Researchers Response to Ethics Reviewer

Researchers Response to Ethics Reviewer Order Instructions: Please read the file: Proposal and then open the file: Ethics Response Form COPY 2 and challenge the Ethics Reviewer’s assessment and write your reply on the: Researcher’s response to Ethics Reviewer

Researchers Response to Ethics Reviewer Sample Answer

ETHICS RESPONSE FORM

 

Researcher name (student):	Faculty reviewer:	Date of Review:
Working Title of Proposal or summary of study scope:
Proposal attached?         _#_ Yes         ___No	Academic Honesty Declaration signed?              _#__Yes       ___ No

Each of the ethical standards below must be adequately addressed by the researcher in order to obtain ethics approval.

In the blue column, the RESEARCHER (student) should perform a self-check using these 35 questions before submitting the ethics form to the faculty member supervising the study.  In each row of the blue column, the RESEARCHER should enter YES, NO, or NA as well as a very brief explanation. The Academic Honesty Declaration must be attached and should be signed and dated.

In the yellow column, the ethics REVIEWER (supervising faculty member) will enter YES, NO, or NA to confirm or challenge the RESEARCHER’S self-check on each standard. With each NO, the ETHICS REVIEWER will indicate what revisions are required for ethics approval. The faculty reviewer will also render a decision at the end of this form and return the form to the RESEARCHER.

If the ETHICS REVIEWER (supervising faculty member) is able to approve “as is” then the orange column is left blank.

 In the orange column, the RESEARCHER (student) will respond to each of the ETHICS REVIEWER’S concerns to explain where/how each of the reviewer’s concerns was met in the resubmitted materials.

 

