Stakeholder Perceptions of the NIH Peer Review Process Focus Groups

OMB Control Number: 0925-0474 Expiration Date 2/28/2018

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Social Solutions International, Inc.

Participant Consent Form

TITLE OF STUDY: Reviewers’/Applicants Experiences with the NIH Peer Review Process

Principal Investigator: Susanna Nemes, PhD Project Director: Ami Lynch, PhD

Phone Number: 866-901-6583 Phone Number: 571-212-8367

IRB Representative: Karen Chen

Phone Number: 703-738-6684

PURPOSE OF THE STUDY

Social Solutions International, Inc. (Social Solutions) has been contracted by the Center for Scientific Review (CSR) at the National Institutes of Health (NIH) to conduct a study, which will include focus groups investigating stakeholder perceptions of the NIH peer review process. There will be a particular emphasis on identification of procedures and practices that are conducive to successful execution of the CSR’s mission to “see that NIH grant applications receive fair, independent, expert, and timely reviews—free from inappropriate influences—so NIH can fund the most promising research.” The study will be comprised of a series of up to 32

focus groups.

An important part of this research involves the conduct of a series of focus groups with NIH Grant Reviewers/Applicants. We are asking for your participation in a focus group with up to eight of your peers. The discussion will involve a series of questions about your individual experience with the grant application and peer review process. The information that you provide may be used by CSR and NIH to improve these processes. Your opinions, experiences, and ideas are very important.

PROCEDURES

The discussion will last approximately 90 minutes. You do not have to do anything to prepare. We will ask questions about the NIH grant application process, including your individual experiences. We would like to hear as many perspectives as possible, but you do not have to answer any questions that you do not want to answer. There are no right or wrong answers – only different points of view.

We will be recording the discussion on audiotape, and a staff person will be taking notes to ensure that data are captured accurately. We will not refer to you by name during the audio recording, and will ask other participants to refrain from doing so as well. This will ensure that no comments you make will be personally identifiable.

PARTICIPATION AND WITHDRAWAL

Participation in this focus group study is completely voluntary. Your participation in this focus group will not affect your ability to apply for or obtain NIH grant funding in the future or your ability to review NIH grants in the future. There is no consequence if you decide not to complete the discussion or if you choose to leave the focus group. You do not have to respond to any questions that you do not want to answer. The focus group facilitator may ask you to withdraw from the discussion, if your participation becomes problematic for the group.

POTENTIAL RISKS

We anticipate very few risks from your participation in this focus group. Although all participants have been asked to keep the discussions private, there is a small chance that other participants in the focus group may share personal information about you with someone not participating in this study. In addition, there is a small chance that you may feel uncomfortable with a question and not want to respond. Please remember that you do not have to answer any questions you do not want to answer. If you do experience negative feelings as a result of the focus group discussion and wish to discuss them with someone, you may call Dr. Susie Nemes, the Principal Investigator of this study, at 866.901.6583. Dr. Nemes is a clinical psychologist, and can provide a referral for counseling if needed. In the extremely unlikely event of physical or other injury resulting from the focus group please call 911 or your doctor. Social Solutions will not provide compensation if you experience injury or other adverse effects, which are not the fault of the investigators.

ANTICIPATED BENEFITS

If you decide to participate in the focus group, you may gain a better understanding of the NIH grant peer review process and how your experience with the application process compares to the experiences of your peers. Additionally, the information that you provide will be used to help CSR address potential problems in the application and peer review process.

PARTICIPATION

You will receive a $75 gift card to cover your transportation, child care, or any associated costs in appreciation for your participation in the 90 minute focus group. A member of the research team will distribute the gift card at the end of the focus group session.

PRIVACY

To protect your identity, none of the information you provide will be associated with any statement or identified personally in any way. Your name and signature will appear on the informed consent statement. Social Solutions will also record your name in the gift card tracking log to track your receipt of the $75 thank-you gift card for your costs associated with participation in todays’ focus group. No additional identifiable information will be collected during the focus group discussion. The consent form and gift card tracking log will be kept separate from the focus group data we collect to make sure that the data cannot be identified.

Prior to and following the focus group discussion, Social Solutions staff will be in contact with you to arrange logistics. In order to make these arrangements, Social Solutions staff will need to record your name, contact information and other personal information. This information will also be kept separate from the data collected during the focus group discussion and will not be used to identify your thoughts or other contributions.

Any information collected by paper or on the participant gift card tracking log will be kept in a locked cabinet. Additionally, the audio recording of the focus group will be destroyed after transcription, and no names or other identifying information stated during the groups will be included in the transcripts. Information transferred and stored electronically will be stored only on password-protected computers. Only specified researchers at Social Solutions will have access to this information, and all researchers are trained in secure and private research protocols. All files will be destroyed 7 years after the study concludes.

At the end of the study, Social Solutions will provide de-identified raw focus group data in the form of transcriptions of the discussion to CSR. No personal information collected through consent forms, gift card tracking logs, or for logistics purposes will be provided, and CSR will not know the identities of focus group participants based on the focus group transcripts or analyzed data.

Information provided during the research will only be disclosed to others if necessary to protect your rights and welfare or if required by law. When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity.

Social Solutions will provide all participants with a date of release of the final report and instructions for locating it, so you may have access to the results of this study.

QUESTIONS AND CONCERNS

If you have any questions about this project, you may call Dr. Susanna Nemes or Dr. Ami Lynch at the phone numbers above. If you have any questions about your rights as a research participant, please call Karen Chen at 703-738-6684.

WRITTEN CONSENT

Informed consent is documented, as approved by the Social Solutions Institutional Review Board (IRB), by your agreement with the informed consent statement below. The Social Solutions IRB is completely independent from NIH. By signing below, you (the participant or the participant’s legally authorized representative) are agreeing with the informed consent statement. Please contact one of the individuals listed above if you have any questions, prior to signing.

Please read and show that you understand what you have read by signing your consent below.

I have read this form and understand all of the information about my involvement in the focus group. By signing below, I agree to participate.

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Name (Printed) Date

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Signature Date

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Signature of Investigator Date

(office use only)