Annex_J_-__MCC_Informed_Consent_Statement_Draft.pdf

MCC Standard Template for Informed Consent August 5, 2016

For MCC, there are a few guiding principles for the Informed Consent:

• Informed Consent statements should be reviewed and approved by the Evaluation Firm and Survey Firm’s Institutional Review Board (IRB)

• The IRB should determine what information should be provided to the respondent regarding anonymized, public use data

• MCC may provide restricted access to personally identifiable information (PII) for licensed use by researchers for statistical purposes only following review and approval by their IRB, either for replication of evaluation results or for additional research purposes outside the original scope of the study. The IRB should advise on language related to who will have access to data with PII

The following are two Informed Consent templates reviewed by the MCC Disclosure Review Board for Evaluation Firms and Survey Firms to reference as they develop their Informed Consents.

Village Leader Consent

My name is [NAME] and I am working with Survey Firm. We are gathering information about X (insert study specific topics) in your community in order to improve projects in this and other communities and would like to ask you some questions about yourself and X. Our study is funded by the Millennium Challenge Corporation, an agency that provides assistance to other countries' development projects, and is being carried out by Evaluation Firm and Survey Firm. The interview is expected to take X minutes. Any information you provide that can identify you will be kept strictly confidential by the parties conducting this study, including MCC employees, employees of the survey firm, and licensed researchers1, to the maximum extent2 permitted by the laws of the United States of America and the laws of Country. These users3 will use data for statistical purposes4 only.

Your participation is voluntary and you may choose not to answer any or all questions for any reason. In other words, you have the alternative to not participate and there will be no consequences for nonparticipation. You may contact Name, the director of Survey Firm, at Phone Number, if you have questions, concerns or complaints about the study or your rights as a participant. If you have any questions for me, please feel free to ask at any time."

Household Consent

My name is [NAME] and I am working with Survey Firm. We are gathering information about X (insert study specific topics) in your community in order to improve projects in this

1 The IRB should review this clause and provide clearance or guidance if this cannot be followed.

2 If requested by stakeholders or respondents, can the IRB and/or MCA provide information on: (i) what specific laws are being referenced, (ii) how they could influence the interviewee, and (iii) where the interviewee could go for additional information?

3 If this needs to be clarified: MCC employees, employees of the survey firm, and licensed researchers.

4 If this needs to be clarified: Statistics provide summaries about the whole sample and about the observations that have been made.

MCC Standard Template for Informed Consent August 5, 2016 and other communities. Our study is funded by the Millennium Challenge Corporation, an agency that provides assistance to other countries' development projects, and is being carried out by Evaluation Firm and Survey Firm. If you agree to participate in this interview, we will talk about your community, your household, and members of your household. The interview is expected to take X minutes. Any information you provide that can identify you will be kept strictly confidential by the parties conducting this study, including MCC employees, employees of the survey firm, and licensed researchers5, to the maximum extent6 permitted by the laws of the United States of America and the laws of Country. These users7 will use data for statistical purposes8 only.

Your participation is voluntary and you may choose not to answer any or all questions for any reason. In other words, you have the alternative to not participate and there will be no consequences for nonparticipation. You may contact Name, the director of Survey Firm, at Phone Number, if you have questions, concerns or complaints about the study or your rights as a participant. If you have any questions for me, please feel free to ask at any time.

5 The IRB should review this clause and provide clearance or guidance if this cannot be followed.

6 If requested by stakeholders or respondents, can the IRB and/or MCA provide information on: (i) what specific laws are being referenced, (ii) how they could influence the interviewee, and (iii) where the interviewee could go for additional information?

7 If this needs to be clarified: MCC employees, employees of the survey firm, and licensed researchers.

8 If this needs to be clarified: Statistics provide summaries about the whole sample and about the observations that have been made.

RESEARCH SUBJECT INFORMATION AND CONSENT FORM

TITLE: Evaluation of {{Program Description}}

INVESTIGATOR: Independent Evaluator Name Address City, State Zip Country

STUDY-RELATED Survey Firm Name PHONE NUMBER(S): Telephone

1. Purpose Hello, you’ve been asked today to participate in a study of {program and short goal/purpose}. The study is funded by the Millennium Challenge Corporation (or MCC), an American foreign aid agency, and is being carried out by {Evaluation Firm} and {Survey Firm}. You are being asked to participate in this study because {insert justification}

2. Procedures

2.1. During this session, I will ask questions about {insert topics; should roughly align with sections of protocol}. This session should take approximately {insert time}. You should feel free to elaborate, give specific examples, or go back to a question if you feel you want to add more information. The information you provide during this session will be kept strictly confidential to the extent permitted by law. [If audo recording: This session will be recorded, but names will not be put into the transcriptions and the audio files will be encrypted. If note-taking: (Names) will be taking notes, but they will not use any names in their note-taking. Instead, they will use a number code.] As well, please keep in mind that your participation is entirely voluntary, which means you may choose to skip any question you may not be comfortable answering, not answer any question, or leave at any time. If you choose not to participate, it will not impact you negatively, and we will not disclose it to anyone.

2.2. [If focus group: To promote confidentiality, we ask that you all agree not to disclose or repeat any of the things that are said by anyone during this session today. However, as we cannot make certain that no one will repeat what you say, you should take care not to say anything that you think could cause you harm if someone were to repeat it outside of this session.]

3. Uses of the Information

3.1. The information we receive from you will be used for research purposes only. The final study that summarizes this research may contain quotations from the sessions we conduct, but the MCC team will make every effort to ensure that no one can be identified using these quotations.

3.2. After the research is completed, MCC and {Evaluator Firm} will remove any identifying information from the transcripts and notes – such as names, dates, and specific locations – so that these sources may be made available for other researchers to use. {Evaluator Firm} and MCC will require others who request access to this information to agree to use it for research purposes only and not to share this information with anyone else. In this way, we hope to ensure that others may benefit from the responses you provide, without risking your privacy.

4. Questions

4.1. If you have questions or concerns after we are finished, please contact {insert name and position} at {insert contact information}. This person has been designated to answer all questions about the research, as well as handle any concerns or complaints that you may have. As well, please feel free to ask me any questions you may have about this research at any time during this session.

4.2.

5. Consent

Commented [JRS1]: Local IRB will guide who should be contact (whether survey firm or Evaluator).

Commented [EW2]: The reasons to include a qual participant may be diverse. They have unique perspectives on certain topics, they live in an area where X is prominent or likely to affect Y. This should be tailored to address the study, and should follow the justification for including them in the first place.

Commented [EW3]: This means that this person must be trained to handle complaints and potential IRB violations – confidentially.

After this explanation, and keeping in mind that you may still refuse to answer questions or participate, do I have your permission to begin?

Commented [EW4]: If an FG, moderator will need to acknowledge consent from all participants. Also, I’ve usually passed IRB with just oral/non-verbal consent, which may be preferable for a number of reasons for the people we might interview.