	Researcher’s ethics self-check   In each row, the researcher should confirm compliance with the ethical standard by entering “Yes,”“No,” or “N/A, ”along with a brief defense of the response (i.e., stating keywords that point to how the ethical standard has been met).	Ethics Reviewer’s assessment:   After the researcher has presented the evidence for compliance with each ethical standard, the Ethics Reviewer should either confirm by entering “Yes” or challenge with “No.” With each “No,” the reviewer must specify what revisions are needed to obtain ethics approval.	Researcher’s response to Ethics Reviewer   Researcher must use this column to explain how and where each of the Ethics Reviewer’s concerns (in the yellow column) has been addressed.
Example: Will data be stored securely?	Yes. Data files will be kept on a password protected computer.	No. Please also address how the paper surveys will be secured prior to being entered as electronic files.	Paper surveys will be in a locked file cabinet. Proposal has been updated.
The first 11 questions apply to all studies (even when the researcher is not interacting with participants to collect new data). Hover the mouse over the blue footnoted words to view extra tips and definitions.
1. Are participant recruitment and data collection steps[i]adequately described, such that the study’s risks and burdens can be discerned?	Yes. How data would be collected through the use of questionnaires is clearly described. Two-hundred participants will complete the closed-ended questionnaires.	Yes	Yes. How data would be collected through the use of questionnaires is clearly described. Two-hundred participants will complete the closed-ended questionnaires.
2. Will the research procedures ensure privacy[ii] during data collection?	Yes. The names and details of the participants will be kept confidential to ensure the anonymity of the study subjects.	Yes	Yes. The names and details of the participants will be kept confidential to ensure the anonymity of the study subjects.
3. Will data be stored securely[iii] with adequate provisions to maintain the confidentiality of the data?	No. Not specified	Needs to be something like: The study will ensure that data is kept in a format and stored on a password protected system.	The research study would ensure that data is kept in a format and stored on a computer system that is protected by a password.
4. Will the data be stored for at least 5 years?	No. Not specified.	Try something like: The data gathered will be stored for at least 5 years for use by other researchers where needed.	The gathered data would be stored for no less than 5 years so that other researchers may use it where needed.
5. If participants’ names or contact info will be recorded in the research records, are they absolutely necessary[iv]?	NA. Participants names or contact information would not be recorded	Yes	NA. Participants names or contact information would not be recorded
6. Do the research procedures and analysis/write-up plans include all possible measures to ensure that participant identities are not directly or indirectly[v] disclosed? For secondary data analyses, the proposal must clearly state when/how de-identification will occur.	Yes. Through the use of questionnaires, the respondents’ anonymity would be observed and their identities would not be disclosed.	Try something like: Yes.  Questionnaires and   survey guides do not include the identities of participants for disclosure. During the analysis of secondary data analysis, the researcher will ensure that identities associated with data are ignored and only deal with data itself.	Yes. Questionnaires and survey guides do not include participants’ identities for disclosure. During the analysis of secondary data, the researcher would make sure that identities linked to data are ignored and only deal with the data itself.
7. Have all potential psychological[vi],relationship[vii], legal[viii], economic/professional[ix], physical[x], and other risks been fully acknowledged[xi] and described?	No. Not specified.	Try something like: Yes. The study will ensure that respondents provide data without any difficulty, either from physical or psychological perspectives.  employees are reassured that they are  allowed to opt out of the data gathering process at any time without problems during and/or before the study. Respondents are giving their views on non-controversial or dangerous issues, related to a business which they know, so there are thought to be effectively no risks in participating in this research.	Yes. The research study would ensure that the participants provide data without any difficulty, either from physical or psychological perspectives. Participants would be reassured that they can opt out of the data gathering process at any time without problems or facing consequences during and/or before the study. The study subjects would give their opinions on non-controversial or dangerous issues relating to a business which they know. Thus, there are thought to be effectively no risks in taking part in this research.
8. Have the above risks been minimized [xii]as much as possible?	No. Not specified.	Something like: Yes. These risks have being addressed in the ethical consideration within the proposal.	Yes. The risks have been addressed in the ethical consideration in the proposal.
9. Has the researcher proactively managed any potential conflicts of interest[xiii]? Note that student researchers may not utilise research assistants to recruit participants or collect research data on behalf of the researcher.	No. Not specified.	You have to make sure that any person or persons involved do not face conflicts of interest. For example, if you are interviewing or giving a questionnaire to a person subordinate to you in the company, how will you ensure that you do not get baised results – they answer what they believe YOU want to hear, rather than what THEY believe?  Similarly if you use suppliers as respondents?	Yes. The researcher will ensure that any person or persons involved do not face conflicts of interest. Research assistants would not be utilized in recruiting respondents or gathering research data on the researcher’s behalf. The researcher will give out the questionnaires himself.
