recommended solutions
1. Missing supporting documentation For example missing: recruitment materials, SOPs, Appendix A, feedback letter, information consent letter, proof of scientific merit if above minimal risk or missing signatures.	Lack of awareness of which pieces of supporting documentation should be included depending on the type of research being conducted. Perception that signatures are not important.	Institutional accountability Responsible Conduct of Research	Refer to supporting documents section for the most common documents to include with an application. Signatures are important since they acknowledge the person has read the protocol. Signatures also bind the signatories to execute the protocol as approved. In the event that a challenge or complaint is received by a participant, a researcher’s first line of defense would be to show that s/he followed a protocol as approved.
2. Vague description of objectives and processes	Perception that researchers can always submit a modification at a later date to refine the application.Perception that researchers have a sense the process is tested and straightforward and therefore reviewers should not require this information or do not trust the researcher.	Respect for Persons Autonomy Informed Consent	Ensure the statement of objectives describes research as an outcome and the contribution of the research is clearly defined. Give clear and explicit detail about processes of recruitment and every interaction researchers anticipate having with participants. Even though it may be minimal risk research, participants have a right to know how the use of their time is making a contribution. Wasting participants’ time on data gathering activities which will not answer the research questions posed is unethical. Cutting and pasting from a grant proposal may not be the best way to communicate the study objectives to members of the general public or the ethics reviewers. Avoid the use of academic jargon and acronyms in information consent letters. Try to write them at a grade 8 level. Use online software to check the writing level of your participant documentation and refer to Using Plain Language in Participant Materials.
3. Information and consent letter is generic and does not align with detailed information submitted in the application	Perception that consent letters are legalistic and formulaic and that “no one reads them anyway”. Perception that consent letters are primarily written to protect the institution from lawsuits.	Respect for Persons Autonomy Informed Consent	If the consent letter appears legalistic and formulaic this is a problem. Your objective is to ensure consent is a process and that you use the consent letter contents, and its layout, to make it the research as understandable as possible. Pictures or diagrams are good, white space is good; bullet points are good. Consider the opportunity to actually show participants the equipment they will be using where applicable by inserting photographs in the letter. If you have any doubt about whether or not a complex procedure has been understood, use “talk back” techniques where you ask the participants to describe in their own words what they have just read. Samples are available on and can be modified to suit the needs of your particular participant group.If there is inconsistency between the application and the consent letter full and complete information has not been provided to participants.
4. Term confusion For example, confusing the terms anonymous, confidential, de-identified and anonymized data in the application, using the terms anonymous and confidential interchangeably, or failing to explain how shared data will be secured and used by others.	Perception that these are finely nuanced distinctions which are not relevant to minimal risk research.	Concern for welfare Privacy and control of information about the person	Minimal risk does not mean that no risk exists for participants. Ensure the characterization of the data being collected is correct and statutory regulations are met (e.g., use of personal information and the regulations associated with PIPEDA and use or collection of personal health information and the regulations associated with PHIPA). Guidelines are available which provide definitions. Waterloo IST has institutional policies and tools available (e.g. encryption software) which will reduce the risk (e.g., highly restricted vs. restricted information).Consider developing a data sharing agreement if the data will be received from or sent to or outside of uWaterloo or shared by multiple parties.
5. Inconsistent or inaccurate information provided in the application and information consent letter. For example, failure to define inclusion and exclusion criteria, missing time commitments from participants, lack of clarity concerning remuneration.	Faculty member has a student or research assistant complete the ethics application.	Respect for Persons Autonomy Informed Consent	Place yourself in the position of the participant. Review your information consent letter to assess whether you would have enough information to decide about participation and understand if you are eligible to participate.
Stage 2: Ethics review feedback problem
Reason for delay	Why it might occur	TCPS2 principles	Recommended solutions
1. Failure to consider both the magnitude and probability of harm when describing risks.	Perception that risks have low magnitude of harm or have low probability of occurring.	Respect for persons Autonomy Informed consent Concern for welfare: Promote welfare in view of forseeable risks	Researchers need to ensure appropriate risk/benefit balance by describing all possible risks. Ensure both the magnitude of occurrence and the probability of harm are fully described. Participants need enough information to be able to adequately assess the risks and the potential benefits. For example, a risk may have a significant magnitude if it occurs but a very low probability of occurring. If only the magnitude is described, the benefits may not be perceived to outweigh the risks. Ensure you have not overstated the risks to “cover” yourself as this may not only negatively impact recruitment but may cause the ethics reviewers to question whether the risk statement is realistic.Ensure you have not overstated the benefits to participants or society.
2. Failure to consider the social and economic vulnerability of participants.	Researcher perception that since it is minimal risk research all potential harms are negligible.	Respect for Persons Autonomy Not exercised in isolation	Consider risks and vulnerability from the participants’ perspective by reading the application and information and consent letter as though you are a participant. Understand vulnerability is assessed related to the research question. No person is always vulnerable or invulnerable.Speak to possible participants about circumstances they may be facing which may affect their participation.
3. Failure to consider and specify any potential undue influence you may have over participants.	This research is critical and I have done similar things in the past without any issues.	Autonomy Informed consent	Use a third party to conduct the recruiting and consent process. Ensure recruitment happens in a neutral environment or if there is potential conflict of interest that recruitment is conducted by a neutral person.Consult the guideline on research in classes or with students as participants before designing a project involving uWaterloo students.
4. Failure to obtain pre-approval from “gate-keepers” who control access to the participants or their data.	Institutional approval and ethical acceptability are two separate concepts.	Autonomy Informed consent	A protocol can be ethically acceptable but a gatekeeper (e.g. CEO, corporate administration, board of directors, committees, school boards) may not wish to be involved in or grant access to potential participants for a variety of reasons (e.g., use of resources, confidentiality concerns, lack of alignment with own values or strategic plans).Wherever possible, obtain details on what you have done or are/will be doing to seek approval when conducting research when participants are part of an organization or group BEFORE you submit an ethics application so you can mention this in the recruitment section.
5. Failure to include a plan to re-consent participants when there is a likelihood of new information emerging.	May take too much time to re-consent participants and may negatively impact on funding deadlines.	Respect for Persons Autonomy Informed Consent	Consent is an ongoing process particularly with clinical or multi-site research. If new information arises during the conduct of the research which may have materially affected the decision to provide consent or participants assessment of the risk/benefit ratio, they need to be provided with an opportunity to consider this new information and confirm their decision to continue participation. (e.g., incidental findings)