GUIDANCE FOR PROTOCOL REVIEW
Researchers: This is the guide that reviewers use in conjunction with the Consent Form Checklist. Items in the checklist correspond to the criteria for protocol review outlined in the Federal Regulations for Protecting Research Subjects. It may be helpful to look over the list of items that are considered during the review of a new protocol.
1. Research Design
- Does the investigator provide sufficient information for the reviewers to understand the theoretical bases for this study?
- Is the study design sound?
- Is the experience of the subjects clearly described?
- Are all of the study materials attached, such as questionnaires and interview questions?
2. Subject Selection
- Is the subject population described in sufficient detail?
- Does the researcher say how many subjects he/she hopes to recruit?
- Are all recruitment materials included (e.g., Subject Pool website posting, flyers, letters of introduction)?
- Do the recruitment materials for adult populations state that subjects must be age 18 or older? (If research is conducted abroad the age of majority may be different from that in the U.S.)
- If there are different experimental conditions, is it clear how subjects will be assigned?
3. Risks & Benefits
- Are there any foreseeable risks to the subjects?
- Are the risks minimized?
- Are foreseeable risks reasonable in relation to anticipated benefits?
- If no benefits to individual subjects are likely, are the benefits to society at large or to the field of study articulated in the protocol?
- Have all direct and indirect identifiers to be collected been described?
- If relevant, has the plan for protecting the confidentiality of the data been described, including storage (location, duration) of the data and access by others?
- If identifiable data about illegal activities are to be collected, does the researcher intend to secure a Certificate of Confidentiality?
- If subjects are to be videotaped, photographed, or audio-taped, and the recordings will be made publicly accessible, is a release form provided? (Does not apply in public settings.)
- If the data are to be collected and stored via the Internet, is the confidentiality protection plan technologically sound? (This may signal the need for review by the computer security consultant.)
- Are there any limits to the confidentiality that the researcher can provide, e.g. the requirement to report suspected child abuse?
- Is the compensation commensurate with the level of respondent effort?
- Is the compensation offered appropriate for the study?
- If a lottery or drawing is used as an incentive, does the protocol include the required justification?
- If subjects will be required to provide their social security numbers in order to receive payment, have the subjects been informed?
6. Informed Consent
- Are all relevant elements of consent included in the consent form or script? (Complete the consent form checklist.)
- If any elements of consent are waived or modified, does the waiver meet all four criteria as specified in the federal regulations?
- Is the consent process consistent with the protocol?
- Is there sufficient information for a potential participant to make an informed decision about whether to participate?
- Is the informed consent process culturally appropriate?
- Will the subjects understand the terminology used?
- Is the reading level appropriate? If there is more than one subject population, is more than one consent form needed?
- If the subjects' primary language is not English, has the researcher provided the consent form in the appropriate language, in addition to the English version? Is a back translation needed?
- If child assent is required, is it appropriate to the children's developmental stage and situation?
- Is the researcher in a position of authority over the research subjects? If so, how can the possibility of undue influence be addressed?
- Are there any other factors that would unduly influence the decision of participants?
- If subjects are offered the right to withdraw their data, is there a clear mechanism for doing so.
- If the researcher's own students or employees will be subjects of the research, is the potential for perceived undue influence adequately managed?
- If a layered consent form is proposed because the potential participant will be asked to make more than one decision (participate in the research and be filmed), is the purpose of the layering clear?
- If the researcher wishes to contact the subjects in the future, has it been explained how and why that contact will take place, and do subjects have the option to decline further contact?
- Does the consent process allow the subjects to ask questions before making a decision to participate?
- Is contact information provided for subjects who have questions during the course of the research or after the research? Is the contact information provided in an appropriate manner, i.e. contact information cards in the absence of written consent?
- If the research will be conducted abroad or in a low-technology environment, would it be appropriate to identify a local contact that could answer questions about subjects' rights?
Documentation of Consent:
- If the researcher has requested a waiver of documentation, can the waiver be approved in accordance with the federal regulations?
- If the subjects are illiterate, and documentation of consent is required, is the procedure respectful and culturally appropriate?
- If a third party needs to witness an oral consent process, is the witness impartial?
- When research will take place on-line does the protocol request a waiver of the requirement to document consent?
- If the research involves deception, is the deception justified?
- Are the subjects appropriately debriefed about the deception?
- If the subjects of the study are members of the Undergraduate Psychology Subject Pool, is the required debriefing provided?
- If the debriefing is given at a time other than immediately following participation, is this justified?
9. Concordance (for DHHS* funded research only)
- Is the protocol concordant with the funding proposal?