10. Are the research risks and burdens[xiv] reasonable, in consideration of the new knowledge[xv] that this research design can offer?	No. Not specified.	Again, you need a complete answer – try something like: Yes. The research design is such that participants will be giving their own views and problems and will be doing so of their own free will. The research should be understood as being completely separate from the researcher’s role and apart from in the interview, data will be collected anonymously. The researcher interviewing senior managers does not pose any burden for them.  The interview is designed to last for 20 minutes and the questionnaire to last for 15 minutes.  Thus, the risks and burdens are expected to be minimal for this research	Yes. The research design is such that respondents would be giving their own viewpoints and problems and would be doing so of their own free will. The research study would be considered as being totally separate from the researcher’s role and the questionnaire data will be collected anonymously. The researcher collecting data from the participants will not pose any burden for them.  Filling out the questionnaire would take about 15 minutes.  Therefore, the risks and burdens are expected to be minimal for this research
11. Is the research site willing to provide an Authorisation Letter (or email) granting permission[xvi]for all relevant data[xvii] access, access to participants, facility use, and/or use of personnel time for research purposes?	Yes. The research site, various oil and gas (O+G) companies, are ready to provide Authorization Letters.	Yes
The remaining questions only apply to studies that involve recruiting participants to collect new data (such as surveys, interviews, observations).  ____Please place an X on this line if NONE of the questions in the next section are applicable to the proposed study.
12. Applicable for student researchers: Will this researcher be appropriately qualified[xviii] and supervised[xix] in all data collection procedures?	Yes. The researcher is well-trained to collect data using questionnaire surveys.	Yes	Yes. The researcher is well-trained to collect data using questionnaire surveys.
13. Is participant recruitment coordinated in a manner that is non-coercive[xx]? Coercive elements include: leveraging an existing relationship to “encourage” participation, recruiting in a group[xxi] setting, extravagant compensation, recruiting individuals in a context of their treatment or evaluation[xxii], etc. A researcher must disclose here whether/how the researcher may already be known to the participants and explain how perceptions of coerced research participation will be minimized[xxiii].	Yes. Anonymous surveys are used to collect data from participants. For online surveys, participants would be invited through email invitations. No one is forced to participate. The researcher is not already known to the participants. Perceptions of coerced research participation would be minimized by informing the participants that they have the right to withdraw from the study at any time without being punished.	Yes	Yes. Anonymous surveys are used to collect data from participants. For online surveys, participants would be invited through email invitations. No one is forced to participate. The researcher is not already known to the participants. Perceptions of coerced research participation would be minimized by informing the participants that they have the right to withdraw from the study at any time without being punished.
14. If anyone would be excluded from participating, is their exclusion justified? Is their exclusion handled respectfully and without stigma[xxiv]?	NO. No exclusion criteria are specified and any respondent metting the research reponse criteria can take part or not, according to their feelings.	Yes	NO. No exclusion criteria are specified and any respondent who meets the research response criteria can either take part or not, according to their feelings.
15. Where the researcher proposes to use an interpreter, has adequate consideration been given to the interpreter’s training regarding confidentiality and principles of informed consent, etc.?	NA. No interpreter would be used.	Because…?	NA. No interpreter would be used because the participants are conversant in the English language; the language that would be used in data collection.
16. Do the informed consent[xxv] procedures provide adequate time to review the study information and ask questions before giving consent?	Yes. There is enough time to review the informed consent form and answer questions.	Yes	Yes. There is enough time to review the informed consent form and answer questions.
17. Will informed consent be appropriately[xxvi]documented?	Yes. It would be documented. No signatures would be required, so as to protect the participants’ privacy.	YEs	Yes. It would be documented. No signatures would be required, so as to protect the participants’ privacy.
18. Is the participant information sheet (PIS) written using language that will be understandable[xxvii] to the potential participants?	Yes. A professional tone is maintained and the language in the PIS is tailored to the readers	Yes	Yes. A professional tone is maintained and the language in the PIS is tailored to the readers.
19. Does the PIS include an understandable[xxviii] explanation of the research purpose?	Yes. The research purpose is clearly stated using appropriate everyday language.	Yes	Yes. The research purpose is clearly stated using appropriate everyday language.
20. Does the PIS explainthe sample’s inclusion criteria in such a way[xxix]that the participants can understand how/why THEY are being asked to participate?	Yes. inclusion criteria is included in the PIS.	Yes	Yes. Inclusion criteria are included in the PIS.
21. Does the PIS clearly state that participation is voluntary?	Yes. This information is included.	Yes	Yes. This information is included.
22. Does the PIS convey that the participant has the right[xxx]to decline or discontinue participation at any time?	Yes. It states that the participants have the right to withdraw from the study.	Yes	Yes. It states that the participants have the right to withdraw from the study at any time.
23. Does the PIS include an understandable description of the data collection procedures?	Yes. Procedures for data collection are described clearly.	Yes	Yes. Procedures for data collection are described clearly.
24. Does the PIS include an estimate of the time commitment[xxxi] for participation?	Yes. It states that the questionnaire would be completed within 20 minutes.	Yes	Yes. It states that the questionnaire would be completed within 20 minutes.
25. Does the PIS describe any thank you gifts, compensation, or reimbursement to participants (for travel costs, etc.) or lack thereof?	Yes. It states that the participants should not expect to be given any compensation, reimbursements or gifts as a result of their participation.	Yes	Yes. It states that the participants should not expect to be given any compensation, reimbursements or gifts as a result of their participation.
26. Does the PIS include a description of reasonably foreseeable risks[xxxii]or discomforts?	No. This information is not included.	Something like: Yes. It describe only the research aims and rationale.  Because individuals will be giving their own views and opinions, freely and without any likely impact on their personal and professional positions, it is not considered that this research will carry much risk or any burden beyond the short time required to fill in the questionnaire or take part in the interview.	Yes. It describes only the research aims and rationale.  Since the participants would be giving their own views and opinions, freely and without any possible impact on their personal and professional positions, it is not considered that this research will carry much risk or any burden beyond the short time needed to complete the questionnaire survey.
27. Does the PIS include a description of anticipated benefits to participants[xxxiii]and/or others?	No. This information is not included	Something like: For most social science studies, it is appropriate to state that there are no particular direct benefits to the individual. In this case, just the wider benefits to society.	Yes. The PIS includes a description of expected benefits not to the participants, but to the wider society in general. There would be no direct benefits to the individual respondents.
28. Does the PIS explain how the participant can contact the researcher and the university’s Research Participant Advocate? (USA number 001-612-312-1210 or email address liverpoolethics@ohecampus.com)	Yes. The contact details are provided.	Yes	Yes. The contact details are provided.
29. Does the PIS describe how privacy will be maintained[xxxiv]?	Yes. It states that the participants’ details would not be disclosed to third parties and will not be used for any other purpose than helping to comlete the research aims.	Yes	Yes. It states that the participants’ details would not be disclosed to third parties and will not be utilized for any other purpose besides helping to complete the research aims.
30. Does the PIS disclose all potential conflicts of interest (specifying that this study is separate from the researcher’s other professional role)?	No. This information is not included	Something like: Yes. This enable the participants have an informed decision to participate in the research.	Yes. This allows the participants to have an informed decision to take part in the study.
31. Do the consent documents preserve the participant’s legal[xxxv]rights?	Yes. The participants are not asked to waive any legal rights.	Something like: Yes, although as they are commenting their own views on organisational matters in a commercial setting, it is not thought ikley that any possible legal issues will arise.	Yes. Although as they are commenting their own views on organizational matters in a commercial setting, it is not thought likely that any possible legal issues will come up.
The remaining questions regarding sensitive content and vulnerable populations should be reviewed and addressed by the researcher (student) and faculty reviewer, but must also be confirmed by the International Online Research Ethics Committee before the study may go ahead. ____Please place an X on this line if NONE of the questions in the next section are applicable to the proposed study.
32. If vulnerable[xxxvi] individuals will be specifically sought out as participants, is such targeted recruitment justified[xxxvii]by a research design that will specifically benefit that vulnerable group at large?	NA. Does not apply to the research study.
33. If the researcher happens to also serve in a trusted or authoritative[xxxviii]role to the participant (e.g., health care provider, teacher etc.), do the recruitment procedures ensure voluntary participation?	NA. Does not apply to the research study.
34. If the research procedures might reveal or create an acute psychological state that necessitates referral, are there suitable procedures in place to manage this?	NA. Does not apply to the research study.
35. If the research procedures might reveal criminal activity, child/elder abuse, or employer policy non-compliance that necessitates[xxxix] reporting, are there suitable procedures in place for managing this? Are limits to confidentiality (i.e., duty to report) appropriately mentioned in the Participant Information Sheet?	NA. Does not apply to the research study.

 

ETHICS APPROVAL DECISION
THIS DOCUMENT MUST BE POSTED IN THE GRADEBOOK AFTER THE SUPERVISING FACULTY MEMBER HAS RENDERED A DECISION.  THE APPROPRIATE ETHICS PATHWAY(S) MUST ALSO BE ENTERED INTO THE MiTSA , eg LOCAL, EXPEDITED OR IOREC APPROVAL(S)   The supervising Faculty Member will mark an X next to box A, B, or C. If box A or B is marked, then the supervising faculty member will also mark an X next to the applicable subcategory (1, 2, 3, etc.):
	A.    APPROVED VIA EXPEDITED (LIGHT TOUCH) ETHICS REVIEW: ·         As the supervising faculty member, I confirm that all applicable criteria 1-35 above are met with either a “Yes” or “N/A.” ·         I understand my responsibilities as a supervisor, and will ensure to the best of my abilities that the student investigator abides by the University’s policy on Research Ethics at all times. ·         I affirm that the research activities fall entirely within the parameters of the design indicated with an X below (1,2 or 3) that the International Online  Research Ethics Committee has authorized faculty members to approve via the expedited (light touch) review:
		1. analysis of publicdocuments, artifacts, behaviour or data;
		2. secondary analysis of existing data that is privately held but released for research purposes (with all identifiers removed);
		3. surveys or interviews ofnon-vulnerable adults on non-sensitive topics (i.e., no potential to participants of coercion, distress, loss of work/school time, damage to professional reputation). Vulnerable populations include children, clinic patients, prisoners, military personnel, facility residents, anyone over whom the researcher holds authority (e.g., students, subordinates), anyone who might feel undue pressure to participate in the study, and any individuals with severe enough mental disabilities to interfere with capacity to consent to the study.
	B.      REFERRED TO ETHICS COMMITTEE:   ·         As the supervising faculty member, I am referring to this study to the full ethics committee (IOREC) because [mark 1, 2, 3, 4 or Other below]. ·         I will email the student’s ethics application and all attachments as a single zip file to the ethics committee vialiverpoolethics@ohecampus.com, copying the DOS (or Programme Director where this exists).   The ethics committee accepts applications until 5 pm Liverpool time zone on the 3rd Thursday of every month. Decisions and feedback will be emailed to the student and DA within 5 business days after the 4th Thursday of the month.
		1. the researcher proposes to collect data from vulnerable individuals such as children, clinic patients, prisoners, military personnel, facility residents, anyone over whom the researcher holds authority (e.g., students, subordinates), anyone who might feel undue pressure to participate in the study, and any individuals with severe enough mental disabilities to interfere with capacity to consent to the study.
		2. some (potential) participants may find the research topic or premise sensitive
		3. participants’ jobs or livelihoods may be placed at any risk by the study activities
		4. the participants’ culture and/or international location suggest that extra participant protections may be necessary
		Other: _____
	c. C.       REVISIONS REQUIRED: The student needs to revise the proposal and ethics materials to address the concerns in the yellow column and resubmit to me before I can select A or B above.

Footnotes

[i] In order to weigh potential risks against benefits, the researcher first needs to plan and clearly articulate all of the following that apply:

how existing data or contact information of potential participants will be obtained,

format and context of the initial contact with potential participants,

informed consent procedures,

assignment to groups (if applicable),

description of any pilot activities,

data collection steps,

transcript review and/or membercheck (if applicable), and

how results will be shared with stakeholders.

[ii] Privacy risks might include unintended breach of confidential information (such as educational or medical records); being observed/overheard by others while meeting researcher or providing data; or intrusion on the privacy of others who are not involved in the study (e.g. participant’s family).

[iii] Secure data storage requires password protection on electronic files and locks for physical data.

[iv] Note that consent forms do not require signatures if the participant can indicate consent by some action such as clicking on a link, returning a completed survey, etc.

[v] Participant identities might be “indirectly” and unintentionally disclosed if a researcher’s final research report fails to withold demographic details or site descriptions that might permit a reader to deduce the identity of a participant. So the researcher needs to think about which demographic descriptors are most important to collect and report, while ensuring that the identity of individual participants is protected. Also, the name of the site/organization is typically masked in scholarly research though in some cases, the organization can elect to publicize their name along with the research results.

[vi] Psychological risks include stress greater than what one would experience in daily life (e.g., materials or topics that could be considered sensitive, offensive, threatening, degrading).

[vii] Relationship risks are present if the recruitment or data collection process are likely to alter the existing dynamics between the researcher and participant (who may be coworkers or have some professional relationship), among participants (if they know one another), or between the participant and the participant’s friends, coworkers, or family members.

[viii] Legal risks are present if data collection might result in a participant’s disclosure of a violation of laws.

[ix] Economic/professional risks are present if data collection could result in the participant disclosing a violation of workplace policies, disagreement with leadership decisions, poor work performance, or anything else that could be damaging to theparticipant’s  position, professional reputation, promotability, or employability. Risks are acceptable but participants need to be made aware of professional risks during the consent process so they can make an informed decision.

[x] Physical risks are not common in social science research but would involve risk of serious physical injury to the participant or the researcher.

[xi]Minimal risks are acceptable but must be identified upfront. Minimal risk is defined as when: “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life.”

[xii] The researcher is responsible for planning measures that will provide participants with reasonable protection from privacy loss, distress, psychological harm, economic loss, damage to professional reputation, and other possible harms.

[xiii] A conflict of interest is caused when the researcher has some sort of dual role in the research context, such as being a teacher, therapist, investor, business-owner, manager, etc. Conflict of interest must be managed to ensure that the research reveals “truth,” not just the outcome that the researcher might desire to see due to their other role.

[xiv] All research activities place some degree of burden on the participants by asking the participants to share personal information, volunteer time, and assume risks.

[xv] Examples of “new knowledge” include: effectively addressing a gap in the literature, generating new theory, enhancing understanding of a phenomenon, assessing effectiveness of a particular professional practice, addressing a local practical problem via data analysis.

[xvi] No documentation of permission is required (a) if the researcher will simply be asking organizations to distribute research invitations on the researcher’s behalf, or (b) if the researcher is using only public means to identify/contact participants.

[xvii] Note that when medical, educational, or business records would be analyzed or used to identify potential research participants, the site needs to explicitly approve access to data for research purposes (even if the researcher normally has access to that data to perform his or her job).

[xviii]Researchers must be able to document their training in the data collection techniques and the ethics committee might require the researcher to obtain additional training prior to ethics approval. For most student researchers, the research course sequence is sufficient but some research procedures (such as interviewing people with mental disabilities) may require additional training. For psychological assessments, the manual indicates specific qualifications required. Data collection from children requires a background check/clearance through a local agency.

[xix] Remote supervision is suitable for most studies but onsite supervision may be required for certain types of sensitive data collection (e.g., interviews or assessment regarding emotional topics).

[xx] For example, anonymous surveys and/or low-pressure communications such as email invitations permit potential participants to opt out with minimal fear of retaliation or other negative consequences.

[xxi] It is not ethically acceptable to invite a “captive audience” to participate in research on the spot (i.e., to ask an entire class or a group of meeting attendees to complete a survey during their session). Such a dynamic would not provide sufficient privacy or respect for their right to decline research participation. However, a researcher may use the last few minutes of a meeting to introduce a study and distribute materials, such that the potential participants can then take their time to decide later about participation.

[xxii] Generally, data collection cannot be approved during work hours or school hours unless a “free period” has been identified (e.g., lunch) so the research activities can be separated from the participants’ regular activities. It is important to maintain an “opt in” dynamic rather than implying that employees/students/group members are expected to participate.

[xxiii]Completion of the study directly benefits the student (allowing him or her to obtain a degree), and so the researcher should minimize the potential for either (a) conflict of interest or (b) perceived coercion to participate. Researchers who are in positions of authority or familiarity must take extra precautions to ensure that potential participants are not pressured to take part in their study. Examples: an instructor researcher may recruit her students AFTER grades have been assigned; a psychologist researcher may recruit clients from ANOTHER psychologist’s practice;  a manager researcher may conduct ANONYMOUS data collection so that subordinates do not perceive their responses or [non]participation as being associated with their job standing.

[xxiv] When applicable, the exclusion criteria should be listed on the recruitment material (flyer, invitation email,etc.) or participant information sheet (PIS) to prevent situations in which the researcher rejects volunteers in a stigmatizing manner.

[xxv]Informed consent is not just a form; it is a process of explaining the study to the participant and encouraging questions before the participant makes a decision about participation.

[xxvi] While documenting consent via signature is common, note that anonymous surveys can obtain “implied consent” by informing the participant, “To protect your privacy, no consent signature is requested. Instead, you may indicate your consent by clicking here/returning this survey in the enclosed envelope.”) It is also acceptable to audiorecord verbal consent for interviews, in order to not have any record of the interviewee’s name.

[xxvii]The ethics committee encourages tailoring the language to the readers as long as a professional tone is maintained.

[xxviii] Minimal jargon should be used during the informed consent process. Everyday layperson language is most appropriate to help a participant make an informed decision about participation.

[xxix] People receiving the PIS should not be left wondering, “How did the researcher get my name?” or “Why am I being invited and not others?” or “Does the researcher already know private information about me?” The means by which the researcher has identified and contacted the potential participant needs to be made clear, if it is not already clear from the context. Sample explanations of inclusion criteria in PIS: (a) The human resources department has forwarded this invitation to all employees who meet the researcher’s study criteria (i.e., have been with the organization at least 2 years and have transitioned into a managerial role within the past year); or (b) The researcher is inviting all attendees of the past year’s XYZ professional conference to be in the study; or (c) The researcher will be randomly selecting possible participants by approaching the residents of every 5^th home in this neighborhood until 100 responses are obtained.

[xxx] When the researcher is already known to the participant, the PIS must include written assurance that declining or discontinuing will not negatively impact the participant’s relationship with the researcher or (if applicable) the invitee’s access to services.

[xxxi] Provide an estimate (in minutes or hours) of each component of data collection (e.g., survey, interview, memberchecking. etc. )

[xxxii] Describe only the possible harms that go beyond the risks of daily life.

[xxxiii] For most social science studies, it is appropriate to state that there are no particular direct benefits to the individual. In this case, just present the benefits to society.

[xxxiv]The PIS shouldexplain that the research report will not include names and that the data will not be used for any purposes other than research. It is not always clear to participants how a research interview is different from a journalistic interview, in which informants might be named.So the PIS should also describe any coding system that will permit the researcher to not use names.  For sensitive interviews, the researcher might also want to assure participants that recordings will be destroyed immediately after transcription.

[xxxv]The consent forms/process should not ask a participant to waive any legal rights.

[xxxvi] Vulnerable participants include children, clinic patients, prisoners, military personnel, facility residents, anyone over whom the researcher holds authority (e.g., students, subordinates), anyone who might feel undue pressure to participate in the study, and any individuals with severe enough mental disabilities to interfere with capacity to consent to the study. Pregnant women (and their unborn children) are only considered a vulnerable population when a study involves physically risky data collection.

[xxxvii]Targeted recruitment of vulnerable participants can only be approved when the ethics committee determines that the study’s benefits justify its risks/costs.

[xxxviii] A researcher with a dual role must use anonymous surveys or some other method that permits potential participants to opt out without fear of negative consequences. Patients, students, and subordinates of the researcher need explicit assurance that their decision about participation will in no way impact their ongoing relationship with the researcher.

[xxxix] Any limits to confidentiality (i.e., duty to report) must be mentioned in the participant information sheet (PIS).